Active ingredient
- larotrectinib sulfate
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: EU/1/19/1385/002.
VITRAKVI hard capsules
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the patient
VITRAKVI 25 mg hard capsules
VITRAKVI 100 mg hard capsules
larotrectinib
▼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 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
1. What VITRAKVI is and what it is used for
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
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.
2. What you need to know before you take VITRAKVI
Do not take VITRAKVI if
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:
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
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.
3. How to take VITRAKVI
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
Adults (from 18 years)
Children and adolescents
An oral solution of VITRAKVI is available for patients who cannot swallow the capsules.
How to take this medicine
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.
If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately contact your doctor if you experience any of the following serious side effects:
Your doctor may decide to lower the dose, or pause or stop the treatment.
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):
Common (may affect up to 1 in 10 people):
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.
5. How to store VITRAKVI
6. Contents of the pack and other information
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:
Printing ink:
What VITRAKVI looks like and the contents of the bottle
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:
This leaflet was last revised in 08/2020
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.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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