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BIKTARVY Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Biktarvy 50 mg/200 mg/25 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. For the ...

3. Pharmaceutical form

Film-coated tablet (tablet). Purplish-brown, capsule-shaped, film-coated tablet debossed with GSI on one side and 9883 on the other side of the tablet. Each tablet is approximately 15 mm × 8 mm.

4.1. Therapeutic indications

Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine ...

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology One tablet to be taken once daily. Missed doses If the patient misses a dose of Biktarvy within 18 hours ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Co-administration with rifampicin and St Johns Wort (Hypericum perforatum) (see section 4.5).

4.4. Special warnings and precautions for use

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission ...

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

Interaction studies have only been performed in adults. Biktarvy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women. A large amount of data on pregnant women (more than 1,000 ...

4.7. Effects on ability to drive and use machines

Patients should be informed that dizziness has been reported during treatment with the components of Biktarvy (see section 4.8).

4.8. Undesirable effects

Summary of the safety profile The assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies with Biktarvy. In clinical studies of treatment-naive patients receiving ...

4.9. Overdose

If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Biktarvy consists of general supportive measures including monitoring of vital signs ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antiviral for systemic use; antivirals for treatment of HIV infections, combinations <b>ATC code:</b> J05AR20 Mechanism of action and pharmacodynamic effects Bictegravir ...

5.2. Pharmacokinetic properties

Absorption Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF. Relative to fasting conditions, the administration ...

5.3. Preclinical safety data

Bictegravir was not mutagenic or clastogenic in conventional genotoxicity assays. Bictegravir was not carcinogenic in a 6-month rasH2 transgenic mouse study (at doses of up to 100 mg/kg/day in males and ...

6.1. List of excipients

<u>Tablet core:</u> Microcrystalline cellulose Croscarmellose sodium Magnesium stearate <u>Film-coating:</u> Polyvinyl alcohol Titanium dioxide (E171) Macrogol Talc Iron oxide red (E172) Iron oxide black ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.

6.5. Nature and contents of container

White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each ...

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

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

8. Marketing authorization number(s)

EU/1/18/1289/001 EU/1/18/1289/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 21 June 2018

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