PIFELTRO Film-coated tablet (2023)

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Περιεχόμενα

Name of the medicinal product

Pifeltro 100 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of doravirine. Excipient with known effect: Each film-coated tablet contains 222 mg lactose (as monohydrate). For the full list of excipients, see section ...

Pharmaceutical form

Film-coated tablet (tablet). White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 700 on one side and plain on the other side.

Therapeutic indications

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with human immunodeficiency ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology The recommended dose is one 100 mg tablet taken orally once daily with or without food. Dose adjustment ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated ...

Special warnings and precautions for use

NNRTI substitutions and use of doravirine Doravirine has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy. NNRTI-associated mutations detected at screening ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on doravirine Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine (see ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of doravirine in pregnant women. Antiretroviral pregnancy registry: To monitor maternal-foetal outcomes in patients exposed to antiretroviral ...

Effects on ability to drive and use machines

Pifeltro has a minor influence on the ability to drive and use machines. Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with doravirine (see section ...

Undesirable effects

Summary of the safety profile In phase 3 clinical trials with doravirine plus 2 NRTIs, the most frequently reported adverse reactions were nausea (4%) and headache (3%). Tabulated summary of adverse reactions ...

Overdose

There is no information on potential acute symptoms and signs of overdose with doravirine.

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use ATC code: J05AG06 Mechanism of action Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits ...

Pharmacokinetic properties

Absorption The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects. Doravirine pharmacokinetics are similar in healthy subjects and HIV-1-infected subjects. Steady ...

Preclinical safety data

Reproductive toxicity Reproduction studies with orally administered doravirine have been performed in rats and rabbits at exposures approximately 9 times (rats) and 8 times (rabbits) the exposure in humans ...

List of excipients

Tablet core: Croscarmellose sodium (E468) Hypromellose acetate succinate Lactose monohydrate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551) Film-coating: ...

Incompatibilities

Not applicable.

Shelf life

30 months. After first opening of the bottle use within 35 days.

Special precautions for storage

Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant. This medicinal product does not require any special temperature storage conditions. ...

Nature and contents of container

Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant. The following pack sizes are available: 1 bottle with 30 film-coated ...

Special precautions for disposal and other handling

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

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/18/1332/001 EU/1/18/1332/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 November 2018

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