Active ingredient
- selpercatinib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 14895/0312.
Retsevmo 40mg, 80 mg
Package leaflet: Information for the patient
Retsevmo 40 mg hard capsules
Retsevmo 80 mg hard capsules
selpercatinib
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Retsevmo is and what it is used for
2. What you need to know before you take 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 an anticancer medicine containing the active substance selpercatinib.
It is used to treat either of the following cancers which are caused by certain abnormal changes in the RET gene and which have spread and/or cannot be removed by surgery:
Retsevmo can be prescribed if prior therapies have failed to control your lung or thyroid cancer.
Your doctor will perform a test to check if your cancer has a change in the RET gene to make sure that Retsevmo is right for you.
How Retsevmo works
In patients whose cancer has an altered RET gene, the change in the gene causes the body to make an abnormal RET protein, which can lead to uncontrolled cell growth and cancer. Retsevmo blocks the action of the abnormal RET protein and so may slow or stop the growth of the cancer. It may also help to shrink the cancer.
If you have any questions about how Retsevmo works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take Retsevmo
Do not take Retsevmo
Warnings and precautions
Talk to your doctor before taking Retsevmo:
Retsevmo may cause hypersensitivity reactions such as fever, rash and pain. If you experience any of these reactions, talk to your doctor. After checking your symptoms, your doctor may ask you to take corticosteroids until your symptoms are better.
A fast breakdown of cancer cells (tumour lysis syndrome, TLS) can occur when you are taking Retsevmo. This can cause 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, because this may increase the risks associated with TLS.
See section 4, “Possible side effects”, and talk to your doctor if you have any symptoms.
What your doctor will check before and during your treatment
Children and adolescents
Retsevmo is not intended for use in patients less than 18 years of age in lung or thyroid cancer other than medullary thyroid cancer.
The medullary thyroid cancer indication does not cover children younger than 12 years of age.
Other medicines and Retsevmo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist before taking Retsevmo if you are taking the following:
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor before taking this medicine.
You should not use Retsevmo during pregnancy, since the effect of Retsevmo on the unborn is not known.
Breast-feeding
Do not breast-feed during treatment with Retsevmo as Retsevmo could harm a breast-fed baby. It is not known if Retsevmo passes into breast milk. You should not breast-feed for at least one week after your last dose of Retsevmo.
Contraception
It is recommended that women avoid becoming pregnant and that men do not father children during treatment with Retsevmo, because this medicine could harm the baby. If there is any possibility that the person taking this medicine may become pregnant or father a child, they must use adequate contraception during treatment and for at least one week after the last dose of Retsevmo.
Fertility
Retsevmo can affect your ability to have children. Talk to your doctor to seek advice about fertility preservation prior to treatment.
Driving and using machines
You should take special care when driving and using machines as you may feel tired or dizzy while taking Retsevmo.
3. How to take Retsevmo
Always take this medicine exactly as your doctor or pharmacist has told you, at the dose prescribed for you. Check with your doctor or pharmacist if you are not sure.
How much to take
Your doctor will prescribe the right dose for you. The maximum recommended dose is as follows:
Retsevmo is taken twice a day at about the same time every day, preferably in the morning and evening.
If you get certain side effects while you are taking Retsevmo your doctor may lower your dose or stop treatment temporarily or permanently.
You can take the capsules either with or without food. Swallow the capsule whole with a glass of water. Do not chew, crush or split the capsule before swallowing.
The bottle is protected by a plastic screw cap:
To open the bottle, push down the plastic screw cap while turning it anticlockwise.
To close the bottle, turn the cap clockwise tightly.
If you take more Retsevmo than you should
If you take too many capsules, or if someone else takes your medicine, 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 the forgotten or vomited dose.
If you stop taking Retsevmo
Do not stop taking Retsevmo unless your doctor tells you to.
If you have any further questions on 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.
Contact your doctor immediately for any of the following: .
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)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the bottle label or blister card and 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 signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Retsevmo contains
The active substance is selpercatinib. Each hard capsule contains 40 or 80 mg selpercatinib.
The other ingredients are:
What Retsevmo looks like and contents of the pack
Retsevmo 40 mg is supplied as grey opaque hard gelatin capsule, with black “Lilly”, “3977” and “40 mg” script.
Retsevmo 80 mg is supplied as blue opaque hard gelatin capsule, with black “Lilly”, “2980” and “80 mg” script.
Retsevmo is available in a white opaque bottle with a plastic screw cap, containing 60 hard capsules of 40 mg and either 60 or 120 hard capsules of 80 mg. Each carton contains one bottle.
Retsevmo is available in blister packs of 14, 42, 56 or 168 hard capsules of 40 mg and 14, 28, 56 or 112 hard capsules of 80 mg.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in June 2022
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The Medicines & Healthcare products Regulatory Agency website: http://www.mhra.gov.uk/ will review new information on this medicine at least every year and this leaflet will be updated as necessary.
RE019
Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA
+44 (0)1256 315 000