AFINITOR Tablet (2022)

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Περιεχόμενα

1. Name of the medicinal product

AFINITOR 5 mg tablets. AFINITOR 10 mg tablets.

2. Qualitative and quantitative composition

AFINITOR 5 mg tablets: Each tablet contains 5 mg everolimus. Excipient with known effect: Each tablet contains 149 mg lactose. AFINITOR 10 mg tablets: Each tablet contains 10 mg everolimus. ...

3. Pharmaceutical form

White to slightly yellow, elongated tablets with a bevelled edge and no score. 5 mg: The tablets are engraved with 5 on one side and NVR on the other. 10 mg: The tablets are engraved with ...

4.1. Therapeutic indications

AFINITOR is indicated for The palliative treatment of patients with advanced renal cell carcinoma, who failed prior treatment with vascular endothelial growth factor receptor tyrosine kinase inhibitor ...

4.2. Posology and method of administration

Treatment with AFINITOR should be initiated by a medical practitioner experienced in the use of anticancer therapies. Posology Treatment should continue as long as clinical benefit is observed or until ...

4.3. Contraindications

Hypersensitivity to everolimus, to other rapamycin derivatives or to any of the excipients of AFINITOR (see section 4.4). Concomitant use of live vaccines. Pregnancy and lactation (see section 4.6).

4.4. Special warnings and precautions for use

Non-infectious interstitial pneumonitis Non-infectious interstitial pneumonitis is a class effect of rapamycin derivatives, including everolimus. Cases of non-infectious interstitial pneumonitis (including ...

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

Vaccinations Immunosuppressants may affect the response to vaccination and vaccination during treatment with AFINITOR may therefore be less effective. The use of live vaccines is contraindicated during ...

4.6. Fertility, pregnancy, and lactation

Pregnancy AFINITOR should not be given to pregnant women (see section 4.3). AFINITOR is contraindicated in pregnancy. Studies in animals have shown reproductive toxicity effects including embryotoxicity ...

4.7. Effects on ability to drive and use machines

Caution is advised when driving and using machines, until the effect of AFINITOR on the individual patient has been established.

4.8. Undesirable effects

Oncology Summary of the safety profile Adverse drug reaction (ADR, suspected to be related to treatment by the investigator) information is based on pooled safety data in patients receiving AFINITOR (N=2672) ...

4.9. Overdose

General symptomatic and supportive measures should be initiated in case of overdose.

5.1. Pharmacodynamic properties

A 34 Other: Selective immunosuppressive agents. Everolimus is an inhibitor targeting mTOR (mammalian target of rapamycin), or more specifically, mTORC1 (mammalian target of rapamycin complex 1). It exerts ...

5.2. Pharmacokinetic properties

Absorption In patients with advanced solid tumours, peak everolimus concentrations are reached 1 to 2 hours after administration of an oral dose of 5 to 710 mg everolimus under fasting conditions or with ...

6.1. List of excipients

Butylated hydroxytoluene (E321) (as antioxidant), magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose anhydrous.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Pack size 30: 3 years. Pack size 60 and 90: 2 years.

6.4. Special precautions for storage

Store at or below 30°C. Protect from light and moisture. Store in original package.

6.5. Nature and contents of container

Clear colourless thermoformed PA/Al/PVC (polyamide/aluminium/polyvinylchloride) blisters with silver aluminium foil backing. Pack size of 30, 60, and 90. Not all pack sizes may be marketed. The blister ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090

8. Marketing authorization number(s)

AFINITOR 5 mg tablets: 43/34/1010 AFINITOR 10 mg tablets: 43/34/1133

9. Date of first authorization / renewal of the authorization

The date on the registration certificate of the medicine: AFINITOR 5 mg tablets: 30 September 2011 AFINITOR 10 mg tablets: 30 September 2011

10. Date of revision of the text

28 October 2022

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