Prospect: information for the patient

Retsevmo 40mg hard capsules

Retsevmo 80mg hard capsules

selpercatinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
• This prospect has been written as if you were reading it yourself. If you are administering this medicine to your child, replace “your” with “your child” in the entire text.

Retsevmo is a medication for cancer treatment that contains the active ingredient selpercatinib.

It is used for the treatment of the following types of cancer that originate from certain alterations in the RET gene and have spread and/or cannot be eliminated with surgery:

• A type of lung cancer called non-microcytic lung cancer in adults who have not been previously treated with a RET inhibitor medication.
• Thyroid cancer (any type) in adults and adolescents 12 years of age or older if radioactive iodine treatment, when appropriate, has not been able to control the cancer.
• A rare type of thyroid cancer called medullary thyroid cancer in adults and adolescents 12 years of age or older.
• Solid tumors (cancer) in other parts of the body in adults after previous treatments have not been able to control the cancer.

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

How Retsevmo works

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

If you have any doubts about how Retsevmo works or why you have been prescribed it, consult your doctor.

Do not take Retsevmo

-if you are allergic to selpercatinib or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor before starting to take Retsevmo:

-If you have lung or respiratory problems other than lung cancer.

-If you have high blood pressure.

-If you have been told by an electrocardiogram (ECG) that you have a heart condition known as prolonged QT interval.

-If you have thyroid problems or abnormal thyroid hormone levels.

-Retsevmo may affect your fertility, which may affect your ability to have children. Consult your doctor if this is a concern for you.

-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, consult your doctor. After checking your symptoms, your doctor may ask you to take corticosteroids until your symptoms improve.

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

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

What your doctor will check before and during your treatment

-Retsevmo may cause a severe and potentially fatal lung inflammation. Your doctor will monitor you before and during treatment with Retsevmo to detect any symptoms. Immediately inform your doctor if you notice any symptoms of lung problems, such as difficulty breathing, coughing, and increased temperature.

-Retsevmo may affect your blood pressure. Your blood pressure will be measured before and during treatment with Retsevmo.

-Retsevmo may affect liver function. Immediately inform your doctor 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 cause abnormal ECG results. An ECG will be performed before and during treatment with Retsevmo. Inform your doctor if you experience dizziness, as it may be a symptom of an abnormal ECG.

-Retsevmo may affect thyroid function. Your doctor will monitor your thyroid function before and during treatment with Retsevmo.

-Regular blood tests will be performed 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 18years of age, your doctor may monitor your growth during treatment. If you experience hip, knee, or leg pain, inform your doctor.

Children and adolescents

Retsevmo is not indicated for use in patients under 18years of age for lung cancer.

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

Other medications and Retsevmo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor or pharmacist before taking Retsevmo, particularly if you are taking the following medications:

• medications 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)

• medications that may reduce the effectiveness of Retsevmo:

• Carbamazepine (used to treat epilepsy, nerve pain, bipolar disorder)
• Rifampicin (used to treat tuberculosis (TB) and other infections)
• St. John's Wort (a medicinal herb used to treat mild depression and anxiety)
• Omeprazole, lansoprazole, or other proton pump inhibitors used to treat acid reflux, ulcers, and stomach ulcers. If you are taking any of these medications, take Retsevmo with a full meal.
• Ranitidine, famotidine, and other H2 blockers used to treat ulcers and acid reflux. If you are taking any of these medications, you need to take them 2 hours after taking Retsevmo.

• medications whose concentration in the blood may increase 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)

• medications that may be less effective if 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 medication.

You should not take Retsevmo while pregnant, as its effect on the fetus is unknown.

Breastfeeding

You should not breastfeed during treatment with Retsevmo, as it may harm your baby. It is unknown whether Retsevmo passes into breast milk. Do not breastfeed your baby for at least one week after receiving your last dose of Retsevmo.

Birth control

It is recommended that women avoid becoming pregnant and that men avoid fathering children during treatment with Retsevmo, as this medication may harm the baby. If there is a possibility that the person taking this medication may become pregnant or father a child, they should use an appropriate contraceptive method 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 to get advice on preserving fertility before starting treatment.

Driving and operating machinery

You should exercise special caution when driving and operating machinery, as you may feel tired or dizzy while taking Retsevmo.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist, at the prescribed dose. In case of doubt, consult your doctor or pharmacist again.

How much to take

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

• Less than 50 kg of body weight: 120 mg twice a day.

-50 kg or more of body weight: 160 mg twice a day.

Retsevmo is taken twice a day, 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 discontinue treatment.

You can 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 blisters and bottles. The bottle is protected by a plastic screw cap:

To open the bottle, press down on the plastic screw cap while turning it counterclockwise, as shown in the figure.

To close the bottle, turn the cap firmly clockwise.

If you take more Retsevmo than you should

If you take many capsules, or if someone else takes your medication, contact a doctor or hospital for advice. Medical treatment may be necessary.

If you forget to take Retsevmo

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

If you discontinue treatment with Retsevmo

Do not discontinue treatment with Retsevmo unless your doctor advises you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Immediately contact your doctor for any of the following:

-Lung or respiratory problems other than lung cancer with symptoms such as difficulty breathing, coughing, and increased temperature (which may affect more than 1 in 10 people)

-Liver problems (which 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 hives (which may affect up to 1 in 10 people)

-High blood pressure (which 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
• Reduction in the number of white blood cells (e.g., lymphocytes, neutrophils, etc.)
• Low levels of albumin in the blood
• Fluid retention that can cause swelling in the hands or ankles (edema)
• Diarrhea
• Increased blood levels of creatinine in the analysis, which may indicate that the kidneys are not working properly (renal disorders)
• Fatigue or tiredness
• Dry mouth
• Low levels of sodium in the blood
• Reduction in the number of platelets in the blood, which may cause bleeding and bruises
• Hives
• Abdominal pain
• Constipation
• Low levels of hemoglobin, which may cause anemia
• Low levels of magnesium in the blood
• Nausea (feeling of discomfort)
• Headache
• Vomiting
• Bleeding symptoms
• Decreased appetite
• ECG altered
• Low levels of potassium in the blood
• Dizziness
• Urinary tract infection
• Fever or high temperature
• Inflammation of the mucous membrane of 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 respiratory problems or abdominal enlargement
• Irregular growth of the hip joint or damage that causes pain or limp in patients <18years of age

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle or on the blister pack and the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe that the inner seal is broken or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Retsevmo

The active ingredient is selpercatinib. Each hard capsule contains 40 or 80 mg of selpercatinib.

The other components are:

-Capsule content: anhydrous colloidal silica, microcrystalline cellulose

-Capsule coating of 40 mg: gelatin, titanium dioxide (E171) and iron oxide (E172).

-Capsule coating of 80 mg: gelatin, titanium dioxide (E171), and Brilliant Blue FCF (E133).

-Black ink: shellac, ethanol (96%), isopropyl alcohol, butanol, propylene glycol, water, purified, concentrated ammonia solution, potassium hydroxide, iron oxide black

Appearance of the product and contents of the package

Retsevmo 40 mg is supplied as a grey opaque hard gelatin capsule, with “Lilly”, “3977” and “40 mg” printed in black.

Retsevmo 80 mg is supplied as a blue opaque hard gelatin capsule, with “Lilly”, “2980” and “80 mg” printed in black.

Retsevmo is available in a white opaque bottle with a plastic screw cap, containing 60 hard capsules of 40 mg or 60 or 120 hard capsules of 80 mg. Each box contains one bottle.

Retsevmo is presented in blisters of 14, 42, 56 or 168 hard capsules of 40 mg and of 14, 28, 56 or 112 hard capsules of 80 mg.

Only some package sizes may be commercially available.

Marketing Authorization Holder

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

Responsible for manufacturing

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:

Spain

Lilly S.A.

Phone: + 34-91 663 50 00

Last review date of this leaflet:July 2024

This medicinal product has been authorized under a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

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