Retsevmo: detailed information

Package leaflet: Information for the patient

Retsevmo 40 mg hard capsules, 80 mg hard capsules

selpercatinib
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
This patient information leaflet has been prepared assuming it will be read by the person taking the medicine. If you are administering the medicine to your child, please replace "you" with "your child".

Contents of this leaflet

What Retsevmo is and what it is used for
What you need to know before taking Retsevmo
How to take Retsevmo
Possible side effects
How to store Retsevmo
Contents of the pack and other information

1. What Retsevmo is and what it is used for

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

a type of lung cancer called non-small cell lung cancer in adults who have not previously been treated with a RET inhibitor medicine.
thyroid cancer (of any type) in adults and adolescents aged 12 years and older, when radioactive iodine treatment, if 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 tumours (cancer) in other parts of the body in adults after previous treatments have failed to control the tumour.

Your doctor will perform a test to check whether your tumour has a RET gene alteration to ensure that Retsevmo is suitable for you.
How Retsevmo works
In patients whose tumour has an altered RET gene, this genetic change causes the body to produce an abnormal RET protein, which can lead to uncontrolled cell growth and cancer. Retsevmo blocks the action of this abnormal RET protein, slowing down or stopping tumour growth. This may also help reduce the size of the tumour.
Speak to your doctor if you have any questions about how Retsevmo works or why this medicine has been prescribed for you.

2. What you should know before taking Retsevmo

Do not take Retsevmo

if you are allergic to selpercatinib or to any of the other ingredients of this medicine (listed in section 6).
if you have previously developed a severe skin rash or skin peeling, blistering, and/or mouth ulcers after taking Retsevmo.

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 that you have an abnormality known as QT interval prolongation on an electrocardiogram (ECG)
if you have thyroid problems or abnormal thyroid hormone levels
Retsevmo may affect fertility in both women and men, which could impact your ability to have children. Speak with 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, contact your doctor. After evaluating your symptoms, your doctor may ask you to take corticosteroids until your symptoms improve.
When taking Retsevmo, rapid breakdown of tumor cells (tumor lysis syndrome, TLS) may occur. This can lead to 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 abnormal hip joint growth or damage in pediatric patients (<18 years of age). If you experience hip or knee pain or unexplained limping, discuss this with your doctor.
This medicine may cause serious skin reactions. Stop taking Retsevmo and contact a doctor immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
Refer to section 4 “Possible side effects” and consult your doctor if you experience any symptoms.

What your doctor will monitor before and during treatment

Retsevmo may cause severe, life-threatening, or fatal lung inflammation. Your doctor will monitor for symptoms before and during treatment with Retsevmo. Inform your doctor immediately if you experience any symptoms of lung problems, including shortness of breath, cough, or increased temperature.
Retsevmo may affect blood pressure. Your blood pressure will be measured before and during treatment with Retsevmo.
Retsevmo may affect liver function. Inform 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 part of the abdomen.
Retsevmo may cause ECG abnormalities. You will undergo an ECG before and during treatment with Retsevmo. Inform your doctor if you experience episodes of fainting, as these may be symptoms of an abnormal ECG.
Retsevmo may affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.
you will undergo regular blood tests before and during treatment with Retsevmo to monitor 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 experience hip, knee, or other leg pain, inform your doctor.

Children and adolescents
Retsevmo must 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist before taking Retsevmo if you are taking:

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

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
You must not take Retsevmo during pregnancy because the effect of Retsevmo on the unborn child is unknown.

Breastfeeding
You must not breastfeed during treatment with Retsevmo because Retsevmo may be harmful to a breastfed child. It is not known whether Retsevmo passes into breast milk. You must not breastfeed for at least one week after the last dose of Retsevmo.

Contraception
Women are advised not to become pregnant and men are advised not to father a child during treatment with Retsevmo, as this medicine may harm the unborn child. If the person taking this medicine could become pregnant or father a child, an effective method of contraception must be used 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 fertility preservation before starting treatment.

Driving and using machines
Exercise caution when driving or operating machinery, 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 exactly the instructions provided 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 recommended maximum dose is as follows:

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

Retsevmo should be taken twice daily, approximately at the same time each day, preferably in the morning and in the evening.
If you experience certain adverse effects while taking Retsevmo, your doctor may reduce the dose or temporarily or permanently discontinue treatment.
You may take the capsules with or without food. Swallow the capsule whole with a glass of water. Do not chew, crush, or divide the capsule before swallowing.
Retsevmo is available in blister packs and in bottles. The bottle is sealed with a plastic screw cap:
To open the bottle, press down on the plastic screw cap while turning it counterclockwise, as shown in the figure.

A hand presses down on the cap of a vial indicated by number 1 and rotates it clockwise indicated by number 2

To close the bottle, turn the cap firmly clockwise.

Schematic drawing of a vial with a curved black arrow indicating a counterclockwise rotation accompanied by number 3

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 required.
If you forget to take a dose of Retsevmo
If you vomit after taking your dose or forget to take a dose, take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose or for a dose that was vomited.
If you stop taking Retsevmo
Do not stop taking Retsevmo unless your doctor tells you to.
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 everyone gets them.
Stop taking Retsevmo and contact your doctor immediately if you notice any of the following symptoms of serious skin reactions:

flat, red spots, target-shaped or circular, located on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome (SJS)).

Contact your doctor immediately if you experience any of the following side effects:

lung or breathing problems unrelated to lung cancer, with symptoms such as shortness of breath, cough and increased temperature (may affect more than 1 in 10 people)
liver problems (may 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 part of the abdomen
allergic reaction typically characterized by fever and muscle and joint pain, followed by skin rash (may affect up to 1 in 10 people)
increased blood pressure (may affect more than 1 in 10 people)
bleeding with symptoms such as coughing up blood.

Inform 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 may cause swelling of the hands or ankles (oedema)
diarrhoea
increased levels of creatinine in the blood, which may indicate impaired kidney function (kidney disorders)
weakness or fatigue
dry mouth
low levels of sodium in the blood
reduced number of platelets which may cause bleeding and/or bruising
skin rash
stomach pain
constipation
low levels of haemoglobin which may cause anaemia
low levels of magnesium in the blood
nausea (feeling unwell)
headache
vomiting
signs of bleeding
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, which may cause breathing difficulties or abdominal swelling.
Abnormal growth of the hip joint or damage causing pain or limping in paediatric patients

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the vial label, on the blister card, and on the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the inner seal is broken or shows any signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Retsevmo contains
The active substance is selpercatinib. Each hard capsule contains 40 or 80 mg of selpercatinib.
The other components are:

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

Description of the appearance of Retsevmo and package contents
Retsevmo 40 mg is supplied as opaque grey hard gelatin capsules, printed in black with “Lilly”,
“3977” and “40 mg”.
Retsevmo 80 mg is supplied as opaque blue hard gelatin capsules, printed in black with “Lilly”,
“2980” and “80 mg”.
Retsevmo is available in an opaque white screw-cap plastic bottle 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 containing 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 Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: + 371 67364000

This medicinal product has been granted a conditional marketing authorization. This means that further data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually, and this package leaflet will be updated if necessary.

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/

Patient information leaflet

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

selpercatinib
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
This patient information leaflet has been prepared on the assumption that it will be read by the person taking the medicine. If you are administering the medicine to your child, replace "you" with "your child".

Contents of this leaflet

What Retsevmo is and what it is used for
What you need to know before taking Retsevmo
How to take Retsevmo
Possible side effects
How to store Retsevmo
Contents of the pack and other information

1. What Retsevmo is and what it is used for

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

a type of lung cancer called non-small cell lung cancer in adults who have not previously been treated with a RET inhibitor medicine.
thyroid cancer (any type) in adults and adolescents aged 12 years and older, when treatment with radioactive iodine, if 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 tumours (cancer) in other parts of the body in adults after previous therapies have failed to control the tumour.

Your doctor will perform a test to check whether your tumour has a RET gene alteration to ensure that Retsevmo is suitable for you.
How Retsevmo works
In patients whose tumour has an altered RET gene, this genetic change causes 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 down or stopping tumour growth. This may also help reduce the size of the tumour.
Speak to your doctor if you have any questions about how Retsevmo works or why this medicine has been prescribed for you.

2. What you should 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)
if you have previously developed a severe skin rash or skin peeling, blistering, and/or mouth ulcers after taking Retsevmo.

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 QT interval prolongation on an electrocardiogram (ECG)
if you have thyroid problems or abnormal thyroid hormone levels
Retsevmo may affect fertility in both women and men, which could impact your ability to have children. Speak with your doctor if this is a concern
if you have recently had significant bleeding.

Retsevmo may cause hypersensitivity reactions such as fever, rash, and pain. If you experience any of these reactions, contact your doctor. After evaluating your symptoms, your doctor may ask you to take corticosteroids until symptoms improve.
When taking Retsevmo, rapid breakdown of tumor cells (tumor lysis syndrome, TLS) may occur. This can lead to 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 abnormal hip joint growth or damage in pediatric patients (< 18 years of age). If you experience hip or knee pain or unexplained limping, speak with your doctor.
This medicine may cause serious skin reactions. Stop taking Retsevmo and contact a doctor immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
Refer to section 4 “Possible side effects” and contact your doctor if you experience any symptoms.

What your doctor will monitor before and during treatment

Retsevmo may cause severe, life-threatening, or fatal lung inflammation. Your doctor will monitor for symptoms before and during treatment with Retsevmo. Inform your doctor immediately if you experience any symptoms of lung problems, including shortness of breath, cough, or increased body temperature.
Retsevmo may affect your blood pressure. Your blood pressure will be checked before and during treatment with Retsevmo.
Retsevmo may affect liver function. Inform your doctor immediately if you develop signs of liver problems such as: jaundice (yellowing of the skin and eyes), loss of appetite, nausea or vomiting, or pain in the upper right part of the stomach area.
Retsevmo may cause abnormalities on ECG. You will undergo an ECG before and during treatment with Retsevmo. Inform your doctor if you experience episodes of fainting, as these may be symptoms of an abnormal ECG.
Retsevmo may affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.
you will undergo regular blood tests before and during treatment with Retsevmo to monitor 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 hip, knee, or other leg pain, inform your doctor.

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

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

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
You must not take Retsevmo during pregnancy, as the effect of Retsevmo on the unborn child is unknown.

Breastfeeding
You must not breastfeed during treatment with Retsevmo, as Retsevmo may be harmful to a breastfed child. It is not known whether Retsevmo passes into breast milk. You must not breastfeed 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 fertility preservation before starting treatment.

Driving and using machines
Exercise caution when driving or operating machinery, 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, i.e., essentially “sodium-free”.

3. How to take Retsevmo

Always take this medicine at the dose prescribed for you, following exactly the instructions provided 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 recommended maximum dose is as follows:

Body weight below 50 kg: 120 mg twice daily
Body weight equal to or above 50 kg: 160 mg twice daily

Retsevmo should be taken twice daily, approximately at the same time each day, preferably in the morning and in the evening.
If you experience certain side effects while taking Retsevmo, your doctor may reduce the dose or temporarily or permanently stop treatment.
You may 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 ensure you receive the correct dose.
If you have difficulty swallowing the larger tablets whole, talk to your doctor about the possibility of taking more tablets of a smaller strength to achieve 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 a dose or miss a dose, take your next dose at the usual time.
Do not take a double dose to make up for a missed dose or a dose that was vomited.

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.
Stop taking Retsevmo and contact a doctor immediately if you notice any of the following symptoms of serious skin reactions:

flat, red spots, target-shaped or circular, located on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS)].

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 body temperature (may affect more than 1 in 10 people)
liver problems (may affect more than 1 in 10 people and may be associated with abnormal 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 part of the stomach area
allergic reaction typically characterized by fever and muscle and joint pain, followed by a skin rash (may affect up to 1 in 10 people)
increased blood pressure (may affect more than 1 in 10 people)
bleeding with symptoms such as coughing up blood.

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 may cause swelling of the hands or ankles (oedema)
diarrhoea
increased levels of creatinine in the blood, which may indicate impaired kidney function (kidney disorders)
weakness or fatigue
dry mouth
low levels of sodium in the blood
reduced number of platelets which may cause bleeding and/or bruising
skin rash
stomach pain
constipation
low levels of haemoglobin which may cause anaemia
low levels of magnesium in the blood
nausea (feeling unwell)
headache
vomiting
symptoms of bleeding
impotence
decreased appetite
abnormal ECG
low levels of potassium in the blood
dizziness
urinary tract infection
fever or increased body temperature
inflammation of the mucous membrane in the mouth
reduced thyroid activity

Common (may affect more than 1 in 100 people)

Lymph fluid may accumulate in the lining of the lungs or in the abdominal cavity, which may cause breathing problems or abdominal swelling.
Abnormal growth of the hip joint or damage causing pain or limping in patients under 18 years of age.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the blister after "EXP" and on the
pack after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any 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 via 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 substance is selpercatinib. Each film-coated tablet contains 40, 80, 120 or 160 mg of selpercatinib.
The other components are:

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

Description of the appearance of Retsevmo and pack contents
Retsevmo 40 mg is supplied as light grey, round, film-coated tablets, with "5340" on one side and "Ret 40" on the other.
Retsevmo 80 mg is supplied as dark red-purple, round, film-coated tablets, with "6082" on one side and "Ret 80" on the other.
Retsevmo 120 mg is supplied as light purple, round, film-coated tablets, with "6120" on one side and "Ret 120" on the other.
Retsevmo 160 mg is supplied as light pink, round, film-coated tablets, with "5562" 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 about this medicine, please contact the local representative of the Marketing Authorisation Holder: