VITRAKVI 20 mg/mL oral solution

• 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.

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

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.

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.

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

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

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.

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

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.

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.

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

• sucrose: it may be harmful to the teeth. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• 22 mg sorbitol in 1 mL. Sorbitol is a source of fructose. If your doctor has told you that you or your child have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you or your child take or receive this medicine.
• less than 1 mmol (or 23 mg) of sodium per 5 mL, that is to say essentially ‘sodium free’.
• 1.2 mg propylene glycol in 1 mL. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
• parahydroxybenzoate: it may cause allergic reactions (possibly delayed).

Adults (from 18 years)

• The recommended dose of VITRAKVI is 100 mg (5 mL), 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 (5 mL), two times a day.
• Your child’s doctor will review the dose and change it as needed.

• VITRAKVI can be taken with or without food.
• Do not eat grapefruit or drink grapefruit juice while taking this medicine.
• Along with this medicine you need a bottle adapter (28 mm diameter) and a syringe that can be used to give medicines by mouth. Use a 1 mL syringe with 0.1 mL marks for doses less than 1 mL. Use a 5 mL syringe with 0.2 mL marks for doses of 1 mL or more.
  • Press the bottle cap and turn it anti-clockwise to open the bottle.
  • Put the bottle adapter into the bottle neck and make sure it is well fixed.
  • Push the plunger fully into the syringe and then put the syringe in the adapter opening. Turn the bottle upside down.
  • Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger upwards to remove any large bubbles that are in the syringe.
  • Pull the plunger down to the mark equal to the dose in mL prescribed by your doctor.
  • Turn the bottle the right way up and take the syringe out of the adapter.
  • Put the syringe in the mouth, pointing towards the inside of the cheek – this will help you swallow the medicine naturally. Slowly press the plunger in.
  • Put the bottle cap on and tightly close the bottle - leave the adapter in the bottle.

If necessary, VITRAKVI may be administered via a nasogastric feeding tube. For details how to do so, please ask your doctor, pharmacist or nurse.

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

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.

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.

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.

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

The active substance is larotrectinib.

Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).

The other ingredients are:

• Purified water
• Sucrose
• Hydroxypropylbetadex 0.69
• Glycerol (E 422)
• Sorbitol (E 420)
• Sodium citrate (E 331)
• Sodium dihydrogen phosphate dihydrate (E 339)
• Citric acid (E 330)
• Propylene glycol (E 1520)
• Potassium sorbate (E 202)
• Methyl parahydroxybenzoate (E 218)
• Citrus fruit flavour
• Natural flavour

See “VITRAKVI contains” in section 2 for more information.

VITRAKVI is a clear yellow to orange oral solution.

Each carton contains 1 child-resistant glass bottle containing 100 mL oral solution.

For any information about this medicine, please contact