Retsevmo - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• – This leaflet has been written as though the person taking the medicine is reading it. If you are giving this medicine to your child, please replace “you” with “your child” throughout.

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:

• – A type of lung cancer called non-small cell lung cancer, in adults.

• – Thyroid cancer (any type) in adults.

• – A rare type of thyroid cancer called medullary thyroid cancer in adults and adolescents 12 years

and older.

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

• – 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 taking Retsevmo:

• – If you have high blood pressure

• – If you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.

• – Retsevmo may affect fertility in females and males, which may affect your ability to have children. Talk to 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, talk to your Doctor. After checking your symptoms, your Doctor may ask you to take corticosteroids until your symptoms are better.

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

• – Retsevmo may affect your blood pressure. You will have your blood pressure measured before and during treatment with Retsevmo.

• – Retsevmo may affect the way your liver works. Tell your doctor right away if you develop symptoms of liver problems including: jaundice (yellow discoloration of the skin and eyes), loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area.

• – Retsevmo may result in abnormal ECGs. You will have an ECG taken before and during your treatment with Retsevmo. Tell your Doctor if you experience fainting as it may be a symptom of abnormal ECG.

• – You will have regular blood tests before and during treatment with Retsevmo, to check your liver function and electrolytes (such as sodium, potassium, magnesium and calcium) in your blood.

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:

• – medicines that may increase the concentration of Retsevmo in the blood:

o Clarithromycin (used to treat bacterial infections)

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

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

• – medicines that may reduce the effectiveness of Retsevmo:

o Carbamazepine (used to treat epilepsy, nerve pain, bipolar disorder)

o Rifampicin (used to treat tuberculosis (TB) and some other infections)

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

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

o Dasabuvir (used to treat hepatitis C)

o Selexipag (used to treat pulmonary arterial hypertension)

o Digoxin (used to treat heart disorders)

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

o Ranitidine, famotidine or other H2 blockers used to treat ulcers and acid reflux. If you are taking any of these medicines, then you need to take them 2 hours after taking Retsevmo

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:

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

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

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 as shown in the picture.

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:

• – Liver problems (which may affect more than 1 in 10 people and can be associated with abnormalities in liver blood tests, such as increased liver enzymes) including: yellow discoloration of the skin and eyes (jaundice), darkening of the urine, loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area

• – Allergic reaction typically shown by fever and muscle and joint pain followed by rash (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

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)

• – Dry mouth

• – Diarrhoea

• – Fatigue or tiredness

• – Constipation

• – Headache

• – Nausea (feeling sick), pain in the belly, vomiting,

• – Decreased appetite

• – Fluid retention that may cause swelling in your hands or ankles (oedema)

• – Increased blood levels of creatinine in tests, which may indicate that kidneys are not working properly (renal disorders)

• – Abnormal ECG

• – Reduced number of blood platelets, which may cause bleeding and/ bruising

• – Bleeding symptoms

• – Fever or high temperature

• – Rash

• – Dizziness

• – Reduced number of white blood cells

• – Low blood levels of magnesium

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. Y ou can also report side effects directly via the national reporting system listed in 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:

• – 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 per cent), Isopropyl alcohol, Butanol, Propylene glycol, Water, purified, Ammonia solution (concentrated), Potassium hydroxide, Iron oxide black

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

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

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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