Retsevmo is a cancer medicine for use in patients whose cancer is caused by changes in a gene called RET. It can be used for:
- Advanced non-small cell lung cancer in adults not previously treated with a RET inhibitor.
- Advanced thyroid cancer in adults who had previously been treated with the cancer medicines sorafenib or Lenvatinib or both.
- Advanced medullary thyroid cancer in patients aged from 12 years.
Generic: Selpercatinib
How is Retsevmo used?
Retsevmo is available as capsules containing 40 or 80 mg selpercatinib. The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer treatments.
The dose of Retsevmo is 160 mg twice daily, reduced to 120 mg twice daily in patients weighing less than 50 kg. Treatment with Retsevmo can continue until it stops working or the patient has severe side effects.
The active substance in Retsevmo, selpercatinib, is a RET inhibitor, which belongs to a broader class of cancer medicines known as tyrosine kinase inhibitors. It blocks the activity of abnormal proteins, which are made by the body due to changes in the RET gene. In patients with such changes, these abnormal proteins can lead to uncontrolled cell growth and cancer. By blocking the proteins, selpercatinib helps to reduce the growth and spread of the cancer cells.
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.
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 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.
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 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 take 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.
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 broke or shows signs of tampering.
- Medicines should not dispose 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.
What are the risks associated with Retsevmo?
The most common side effects with Retsevmo (which may affect more than 1 in 10 people) are loss of appetite, headache, dizziness, prolonged QT interval (changes in the heart’s electrical activity), high blood pressure, abdominal (belly) pain, diarrhea, nausea (feeling sick), vomiting, constipation, dry mouth, rash, fever, tiredness, oedema (swelling caused by fluid build-up), bleeding, and blood tests showing changes in liver enzymes (indicating stress on the liver), decreased platelet (components that help the blood clot) and white blood cell counts, decreased magnesium and increased creatinine (indicating kidney problems).
The most common serious side effects are abdominal pain, hypersensitivity (allergic reactions), diarrhea and blood tests showing changes in liver enzymes.
Why is Retsevmo Authorized in the EU?
Retsevmo was find to effective at treating cancers involving changes to the RET gene, reducing the size of the cancer in most patients. Its side effects are consider manageable. The European Medicines Agency therefore decide that Retsevmo benefits are greater than its risks and it can Authorize for use in the EU.
Retsevmo has give ‘conditional Authorisation’. This means that although the European Medicines Agency decide that the benefits of Retsevmo are greater than its risks, the company will have to provide additional evidence after authorisation. Conditional authorisation is grant on the basis of less comprehensive data than are normally require. It is grant for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associate with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available, and this overview will be updated as necessary.
What information is still Awaited for Retsevmo?
Since Retsevmo has give conditional authorisation, the company that markets Retsevmo will provide results of studies to confirm its long-term effectiveness and safety, particularly in comparison with other medicines that are use for the cancers for which Retsevmo has authorize.
What benefits of Retsevmo have show in studies?
In one main study in patients with cancers cause by abnormalities in the RET gene, Retsevmo was effective at reducing Tumour size. In this study, Retsevmo was not compare with other medicines or placebo (a dummy treatment).
Advanced non-small cell lung cancer
In adults with non-small cell lung cancer who had previously received treatment with platinum-based chemotherapy, the cancer shrank in 64% (67 out of 105) of patients treated with Retsevmo. In previously untreated patients, 84% (58 out of 69) had a complete (no signs of cancer) or partial (shrinkage of the Tumour) response to treatment with Retsevmo.
Advanced thyroid cancer
In 19 adults with thyroid cancer who had previously been treat with sorafenib or Lenvatinib or both, the cancer shrank in 79% of patients.
Advanced medullary thyroid cancer
In adults and adolescents aged from 15 years with medullary thyroid cancer. The cancer shrank in 73.5% (111 out of 151) of patients who had previously treat with Cabozantinib or Vandetanib. And in 81% (115 out of 142) of patients who had not previously received treatment with Cabozantinib or Vandetanib.
Retsevmo is also expect to be effective in adolescents from 12 years of age with medullary thyroid cancer. Because the medicine is distribute in, and removed from, the body of these patients in the same way as for adults.
