VITRAKVI 100mg hard capsules

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 VITRAKVI is and what it is used for
2. What you need to know before you take VITRAKVI
3. How to take VITRAKVI
4. Possible side effects
5. How to store VITRAKVI
6. Contents of the pack and other information

What VITRAKVI is used for

VITRAKVI contains the active substance larotrectinib.

It is used in adults, adolescents and children to treat solid tumours (cancer) in various parts of the body that are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).

VITRAKVI is only used when

• these cancers are advanced or have spread to other parts of the body or if a surgery to remove the cancer is likely to cause severe complications and
• there are no satisfactory treatment options.

Before you are given VITRAKVI, your doctor will do a test to check if you have the change in the NTRK gene.

How VITRAKVI works

In patients whose cancer is due to an altered NTRK gene, the change in the gene causes the body to make an abnormal protein called TRK fusion protein, which can lead to uncontrolled cell growth and cancer. VITRAKVI blocks the action of TRK fusion proteins and so may slow or stop the growth of the cancer. It may also help to shrink the cancer.

If you have any questions on how VITRAKVI works or why it has been prescribed for you, ask your doctor, pharmacist or nurse.

Do not take VITRAKVI if

• you are allergic to larotrectinib or any of the other ingredients of this medicine (listed in section 6).

Tests and checks

VITRAKVI can increase the amount of the liver enzymes ALT and AST in your blood. Your doctor will do blood tests before and during treatment to check the level of ALT and AST and check how well your liver is working.

Other medicines and VITRAKVI

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way VITRAKVI works or VITRAKVI may affect how other medicines work.

In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• medicines used to treat fungal or bacterial infections called itraconazole, voriconazole, clarithromycin, telithromycin, troleandomycin
• a medicine used to treat Cushing’s syndrome called ketoconazole
• medicines used to treat HIV infection called atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, rifabutin, efavirenz
• a medicine used to treat depression called nefazodone
• medicines used to treat epilepsy called phenytoin, carbamazepine, phenobarbital
• a herbal medicine used to treat depression called St. John’s wort
• a medicine used to treat tuberculosis called rifampicin
• a medicine used for strong pain relief called alfentanil
• medicines used to prevent organ rejection after an organ transplant called ciclosporin, sirolimus, tacrolimus
• a medicine used to treat an abnormal heart rhythm called quinidine
• medicines used to treat migraines called dihydroergotamine, ergotamine
• a medicine used to treat long-term pain called fentanyl
• a medicine used to control involuntary movements or sounds called pimozide
• a medicine to help you stop smoking called bupropion
• medicines to reduce blood sugar levels called repaglinide, tolbutamide
• a medicine that prevents blood clots called warfarin
• a medicine used to reduce the amount of acid produced in the stomach called omeprazole
• a medicine used to help control high blood pressure called valsartan
• a group of medicines used to help lower cholesterol called statins
• hormonal medicines used for contraception, see section “contraception – for men and women” below.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse.

Taking VITRAKVI with food and drink

Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI. This is because it may increase the amount of VITRAKVI in your body.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use VITRAKVI during pregnancy since the effect of VITRAKVI on the unborn is not known.

Breast-feeding

Do not breast-feed while taking this medicine and for 3 days after the last dose. This is because it is not known if VITRAKVI passes into breast milk.

Contraception – for men and women

You should avoid getting pregnant while taking this medicine.

If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment. You must use effective methods of contraception while taking VITRAKVI and for at least 1 month after the last dose, if

• you are able to become pregnant. If you use hormonal contraceptives, you should also use a barrier method, such as a condom.
• you have sex with a woman able to become pregnant.

Ask your doctor about the best method of contraception for you.

Driving, cycling and using machines

VITRAKVI may make you feel dizzy or tired. If this happens, do not drive, cycle or use any tools or machines.

How much to take

Adults (from 18 years)

• The recommended dose of VITRAKVI is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg), two times a day.
• Your doctor will review your dose and change it as needed.

Children and adolescents

• Your child’s doctor will work out the right dose for your child based on their height and weight.
• The maximum recommended dose is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg), two times a day.
• Your child’s doctor will review the dose and change it as needed.

An oral solution of VITRAKVI is available for patients who cannot swallow the capsules.

How to take this medicine

• VITRAKVI can be taken with or without food.
• Do not eat grapefruit or drink grapefruit juice while taking this medicine.
• Swallow the VITRAKVI capsules whole with a glass of water. Do not open, chew or crush the capsule as it has a very bitter taste.

If you take more VITRAKVI than you should

Talk to your doctor, pharmacist or nurse or go to a hospital straight away. Take the medicine pack and this leaflet with you.

If you miss a dose of VITRAKVI

Do not take a double dose to make up for a forgotten dose or if you vomit after taking this medicine. Take your next dose at the usual time.

If you stop taking VITRAKVI

Do not stop taking this medicine without talking to your doctor first. It is important to take VITRAKVI for as long as your doctor tells you.

If you are not able to take the medicine as your doctor prescribed talk to your doctor straight away.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

What VITRAKVI contains

The active substance is larotrectinib.

Each VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).

Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinb (as sulfate).

The other ingredients are:

Capsule shell:

• Gelatin
• Titanium dioxide (E 171)

Printing ink:

• Shellac
• Indigo carmine aluminium lake (E 132)
• Titanium dioxide (E 171)
• Propylene glycol (E 1520)
• Dimeticone

What VITRAKVI looks like and the contents of the bottle

• VITRAKVI 25 mg is supplied as white opaque hard gelatine capsule, (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “25 mg” on the body of the capsule
• VITRAKVI 100 mg is supplied as white opaque hard gelatine capsule, (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “100 mg” on the body of the capsule

Each carton contains 1 child-resistant plastic bottle containing 56 hard gelatine capsules.

Marketing Authorisation Holder

Manufacturer

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