Retsevmo 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

selpercatinib

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.

  • If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
  • This leaflet has been written as if the person reading it is the patient. If you are administering this medicine to your child, replace “your” with “your child’s” throughout the text.

Contents of the leaflet

1. What Retsevmo is 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

1. What Retsevmo is and what it is used for

Retsevmo is a cancer medicine that contains the active substance selpercatinib.

It is used to treat the following types of cancer caused by certain alterations in the RET gene that have spread and/or cannot be removed by surgery:

• 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 treatments have failed to control the cancer.

Your doctor will carry out a test to check whether your cancer has a change in the RET gene to ensure that Retsevmo is suitable for you.

How Retsevmo works

In patients with cancer caused by an alteration in the RET gene, this genetic change causes the body to produce an abnormal RET protein, which may lead to uncontrolled cell growth and cancer. Retsevmo blocks the action of this abnormal RET protein and may therefore slow down or stop cancer growth. It may also help reduce tumour size.

If you have any questions about how Retsevmo works or why it has been prescribed for you, speak with your doctor.

2. What you need to know before starting 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 starting Retsevmo:

• If you have lung or breathing problems other than lung cancer.
• If you have high blood pressure.
• If an electrocardiogram (ECG) has shown that you have a heart abnormality known as QT interval prolongation.
• If you have thyroid problems or abnormal thyroid hormone levels.
• Retsevmo may affect fertility in women and men, which could impact your ability to have children. Speak to your doctor if this is a concern for you.
• If you have recently had a significant bleeding event.

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.

While taking Retsevmo, rapid destruction of cancer cells (tumor lysis syndrome, TLS) may occur. This can lead to irregular heartbeats, 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 growth or damage to the hip joint in pediatric patients (<18 years of age). If you experience hip or knee pain or have unexplained limping, contact your doctor.

See section 4, "Possible side effects", and consult your doctor if you experience any symptoms.

What your doctor will monitor before and during your treatment

• Retsevmo may cause severe, potentially fatal or fatal, lung inflammation. Your doctor will monitor you before and during treatment with Retsevmo for any signs of lung problems. Inform your doctor immediately if you experience symptoms such as difficulty breathing, cough, or fever.
• Retsevmo may affect your 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 experience symptoms of liver problems, including: jaundice (yellowing of the skin and eyes), loss of appetite, nausea or vomiting, or pain in the upper right side of your abdomen.
• Retsevmo may lead to abnormal ECG results. An ECG will be performed before and during treatment with Retsevmo. Inform your doctor if you experience fainting, as this may be a sign of an abnormal ECG.
• Retsevmo may affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.
• Blood tests will be performed regularly before and during treatment with Retsevmo to check liver function and electrolyte levels (such as sodium, potassium, magnesium, and calcium) in your blood.
• 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 is not indicated for use in patients under 18 years of age with lung cancer.

The indications for thyroid cancer (including medullary thyroid cancer) do not include children under 12 years of age.

Other medicines and Retsevmo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor or pharmacist before taking Retsevmo, especially if you are taking the following medicines:

• Medicines that may increase the concentration of Retsevmo in the blood:

• Clarithromycin (used to treat bacterial infections)

• Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections)

• Atazanavir, ritonavir, cobicistat (used to treat HIV/AIDS infections)

• Medicines that may reduce the effectiveness of Retsevmo:

• Carbamazepine (used to treat epilepsy, nerve-related pain, bipolar disorder)

• Rifampicin (used to treat tuberculosis (TB) and certain other infections)

• St. John’s wort (a herbal remedy used to treat mild depression and anxiety)

• Omeprazole, lansoprazole, or other proton pump inhibitors used to treat heartburn, ulcers, and gastroesophageal reflux. If you are taking any of these medicines, take Retsevmo with a full meal.

• Ranitidine, famotidine, and other H2 blockers used to treat ulcers and gastroesophageal reflux. If you are taking any of these medicines, take them at least 2 hours after taking Retsevmo.

• Medicines whose blood concentration may increase when taken with Retsevmo:

• Repaglinide (used to treat type 2 diabetes and control blood sugar)

• Dasabuvir (used to treat hepatitis C)

• Selexipag (used to treat pulmonary arterial hypertension)

• Digoxin (used to treat heart conditions)

• Lovastatin and simvastatin (used to treat high cholesterol)

• Dabigatran (used to prevent and treat blood clots)

• Medicines that may be less effective when taken with Retsevmo:

• Levothyroxine (used to treat hypothyroidism)

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You must not take Retsevmo during pregnancy, as its effects on the unborn baby are unknown.

Breastfeeding

Do not breastfeed during treatment with Retsevmo, as Retsevmo could harm a breastfed baby. It is not known whether Retsevmo passes into breast milk. You must not breastfeed for at least one week after receiving your last dose of Retsevmo.

Contraception

Women should avoid becoming pregnant and men should avoid fathering a child during treatment with Retsevmo, as this medicine may harm the unborn baby. If there is any possibility that you or your partner could become pregnant or conceive a child while taking this medicine, you should use an effective method of contraception 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 about fertility preservation options before starting treatment.

Driving and using machines

Exercise caution when driving or operating machinery, as you may feel tired or dizzy while taking Retsevmo.

Retsevmo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, “sodium-free”.

3. How to take Retsevmo

Follow exactly the instructions for using this medicine given by your doctor or pharmacist, at the prescribed dose. If in doubt, consult your doctor or pharmacist again.

How much to take

Your doctor will prescribe the appropriate dose for you. The recommended maximum dose is as follows:

• Less than 50 kg body weight: 120 mg twice daily.

• 50 kg body weight or more: 160 mg twice daily.

Retsevmo is taken twice daily, approximately at the same time each day, preferably in the morning and at night.

If you experience any adverse effects while taking Retsevmo, your doctor may reduce your dose or temporarily or permanently interrupt treatment.

You may take the tablets with or without food. Swallow the tablet whole with a glass of water. Do not chew, crush, or divide the tablet before swallowing to ensure you receive the correct dose.

If you have difficulty swallowing the larger tablets whole, consult your doctor about the possibility of taking several smaller tablets to achieve your prescribed dose.

If you take more Retsevmo than you should

If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice. Medical treatment may be required.

If you forget to take 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 missed or vomited doses.

If you stop taking Retsevmo

Do not stop treatment with Retsevmo unless instructed by your doctor.

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 will experience them.

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

• Lung or breathing problems other than lung cancer, with symptoms such as difficulty breathing, 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), darkening of the urine, loss of appetite, nausea or vomiting, or pain in the upper right side of your abdomen
• Allergic reactions, generally characterized by fever and muscle and joint pain followed by a rash (may affect up to 1 in 10 people)
• High 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
• Decrease in the number of white blood cells (e.g., lymphocytes, neutrophils, etc.)
• Low levels of albumin in the blood
• Fluid retention that may cause swelling in the hands or ankles (edema)
• Diarrhea
• Increased blood creatinine levels in laboratory tests, which may indicate that the kidneys are not functioning properly (renal disorders)
• Fatigue or tiredness
• Dry mouth
• Low levels of sodium in the blood
• Decrease in the number of platelets in the blood, which may cause bleeding and bruising
• Rash
• Stomach pain
• Constipation
• Low levels of hemoglobin, which may cause anemia
• 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 high temperature
• Inflammation of the mucous membrane in the mouth
• Decreased thyroid function

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 problems or abdominal swelling
• Irregular growth of the hip joint or damage causing pain or limping in patients < 18 years of age

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Retsevmo Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after “EXP” and “CAD”, respectively. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if the inner seal is broken or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Retsevmo

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, sodium croscarmellose, 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].

Appearance of the product and contents of the pack

Retsevmo 40 mg is supplied as a round, light grey, film-coated tablet, engraved on one side with “5340” and on the other side with “Ret 40”.

Retsevmo 80 mg is supplied as a round, dark purple-red, film-coated tablet, engraved on one side with “6082” and on the other side with “Ret 80”.

Retsevmo 120 mg is supplied as a round, light purple, film-coated tablet, engraved on one side with “6120” and on the other side with “Ret 120”.

Retsevmo 160 mg is supplied as a round, light pink, film-coated tablet, engraved on one side with “5562” and on the other side with “Ret 160”.

Retsevmo is available in packs of 30, 56 or 60 film-coated tablets of 40 mg, 80 mg, 120 mg and 160 mg.

Only certain 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.

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

This medicinal product has been authorised under a "conditional approval". This type of approval means that additional information on this medicine is expected to become available.

The European Medicines Agency will review the new information on this medicine at least once a year, and this leaflet will be updated when necessary.

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).