RETSEVMO 40 mg Hard Capsule

Зміст інструкції

1. Retsevmo 40 mg hard capsules, 80 mg hard capsules
   1. What is Retsevmo and what is it used for
   2. What you need to know before you take Retsevmo
   3. How to take Retsevmo
   4. Possible side effects
   5. How to store Retsevmo
   6. Package contents and other information
2. Retsevmo 40 mg film-coated tablets, 80 mg film-coated tablets, 120 mg film-coated tablets, 160 mg film-coated tablets
   1. What is Retsevmo and what it is used for
   2. What you need to know before taking Retsevmo
   3. How to take Retsevmo
   4. Possible side effects
   5. How to store Retsevmo
   6. Contents of the pack and other information

Retsevmo 40 mg hard capsules, 80 mg hard capsules

selpercatinib

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 medicinal product. See the end of section 4 for
information on how to report adverse effects.

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

the medicine. If you are giving the medicine to your child, replace "you" with "your child".

Contents of this leaflet

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

1. What is Retsevmo and what is it used for

Retsevmo is an anti-cancer medicine that contains the active substance selpercatinib.
It is used to treat the following cancers caused by certain abnormal changes in the RET gene and that have
spread and/or cannot be removed surgically:

• a type of lung cancer, called non-small cell lung cancer, in adults who have not previously been treated with a RETinhibitor medicine.
• thyroid cancer (of any type) in adults and adolescents aged 12 years and older, if treatment with radioactive iodine, when appropriate, has not been able to control the cancer.
• a rare type of thyroid cancer called medullary thyroid cancer in adults and adolescents aged 12 years and older.
• solid tumors (cancer) in other parts of the body in adults after failure of previous therapies to control the cancer.

The doctor will perform a test to check if the tumor has a RET gene alteration to
make sure that Retsevmo is right for you.

How Retsevmo works
In patients in whom the tumor has an altered RET gene, the gene change leads
the body to produce an abnormal RET protein that can lead to uncontrolled
cell growth and cancer. Retsevmo blocks the action of the abnormal RET protein, slowing or
stopping the growth of the tumor. This may also help to reduce the tumor.
Talk to your doctor if you have any questions about how Retsevmo works or why this
medicine has been prescribed for you.

2. What you need to know before you take Retsevmo

Do not take Retsevmo

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

Warnings and precautions
Talk to your doctor before taking Retsevmo:

• if you have lung or breathing problems other than lung cancer
• if you have high blood pressure
• if you have been told you have an abnormality known as prolonged QT interval on your heart tracing (ECG)
• if you have problems with your thyroid or thyroid hormone levels
• Retsevmo may affect the fertility of women and men, this may affect your ability to have children. Talk to your doctor if this is a concern
• if you have a recent history of significant bleeding.

Retsevmo may cause hypersensitivity reactions such as fever, rash and pain. If you experience
any of these reactions, see your doctor. After checking the symptoms, your doctor may ask you to
take corticosteroids until the symptoms improve.
When taking Retsevmo, rapid breakdown of tumor cells can occur (tumor lysis syndrome, TLS). This can cause irregular heartbeat, kidney failure, or abnormal
blood test results. Talk to your doctor if you have a history of kidney problems or low blood
pressure as this may increase the risks associated with TLS.
Retsevmo may cause irregular growth of the hip joint or damage in pediatric
patients (<18 years of age). If you experience hip or knee pain or have unexplained limping, talk to your
doctor.
Refer to section 4 “Possible side effects” and see your doctor if you experience any
symptoms.

What your doctor will check before and during treatment

• Retsevmo can cause severe, life-threatening or fatal lung inflammation. Your doctor will monitor symptoms before and during treatment with Retsevmo. Immediately inform your doctor if you notice any symptoms of lung problems including shortness of breath, cough, and increased temperature.
• Retsevmo can affect blood pressure. Your blood pressure will be measured before and during treatment with Retsevmo
• Retsevmo can affect liver function. Immediately inform your doctor if you develop symptoms of liver problems such as: jaundice (yellowing of the skin and eyes), loss of appetite, nausea or vomiting, or pain in the upper right area of the stomach
• Retsevmo may cause ECG abnormalities. You will have an ECG before and during treatment with Retsevmo. Tell your doctor if you experience episodes of fainting as they may be symptoms of an abnormal ECG
• Retsevmo can affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.
• you will have regular blood tests before and during treatment with Retsevmo to check liver function and blood electrolytes (such as sodium, potassium, magnesium, and calcium).
• if you are under 18 years of age, your doctor may monitor your growth during treatment. If you have pain in your hip, knee, or other leg pain, tell your doctor.

Children and adolescents
Retsevmo should not be used in patients under 18 years of age for lung cancer.
The indications for thyroid cancer (including medullary thyroid cancer) do not
include patients under 12 years of age.

Other medicines and Retsevmo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist before taking Retsevmo if you are taking:

• medicines that can increase the concentration of Retsevmo in the blood: such as clarithromycin (used to treat bacterial infections) or itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) or atazanavir, ritonavir, cobicistat (used to treat HIV/AIDS infections)
• medicines that can reduce the effectiveness of Retsevmo: such as carbamazepine (used to treat epilepsy, nerve pain, bipolar disorder) or rifampicin (used to treat tuberculosis (TB) and some other infections) or St John's Wort (a herbal product used to treat mild depression and anxiety) or omeprazole, lansoprazole or other proton pump inhibitors used to treat heartburn, ulcers and acid reflux. If you are taking any of these medicines, you must take Retsevmo with a full meal or ranitidine, famotidine or other H2 blockers used to treat ulcers and acid reflux. If you are taking any of these medicines, you should take it 2 hours after taking Retsevmo
• medicines whose concentrations in the blood may be increased by Retsevmo: such as repaglinide (used to treat type 2 diabetes and control blood sugar levels) or dasabuvir (used to treat hepatitis C) or selexipag (used to treat pulmonary arterial hypertension) or digoxin (used to treat heart disorders) or lovastatin and simvastatin (used to treat high cholesterol) or dabigatran (used to prevent and treat blood clots)
• medicines that may be less effective if taken with Retsevmo: such as levothyroxine (used to treat hypothyroidism)

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, or suspect you may be pregnant or are planning to become pregnant ask your doctor
before taking this medicine.
You should not take Retsevmo during pregnancy as the effect of Retsevmo on the unborn child is
not known.
Breastfeeding
You should not breastfeed during treatment with Retsevmo as Retsevmo may be harmful to a
breastfed baby. It is not known whether Retsevmo passes into breast milk. You should not breastfeed
for at least one week after the last dose of Retsevmo.
Contraception
Women of childbearing potential are recommended to avoid becoming pregnant and men are recommended to avoid fathering a child during treatment with Retsevmo, because this medicine may cause
harm to the baby. If a person taking this medicine could become pregnant or father a child, they must use effective contraceptive measures during treatment and for
at least one week after the last dose of Retsevmo.
Fertility
Retsevmo may affect your ability to have children. Talk to your doctor for advice on
preserving fertility before treatment.

Driving and using machines
Be particularly careful when driving and using machines as you may experience fatigue or dizziness
while taking Retsevmo.

3. How to take Retsevmo

Always take this medicine at the dose prescribed for you, following the instructions exactly
given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much to take
Your doctor will prescribe the correct dose for you. The maximum recommended dose is as follows:

• body weight less than 50 kg: 120 mg twice a day
• body weight equal to or greater than 50 kg: 160 mg twice a day.

Retsevmo must be taken twice a day at approximately the same time each day,
preferably in the morning and evening.
If you experience any side effects while taking Retsevmo, your doctor may decrease
the dose or temporarily or permanently interrupt treatment.
You can take the capsules with or without food. Swallow the capsule whole with a glass of water. Do not
chew, break, or divide the capsule before swallowing.
Retsevmo is available in blister packs and bottles. The bottle is protected by a screw cap made of
plastic:
To open the bottle, push down on the plastic screw cap while turning it counterclockwise
as shown in the figure.

To close the bottle, turn the cap tightly clockwise.

If you take more Retsevmo than you should
If you take too many capsules or if someone else takes your medicine, contact your doctor or hospital
for assistance. Medical treatment may be necessary.

If you forget to take a dose of Retsevmo
If you vomit after taking the dose or forget a dose, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose or a vomited dose.

If you stop taking Retsevmo
Do not stop taking Retsevmo unless your doctor tells you to do so.
If you have any further questions 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 everybody gets them.
Contact your doctor immediately if you experience any of the following side effects:

• lung or breathing problems other than lung cancer with symptoms such as shortness of breath, cough and increased temperature (which can affect more than 1 in 10 people)
• liver problems (which can affect more than 1 in 10 people and may be associated with abnormalities in liver blood tests, such as increased liver enzymes) including: yellowing of the skin and eyes (jaundice), dark urine, loss of appetite, nausea or vomiting or pain in the upper right area of the abdomen
• allergic reaction typically characterised by fever and muscle and joint pain, followed by skin rash (which can affect up to 1 in 10 people)
• increased blood pressure (which can affect more than 1 in 10 people)
• bleeding with symptoms such as blood when coughing.

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

• low levels of calcium in the blood
• reduced number of white blood cells in the blood (e.g. lymphocytes, neutrophils, etc.)
• low levels of albumin in the blood
• fluid retention which can cause swelling of the hands or ankles (edema)
• diarrhoea
• increased levels of creatinine in the blood, which may be indicative of impaired kidney function (kidney disorders)
• weakness or fatigue
• dry mouth
• low levels of sodium in the blood
• reduced number of platelets which can cause bleeding and bruising
• skin rash
• abdominal pain
• constipation
• low levels of haemoglobin which can cause anaemia
• low levels of magnesium in the blood
• nausea (feeling unwell)
• headache
• vomiting
• bleeding symptoms
• impotence
• decreased appetite
• abnormal ECG
• low levels of potassium in the blood
• dizziness
• urinary tract infection
• fever or increased temperature
• inflammation of the mucous membrane of the mouth
• reduced thyroid activity

Common (may affect more than 1 in 100 people)

• Lymphatic fluid may accumulate in the lining of the lungs or in the abdominal cavity and this can cause breathing problems or abdominal enlargement.
• Irregular growth of the hip joint or damage causing pain or limping in patients under 18 years of age.

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 Retsevmo

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 bottle or on the
blister pack and on the box after “Exp”. The expiry date refers to the last day of that
month.
This medicine does not require special storage conditions.
Do not use this medicine if you notice that the inner seal is broken 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 Retsevmo contains
The active ingredient is selpercatinib. Each hard capsule contains 40 or 80 mg of selpercatinib.
The other ingredients are:

• capsule content: anhydrous colloidal silica, microcrystalline cellulose
• capsule shell 40 mg: gelatin, titanium dioxide (E171) and iron oxide (E172)
• capsule shell 80 mg: gelatin, titanium dioxide (E171) and Brilliant Blue FCF (E133)
• black ink: shellac, ethanol (96 percent), isopropyl alcohol, butanol, propylene glycol, purified water, ammonia solution (concentrated), potassium hydroxide, black iron oxide.

Description of the appearance of Retsevmo and package contents
Retsevmo 40 mg is supplied in opaque grey hard gelatin capsules, imprinted with “Lilly”,
“3977” and “40 mg” in black.
Retsevmo 80 mg is supplied in opaque blue hard gelatin capsules, imprinted with “Lilly”,
“2980” and “80 mg” in black.
Retsevmo is available in an opaque white bottle with a plastic screw cap, containing
60 hard capsules of 40 mg and 60 or 120 hard capsules of 80 mg. Each carton contains one bottle.
Retsevmo is also available in blister packs of 14, 42, 56 or 168 hard capsules of 40 mg and 14, 28, 56 or
112 hard capsules of 80 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Netherlands.

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000
A marketing authorisation has been granted subject to conditions. This means that
further data on this medicine are required.
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/

Retsevmo 40 mg film-coated tablets, 80 mg film-coated tablets, 120 mg film-coated tablets, 160 mg film-coated tablets

selpercatinib

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

Read this leaflet carefully before 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

the medicine. If you are giving the medicine to your child, replace "you" with "your child".

Contents of this leaflet

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

1. What is Retsevmo and what it is used for

Retsevmo is an anti-cancer medicine that contains the active substance selpercatinib.
It is used to treat the following cancers caused by certain abnormal changes in the RET gene and that have
spread and/or cannot be removed surgically:

• a type of lung cancer, called non-small cell lung cancer, in adults who have not previously been treated with a RETinhibitor medicine.
• thyroid cancer (of any type) in adults and adolescents aged 12 years and older, if treatment with radioactive iodine, when appropriate, has not been able to control the cancer.
• a rare type of thyroid cancer called medullary thyroid cancer in adults and adolescents aged 12 years and older.
• solid tumors (cancer) in other parts of the body in adults after failure of previous therapies to control the cancer.

The doctor will perform a test to check if the tumor has a RET gene alteration to
make sure that Retsevmo is right for you.

How Retsevmo works
In patients in whom the tumor has an altered RET gene, the gene change leads
the body to produce an abnormal RET protein that can lead to uncontrolled
cell growth and cancer. Retsevmo blocks the action of the abnormal RET protein, slowing or
stopping the growth of the tumor. This may also help to reduce the tumor.
Talk to your doctor if you have any questions about how Retsevmo works or why this
medicine has been prescribed for you.

2. What you need to know before taking Retsevmo

Do not take Retsevmo

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

Warnings and precautions
Talk to your doctor before taking Retsevmo:

• if you have lung problems or breathing difficulties other than lung cancer
• if you have high blood pressure
• if you have been told you have an abnormality known as prolonged QT interval on your heart tracing (ECG)
• if you have problems with your thyroid or thyroid hormone levels
• Retsevmo may affect the fertility of women and men, this may affect your ability to have children. Talk to your doctor if this is a concern
• if you have a recent history of significant bleeding.

Retsevmo may cause hypersensitivity reactions such as fever, rash and pain. If you experience
any of these reactions, talk to your doctor. After checking the symptoms, your doctor may ask you to
take corticosteroids until the symptoms improve.
When taking Retsevmo, rapid breakdown of cancer cells can occur (tumour lysis syndrome, TLS). This can cause irregular heartbeat, kidney failure or abnormal
blood test results. Talk to your doctor if you have a history of kidney problems or low blood
pressure as this may increase the risks associated with TLS.
Retsevmo may cause irregular growth of the hip joint or damage in paediatric patients
(<18 years of age). if you experience hip or knee pain unexplained limping, talk to your
doctor.
Refer to section 4 “Possible side effects” and talk to your doctor if you experience any
symptoms.

What your doctor will check before and during treatment

• Retsevmo can cause a serious, life-threatening or fatal inflammation of the lungs. Your doctor will monitor your symptoms before and during treatment with Retsevmo. Tell your doctor immediately if you notice any symptoms of lung problems including shortness of breath, cough and increased temperature.
• Retsevmo can affect blood pressure. Your blood pressure will be measured before and during treatment with Retsevmo
• Retsevmo can affect liver function. Tell your doctor immediately if you develop symptoms of liver problems such as: jaundice (yellowing of the skin and eyes), loss of appetite, nausea or vomiting or pain in the upper right area of the stomach
• Retsevmo may cause ECG abnormalities. You will have an ECG before and during treatment with Retsevmo. Tell your doctor if you experience episodes of fainting as these may be symptoms of an abnormal ECG
• Retsevmo can affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.
• you will have regular blood tests before and during treatment with Retsevmo to check liver function and blood electrolytes (such as sodium, potassium, magnesium and calcium).
• if you are under 18 years of age, your doctor may monitor your growth during treatment. If you have pain in your hip, knee or other leg pain, tell your doctor.

Children and adolescents
Retsevmo should not be used in patients under 18 years of age for lung cancer.
The indications for thyroid cancer (including medullary thyroid cancer) do not
include patients under 12 years of age.

Other medicines and Retsevmo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular tell your doctor or pharmacist before taking Retsevmo if you are taking:

• medicines that can increase the concentration of Retsevmo in the blood: such as clarithromycin (used to treat bacterial infections) or itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) or atazanavir, ritonavir, cobicistat (used to treat HIV/AIDS infections)
• medicines that can reduce the effectiveness of Retsevmo: such as carbamazepine (used to treat epilepsy, nerve pain, bipolar disorder) or rifampicin (used to treat tuberculosis (TB) and some other infections) or St John's Wort (a herbal product used to treat mild depression and anxiety) or omeprazole, lansoprazole or other proton pump inhibitors used to treat heartburn, ulcers and acid reflux. If you are taking any of these medicines, you must take Retsevmo with a full meal or ranitidine, famotidine or other H2 blockers used to treat ulcers and acid reflux. If you are taking any of these medicines, you should take it 2 hours after taking Retsevmo
• medicines whose concentrations in the blood may be increased by Retsevmo: such as repaglinide (used to treat type 2 diabetes and control blood sugar levels) or dasabuvir (used to treat hepatitis C) or selexipag (used to treat pulmonary arterial hypertension) or digoxin (used to treat heart disorders) or lovastatin and simvastatin (used to treat high cholesterol) or dabigatran (used to prevent and treat blood clots)
• medicines that may be less effective if taken with Retsevmo: such as levothyroxine (used to treat hypothyroidism)

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant ask your doctor for
advice before taking this medicine.
You should not take Retsevmo during pregnancy as the effect of Retsevmo on the unborn child is
not known.
Breastfeeding
You should not breastfeed during treatment with Retsevmo as Retsevmo may be harmful to a
breastfed baby. It is not known whether Retsevmo passes into breast milk. You should not breastfeed
for at least one week after the last dose of Retsevmo.
Contraception
Women should be recommended not to become pregnant and men should use contraception during treatment with Retsevmo, because this medicine can cause
harm to the baby. If a person taking this medicine is able to become
pregnant or father a child, they should use effective contraceptive measures during treatment and for
at least one week after the last dose of Retsevmo.
Fertility
Retsevmo may affect your ability to have children. Talk to your doctor for advice on
preserving fertility before treatment.

Driving and using machines
Take particular care when driving or using machines as you may experience fatigue or dizziness
while taking Retsevmo.

Retsevmo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say it is essentially
“sodium-free”.

3. How to take Retsevmo

Always take this medicine at the dose prescribed, following the instructions exactly
given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much to take
Your doctor will prescribe the correct dose for you. The maximum recommended dose is as follows:

• body weight less than 50 kg: 120 mg twice daily
• body weight equal to or greater than 50 kg: 160 mg twice daily.

Retsevmo must be taken twice a day at approximately the same time each day,
preferably in the morning and evening.
If you experience any undesirable effects while taking Retsevmo, your doctor may decrease
the dose or temporarily or permanently interrupt the treatment.
You can take the tablets with or without food. Swallow the tablet whole with a glass of
water. Do not chew, break, or divide the tablet before swallowing to be sure to receive the
correct dose.
If you have difficulty swallowing the larger tablets whole, talk to your doctor about
the possibility of taking more smaller tablets to reach the prescribed dose.

If you take more Retsevmo than you should
If you take too many tablets or if someone else takes your medicine, contact your doctor or hospital
for assistance. Medical treatment may be necessary.

If you forget to take a dose of Retsevmo
If you vomit after taking the dose or forget a dose, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose or a vomited dose.

If you stop taking Retsevmo
Do not stop taking Retsevmo unless your doctor tells you to do so.
If you have any further questions 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 everybody gets them.
Contact your doctor immediately if you experience any of the following side effects:

• lung or breathing problems other than lung cancer with symptoms such as shortness of breath, cough and increased temperature (which can affect more than 1 in 10 people)
• liver problems (which can affect more than 1 in 10 people and may be associated with abnormalities in liver blood tests, such as increased liver enzymes) including: yellowing of the skin and eyes (jaundice), dark urine, loss of appetite, nausea or vomiting or pain in the upper right area of the abdomen
• allergic reaction typically characterized by fever and muscle and joint pain, followed by a skin rash (which can affect up to 1 in 10 people)
• increased blood pressure (which can affect more than 1 in 10 people)
• bleeding with symptoms such as blood when coughing.

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

• low levels of calcium in the blood
• reduction in the number of white blood cells in the blood (e.g. lymphocytes, neutrophils, etc.)
• low levels of albumin in the blood
• fluid retention which can cause swelling of the hands or ankles (edema)
• diarrhea
• increased levels of creatinine in the blood, which may be indicative of impaired kidney function (kidney disorders)
• weakness or fatigue
• dry mouth
• low levels of sodium in the blood
• reduction in the number of platelets which can cause bleeding and bruising
• skin rash
• abdominal pain
• constipation
• low levels of hemoglobin which can cause anemia
• low levels of magnesium in the blood
• nausea (feeling unwell)
• headache
• vomiting
• bleeding symptoms
• impotence
• decreased appetite
• abnormal ECG
• low levels of potassium in the blood
• dizziness
• urinary tract infection
• fever or increased temperature
• inflammation of the mucous membrane of the mouth
• reduced thyroid activity

Common (may affect more than 1 in 100 people)

• Lymphatic fluid may accumulate in the lining of the lungs or in the abdominal cavity and this can cause breathing problems or abdominal enlargement.
• Irregular growth of the hip joint or damage causing pain or limping in patients under < 18 years of age.

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 Retsevmo

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 blister after “EXP” and on the
pack after “Scad”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not use this medicine if you notice that the inner seal is broken 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 Retsevmo contains
The active substance is selpercatinib. Each film-coated tablet contains 40, 80, 120 or 160 mg
of selpercatinib.
The other ingredients are:

• tablet contents: microcrystalline cellulose, mannitol, sodium croscarmellose, hydroxypropylcellulose, sodium stearyl fumarate
• Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) [only 80 mg, 120 mg and 160 mg tablets] and black iron oxide (E172) [only 40 mg, 80 mg and 120 mg tablets]

Description of Retsevmo and contents of the pack
Retsevmo 40 mg is supplied as light grey film-coated round tablets,
with "5340" imprinted on one side and "Ret 40" on the other.
Retsevmo 80 mg is supplied as dark reddish-purple film-coated round tablets
with "6082" imprinted on one side and "Ret 80" on the other.
Retsevmo 120 mg is supplied as light purple film-coated round tablets,
with "6120" imprinted on one side and "Ret 120" on the other.
Retsevmo 160 mg is supplied as light pink film-coated round tablets,
with "5562" imprinted on one side and "Ret 160" on the other.
Retsevmo is available in blisters of 30, 56 or 60 film-coated tablets of 40 mg, 80 mg, 120 mg
and 160 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000
A marketing authorisation has been granted subject to conditions. 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 European Medicines Agency website,
https://www.ema.europa.eu/