Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vitrakvi

Document Subject

Generated Narrative: MedicinalProductDefinition mpf7d3ef50226760b75f06fdcf55be16ab

identifier: http://ema.europa.eu/identifier/EU/1/19/1385/001 – VITRAKVI 25 mg

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VITRAKVI 25 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f7d3ef50226760b75f06fdcf55be16ab

identifier: http://ema.europa.eu/identifier/EU/1/19/1385/001 – VITRAKVI 25 mg

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - vitrakvi

Attesters

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 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.

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.

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)

• 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. If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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:

• feeling dizzy (very common side effect, may affect more than 1 in 10 people), tingling, feeling numb, or a burning feeling in your hands and feet, difficulty walking normally (common side effect, may affect up to 1 in 10 people). This could be symptoms of nervous system problems. 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):

• you may look pale and feel your heart pumping, which could be symptoms of low red blood cells (anaemia)
• flu like symptoms including fever, which could be symptoms of low white blood cells (neutropenia, leukopenia)
• feeling or being sick (nausea or vomiting)
• diarrhoea
• constipation
• muscle pain (myalgia)
• feeling tired (fatigue)
• increased amount of liver enzymes in blood tests
• weight increase.

Common (may affect up to 1 in 10 people):

• you may bruise or bleed more easily, which could be symptoms of reduced number of platelets (thrombocytopenia)
• change in how things taste (dysgeusia)
• muscle weakness
• increased amount of alkaline phosphatase in blood tests (very common in children).

Not known (not known how often they occur)

• you may experience a combination of tiredness, upper right stomach pain, loss of appetite, nausea or vomiting, yellowing of your skin or eyes, bruising or bleeding more easily, and dark urine. These could be symptoms of liver problems.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 carton and the bottle label 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 capsules look damaged.
• 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 to protect the environment.

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 larotrectinib (as sulfate).

The other ingredients are: Capsule shell:

• Gelatin

• Titanium dioxide (E 171) Printing ink:

• Shellac, bleached dewaxed

• Indigo carmine aluminium lake (E 132)

• Titanium dioxide (E 171)

• Propylene glycol (E 1520)

• Dimeticone 1What 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
Bayer AG 51368 Leverkusen
Germany

Manufacturer Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen
Germany

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

Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +37 05 23 36

T .: +359 (0)2 4247Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel:+36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-23-799 1Eesti Bayer O
Tel: +372 655 8Norge Bayer AS Tlf: +47 23 13 05
Bayer
: +30-210-61 87 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer SRL Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 8 1 Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785
NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3This 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.

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