40mg, 80 mg Hard capsules
selperkatinib
What Retsevmo is and what it is used for
Retsevmo is a cancer drug that contains the active substance selperkatinib.
It is used to treat any of the following cancers that are caused by certain changes in the so-called RET gene and that have spread and/or cannot be removed by surgery:
- A type of lung cancer, so-called non-small cell lung cancer, in adults.
- Thyroid cancer (all types) in adults.
- A rare type of thyroid cancer called medullary thyroid cancer, in adults and adolescents from 12 years of age.
Retsevmo can be prescribed if previous treatments for lung or thyroid cancer have not worked.
To be sure that Retsevmo is the right medicine for you, your doctor will perform a test to check that your cancer has a change in the RET gene.
How Retsevmo works
If cancer has an altered RET gene, this gene change leads to the body producing an abnormal RET protein. It can lead to uncontrolled cell growth and cancer. Retsevmo blocks the abnormal RET protein and can thus slow down or stop the growth of cancer. It can also cause a tumor to shrink.
If you have any questions about how Retsevmo works or why you have been given this medicine, ask your doctor.
What you need to know before using Retsevmo
Do not use Retsevmo
- if you are allergic to selperkatinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking Retsevmo:
- if you have high blood pressure
- if you have a heart rhythm disorder is seen on ECG ( electrocardiogram ), the so-called prolonged QT interval
- Retsevmo can affect the fertility of men and women and thus your ability to have children. Talk to your doctor if this worries you.
- if you have had major bleeding in the past.
Retsevmo can cause hypersensitivity reactions such as fever, rash, and pain. Talk to a doctor if you get such a reaction. After checking your symptoms, your doctor may ask you to take corticosteroids ( cortisone ) until your symptoms improve.
Rapid degradation of cancer cells (tumor lysis syndrome, TLS) can occur when you take Retsevmo. This can cause irregular heartbeat, kidney failure, or abnormal blood test results. Talk to your doctor if you have previously had kidney problems or low blood pressure as this may increase the risks associated with TLS.
See section 4 “Possible side effects” and talk to your doctor if you get any symptoms.
Medical examinations before and during treatment
- Retsevmo can affect blood pressure. Blood pressure is measured before and during treatment with Retsevmo.
- Retsevmo may affect liver function. Tell your doctor immediately if you experience symptoms of hepatic effects such as jaundice (yellowing of the skin and eyes), decreased appetite, nausea or vomiting, or if you get pain in the upper right side of the abdomen.
- Retsevmo can cause abnormal ECG. ECG is taken both before and during treatment with Retsevmo. Tell your doctor if you faint as it may be a symptom of an abnormal ECG.
- Before and during treatment with Retsevmo, blood samples are taken at regular intervals to check liver function and electrolytes (such as sodium, potassium, magnesium, and calcium ) in the blood.
Children and young people
Retsevmo is not for use in patients under 18 years of age who have lung or thyroid cancer other than medullary thyroid cancer. Adolescents from the age of 12 who have medullary thyroid cancer can be treated with this drug.
Other medicines and Retsevmo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor or pharmacist before taking Retsevmo if you are taking any of the following:
- drugs that can increase the concentration of Retsevmo in the blood:
- clarithromycin (for the treatment of bacterial infections)
- itraconazole, ketoconazole , posaconazole, voriconazole (used to treat fungal infections)
- atazanavir, ritonavir, cobicistat (for the treatment of HIV infection / AIDS)
- drugs that can reduce the effect of Retsevmo:
- carbamazepine (for the treatment of epilepsy, nerve pain, and bipolar disorder )
- rifampicin (for the treatment of tuberculosis (TB) and other infections )
- St. John’s wort (a (traditional) herbal medicine for the treatment of mild depression and anxiety)
- repaglinide (for the treatment of type 2 diabetes and to control blood sugar)
- dasabuvir (for the treatment of hepatitis C)
- selexipag (for high blood pressure in the pulmonary arteries)
- digoxin (for the treatment of heart disease)
- omeprazole, lansoprazole, or other proton pump inhibitors used for heartburn, stomach ulcers, and acid reflux; If you are taking any of these medicines, take Retsevmo with a full meal.
- ranitidine, famotidine, or other H2 blockers against stomach ulcers and acid reflux; if you are taking any of these medicines, you must take them 2 hours after taking Retsevmo.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not use Retsevmo during pregnancy as it is not known how Retsevmo can affect the unborn baby. Women should avoid becoming pregnant and men should avoid getting a woman pregnant during treatment with Retsevmo, as the drug could harm the baby. If there is a possibility that you may become pregnant or can make a woman pregnant, you must use an effective contraceptive during treatment and for at least one week after the last dose of Retsevmo.
Breast-feeding
Do not breastfeed during treatment with Retsevmo. Retsevmo could harm the breastfed baby. It is not known if Retsevmo passes into breast milk. Do not breastfeed for at least one week after the last dose of Retsevmo.
Fertility
Retsevmo can affect your chances of having children. Talk to your doctor about fertility preservation measures before treatment.
Driving and using machines
Take special care when driving or using machines as you may feel tired or dizzy while taking Retsevmo.
Retsevmo contains excipients
Always take this medicine exactly as your doctor or pharmacist has told you, and in the dose prescribed. Ask your doctor or pharmacist if you are unsure.
Retsevmo is taken twice a day at about the same time each day, preferably in the morning and evening.
If you get any side effects from Retsevmo, your doctor may reduce your dose or stop the treatment temporarily or permanently.
You can take the capsules with or without food. Swallow the capsule whole with a glass of water. The capsules must not be chewed, crushed, or divided before swallowing.
The jar is equipped with a screw cap:
Push the screw cap downwards and at the same time turn it counterclockwise to open the jar, as shown in the picture.
To close the jar, turn the lid clockwise until it is firmly seated.
How to use Retsevmo
If you use more Retsevmo than you should
If you have taken too many capsules, or if another person has taken your medicine, contact your doctor or hospital for advice. Medical treatment may be necessary.
If you forget to use Retsevmo
If you vomit after taking a dose or have forgotten to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten or vomited dose.
If you stop using Retsevmo
Do not stop taking Retsevmo unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you get any of the following:
- Liver problems (may affect more than 1 in 10 people and may cause abnormal liver values in blood tests, such as increased liver enzymes), such as yellowing of the skin and eyes (jaundice), dark-colored urine, decreased appetite, nausea or vomiting, or pain in the upper right part of the abdomen.
- Allergic reaction with fever, muscle and joint pain, accompanied by a rash (may affect up to 1 in 10 people).
- High blood pressure (may affect more than 1 user in 10).
- Bleeding with symptoms such as bloody cough.
Tell your doctor, pharmacist, or nurse if you get any of the following side effects:
Very common (may affect more than 1 user in 10)
- Dry mouth
- Diarrhea
- Fatigue or tiredness
- Constipation
- Headache
- Nausea, abdominal pain, vomiting
- Reduced appetite
- Accumulation of fluid that can cause swollen hands or ankles ( edema )
- The increased amount of creatinine in the blood, which may indicate that the kidneys are not working properly (kidney disease)
- Abnormal ECG
- Decreased platelet count, which may lead to bleeding and/or bruising
- Symptoms of bleeding
- Fever
- Rash
- Dizziness
- Decreased white blood cell count
- Low magnesium levels in the blood
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 can or blister card and the carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is selperkatinib. Each hard capsule contains 40 mg or 80 mg of selperkatinib.
Other ingredients are:
- Capsule content: colloidal anhydrous 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%), isopropyl alcohol, butanol, propylene glycol, purified water, concentrated ammonia, potassium hydroxide, black iron oxide.
What the medicine looks like and the contents of the pack
Retsevmo 40 mg is a gray, opaque hard gelatin capsule, marked with “Lilly”, “3977” and “40 mg” in black.
Retsevmo 80 mg is a blue, opaque hard gelatin capsule, marked with “Lilly”, “2980” and “80 mg” in black.
Retsevmo is supplied in white opaque plastic jars with a plastic screw cap, which contains either 60 hard 40 mg capsules or 60 or 120 hard 80 mg capsules. Each carton contains a jar.
Retsevmo is available in blister packs of 14, 42, 56, or 168 hard 40 mg capsules and 14, 28, 56, or 112 80 mg capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Eli Lilly Nederland BV, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Manufacturer
Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Contact the representative of the marketing authorization holder if you would like to know more about this medicine: Eli Lilly Sweden AB Tel: + 46- (0) 8 7378800