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VITRAKVI Hard capsule (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

VITRAKVI 25 mg hard capsules. VITRAKVI 100 mg hard capsules.

2. Qualitative and quantitative composition

<u>VITRAKVI 25 mg hard capsules:</u> Each hard capsule contains larotrectinib sulfate equivalent to 25 mg of larotrectinib. <u>VITRAKVI 100 mg hard capsules:</u> Each hard capsule contains larotrectinib ...

3. Pharmaceutical form

Hard capsule (capsule). <u>VITRAKVI 25 mg hard capsules:</u> White opaque hard gelatine capsule, size 2 (18 mm long x 6 mm wide), with blue printing of BAYER-cross and LARO 25 mg on body of capsule. <u> ...

4.1. Therapeutic indications

VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that ...

4.2. Posology and method of administration

Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies. The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Efficacy across tumour types The benefit of VITRAKVI has been established in single arm trials encompassing a relatively small sample of patients whose tumours exhibit NTRK gene fusions. Favourable effects ...

4.5. Interaction with other medicinal products and other forms of interaction

Effects of other agents on larotrectinib Effect of CYP3A, P-gp and BCRP inhibitors on larotrectinib Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females Based on the mechanism of action, foetal harm cannot be excluded when administering larotrectinib to a pregnant woman. Women of childbearing ...

4.7. Effects on ability to drive and use machines

VITRAKVI has a moderate influence on the ability to drive and use machines. Dizziness and fatigue have been reported in patients receiving larotrectinib, mostly Grade 1 and 2 during the first 3 months ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse drug reactions (≥ 20%) of VITRAKVI in order of decreasing frequency were increased ALT (32%), fatigue (30%), constipation (29%), increased AST (27%), ...

4.9. Overdose

There is limited experience of overdose with VITRAKVI. Symptoms of overdose are not established. In the event of overdose, physicians should follow general supportive measures and treat symptomatically. ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antineoplastic and immunomodulating agents, antineoplastic agents, protein kinase inhibitors <b>ATC code:</b> L01XE53 Mechanism of action Larotrectinib is an adenosine ...

5.2. Pharmacokinetic properties

In cancer patients given VITRAKVI capsules, peak plasma levels (C<sub>max</sub>) of larotrectinib were achieved at approximately 1 hour after dosing. Half-life (t<sub>½</sub>) is approximately 3 hours ...

5.3. Preclinical safety data

Systemic toxicity Systemic toxicity was assessed in studies with daily oral administration up to 3 months in rats and monkeys. Dose limiting skin lesions were only seen in rats and were primarily responsible ...

6.1. List of excipients

<u>Capsule shell:</u> Gelatin Titanium dioxide (E171) <u>Printing ink:</u> Shellac Indigo carmine aluminium lake (E132) Titanium dioxide (E171) Propylene glycol (E1520) Dimeticone

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer. Each carton contains one bottle of 56 hard capsules.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

8. Marketing authorization number(s)

EU/1/19/1385/001 – VITRAKVI 25 mg EU/1/19/1385/002 – VITRAKVI 100 mg

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 19 September 2019

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