25 mg and 100 mg hard capsules
larotrectinib
What VITRAKVI is and what it is used for
What VITRAKVI is used for
VITRAKVI contains the active substance larotrectinib.
The medicine is used for adults, adolescents, and children to treat solid tumors (cancer) in various places in the body and which are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).
VITRAKVI is used only when
- these tumors are advanced or have spread to other parts of the body or if an operation to remove the cancer is likely to cause serious complications and
- there is no satisfactory treatment option.
Before you receive VITRAKVI, the doctor will do a test to check if you carry the change in the NTRK gene.
How VITRAKVI works
In patients whose cancer is caused by a changed NTRK gene, the gene change causes the body to produce an abnormal protein, the so-called TRK fusion protein, which can lead to uncontrolled cell growth and cancer. VITRAKVI blocks the action of the TRK fusion proteins and can thus delay or stop cancer’s growth. It can also help shrink a tumor.
If you have any questions about how VITRAKVI works or why it has been prescribed for you, ask your doctor, pharmacist, or nurse.
What you need to know before you take VITRAKVI
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 cause the amount of the liver enzymes ALT and AST in your blood to increase. The doctor takes blood samples before and during treatment to check the levels of ALT and AST in the blood 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, as some medicines can affect how VITRAKVI works. Conversely, VITRAKVI can affect how other medicines work.
You must tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- itraconazole, voriconazole, clarithromycin, telithromycin, and troleandomycin for the treatment of fungal and bacterial infections
- ketoconazole for the treatment of Cushing’s syndrome
- atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, rifabutin or efavirenz to treat HIV infection
- nefazodone for the treatment of depression
- phenytoin, carbamazepine, and phenobarbital for the treatment of epilepsy
- (Traditional) herbal medicines containing St. John’s wort for the treatment of mild depression
- rifampicin for the treatment of tuberculosis
- alfenthalin, a strong pain reliever
- ciclosporin, sirolimus, or tacrolimus to prevent organ rejection after organ transplantation
- quinidine to treat abnormal heart rhythms
- dihydroergotamine or ergotamine for the treatment of migraine
- fentanyl for the treatment of chronic pain
- pimozide to control involuntary movements or sounds
- bupropion to help you quit smoking
- repaglinide and tolbutamide, to reduce blood sugar levels
- warfarin, to prevent blood clots
- omeprazole, to reduce the amount of acid produced in the stomach
- valsartan for the treatment of high blood pressure
- statins for the treatment of high blood lipids
- hormonal contraceptives, see the section “Contraceptives – for men and women” below.
Talk to your doctor, pharmacist, or nurse if you are taking any of these (or if you are not sure).
VITRAKVI with food and drink
Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI, as this may increase the amount of VITRAKVI in your body.
Pregnancy and breastfeeding
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 using this medicine.
- You should not use VITRAKVI during pregnancy because the effect of VITRAKVI on the fetus is unknown.
Breast-feeding
Do not breastfeed while taking this medicine and for 3 days after the last dose because it is unknown whether VITRAKVI is excreted in breast milk.
Contraceptives – for men and women
You should avoid becoming pregnant while taking this medicine.
If you are likely to become pregnant, your doctor should do a pregnancy test before starting your treatment.
You must use an effective method of contraception while taking VITRAKVI and for at least one month after the last dose if:
- you may be pregnant. If you use hormonal contraceptives, you must also use a barrier method, such as a condom
- you have sex with a woman who could become pregnant.
Talk to your doctor about the best birth control method for you.
Ability to drive, cycle and use machinery
VITRAKVI may cause dizziness or tiredness. If this happens, do not drive, ride a bicycle or use any tools or machinery.
How to take VITRAKVI
Always take this medicine as directed by your doctor or pharmacist. Consult a doctor, pharmacist, or nurse if you are unsure.
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), twice a day.
- The doctor will check the dose and adjust it if necessary.
Children and young people
- Your child’s doctor will calculate the appropriate dose for the child based on the child’s height and weight.
- The maximum recommended dose is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg) twice daily.
- Your child’s doctor will check the dose and adjust it if necessary.
VITRAKVI is available as an oral solution for patients who cannot swallow the capsules.
How to take the medicine
- VITRAKVI can be taken with or without food.
- Do not eat grapefruit or drink grapefruit juice while taking this medicine.
How to take this medicine
Swallow the VITRAKVI capsules whole with a glass of water. The capsules should not be opened, chewed, or crushed as the contents have a very bitter taste.
If you have taken too much VITRAKVI
Talk to a doctor, pharmacist, or nurse, or go to the hospital immediately. Take the medicine package and this leaflet with you.
If you have missed a dose of VITRAKVI
Do not take a double dose to make up for a missed dose or if you vomit after taking this medicine. Take the next dose at the usual time.
If you stop taking VITRAKVI
Do not stop taking this medicine without first talking to your doctor. You must take VITRAKVI for as long as your doctor tells you to.
Talk to the doctor immediately if you cannot take this medicine as prescribed by the doctor.
If you have any further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact a doctor immediately if you experience any of the following serious side effects :
- dizziness (very common side effect, may affect more than 1 in 10 users), tingling, numbness, or a burning sensation in the hands and feet, difficulty walking normally (common side effect, may affect up to 1 in 10 users). This may be a sign of problems with the nervous system.
The doctor may decide to lower the dose or to stop the treatment temporarily or permanently.
Tell your doctor, pharmacist, or nurse if you get any of the following side effects:
Very common (may affect more than 1 in 10 users):
- you may be pale and have palpitations which may be symptoms of a low number of red blood cells (anemia)
- flu-like symptoms, i.a. fever which can be symptoms of a low number of white blood cells ( neutropenia and leukopenia )
- nausea or vomiting
- constipation
- muscle pain ( myalgia )
- fatigue
- the increased amount of liver enzymes in blood samples
- weight gain.
Common (may affect up to 1 in 10 users):
- taste changes ( dysgeusia )
- muscle weakness
- elevated alkaline phosphatase in blood tests (very common in children).
How to store VITRAKVI
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton and can label after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if the capsules appear damaged.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is larotrectinib.
One VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).
One VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Other ingredients are:
Capsule shell:
- Gelatine
- Titanium dioxide (E 171)
Printing ink:
- Shellac, bleached, waxed
- Indigo carmine aluminum lacquer (E 132)
- Titanium dioxide (E 171)
- Propylene glycol (E 1520)
- Dimethicone 1000
Appearance and package sizes of the medicine
- VITRAKVI 25 mg is supplied as white opaque hard gelatin capsules (18 mm long x 6 mm wide), marked with a “BAYER” cross and “25 mg” in blue ink on the capsule base.
- VITRAKVI 100 mg is supplied as white opaque hard gelatin capsules (22 mm long x 7 mm wide), marked with a “BAYER” cross and “100 mg” in blue ink on the capsule base.
A carton contains 1 child-resistant plastic jar containing 56 hard gelatin capsules.
Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany