AYVAKYT 100 mg Film-Coated Tablets

Зміст інструкції

1. AYVAKYT 25 mg film-coated tablets
   1. What is AYVAKYT and what is it used for
   2. What you need to know before taking AYVAKYT
   3. How to take AYVAKYT
   4. Possible side effects
   5. How to store AYVAKYT
   6. Contents of the pack and other information
2. AYVAKYT 50 mg film-coated tablets
   1. What is AYVAKYT and what is it used for
   2. What you need to know before you take AYVAKYT
   3. How to take AYVAKYT
   4. Possible side effects
   5. How to store AYVAKYT
   6. Contents of the pack and other information
3. AYVAKYT 100 mg film-coated tablets
   1. What is AYVAKYT and what is it used for
   2. What you need to know before taking AYVAKYT
   3. How to take AYVAKYT
   4. Possible side effects
   5. How to store AYVAKYT
   6. Package Contents and Other Information
4. AYVAKYT 200 mg film-coated tablets
   1. What is AYVAKYT and what is it used for
   2. What you need to know before taking AYVAKYT
   3. How to take AYVAKYT
   4. Possible side effects
   5. How to store AYVAKYT
   6. Package Contents and Other Information
5. AYVAKYT 300 mg film-coated tablets
   1. What is AYVAKYT and what is it used for
   2. What you need to know before taking AYVAKYT
   3. How to take AYVAKYT
   4. Possible side effects
   5. How to store AYVAKYT
   6. Package contents and other information

AYVAKYT 25 mg film-coated tablets

avapritinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AYVAKYT is and what it is used for
• 2. What you need to know before you take AYVAKYT
• 3. How to take AYVAKYT
• 4. Possible side effects
• 5. How to store AYVAKYT
• 6. Contents of the pack and other information

1. What is AYVAKYT and what is it used for

What is AYVAKYT
AYVAKYT is a medicine containing the active substance avapritinib.

What is AYVAKYT used for
AYVAKYT is used in adults for the treatment of aggressive mastocytosis (ASM), systemic mastocytosis associated with a hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL), following at least one systemic therapy. These are conditions in which the body produces too many mast cells, a type of white blood cell in the blood. Symptoms occur when an excessive number of mast cells enter different organs of the body, such as the liver, bone marrow, or spleen. Furthermore, mast cells release substances, such as histamine, which cause various widespread symptoms that you may experience along with damage to the affected organs.
The combination of ASM, SM-AHN and MCL refers to advanced systemic mastocytosis (AdvSM);
AYVAKYT is also used for the treatment of adults with indolent systemic mastocytosis (ISM) with moderate to severe symptoms not adequately controlled with symptomatic treatment. This is a disease in which many abnormal mast cells are present in the body. Mast cells are the white blood cells responsible for allergic reactions. These cells can be found in any tissue of the body, but are often present in the skin, intestines, and bone marrow. These abnormal mast cells can cause symptoms such as severe allergic reactions, diarrhea, rash, and difficulty thinking.

How AYVAKYT works
AYVAKYT blocks the activity of a group of proteins in the body called kinases. In patients with AdvSM and ISM, mast cells usually have changes (mutations) in the genes involved in the production of specific kinases associated with the growth and spread of the cells themselves.
If you have questions about how AYVAKYT works or why this medicine has been prescribed for you, please ask your doctor.

2. What you need to know before taking AYVAKYT

Do not take AYVAKYT

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have had a vascular aneurysm(a bulge and weakening of the wall of a blood vessel) or a brain hemorrhagein the last year.
• if you have a low platelet count.
• if you are taking a medicine that thins the blood to prevent the formation ofblood clots, such as warfarin or phenprocoumon.

Pay particular attention with this medicine:

• you may develop symptoms such as severe headache, vision problems, severedrowsiness, or severe weakness on one side of the body (signs of a brain hemorrhage).In this case, contact your doctor immediately and temporarily stop treatment. For patients with AdvSM, before starting treatment, the doctor will assess platelet counts and monitor them as needed during therapy with avapritinib;
• treatment with this medicine may lead to an increased risk of bleedingin patients with AdvSM .Avapritinib can cause bleeding in the digestive tract, such as the stomach, rectum, or intestine. Tell your doctor if you have or have had any bleeding problems. Before starting to take avapritinib, your doctor may decide to perform blood tests. Seek immediate medical attention if you experience the following symptoms: blood in your stools or black stools, stomach pain, coughing/vomiting with blood;
• you may also develop memory loss, changes in memory, orconfusion(signs of a cognitive effect).Avapritinib can sometimes change the way you think and remember information. Contact your doctor if you experience these symptoms or if a family member, caregiver, or someone who knows you notices that you are losing memory or are confused;
• during treatment with this medicine, immediately tell your doctor if you rapidly gainweight, if you develop swelling in your face or limbs, if you have difficultybreathing or shortness of breath. This medicine can cause fluid retention in the body (severe fluid retention may occur in patients with AdvSM);
• avapritinib can cause irregular heartbeat. Your doctor may prescribe tests to assess these problems during treatment with avapritinib. Tell your doctor if you experience dizziness, fainting, or have irregular heartbeats while taking this medicine;
• you may have serious stomach and intestinal problems (diarrhea, nausea, and vomiting)if you have AdvSM. Seek immediate medical attention if you experience these symptoms;
• you may become more sensitive to sunlightwhile taking this medicine. It is important to cover areas of skin exposed to the sun and use a high-protection sunscreen (SPF).

While you are taking avapritinib, your doctor will ask you to undergo regular blood tests and will
weigh you regularly if you have AdvSM.
For more information, see section 4.

Children and adolescents
AYVAKYT has not been studied in children and adolescents under 18 years of age. Do not
give this medicine to children and adolescents under 18 years of age.

Other medicines and AYVAKYT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. AYVAKYT can affect the mechanism of action of other medicines and
certain other medicines can affect the mechanism of action of this medicine.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of
the following medicines
The following medicines can increase the effects of avapritinib and may increase its side
effects:

• boceprevir - used to treat hepatitis C
• cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir - used to treat HIV/AIDS infections
• clarithromycin, erythromycin, telithromycin - used to treat bacterial infections
• itraconazole, ketoconazole, posaconazole, voriconazole - used to treat serious fungal infections
• conivaptan - used to treat low sodium levels in the blood (hyponatremia).

The following medicines can reduce the effects of avapritinib:

• rifampicin - used to treat tuberculosis (TB) and other bacterial infections
• carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital - used to treat epilepsy
• St John's wort ( Hypericum perforatum) - a herbal remedy used for depression
• bosentan - used to treat high blood pressure
• efavirenz and etravirine - used to treat HIV/AIDS infections
• modafinil - used to treat sleep disorders
• dabrafenib - used to treat some types of cancer
• nafcillin - used to treat some bacterial infections
• dexamethasone - used to reduce inflammation.

This medicine can alter the functioning of the following medicines or increase their side
effects:

• alfentanil - used to control pain during operations and medical procedures
• atazanavir - used to treat HIV/AIDS infection
• midazolam - used for anesthesia, sedation, or to reduce anxiety
• simvastatin - used to treat high cholesterol
• sirolimus, tacrolimus - used to prevent organ transplant rejection.

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYTwith food and drink
You should not drink grapefruit juice or eat grapefruit while being treated with AYVAKYT.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless it is
clearly necessary. Avoid becoming pregnant during treatment with this medicine, as it could harm the fetus. Your doctor will explain the potential risks of taking
AYVAKYT during pregnancy.
Your doctor may check if you are pregnant before starting treatment with this
medicine.
Women of childbearing potential must use effective contraceptive methods during treatment
and for at least 6 weeks after its completion. Men with female partners of
childbearing potential must use effective contraceptive methods during treatment and for
at least 2 weeks after its completion. Ask your doctor about effective contraceptive methods you can use.
Breastfeeding
Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known whether
AYVAKYT passes into breast milk. Do not breastfeed during treatment with this medicine and for
at least 2 weeks after the last dose. Ask your doctor what is the best way to feed
your baby during this period.
Fertility
AYVAKYT may cause fertility problems in men and women. Consult your doctor if
this concerns you.

Driving and using machines
AYVAKYT can cause symptoms that affect your ability to concentrate and react (see
section 4). Therefore, AYVAKYT may affect your ability to drive and use
machines. Be particularly careful when driving a vehicle or using machines if
you experience these side effects.

AYVAKYT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say
essentially ‘sodium-free’.

3. How to take AYVAKYT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Recommended dose of AYVAKYT
The recommended dose of AYVAKYT depends on your condition (see below).
AYVAKYT is available in tablets of different dosages: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
Your doctor will tell you the dose and the number of tablets to take:

Treatment of AdvSM
The recommended dose is 200 mg orally once a day.

Treatment of ISM
The recommended dose is 25 mg orally once a day.
If you have liver problems, your doctor may start treatment at a reduced dose of AYVAKYT.
If you experience undesirable effects, your doctor may modify the dose, temporarily interrupt or
definitely stop the treatment. Do not change the dose or stop taking AYVAKYT unless
your doctor tells you to do so.
Swallow the AYVAKYT tablet(s) whole with a glass of water, on an empty stomach.
Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take the
next dose at the scheduled time.

If you take more AYVAKYTthan you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may
need medical attention.

If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you remember, unless the next
scheduled dose is due within 8 hours. Take the next dose at the usual time.
Do not take two doses within less than 8 hours to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

More serious side effects in patients with AdvSM
Some side effects can be serious. Tell your doctor immediately if you experience
any of the following symptoms(see also section 2):

• severe headache, vision problems, severe drowsiness, severe weakness on one side of the body (signs of cerebral haemorrhage)
• memory loss, memory changes or confusion (signs of a cognitive effect).

Other side effects in patients with AdvSM may include
Very common(may affect more than 1 in 10 people):

• altered sense of taste
• memory loss, memory changes or confusion (cognitive effects)
• diarrhoea
• nausea, vomiting and retching
• change in hair colour
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a low platelet count, often associated with easy bruising or bleeding
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• decreased sensation, numbness, tingling or increased sensitivity to pain in arms and legs
• cerebral haemorrhages
• increased tearing
• epistaxis (nosebleed)
• shortness of breath
• heartburn
• increased abdominal fluid
• dry eyes, lips, mouth and skin
• constipation, flatulence (gas)
• abdominal pain (stomach ache)
• gastrointestinal bleeding
• skin rash
• hair loss
• pain
• weight gain
• changes in heart electrical activity
• bruising
• blood tests showing increased stress on the liver and high levels of bilirubin, a substance produced by the liver

Uncommon(may affect up to 1 in 100 people):

• fluid around the heart
• redness of the skin or itching
• blood tests showing reduced kidney function

Side effects in patients with ISM may include
Very common(may affect more than 1 in 10 people):

• swelling of the arms and legs

Common(may affect up to 1 in 10 people):

• difficulty falling asleep (insomnia)
• flushing
• red or itchy skin
• facial swelling
• blood test showing an effect on the bones (increased blood alkaline phosphatase)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AYVAKYT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
outer packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the vial is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsAYVAKYT

• The active ingredient is avapritinib. Each film-coated tablet contains 25 mg of avapritinib.
• The other ingredients are:
• the tablet core contains: microcrystalline cellulose, copovidone, sodium croscarmellose and magnesium stearate (see section 2 “AYVAKYT contains sodium”);
• the tablet coating contains: talc, macrogol 3350, polyvinyl alcohol and titanium dioxide (E171).

Description of the appearance of AYVAKYT and contents of the pack
AYVAKYT 25 mg film-coated tablets are round, white, with a diameter of 5 mm,
with “BLU” inscribed on one side and “25” on the other.
AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each pack contains
one bottle.
Keep the desiccant container in the bottle.

Marketing authorisation holderand manufacturer
Blueprint Medicines (Netherlands) B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Eesti,
España,France, Hrvatska, Ireland, Ísland,
Italia, Latvija, Lietuva,
Luxembourg/Luxemburg,Magyarország,
Malta, Nederland, Norge,Österreich, Polska,
Portugal, România,Slovenija, Slovenská
republika,Suomi/Finland, Sverige, United
Kingdom(Northern Ireland)
Blueprint Medicines (Netherlands) B.V.
Tel: +31 85 064 4001
E-mail: [email protected]

Ελλάδα, Κύπρος
Swixx Biopharma S.M.S.A.
Tel: +30 214 444 9670
A “conditional authorisation” has been granted for this medicinal product. This means that
further data on this medicinal product must be provided.
The European Medicines Agency will review the new information at least annually on this

Other sources of information
Detailed information on this medicine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu/en.

AYVAKYT 50 mg film-coated tablets

avapritinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AYVAKYT is and what it is used for
• 2. What you need to know before you take AYVAKYT
• 3. How to take AYVAKYT
• 4. Possible side effects
• 5. How to store AYVAKYT
• 6. Contents of the pack and other information

1. What is AYVAKYT and what is it used for

What is AYVAKYT
AYVAKYT is a medicine containing the active substance avapritinib.

What is AYVAKYT used for
AYVAKYT is used in adults for the treatment of aggressive mastocytosis (ASM), systemic mastocytosis associated with a hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL), following at least one systemic therapy. These are conditions in which the body produces too many mast cells, a type of white blood cell in the blood. Symptoms occur when an excessive number of mast cells enter various organs of the body, such as the liver, bone marrow, or spleen. Furthermore, mast cells release substances, such as histamine, which cause various widespread symptoms that you may experience along with damage to the affected organs.
The combination of ASM, SM-AHN and MCL refers to advanced systemic mastocytosis (AdvSM).

How does AYVAKYT work
AYVAKYT blocks the activity of a group of proteins in the body called kinases. Mast cells in patients with AdvSM usually have changes (mutations) in the genes involved in the production of specific kinases associated with the growth and spread of these cells.
If you have any questions about how AYVAKYT works or why this medicine has been prescribed for you, please ask your doctor.

2. What you need to know before you take AYVAKYT

Do not take AYVAKYT

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have had a vascular aneurysm(a bulge and weakening of the wall of a blood vessel) or a brain haemorrhagein the last year;
• if you have low platelet counts.
• if you are taking a medicine that thins the blood to prevent the formation ofblood clots, such as warfarin or phenprocoumon.

Take special care with this medicine:

• you may develop symptoms such as severe headache, vision problems, severedrowsiness or severe weakness on one side of the body (signs of a brain haemorrhage).In this case, contact your doctor immediately and temporarily stop treatment. For patients with AdvSM, before starting treatment, the doctor will assess platelet counts and monitor them as needed during therapy with
• Treatment with this medicine may lead to a higher risk of bleeding.Avapritinib can cause bleeding in the digestive tract, such as the stomach, rectum or intestine. Tell your doctor if you have or have had any bleeding problems. Before starting to take avapritinib, your doctor may decide to perform blood tests. Seek immediate medical attention if you experience the following symptoms: blood in your stools or black stools, stomach pain, coughing/vomiting with blood;
• you may also develop memory loss, changes in memory or a sense ofconfusion(signs of a cognitive effect).Avapritinib can sometimes change the way you think and remember information. Contact your doctor if you experience these symptoms or if a family member, caregiver or someone who knows you notices that you are losing your memory or are confused;
• during treatment with this medicine, immediately tell your doctor if you gainweight very quickly, if you develop swelling of the face or limbs, if you have difficultybreathing or shortness of breath. This medicine can cause fluid retention in the body (severe fluid retention);
• Avapritinib can cause irregular heartbeat. Your doctor may prescribe tests to evaluate these problems during treatment with avapritinib. Tell your doctor if you experience dizziness, fainting or have irregular heartbeats while taking this medicine;
• you may have serious problems with your stomach and intestines (diarrhoea, nausea and vomiting).Seek medical attention immediately if you experience these symptoms;
• you may become more sensitive to sunlightwhile taking this medicine. It is important to cover areas of skin exposed to the sun and use a high protection factor sunscreen (SPF).

While you are taking avapritinib, your doctor will ask you to undergo regular blood tests.
You will also need to be weighed regularly.
For more information, see section 4.

Children and adolescents
AYVAKYT has not been studied in children and adolescents under 18 years of age. Do not
give this medicine to children and adolescents under 18 years of age.

Other medicines and AYVAKYT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. AYVAKYT can affect the mechanism of action of other medicines and
certain other medicines can affect the mechanism of action of this medicine.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of the
following medicines:
The following medicines can increase the effects of avapritinib and may increase its side
effects:

• boceprevir - used to treat hepatitis C
• cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir - used to treat HIV/AIDS infections
• clarithromycin, erythromycin, telithromycin - used to treat bacterial infections
• itraconazole, ketoconazole, posaconazole, voriconazole - used to treat serious fungal infections
• conivaptan - used to treat low levels of sodium in the blood (hyponatremia).

The following medicines can reduce the effects of avapritinib:

• rifampicin - used to treat tuberculosis (TB) and other bacterial infections
• carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital - used to treat epilepsy
• St John's wort ( Hypericum perforatum) - a herbal remedy used for depression
• bosentan - used to treat high blood pressure
• efavirenz and etravirine - used to treat HIV/AIDS infections
• modafinil - used to treat sleep disorders
• dabrafenib - used to treat some types of cancer
• nafcillin - used to treat some bacterial infections
• dexamethasone - used to reduce inflammation.

AYVAKYT can alter the functioning of the following medicines or increase their side
effects:

• alfentanil - used to control pain during operations and medical procedures
• atazanavir - used to treat HIV/AIDS infection
• midazolam - used for anesthesia, sedation or to reduce anxiety
• simvastatin - used to treat high cholesterol
• sirolimus, tacrolimus - used to prevent organ transplant rejection.

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYTwith food and drink
You should not drink grapefruit juice or eat grapefruit while being treated with AYVAKYT.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless it is
clearly necessary. Avoid becoming pregnant during treatment with this medicine, as it could
harm the fetus. Your doctor will explain the potential risks of taking
AYVAKYT during pregnancy.
Your doctor may check if you are pregnant before starting treatment with this
medicine.
Women of childbearing potential must use effective contraceptive methods during treatment
and for at least 6 weeks after its completion. Men with female partners
of childbearing potential must use effective contraceptive methods during treatment and for
at least 2 weeks after its completion. Ask your doctor about effective contraceptive methods
you can use.
Breastfeeding
Ask your doctor if you are breastfeeding or plan to breastfeed. It is not known whether
AYVAKYT passes into breast milk. Do not breastfeed during treatment with this medicine and for
at least 2 weeks after the last dose. Ask your doctor about the best way to feed
your baby during this period.
Fertility
AYVAKYT may cause fertility problems in men and women. Consult your doctor if
this concerns you.

Driving and operating machinery
AYVAKYT can cause symptoms that affect your ability to concentrate and react (see
section 4). Therefore, AYVAKYT may affect your ability to drive and operate
machinery. Take particular care when driving a vehicle or using machinery if
you experience these side effects.

AYVAKYT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
‘sodium-free’.

3. How to take AYVAKYT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Recommended dose of AYVAKYT
The recommended dose of AYVAKYT depends on your condition (see below).
AYVAKYT is available in tablets of different dosages: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
Your doctor will tell you the dose and the number of tablets to take:

Treatment of AdvSM
The recommended dose is 200 mg orally once a day.
If you have liver problems, your doctor may start treatment with a reduced dose of AYVAKYT.
If you experience undesirable effects, your doctor may change the dose, temporarily interrupt or
definitely stop the treatment. Do not change the dose or stop taking AYVAKYT unless
your doctor tells you to do so.
Swallow the AYVAKYT tablet(s) whole with a glass of water, on an empty stomach.
Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take
the next dose at the scheduled time.

If you take more AYVAKYTthan you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may
need medical attention.

If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you remember, unless the next
scheduled dose is due within 8 hours. Take the next dose at the usual time.
Do not take two doses within less than 8 hours to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

More serious side effects
Some side effects can be serious. Tell your doctor immediately if you experience
any of the following symptoms(see also section 2):

• severe headache, vision problems, severe drowsiness, severe weakness on one side of the body (signs of cerebral haemorrhage)
• memory loss, memory changes or confusion (signs of a cognitive effect).

Other side effects may include:
Very common(may affect more than 1 in 10 people):

• altered sense of taste
• memory loss, memory changes or confusion (cognitive effects)
• diarrhoea
• nausea, retching and vomiting
• change in hair colour
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a low platelet count, often associated with easy bruising or bleeding
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• decreased sensitivity, numbness, tingling or increased sensitivity to pain in arms and legs
• cerebral haemorrhages
• increased tearing
• epistaxis (nosebleed)
• shortness of breath
• heartburn
• increased abdominal fluid
• dry eyes, lips, mouth and skin
• constipation, flatulence (gas)
• abdominal pain (stomach ache)
• gastrointestinal bleeding
• skin rash
• hair loss
• pain
• weight gain
• changes in the heart's electrical activity
• bruising
• blood tests showing increased stress on the liver and elevated levels of bilirubin, a substance produced by the liver

Uncommon(may affect up to 1 in 100 people):

• fluid around the heart
• redness of the skin or itching
• blood tests indicate reduced kidney function

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AYVAKYT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
outer packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the vial is damaged or shows signs of tampering.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What containsAYVAKYT

• The active ingredient is avapritinib. Each film-coated tablet contains 50 mg of avapritinib.
• The other ingredients are:
• the tablet core contains: microcrystalline cellulose, copovidone, sodium croscarmellose and magnesium stearate (see section 2 “AYVAKYT contains sodium”);
• the tablet coating contains: talc, macrogol 3350, polyvinyl alcohol and titanium dioxide (E171).

Description of the appearance of AYVAKYT and contents of the pack
AYVAKYT 50 mg film-coated tablets are round, white, with a diameter of 6 mm,
with “BLU” imprinted on one side and “50” on the other.
AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each pack contains
one bottle.
Keep the desiccant container in the bottle.

Marketing authorisation holderand manufacturer
Blueprint Medicines (Netherlands) B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Eesti,
España,France, Hrvatska, Ireland, Ísland,
Italia, Latvija, Lietuva,
Luxembourg/Luxemburg,Magyarország,
Malta, Nederland, Norge,Österreich, Polska,
Portugal, România,Slovenija, Slovenská
Ελλάδα, Κύπρος
Swixx Biopharma S.M.S.A.
Τηλ: +30 214 444 9670

republika,Suomi/Finland, Sverige, United
Kingdom(Northern Ireland)
Blueprint Medicines (Netherlands) B.V.
Tél/Tel/Teл/Tlf/Sími/Puh: +31 85 064 4001
E-mail: [email protected]
This medicinal product is subject to ‘conditional approval’. This means that further data on this
medicinal product must be provided. The European Medicines Agency will review at least annually the new information on this

Other sources of information
Detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/en.

AYVAKYT 100 mg film-coated tablets

avapritinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AYVAKYT is and what it is used for
• 2. What you need to know before you take AYVAKYT
• 3. How to take AYVAKYT
• 4. Possible side effects
• 5. How to store AYVAKYT
• 6. Contents of the pack and other information

1. What is AYVAKYT and what is it used for

What is AYVAKYT
AYVAKYT is a medicine containing the active substance avapritinib.

What is AYVAKYT used for
AYVAKYT is used for the treatment of:

• a type of digestive system tumor called gastrointestinal stromal tumor (GIST), when this cannot be treated with surgery (non-resectable) or has spread to other parts of the body (metastatic) and that presents a specific mutation (D842V) in the gene responsible for the production of a kinase protein called platelet-derived growth factor receptor alpha (PDGFRA).
• aggressive systemic mastocytosis (ASM), systemic mastocytosis associated with a hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL), following at least one systemic therapy. These are conditions in which the body produces too many mast cells, a type of white blood cell in the blood. Symptoms occur when an excessive number of mast cells enter different organs of the body, such as the liver, bone marrow, or spleen. In addition, mast cells release substances, such as histamine, which cause various generalized symptoms that you may experience along with damage to the affected organs. The combination of ASM, SM-AHN and MCL refers to advanced systemic mastocytosis (AdvSM).

How AYVAKYT works
AYVAKYT blocks the activity of a group of proteins in the body called kinases. Mast cells in
patients affected by AdvSM or the cells that make up the tumor usually have changes
(mutations) in the genes involved in the production of specific kinases associated with the growth and
spread of these cells.
If you have questions about how AYVAKYT works or why this medicine has been prescribed to you,
ask your doctor.

2. What you need to know before taking AYVAKYT

Do not take AYVAKYT:

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have had a vascular aneurysm(a bulge and weakening of the wall of a blood vessel) or a cerebral hemorrhagein the last year.
• if you have low platelet counts.
• if you are taking a medicine that thins the blood to prevent the formation ofblood clots, such as warfarin or phenprocoumon.

Take special care with this medicine:

• you may develop symptoms such as severe headache, vision problems, severedrowsiness, or severe weakness on one side of the body (signs of cerebral hemorrhage).In this case, contact your doctor immediately and temporarily stop treatment; For patients with AdvSM, before starting treatment, the doctor will assess platelet counts and monitor them as needed during therapy with avapritinib.
• treatment with this medicine may lead to an increased risk of bleeding.Avapritinib can cause bleeding in the digestive tract, such as the stomach, rectum, or intestine. In patients with GIST, avapritinib can also cause bleeding in the liver, as well as bleeding from the tumor. Tell your doctor if you have had any bleeding problems. Before starting to take avapritinib, your doctor may decide to perform blood tests. Seek immediate medical attention if you experience the following symptoms: blood in your stool or black stools, stomach pain, coughing up blood/vomiting blood;
• you may also develop memory loss, changes in memory, orconfusion(signs of a cognitive effect).Avapritinib can sometimes change the way you think and remember information. Contact your doctor if you experience these symptoms or if a family member, caregiver, or someone who knows you notices that you are losing memory or are confused;
• during treatment with this medicine, immediately tell your doctor if you gainweight very rapidly, if you develop swelling in your face or limbs, if you have difficultybreathing or shortness of breath. This medicine can cause fluid retention in the body (severe fluid retention);
• Avapritinib can cause irregular heartbeat. Your doctor may perform tests to assess these problems during treatment with avapritinib. Tell your doctor if you experience dizziness, fainting, or have an irregular heartbeat while taking this medicine;
• you may have severe stomach and intestinal problems (diarrhea, nausea, and vomiting).Seek immediate medical attention if you experience these symptoms;
• you may become more sensitive to sunlightwhile taking this medicine. It is important to cover areas of skin exposed to the sun and use a high-protection sunscreen (SPF).

While you are taking avapritinib, your doctor will ask you to undergo regular blood tests.
You will also need to be weighed regularly.
For more information, see section 4.

Children and adolescents
AYVAKYT has not been studied in children and adolescents under 18 years of age. Do not
give this medicine to children and adolescents under 18 years of age.

Other medicines and AYVAKYT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. AYVAKYT can affect the mechanism of action of other drugs and
certain other drugs can affect the mechanism of action of this medicine.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of the
following medicines
The following medicines can increase the effects of avapritinib and can increase its side
effects:

• boceprevir - used to treat hepatitis C
• cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir - used to treat HIV/AIDS infections
• clarithromycin, erythromycin, telithromycin - used to treat bacterial infections
• itraconazole, ketoconazole, posaconazole, voriconazole - used to treat serious fungal infections
• conivaptan - used to treat low sodium levels in the blood (hyponatremia).

The following medicines can reduce the effects of avapritinib:

• rifampicin - used to treat tuberculosis (TB) and other bacterial infections
• carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital - used to treat epilepsy
• St. John's wort ( Hypericum perforatum) - a herbal remedy used for depression
• bosentan - used to treat high blood pressure
• efavirenz and etravirine - used to treat HIV/AIDS infections
• modafinil - used to treat sleep disorders
• dabrafenib - used to treat some types of cancer
• nafcillin - used to treat some bacterial infections
• dexamethasone - used to reduce inflammation.

AYVAKYT can alter the functioning of the following medicines or increase their side
effects:

• alfentanil - used to control pain during operations and medical procedures
• atazanavir - used to treat HIV/AIDS infection
• midazolam - used for anesthesia, sedation, or to reduce anxiety
• simvastatin - used to treat high cholesterol
• sirolimus, tacrolimus - used to prevent organ transplant rejection.

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYTwith food and drink
You should not drink grapefruit juice or eat grapefruit while being treated with AYVAKYT.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless it is
clearly necessary. Avoid becoming pregnant during treatment with this medicine, as
this could harm the fetus. Your doctor will explain the potential risks of taking AYVAKYT
during pregnancy.
Your doctor may check if you are pregnant before starting treatment with this
medicine.
Women of childbearing potential must use effective contraceptive methods during treatment
and for at least 6 weeks after completion of treatment. Men with female partners
of childbearing potential must use effective contraceptive methods during treatment and for
at least 2 weeks after its completion. Ask your doctor about effective contraceptive methods
that you can use.
Breastfeeding
Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known whether
AYVAKYT passes into breast milk. Do not breastfeed during treatment with this medicine and for
at least 2 weeks after the last dose. Ask your doctor about the best way to feed
your baby during this time.
Fertility
AYVAKYT can cause fertility problems in men and women. Talk to your doctor if
this concerns you.

Driving and using machines
AYVAKYT can cause symptoms that affect your ability to concentrate and react (see
section 4). Therefore, AYVAKYT can affect your ability to drive vehicles and use
machinery. Be especially careful when driving a vehicle or using machinery if
you experience these side effects.

AYVAKYT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say
essentially ‘sodium-free’.

3. How to take AYVAKYT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Recommended dose of AYVAKYT
The recommended dose of AYVAKYT depends on your condition (see below).
AYVAKYT is available in tablets of different strengths: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
Your doctor will tell you the dose and the number of tablets to take:

GIST treatment
The recommended dose is 300 mg orally once a day.

AdvSM treatment
The recommended dose is 200 mg orally once a day.
If you have liver problems, your doctor may start treatment at a reduced dose of AYVAKYT.
If you experience undesirable effects, your doctor may change the dose, temporarily or permanently interrupt the treatment. Do not change the dose or stop taking AYVAKYT unless your doctor tells you to.
Swallow the AYVAKYT tablet whole with a glass of water, on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take the next dose at the scheduled time.

If you take more AYVAKYTthan you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may need medical attention.

If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you remember, unless the next scheduled dose is due within 8 hours. Take the next dose at the usual time.
Do not take two doses within less than 8 hours to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

More serious side effects
Some side effects may be serious. Tell your doctor immediately if you experience
any of the following symptoms(see also section 2):

• severe headache, vision problems, severe drowsiness, severe weakness on one side of the body (signs of cerebral haemorrhage)
• memory loss, memory changes or confusion (signs of a cognitive effect).

Other side effects in patients with GIST may include:
Very common(may affect more than 1 in 10 people):

• loss of appetite
• memory loss, memory changes or confusion (signs of a cognitive effect)
• dizziness
• altered sense of taste
• increased tear production
• abdominal pain (stomach ache)
• nausea, vomiting and retching
• diarrhoea
• dry eyes, lips, mouth and skin
• heartburn
• change in hair colour
• skin rash
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells
• blood tests showing an increase in stress on the liver and elevated levels of bilirubin, a substance produced by the liver

Common(may affect up to 1 in 10 people):

• red or painful eyes, blurred vision
• dehydration
• low levels of albumin in the blood
• depression
• anxiety
• difficulty sleeping (insomnia)
• cerebral haemorrhages
• decreased sensitivity, numbness, tingling or increased sensitivity to pain in arms and legs
• feeling of weakness or unusual drowsiness
• speech or hoarse voice disorders
• movement disorder
• headache
• tremor bleeding in the eye
• increased sensitivity to light
• increased blood pressure
• shortness of breath
• nasal congestion
• cough, including that associated with mucus production
• gastrointestinal bleeding
• increased fluid in the abdomen
• constipation, flatulence (gas)
• difficulty swallowing
• pain in the mouth, lips or tongue, thrush
• increased saliva production
• red or itchy skin
• skin discoloration
• hair loss
• pain
• muscle spasms
• blood in the urine
• fever or feeling generally unwell
• changes in the electrical activity of the heart
• weight gain or loss
• blood tests showing low levels of platelets, often associated with easy bruising or bleeding
• blood tests showing an altered amount of minerals in the blood
• blood tests showing reduced kidney function
• blood tests showing increased muscle breakdown

Uncommon(may affect up to 1 in 100 people):

• bleeding in the tumor
• fluid around the heart
• bleeding in the liver

Other side effects in patients with AdvSM may include
Very common(may affect more than 1 in 10 people):

• altered sense of taste
• memory loss, memory changes or confusion (cognitive effects)
• diarrhoea
• nausea, vomiting and retching
• change in hair colour
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a low platelet count, often associated with easy bruising or bleeding
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• decreased sensitivity, numbness, tingling or increased sensitivity to pain in arms and legs
• cerebral haemorrhages
• increased tearing
• epistaxis (nosebleed)
• shortness of breath
• heartburn
• increased abdominal fluid
• dry eyes, lips, mouth and skin
• constipation, flatulence (gas)
• abdominal pain (stomach ache)
• gastrointestinal bleeding
• skin rash
• hair loss
• pain
• weight gain
• changes in the electrical activity of the heart
• bruising
• blood tests showing an increase in stress on the liver and elevated levels of bilirubin, a substance produced by the liver

Uncommon(may affect up to 1 in 100 people):

• fluid around the heart
• redness of the skin or itching
• blood tests indicate reduced kidney function

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By
reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AYVAKYT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
outer packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the vial is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What the pack containsAYVAKYT

• The active ingredient is avapritinib. Each film-coated tablet contains 100 mg of avapritinib.
• The other ingredients are (see section 2 “AYVAKYT contains sodium”):
• the tablet core contains microcrystalline cellulose, copovidone, sodium croscarmellose and magnesium stearate
• the tablet coating contains: talc, macrogol 3350, polyvinyl alcohol and titanium dioxide (E171)
• the printing ink contains: shellac glaze 45% (20% esterified) in ethanol, Brilliant Blue FCF (E133), titanium dioxide (E171) black iron oxide (E172) and propylene glycol.

Description of the appearance of AYVAKYT and contents of the pack
AYVAKYT 100 mg film-coated tablets are round, white, with a diameter of 9 mm,
with “BLU” printed in blue ink on one side and “100” on the other.
AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each carton contains
one bottle.
Keep the desiccant container in the bottle.

Marketing Authorisation Holderand Manufacturer
Blueprint Medicines (Netherlands) B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Eesti,
España,France, Hrvatska, Ireland, Ísland,
Italia, Latvija, Lietuva,
Luxembourg/Luxemburg,Magyarország,
Malta, Nederland, Norge,Österreich, Polska,
Portugal, România,Slovenija, Slovenská
republika,Suomi/Finland, Sverige, United
Kingdom(Northern Ireland)
Blueprint Medicines (Netherlands) B.V.
Tel: +31 85 064 4001
E-mail: [email protected]

Ελλάδα, Κύπρος
Swixx Biopharma S.M.S.A.
Τηλ: +30 214 444 9670
A conditional marketing authorisation has been granted for this medicinal product. This means that
further data on this medicinal product must be provided.
The European Medicines Agency will review the new information at least annually.

Other sources of information
Detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/en.

AYVAKYT 200 mg film-coated tablets

avapritinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AYVAKYT is and what it is used for
• 2. What you need to know before you take AYVAKYT
• 3. How to take AYVAKYT
• 4. Possible side effects
• 5. How to store AYVAKYT
• 6. Contents of the pack and other information

1. What is AYVAKYT and what is it used for

What is AYVAKYT
AYVAKYT is a medicine containing the active substance avapritinib.

What is AYVAKYT used for
AYVAKYT is used for the treatment of:

• a type of tumor of the digestive system called gastrointestinal stromal tumor (GIST), when this cannot be treated with surgery (unresectable) or has spread to other parts of the body (metastatic) and which presents a specific mutation (D842V) in the gene responsible for the production of a kinase protein called platelet-derived growth factor receptor alpha (PDGFRA).
• aggressive systemic mastocytosis (ASM), systemic mastocytosis associated with hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL), following at least one systemic therapy. These are conditions in which the body produces too many mast cells, a type of white blood cell in the blood. Symptoms occur when an excessive number of mast cells enter various organs of the body, such as the liver, bone marrow, or spleen. In addition, mast cells release substances, such as histamine, which cause various widespread symptoms that you may experience along with damage to the affected organs. The combination of ASM, SM-AHN and MCL refers to advanced systemic mastocytosis (AdvSM).

How AYVAKYT works
AYVAKYT blocks the activity of a group of proteins in the body called kinases. Mast cells in
patients with AdvSM or the cells that make up the tumor usually have changes
(mutations) in the genes involved in the production of specific kinases associated with the growth and
spread of these cells.
If you have questions about how AYVAKYT works or why this medicine has been prescribed to you, ask your doctor.

2. What you need to know before taking AYVAKYT

Do not take AYVAKYT

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have had a vascular aneurysm(a bulge and weakening of the wall of a blood vessel) or a brain hemorrhagein the last year.
• if you have low platelet counts.
• if you are taking a medicine that thins the blood to prevent the formation ofblood clots, such as warfarin or phenprocoumon.

Pay particular attention with this medicine:

• you may develop symptoms such as severe headache, vision problems, severedrowsiness or severe weakness on one side of the body (signs of a brain hemorrhage).In this case, contact your doctor immediately and temporarily stop treatment. For patients with AdvSM, before starting treatment, the doctor will assess platelet counts and monitor them as needed during therapy with avapritinib;
• treatment with this medicine may lead to a higher risk of bleeding.Avapritinib can cause bleeding in the digestive tract, such as the stomach, rectum or intestine. In patients with GIST, avapritinib can also cause bleeding in the liver, as well as bleeding from the tumor. Tell your doctor if you have or have had any bleeding problems. Before starting to take avapritinib, your doctor may decide to perform blood tests. Seek immediate medical attention if you experience the following symptoms: blood in your stools or black stools, stomach pain, coughing/vomiting with blood;
• you may also develop memory loss, changes in memory orconfusion(signs of a cognitive effect).Avapritinib can sometimes change the way you think and remember information. Contact your doctor if you experience these symptoms or if a family member, caregiver or someone who knows you notices that you are losing memory or are confused;
• during treatment with this medicine, immediately tell your doctor if you gainweight very rapidly, if you develop swelling in your face or limbs, if you have difficultybreathing or shortness of breath. This medicine can cause fluid retention in the body (severe fluid retention);
• Avapritinib can cause irregular heartbeat. Your doctor may perform tests to assess these problems during treatment with avapritinib. Tell your doctor if you experience dizziness, fainting or have irregular heartbeats while taking this medicine;
• you may have serious stomach and intestinal problems (diarrhea, nausea and vomiting).Seek immediate medical attention if you experience these symptoms;
• you may become more sensitive to sunlightwhile taking this medicine. It is important to cover areas of skin exposed to the sun and use a high sun protection factor (SPF) sunscreen.

While you are taking avapritinib, your doctor will ask you to undergo regular blood tests.
You will also need to be weighed regularly.
For more information, see section 4.

Children and adolescents
AYVAKYT has not been studied in children and adolescents under 18 years of age. Do not
give this medicine to children and adolescents under 18 years of age.

Other medicines and AYVAKYT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. AYVAKYT can affect the mechanism of action of other drugs and
certain other drugs can affect the mechanism of action of this medicine.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of
the following medicines
The following medicines can increase the effects of avapritinib and can increase its side
effects:

• boceprevir - used to treat hepatitis C
• cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir - used to treat HIV/AIDS infections
• clarithromycin, erythromycin, telithromycin - used to treat bacterial infections
• itraconazole, ketoconazole, posaconazole, voriconazole - used to treat serious fungal infections
• conivaptan - used to treat low levels of sodium in the blood (hyponatremia).

The following medicines can reduce the effects of avapritinib:

• rifampicin - used to treat tuberculosis (TB) and other bacterial infections
• carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital - used to treat epilepsy
• St John's wort ( Hypericum perforatum) - a herbal remedy used for depression
• bosentan - used to treat high blood pressure
• efavirenz and etravirine - used to treat HIV/AIDS infections
• modafinil - used to treat sleep disorders
• dabrafenib - used to treat some types of cancer
• nafcillin - used to treat some bacterial infections
• dexamethasone - used to reduce inflammation.

AYVAKYT can alter the functioning of the following medicines or increase their side
effects:

• alfentanil - used to control pain during operations and medical procedures
• atazanavir - used to treat HIV/AIDS infection
• midazolam - used for anesthesia, sedation or to reduce anxiety
• simvastatin - used to treat high cholesterol
• sirolimus, tacrolimus - used to prevent organ transplant rejection.

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYTwith food and drink
You should not drink grapefruit juice or eat grapefruit while being treated with AYVAKYT.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless it is
clearly necessary. Avoid becoming pregnant during treatment with this medicine, as
this could harm the fetus. Your doctor will explain the potential risks of taking AYVAKYT
during pregnancy.
Your doctor may check if you are pregnant before starting treatment with this
medicine.
Women of childbearing potential must use effective contraceptive methods during treatment
and for at least 6 weeks after completion of treatment. Men with female partners of
childbearing potential must use effective contraceptive methods during treatment and for
at least 2 weeks after its completion. Ask your doctor about effective contraceptive methods
you can use.
Breastfeeding
Ask your doctor if you are breastfeeding or plan to breastfeed. It is not known whether
AYVAKYT passes into breast milk. Do not breastfeed during treatment with this medicine and for
at least 2 weeks after the last dose. Ask your doctor about the best way to feed
your baby during this period.
Fertility
AYVAKYT can cause fertility problems in men and women. Consult your doctor if
this concerns you.

Driving and using machines
AYVAKYT can cause symptoms that affect the ability to concentrate and react (see
section 4). Therefore, AYVAKYT can affect the ability to drive and use
machines. Pay particular attention when driving a vehicle or using machines if
you experience these side effects.

AYVAKYT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take AYVAKYT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Recommended dose of AYVAKYT
The recommended dose of AYVAKYT depends on your disease (see below).
AYVAKYT is available in tablets of different dosages: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
Your doctor will tell you the dose and the number of tablets to take:

GIST treatment
The recommended dose is 300 mg orally once a day.

AdvSM treatment
The recommended dose is 200 mg orally once a day.
If you have liver problems, your doctor may start treatment at a reduced dose of AYVAKYT.
If you experience undesirable effects, your doctor may change the dose, temporarily interrupt or
definitely stop treatment. Do not change the dose or stop taking AYVAKYT unless
your doctor tells you to do so.
Swallow the AYVAKYT tablet(s) whole with a glass of water, on an empty stomach.
Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take
the next dose at the scheduled time.

If you take more AYVAKYTthan you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may
need medical attention.

If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you remember, unless the next
scheduled dose is due within 8 hours. Take the next dose at the usual time.
Do not take two doses within less than 8 hours to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

More serious side effects
Some side effects can be serious. Tell your doctor immediately if you experience
any of the following symptoms(see also section 2):

• severe headache, vision problems, severe drowsiness, severe weakness on one side of the body (signs of cerebral haemorrhage)
• memory loss, memory changes or confusion (signs of a cognitive effect).

Other side effects in patients with GIST may include:
Very common(may affect more than 1 in 10 people):

• loss of appetite
• memory loss, memory changes or confusion (signs of a cognitive effect)
• dizziness
• altered sense of taste
• increased tear production
• abdominal pain (stomach ache)
• nausea, vomiting and retching
• diarrhoea
• dry eyes, lips, mouth and skin
• heartburn
• change in hair colour
• skin rash
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells
• blood tests showing an increase in stress on the liver and high levels of bilirubin, a substance produced by the liver

Common(may affect up to 1 in 10 people):

• red or painful eyes, blurred vision
• dehydration
• low levels of albumin in the blood
• depression
• anxiety
• difficulty sleeping (insomnia)
• cerebral haemorrhages
• decreased sensitivity, numbness, tingling or increased sensitivity to pain in arms and legs
• feeling of weakness or unusual drowsiness
• speech or voice disorders
• movement disorder
• headache
• tremor bleeding in the eye
• increased sensitivity to light
• increased blood pressure
• shortness of breath
• nasal congestion
• cough, including that associated with mucus production
• gastrointestinal bleeding
• increased fluid in the abdomen
• constipation, flatulence (gas)
• difficulty swallowing
• pain in the mouth, lips or tongue, thrush
• increased saliva production
• red or itchy skin
• skin discolouration
• hair loss
• pain
• muscle spasms
• blood in urine
• fever or feeling generally unwell
• changes in the electrical activity of the heart
• weight gain or loss
• blood tests showing low levels of platelets, often associated with easy bruising or bleeding
• blood tests showing an altered amount of minerals in the blood
• blood tests showing reduced kidney function
• blood tests showing increased muscle breakdown

Uncommon(may affect up to 1 in 100 people):

• bleeding in the tumour
• fluid around the heart
• bleeding in the liver

Other side effects in patients with AdvSM may include
Very common(may affect more than 1 in 10 people):

• altered sense of taste
• memory loss, memory changes or confusion (cognitive effects)
• diarrhoea
• nausea, vomiting and retching
• change in hair colour
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a low platelet count, often associated with easy bruising or bleeding
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells

Common(may affect up to 1 in 10 people):

• headache
• dizziness
• decreased sensitivity, numbness, tingling or increased sensitivity to pain in arms and legs
• cerebral haemorrhages
• increased tearing
• nosebleeds (blood from the nose)
• shortness of breath
• heartburn
• increased abdominal fluid
• dry eyes, lips, mouth and skin
• constipation, flatulence (gas)
• abdominal pain (stomach ache)
• gastrointestinal bleeding
• skin rash
• hair loss
• pain
• weight gain
• changes in the electrical activity of the heart
• bruising
• blood tests showing an increase in stress on the liver and high levels of bilirubin, a substance produced by the liver

Uncommon(may affect up to 1 in 100 people):

• fluid around the heart
• redness of the skin or itching
• blood tests indicate reduced kidney function

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AYVAKYT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
outer packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the vial is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What the medicine containsAYVAKYT

• The active ingredient is avapritinib. Each film-coated tablet contains 200 mg of avapritinib.
• The other ingredients are (see section 2 “AYVAKYT contains sodium”):
• the tablet core contains microcrystalline cellulose, copovidone, sodium croscarmellose and magnesium stearate
• the tablet coating contains: talc, macrogol 3350, polyvinyl alcohol and titanium dioxide (E171)
• the printing ink contains: shellac glaze 45% (20% esterified) in ethanol, Brilliant Blue FCF (E133), titanium dioxide (E171) black iron oxide (E172) and propylene glycol.

Description of the appearance of AYVAKYT and package contents
AYVAKYT 200 mg film-coated tablets are oval, white, 16 mm in length
and 8 mm in width, with “BLU” printed in blue ink on one side and “200” on the other.
AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each pack contains
one bottle.
Keep the desiccant container in the bottle.

Marketing Authorisation Holderand Manufacturer
Blueprint Medicines (Netherlands) B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Eesti,
España,France, Hrvatska, Ireland, Ísland,
Italia, Latvija, Lietuva,
Luxembourg/Luxemburg,Magyarország,
Malta, Nederland, Norge,Österreich, Polska,
Portugal, România,Slovenija, Slovenská
republika,Suomi/Finland, Sverige, United
Kingdom(Northern Ireland)
Blueprint Medicines (Netherlands) B.V.
Tel: +31 85 064 4001
E-mail: [email protected]

Ελλάδα, Κύπρος
Swixx Biopharma S.M.S.A.
Tel: +30 214 444 9670
This medicine has been granted a “conditional marketing authorisation”. This means that
further data on this medicine must be provided.
The European Medicines Agency will review at least annually new information on this

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu/en.

AYVAKYT 300 mg film-coated tablets

avapritinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What AYVAKYT is and what it is used for
• 2. What you need to know before you take AYVAKYT
• 3. How to take AYVAKYT
• 4. Possible side effects
• 5. How to store AYVAKYT
• 6. Contents of the pack and other information

1. What is AYVAKYT and what is it used for

What is AYVAKYT
AYVAKYT is a medicine containing the active substance avapritinib.

What is AYVAKYT used for
AYVAKYT is used for the treatment of adults with a type of digestive system tumor
called gastrointestinal stromal tumor (GIST), when this cannot be treated with
surgery (non-resectable) or has spread to other parts of the body (metastatic) and that
presents a specific mutation (D842V) in the gene responsible for the production of a protein
kinase called platelet-derived growth factor receptor alpha (PDGFRA).

How does AYVAKYT work
AYVAKYT blocks the activity of a group of proteins in the body called kinases. Mast cells in
patients affected by AdvSM or the cells that make up the tumor usually have changes
(mutations) in the genes involved in the production of specific kinases associated with the growth and
spread of these cells.
If you have any questions about how AYVAKYT works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before taking AYVAKYT

Do not take AYVAKYT

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have had a vascular aneurysm(a bulge and weakening of the wall of a blood vessel) or a cerebral hemorrhagein the last year.
• if you are taking a medicine that thins the blood to prevent the formation ofblood clots, such as warfarin or phenprocoumon.

Pay particular attention with this medicine:

• you may develop symptoms such as severe headache, vision problems, severedrowsiness or severe weakness on one side of the body (signs of cerebral hemorrhage).In this case, contact your doctor immediately and temporarily stop treatment;
• treatment with this medicine may lead to a higher risk of bleeding.Avapritinib can cause bleeding in the digestive tract, such as the stomach, rectum or intestine. In patients with GIST, avapritinib can also cause bleeding of the liver, as well as bleeding of the tumor. Tell your doctor if you have or have had any bleeding problems. Before starting to take avapritinib, your doctor may decide to perform blood tests. Seek immediate medical attention if you experience the following symptoms: blood in your stools or black stools, stomach pain, coughing/vomiting with blood;
• you may also develop memory loss, changes in memory or a sense ofconfusion(signs of a cognitive effect).Avapritinib can sometimes change the way you think and remember information. Contact your doctor if you experience these symptoms or if a family member, caregiver or someone who knows you notices that you are losing memory or are confused;
• during treatment with this medicine, immediately tell your doctor if you gainweight very rapidly, if you develop swelling in your face or limbs, if you have difficultybreathing or shortness of breath. This medicine can cause fluid retention in the body (severe fluid retention);
• Avapritinib can cause irregular heartbeat. Your doctor may perform tests to assess these problems during treatment with avapritinib. Tell your doctor if you experience dizziness, fainting or have irregular heartbeats while taking this medicine;
• you may have severe stomach and intestinal problems (diarrhea, nausea and vomiting).Seek immediate medical attention if you experience these symptoms;
• you may become more sensitive to sunlightwhile taking this medicine. It is important to cover areas of skin exposed to the sun and use a sunscreen with a high sun protection factor (SPF).

While you are taking avapritinib, your doctor will ask you to undergo regular blood tests.
You will also need to be weighed regularly.
For more information, see section 4.

Children and adolescents
AYVAKYT has not been studied in children and adolescents under 18 years of age. Do not
give this medicine to children and adolescents under 18 years of age.

Other medicines and AYVAKYT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. AYVAKYT can affect the mechanism of action of other medicines and
certain other medicines can affect the mechanism of action of this medicine.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of
the following medicines
The following medicines can increase the effects of avapritinib and can increase its side
effects:

• boceprevir - used to treat hepatitis C
• cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir - used to treat HIV/AIDS infections
• clarithromycin, erythromycin, telithromycin - used to treat bacterial infections
• itraconazole, ketoconazole, posaconazole, voriconazole - used to treat serious fungal infections
• conivaptan - used to treat low levels of sodium in the blood (hyponatremia).

The following medicines can reduce the effects of avapritinib:

• rifampicin - used to treat tuberculosis (TB) and other bacterial infections
• carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital - used to treat epilepsy
• St John's wort ( Hypericum perforatum) - a herbal remedy used for depression
• bosentan - used to treat high blood pressure
• efavirenz and etravirine - used to treat HIV/AIDS infections
• modafinil - used to treat sleep disorders
• dabrafenib - used to treat some types of cancer
• nafcillin - used to treat some bacterial infections
• dexamethasone - used to reduce inflammation.

This medicine can alter the functioning of the following medicines or increase their side
effects:

• alfentanil - used to control pain during operations and medical procedures
• atazanavir - used to treat HIV/AIDS infection
• midazolam - used for anesthesia, sedation or to reduce anxiety
• simvastatin - used to treat high cholesterol
• sirolimus, tacrolimus - used to prevent organ transplant rejection.

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYTwith food and drink
You should not drink grapefruit juice or eat grapefruit while being treated with AYVAKYT.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not recommended for use during pregnancy unless it is
clearly necessary. Avoid becoming pregnant during treatment with this medicine, as
this could harm the fetus. Your doctor will explain the potential risks of taking AYVAKYT
during pregnancy.
Your doctor may check if you are pregnant before starting treatment with this
medicine.
Women of childbearing potential must use effective contraceptive methods during treatment
and for at least 6 weeks after completion of treatment. Men with female partners of
childbearing potential must use effective contraceptive methods during treatment and for
at least 2 weeks after its completion. Ask your doctor about effective contraceptive methods
that you can use.
Breastfeeding
Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if
AYVAKYT passes into breast milk. Do not breastfeed during treatment with this medicine and for
at least 2 weeks after the last dose. Ask your doctor about the best way to feed your
baby during this period.
Fertility
AYVAKYT can cause fertility problems in men and women. Consult your doctor if
this concerns you.

Driving and using machines
AYVAKYT can cause symptoms that affect your ability to concentrate and react (see
section 4). Therefore, AYVAKYT may affect your ability to drive and operate
machinery. Take particular care when driving a vehicle or using machinery if
you experience these side effects.

AYVAKYT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take AYVAKYT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Recommended dose of AYVAKYT
The recommended dose of AYVAKYT depends on your condition (see below).
AYVAKYT is available in tablets of different dosages: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
Your doctor will indicate the dose and the number of tablets to be taken:

GIST treatment
The recommended dose is 300 mg by mouth once a day.
If you have liver problems, your doctor may start treatment at a reduced dose of AYVAKYT.
If you experience undesirable effects, your doctor may modify the dose, temporarily or
definitely interrupt the treatment. Do not change the dose or stop taking AYVAKYT unless
your doctor tells you to do so.
Swallow the AYVAKYT tablet(s) whole with a glass of water, on an empty stomach.
Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take the
next dose at the scheduled time.

If you take more AYVAKYTthan you should
If you have accidentally taken too many tablets, contact your doctor immediately. You may
need medical attention.

If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you remember, unless the next
scheduled dose is due within 8 hours. Take the next dose at the usual time.
Do not take two doses within less than 8 hours to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

More serious side effects
Some side effects may be serious. Tell your doctor immediately if you experience
any of the following symptoms(see also section 2):

• severe headache, vision problems, severe drowsiness, severe weakness on one side of the body (signs of cerebral haemorrhage)
• memory loss, memory changes or confusion (signs of a cognitive effect).

Other side effects may include:
Very common(may affect more than 1 in 10 people):

• loss of appetite
• memory loss, memory changes or confusion (cognitive effects)
• dizziness
• altered sense of taste
• increased tear production
• abdominal pain (stomach pain)
• nausea, retching and vomiting
• diarrhoea
• dry eyes, lips, mouth and skin
• heartburn
• change in hair colour
• skin rash
• swelling (e.g. feet, ankles, face, eyes, joints)
• fatigue
• blood tests showing a decrease in red blood cells (anaemia) and white blood cells
• blood tests showing increased stress on the liver and high levels of bilirubin, a substance produced by the liver

Common(may affect up to 1 in 10 people):

• red or painful eyes, blurred vision
• dehydration
• low levels of albumin in the blood
• depression
• anxiety
• difficulty sleeping (insomnia)
• cerebral haemorrhages
• decreased sensation, numbness, tingling or increased sensitivity to pain in arms and legs
• feeling of weakness or unusual drowsiness
• speech disorder or hoarse voice
• movement disorder
• headache
• tremor
• bleeding in the eye
• increased sensitivity to light
• increased blood pressure
• shortness of breath
• blocked nose
• cough, including that associated with mucus production
• gastrointestinal bleeding
• increased fluid in the abdomen
• constipation, flatulence (gas)
• difficulty swallowing
• pain in the mouth, lips or tongue, thrush
• increased saliva production
• red or itchy skin
• skin discolouration
• hair loss
• pain
• muscle spasms
• blood in urine
• fever or feeling generally unwell
• changes in the electrical activity of the heart
• weight gain or loss
• blood tests showing low levels of platelets, often associated with easy bruising or bleeding
• blood tests showing an altered amount of minerals in the blood
• blood tests showing reduced kidney function
• blood tests showing increased muscle breakdown

Uncommon(may affect up to 1 in 100 people):

• bleeding in the tumour
• fluid around the heart
• bleeding in the liver

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AYVAKYT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
outer packaging after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the vial is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What the pack containsAYVAKYT

• The active ingredient is avapritinib. Each film-coated tablet contains 300 mg of avapritinib.
• The other ingredients are:
• the tablet core contains microcrystalline cellulose, copovidone, sodium croscarmellose and magnesium stearate
• the tablet coating contains: talc, macrogol 3350, polyvinyl alcohol and titanium dioxide (E171)
• the printing ink contains: shellac glaze 45% (20% esterified) in ethanol, Brilliant Blue FCF (E133), titanium dioxide (E171) black iron oxide (E172) and propylene glycol.

Description of the appearance of AYVAKYT and pack contents
AYVAKYT 300 mg film-coated tablets are oval, white, 18 mm in length
and 9 mm in width, with “BLU” printed in blue ink on one side and “300” on the other.
AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each pack contains
one bottle.
Keep the desiccant container in the bottle.

Marketing authorisation holderand manufacturer
Blueprint Medicines (Netherlands) B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien, България, Česká
republika, Danmark, Deutschland, Eesti,
España,France, Hrvatska, Ireland, Ísland,
Italia, Latvija, Lietuva,
Luxembourg/Luxemburg,Magyarország,
Malta, Nederland, Norge,Österreich, Polska,
Portugal, România,Slovenija, Slovenská
republika,Suomi/Finland, Sverige, United
Kingdom(Northern Ireland)
Blueprint Medicines (Netherlands) B.V.
Tel: +31 85 064 4001
E-mail: [email protected]

Ελλάδα, Κύπρος
Swixx Biopharma S.M.S.A.
Tel: +30 214 444 9670
A marketing authorisation has been granted subject to conditions. This means that
further data on this medicine must be provided.
The European Medicines Agency will review at least annually the new information on this

Other sources of information
More detailed information on this medicine is available on the European Medicines
Agency website, https://www.ema.europa.eu/en