JAKAVI 5 мг Таблетка

Содержание инструкции

1. Jakavi 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
   1. What Jakavi is and what it is used for
   2. What you need to know before you take Jakavi
   3. How to take Jakavi
   4. Possible side effects
   5. How to store Jakavi
   6. Contents of the pack and other information
2. Jakavi 5 mg/ml oral solution
   1. What is Jakavi and what is it used for
   2. What you need to know before you take Jakavi
   3. How to take Jakavi
   4. Possible side effects
   5. How to store Jakavi
   6. Contents of the pack and other information
3. Jakavi 5 mg/ml oral solution

Jakavi 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

ruxolitinib

Read this leaflet carefully before you start taking this medicine because it 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• The information in this leaflet is for you or your child but the leaflet will refer to “you” only.

Contents of this leaflet

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

1. What Jakavi is and what it is used for

Jakavi contains the active ingredient ruxolitinib.
Jakavi is used to treat adult patients with an enlarged spleen or with symptoms related to
myelofibrosis, a rare form of blood cancer.
Jakavi is also used to treat adult patients with polycythemia vera who are resistant or intolerant to
hydroxyurea.
Jakavi is also used to treat:

• children aged 28 days or older and adults with acute graft-versus-host disease (GvHD).
• children aged 6 months or older and adults with chronic GvHD. There are two forms of GvHD: an early form called acute GvHD which normally develops shortly after a transplant and can involve the skin, liver and gastrointestinal tract, and a form called chronic GvHD, which develops later, usually weeks or months after the transplant. Almost every organ can be affected by chronic GvHD.

How Jakavi works
One of the characteristics of myelofibrosis is enlargement of the spleen. Myelofibrosis is a
bone marrow disorder, in which the marrow is replaced by scar tissue. The abnormal marrow can no longer
produce a sufficient number of blood cells and, as a result, the spleen becomes significantly enlarged.
By blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi
can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever,
night sweats, bone pain and weight loss in patients with myelofibrosis. Jakavi may
help to reduce the risk of serious blood or vascular complications.
Polycythemia vera is a bone marrow disorder, in which the marrow produces too many red blood cells. The
blood becomes thicker as a result of the increased red blood cells. Jakavi can relieve the
symptoms, reduce the size of the spleen and the volume of red blood cells produced in patients with
polycythemia vera by selectively blocking enzymes called Janus Associated Kinases (JAK1 and
JAK2), thus potentially reducing the risk of serious blood or vascular complications.
Graft-versus-host disease is a complication that occurs after a transplant when
specific cells (T cells) present in the donor organ (e.g. bone
marrow) do not recognize the host's cells/organs and attack them. By selectively blocking certain
enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces the signs and symptoms of the
acute and chronic forms of graft-versus-host disease, leading to an improvement in the
disease and the survival of the transplanted cells.
If you have any questions about how Jakavi works or why this medicine has been prescribed to you, ask your doctor.

2. What you need to know before you take Jakavi

Follow all of your doctor's instructions carefully. These instructions may be different from the general information contained in this leaflet.

Do not take Jakavi

• if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception” ).

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

• you have infections. It may be necessary to treat the infection before starting treatment with Jakavi.
• you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis or other infections.
• you have ever had hepatitis B.
• you have kidney problems or have ever had liver problems because your doctor may need to prescribe a different dose of Jakavi.
• you have ever had cancer, particularly skin cancer.
• you have or have had heart problems.
• you are 65 years of age or older. Patients 65 years of age or older may have an increased risk of heart problems, including heart attack, and some types of cancer.
• you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during treatment with Jakavi if:

• you develop fever, chills or other symptoms of infection.
• you develop a chronic cough with blood-streaked sputum, fever, night sweats and weight loss (these may be signs of tuberculosis).
• you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty concentrating, loss of balance or difficulty walking, lack of coordination, difficulty speaking, decreased strength or weakness on one side of the body, blurred vision and/or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further tests and follow-up.
• you develop painful blistering rashes (these are signs of shingles).
• you experience changes in your skin. This may require further observation, as some types of skin cancer (non-melanoma) have been reported.
• you experience sudden shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or tenderness in the leg, or redness or discoloration in the leg or arm as these may be signs of blood clots in the veins.

Children and adolescents
The use of this medicine is not indicated in children or adolescents under 18 years of age who are affected by myelofibrosis or polycythemia vera because it has not been studied in this age group.
For the treatment of graft-versus-host disease, Jakavi can be used in patients aged 28 days or older.

Other medicines and Jakavi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. While you are taking Jakavi you should never start taking a new medicine without first consulting the doctor who prescribed Jakavi. This applies to prescription medicines, over-the-counter medicines and herbal or alternative medicines.
It is particularly important that you tell your doctor about medicines containing the following active substances, because your doctor may need to adjust the dose of Jakavi.

• Some medicines used to treat infections:
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole)
• antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
• medicines to treat viral infections, including HIV/AIDS infection (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
• medicines to treat hepatitis C (boceprevir, telaprevir).
• A medicine to treat depression (nefazodone).
• Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness or pain (chronic angina pectoris) (mibefradil or diltiazem).
• A medicine to treat heartburn (cimetidine).
• A medicine to treat heart disease (avasimibe).
• Medicines used to block seizures or convulsions (phenytoin, carbamazepine or phenobarbital and other anti-epileptics).
• Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
• An herbal product used for the treatment of depression (St John's wort ( Hypericum perforatum)). If you are unsure whether the above applies to you, ask your doctor.

Pregnancy, breastfeeding and contraception

Pregnancy

• If you are pregnant, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breastfeeding

• Do not breastfeed while taking Jakavi (see section 2 “Do not take Jakavi”). Ask your doctor.

Contraception

• Taking Jakavi is not recommended for women who could become pregnant and are not using contraceptive measures. Talk to your doctor about how to use appropriate contraceptive measures to avoid becoming pregnant during treatment with Jakavi.
• Talk to your doctor if you become pregnant while taking Jakavi.

Driving and using machines
If you experience dizziness after taking Jakavi, do not drive or use machines.

Jakavi contains lactose and sodium
Jakavi contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free’.

3. How to take Jakavi

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Before starting treatment with Jakavi and during treatment, your doctor will perform blood tests to determine the best dose, to assess how you are responding to treatment and if
Jakavi is having an undesirable effect. Your doctor may need to adjust the dose or
interrupt the treatment. Your doctor will carefully check if you have any signs or symptoms
of infection before starting and during treatment with Jakavi.

Myelofibrosis

• Adults: The recommended starting dose in myelofibrosis is from 5 to 20 mg twice a day. The maximum dose is 25 mg twice a day.

Polycythemia vera

• Adults: The recommended starting dose in polycythemia vera is 10 mg twice a day. The maximum dose is 25 mg twice a day.

Acute and chronic graft-versus-host disease

• Children aged between 6 years and less than 12 years: the recommended starting dose is 5 mg twice a day.
• Children aged 12 years or older and adults: the recommended starting dose is 10 mg twice a day.

An oral solution is available if you have difficulty swallowing the whole tablets and for
children under 6 years of age.
You must take Jakavi every day at the same time, with or without food.
Your doctor will always tell you exactly how many Jakavi tablets to take.
You must continue to take Jakavi for as long as your doctor tells you.

If you take more Jakavi than you should
If you accidentally take more Jakavi than prescribed by your doctor, contact your
doctor or pharmacist immediately.

If you forget to take Jakavi
If you forget to take Jakavi, simply take the next dose when due. Do not
take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most of the side effects of Jakavi are mild to moderate and usually disappear
after a period of treatment lasting from a few days to a few weeks.

Myelofibrosis and polycythemia vera
Some side effects can be serious.
Contact your doctor immediately before taking the next scheduled dose if you experience any of the
following serious side effects:
Very common (may affect more than 1 in 10 people):

• any sign of bleeding in the stomach or intestines, such as black or tarry stools, or vomiting blood
• bruising and/or unexpected bleeding, unusual fatigue, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections - possible symptoms of blood disease
• painful blistering rash - possible symptoms of shingles (herpes zoster)
• fever, chills, or other symptoms of infection
• low levels of red blood cells (anemia), low levels of white blood cells (neutropenia), or low levels of platelets (thrombocytopenia)

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

• any sign of bleeding in the brain, such as sudden change in consciousness, persistent headache, numbness, tingling, weakness, or paralysis

Other side effects
Other possible side effects include those listed below. If you experience these side
effects, contact your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):

• high levels of cholesterol or fats in the blood (hypertriglyceridemia)
• abnormal liver function test results
• dizziness
• headache
• urinary tract infections
• weight gain
• fever, cough, difficulty breathing or painful breathing, wheezing, chest pain during breathing - possible symptoms of pneumonia
• high blood pressure (hypertension), which can also cause dizziness and headache
• constipation
• elevated lipase levels in the blood

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

• decreased number of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
• frequent flatulence

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

• tuberculosis
• recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and feeling sick or unwell)

Graft-versus-host disease (GvHD)
Some side effects can be serious
Contact your doctor immediately before taking the next scheduled dose if you experience any of the
following serious side effects:
Very common (may affect more than 1 in 10 people):

• signs of infections with associated fever:
• muscle pain, redness of the skin and/or difficulty breathing (cytomegalovirus infection)
• pain when urinating - (urinary tract infection
• fast heartbeat, confusion, and shortness of breath - (sepsis, a condition associated with infection and widespread inflammation
• frequent infections, fever, chills, sore throat, and mouth ulcers
• spontaneous bleeding or bruising - possible symptoms of thrombocytopenia, a condition caused by low platelet levels

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

• headache
• elevated blood pressure (hypertension)
• abnormal values in blood test results, including:
• high levels of lipase and/or amylase
• high levels of cholesterol
• abnormal liver function
• increased levels of an enzyme present in the muscles (increased blood creatine phosphokinase)
• increased levels of creatinine, an enzyme that may indicate that your kidneys are not working properly
• low levels of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
• nausea fatigue, tiredness, pale skin - possible symptoms of anemia, a condition caused by low levels of red blood cells Common (may affect up to 1 in 10 people):
• fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold or difficulty breathing - possible symptoms of a BK virus infection
• weight gain
• constipation

Reporting of side effects
If you get any side effect, 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 Jakavi

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 box or blister after
“Scad./EXP”.
Do not store at a temperature above 30°C.
Do not dispose of any medicine via water 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 Jakavi contains

• The active ingredient of Jakavi is ruxolitinib.
• Each Jakavi 5 mg tablet contains 5 mg of ruxolitinib.
• Each Jakavi 10 mg tablet contains 10 mg of ruxolitinib.
• Each Jakavi 15 mg tablet contains 15 mg of ruxolitinib.
• Each Jakavi 20 mg tablet contains 20 mg of ruxolitinib.
• Other ingredients are: microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide, sodium carboxymethylcellulose (see section 2), povidone, hydroxypropylcellulose, lactose monohydrate (see section 2).

Description of Jakavi and contents of the pack
Jakavi 5 mg tablets are round, white to off-white tablets marked with “NVR” on
one side and “L5” on the other side.
Jakavi 10 mg tablets are round, white to off-white tablets marked with “NVR” on
one side and “L10” on the other side.
Jakavi 15 mg tablets are oval, white to off-white tablets marked with “NVR” on
one side and “L15” on the other side.
Jakavi 20 mg tablets are elongated, white to off-white tablets marked with “NVR”
on one side and “L20” on the other side.
Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multi-packs
containing 168 (3 packs of 56) tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

Jakavi 5 mg/ml oral solution

ruxolitinib

Read this leaflet carefully before you start taking this medicine as it 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• The information in this leaflet is for you or for the child but the leaflet will refer to “you” only.

Contents of this leaflet

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

1. What is Jakavi and what is it used for

Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat:

• children aged 28 days or older and adults with acute graft-versus-host disease (GvHD)
• children aged 6 months or older and adults with chronic GvHD. There are two forms of GvHD: an early form called acute GvHD which normally develops soon after a transplant and can involve the skin, liver and gastrointestinal tract, and a form called chronic GvHD, which develops later, usually weeks or months after the transplant. Almost every organ can be affected by chronic GvHD.

How Jakavi works
Graft-versus-host disease is a complication that occurs after a transplant when
specific cells (T cells) present in the donor’s transplanted organ (e.g. bone
marrow) do not recognize the host’s cells/organs and attack them. By selectively blocking certain
enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces the signs and symptoms of the
acute and chronic forms of graft-versus-host disease, leading to an improvement in the
disease and the survival of the transplanted cells.
If you have any questions about how Jakavi works or why this
medicine has been prescribed to you, please ask your doctor.

2. What you need to know before you take Jakavi

Follow all of your doctor's instructions carefully. These instructions may be different from the
general information contained in this leaflet.

Do not take Jakavi

• if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception”).

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

• you have infections. The infection may need to be treated before starting treatment with Jakavi.
• you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis or other infections.
• you have ever had hepatitis B.
• you have kidney problems or have or have ever had liver problems because your doctor may need to prescribe a different dose of Jakavi.
• you have ever had cancer, particularly skin cancer.
• you have or have had heart problems. You are 65 years of age or older. Patients 65 years of age or older may have an increased risk of heart problems, including heart attack, and some types of cancer.
• you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during treatment with Jakavi if:

• you develop fever, chills or other symptoms of infection.
• you develop a chronic cough with blood-streaked sputum, fever, night sweats and weight loss (these may be signs of tuberculosis).
• you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty concentrating, loss of balance or difficulty walking, lack of coordination, difficulty speaking, decreased strength or weakness on one side of the body, blurred vision and/or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further tests and follow-up.
• you develop painful blistering rashes (these are signs of shingles).
• you experience changes in the skin. This may require further observation, as some types of skin cancer (non-melanoma) have been reported.
• you experience sudden shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or tenderness in the leg, or redness or discoloration in the leg or arm as these may be signs of blood clots in the veins.

Other medicines and Jakavi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. You should never start taking a new medicine without first
consulting the doctor who prescribed Jakavi. This applies to prescription medicines,
over-the-counter medicines and herbal or alternative medicines.
It is particularly important that you tell your doctor about medicines containing the following active
ingredients, because your doctor may need to adjust the dose of Jakavi.

• Some medicines used to treat infections:
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole)
• antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
• medicines to treat viral infections, including HIV/AIDS infection (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
• medicines to treat hepatitis C (boceprevir, telaprevir).
• A medicine to treat depression (nefazodone).
• Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness or pain (chronic angina pectoris) (mibefradil or diltiazem).
• A medicine to treat heartburn (cimetidine).
• A medicine to treat heart disease (avasimibe).
• Medicines used to stop seizures or convulsions (phenytoin, carbamazepine or phenobarbital and other anti-epileptics).
• Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
• An herbal product used for the treatment of depression (St. John's Wort ( Hypericum perforatum)). If you are unsure if the above applies to you, ask your doctor.

Pregnancy, breastfeeding and contraception

Pregnancy

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breastfeeding

• Do not breastfeed while you are being treated with Jakavi (see section 2 “Do not take Jakavi”). Ask your doctor.

Contraception

• Taking Jakavi is not recommended for women who could become pregnant and are not using contraceptive measures. Talk to your doctor about how to take appropriate contraceptive measures to avoid becoming pregnant while being treated with Jakavi.
• Talk to your doctor if you become pregnant while taking Jakavi.

Driving and using machines
If you experience dizziness after taking Jakavi, do not drive, ride a bicycle/scooter,
use machines, or engage in other activities that require attention.

Jakavi contains propylene glycol
This medicine contains 150 mg of propylene glycol per ml of oral solution.
If the child is under 5 years of age, talk to your doctor or pharmacist before giving
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.

Jakavi contains methylparaben and propylparaben
May cause allergic reactions (including delayed reactions).

3. How to take Jakavi

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
Before starting treatment with Jakavi and during treatment, your doctor will perform blood tests to determine the best dose, to assess how you are responding to treatment and if
Jakavi is having an undesirable effect. Your doctor may need to adjust the dose or
stop treatment. Your doctor will carefully check if you have any signs or symptoms
of infection before starting and during treatment with Jakavi.
You must take Jakavi twice a day approximately at the same time each day. Your doctor will
tell you the correct dose for you. Always follow the instructions provided by your doctor. Jakavi can be
taken with or without food. You can drink water afterwards to ensure that the entire dose of Jakavi oral solution
is swallowed.
You must continue to take Jakavi for as long as your doctor tells you.
For detailed instructions on how to use the oral solution, see “Instructions for Use” at the end of
Jakavi tablets are available for patients over 6 years of age who can swallow the
whole tablets.

If you take more Jakavi than you should
If you accidentally take more Jakavi than prescribed by your doctor, contact your
doctor or pharmacist immediately.

If you forget to take Jakavi
If you forget to take Jakavi, simply take the next dose when due. Do not
take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects of Jakavi are mild to moderate and usually disappear
after a period of treatment lasting from a few days to a few weeks.

Some side effects can be serious
Contact your doctor immediately before taking your next scheduled dose if you experience any of the
following serious side effects:
Very common (may affect more than 1 in 10 people):

• signs of infections with fever associated with:
• muscle pain, skin redness and/or difficulty breathing (cytomegalovirus infection)
• pain when urinating - (urinary tract infection)
• fast heartbeat, confusion and shortness of breath (sepsis, a condition associated with widespread infection and inflammation)
• frequent infections, fever, chills, sore throat and mouth ulcers
• spontaneous bleeding or bruising - possible symptoms of thrombocytopenia, a condition caused by low platelet levels

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

• headache
• high blood pressure (hypertension)
• abnormal values in blood tests, including:
• high levels of lipase and/or amylase
• high levels of cholesterol
• abnormal liver function
• increased levels of an enzyme present in the muscles (increased blood creatine phosphokinase)
• increased levels of creatinine, an enzyme that may indicate that your kidneys are not functioning properlylow levels of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
• nausea
• tiredness, fatigue, pale skin - possible symptoms of anemia, a condition caused by low levels of red blood cells

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

• fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold or difficulty breathing - possible symptoms of a BK virus infection
• weight gain
• constipation

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Jakavi

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 pack or the bottle after
“Exp.”.
Do not store at a temperature above 30°C.
Use within 60 days after opening.
Do not dispose of any medicine in waste water 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 Jakavi contains

• The active substance of Jakavi is ruxolitinib.
• Each ml of solution contains 5 mg of ruxolitinib.
• The other components are: propylene glycol (E 1520) (see section 2), anhydrous citric acid, methyl parahydroxybenzoate (E 218) (see section 2), propyl parahydroxybenzoate (E 216) (see section 2), sucralose (E 955), strawberry flavour, purified water.

Description of Jakavi and contents of the pack
Jakavi 5 mg/ml oral solution is presented as a clear solution, from colourless to light yellow which may
contain small colourless particles or a slight sediment.
Jakavi oral solution is available in amber glass bottles with a child-resistant screw cap
in white polypropylene.
Packs containing one 60 ml bottle of oral solution, two 1 ml oral administration syringes
and a pressure bottle adapter.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

Instructions for use

Jakavi 5 mg/ml oral solution

Please read these “Instructions for Use” carefully before using Jakavi. The healthcare professional must show you how to measure and administer a dose of Jakavi correctly. If you have any doubts about the use of Jakavi, please contact your healthcare professional.

The Jakavi pack must contain:	a 1 bottle containing Jakavi oral m solution 2 syringes for oral administration or reusable (capacity of 1 with graduation markings from 0.1 ml) r 1 bottle adapter a Cylinder Plunger Knob F Black rubber Graduated scale
IMPORTANT INFORMATION
l The healthcare professional must determine whether the patient can self-administer the medicine or whether assistance from a caregiver is necessary. Do not use Jakavi oral solution if the pack is damaged or if the expiry date has passed. Do not use the syringe if it is damaged or if the graduated scale is faded. Always use a new oral use syringe for each new bottle of Jakavi oral solution. If Jakavi oral solution comes into contact with the skin, wash the area thoroughly immediately with water and soap. If Jakavi oral solution comes into contact with the eyes, rinse the eyes thoroughly immediately with cold water.

Administration

• 1. Always wash and dry your hands before measuring and administering a dose of Jakavi oral solution to avoid any possible contamination. If Jakavi oral solution comes into contact with the skin, wash the area thoroughly immediately with water and soap. If Jakavi oral solution comes into contact with the eyes, rinse the eyes thoroughly immediately with cold water.
• 2. Check that the tamper-evident seal is intact and check the expiry date on the bottle label.

Do not administerJakavi oral solution if the tamper-evident seal is broken or if the expiry date has passed.

• 3. Shake the bottle before opening.

Remove the child-resistant cap

by pushing down on the cap and
rotating it in the direction of the arrow (counter-
clockwise).
Write the date of first opening on the label
of the bottle.

• 4. Place the bottle on a flat surface and hold it firmly. With the other hand, insert the adapter into the bottle using your thumb or palm.

Important:Inserting the adapter may
require a lot of force. Push firmly until
it is fully inserted.
The adapter must be completely flush
with the bottle and there must be no gaps.

• 5. Push the plunger into the syringe to remove all the air inside.
• 6. Insert the tip of the syringe into the opening of the bottle adapter.

Push down to ensure that the
syringe is firmly attached.

• 7. Gently turn the bottle upside down and push the plunger down until the top of the black rubber is aligned with the prescribed dose on the syringe cylinder.

Note:Small air bubbles are normal.

• 8. Continue to hold the syringe in place and gently return the bottle to the vertical position.

Remove the syringe from the bottle by gently
pulling upwards.

• 9. Make sure again that the top of the black rubber is aligned with the prescribed dose.

If this is not the case, repeat the
measurement steps again.

• 10. Make sure the child is sitting upor standing.

Place the end of the syringe inside
the mouth, keeping the tip against
the inside of a cheek.
Slowly push the plunger all the way down
to administer the prescribed dose of Jakavi
oral solution.

WARNING:Administering into the throat or
pushing the plunger too quickly can
cause choking.

• 11. Check that there is no Jakavi oral solution residue left in the syringe. If there is Jakavi oral solution residue left in the syringe, administer it.

The child can be given a glass of water after administration to ensure
that the entire dose of Jakavi oral solution is swallowed.

Note:If the prescribed dose requires the use of the syringe twice, repeat the
administration steps until the prescribed dose has been administered.

• 12. Do not removethe bottle adapter.

Place the child-resistant cap back on the bottle and turn clockwise to
close it.
Make sure the cap is securely attached to the bottle.

Cleaning the syringe
Note: Keep the oral administration syringe separate from other kitchen utensils to
keep it clean.

• 1. Fill a glass with warm water.
• 2. Place the syringe in the glass with warm water.

Pull up and then push down on the plunger to push water in and out of the
syringe 4 or 5 times.

• 3. Remove the plunger from the cylinder.

Rinse the glass, plunger and cylinder under warm tap water.

• 4. Leave the plunger and cylinder to air dry on a dry surface before next use.

Always keep the syringe out of the sight and reach of children.

Administration via feeding tube

• Always consult your healthcare professional before administering Jakavi oral solution via feeding tube. The healthcare professional must show you how to administer Jakavi oral solution via feeding tube.
• Jakavi oral solution can be administered via nasogastric or gastric feeding tube of size French 4(or larger) and not exceeding 125 cmin length.
• You may need an ENFIT adapter (not included in the pack) to connect the 1 ml syringe to the feeding tube.
• Flush the feeding tube immediately before and after administering Jakavi oral solution, according to the manufacturer's instructions.