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KISQALI Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Kisqali 200 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib. Excipients with known effect: Each film-coated tablet contains 0.344 mg soya lecithin. For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet. Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with RIC on one side and NVR on the other side.

Therapeutic indications

Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination ...

Posology and method of administration

Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies. Posology The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily ...

Contraindications

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

Special warnings and precautions for use

Critical visceral disease The efficacy and safety of ribociclib have not been studied in patients with critical visceral disease. Neutropenia Based on the severity of the neutropenia, treatment with Kisqali ...

Interaction with other medicinal products and other forms of interaction

Substances that may increase ribociclib plasma concentrations Ribociclib is primarily metabolised by CYP3A4. Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics ...

Fertility, pregnancy and lactation

Women of childbearing potential / Contraception Pregnancy status should be verified prior to starting treatment with Kisqali. Women of childbearing potential who are receiving Kisqali should use effective ...

Effects on ability to drive and use machines

Kisqali may have minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines in case they experience fatigue, dizziness or vertigo ...

Undesirable effects

Summary of the safety profile The most common ADRs and the most common grade ¾ ADRs (reported at a frequency ≥20% and ≥2%, respectively) in the pooled dataset for which the frequency for Kisqali plus any ...

Overdose

There is only limited experience with reported cases of overdosage with Kisqali. In the event of an overdose, symptoms such as nausea and vomiting may occur. In addition, haematological (e.g. neutropenia, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE42 Mechanism of action Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting ...

Pharmacokinetic properties

The pharmacokinetics of ribociclib were investigated in patients with advanced cancer following oral daily doses of 50 mg to 1200 mg. Healthy subjects received single oral doses ranging from 400 mg to ...

Preclinical safety data

Safety pharmacology In vivo cardiac safety studies in dogs demonstrated dose and concentration related QTc interval prolongation at an exposure that would be expected to be achieved in patients following ...

List of excipients

Tablet core: Microcrystalline cellulose Crospovidone type A Low-substituted hydroxypropylcellulose Magnesium stearate Colloidal anhydrous silica Film coating: Iron oxide black (E172) Iron oxide red (E172) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets. Unit packs containing 21, 42 or 63 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

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

EU/1/17/1221/001-012

Date of first authorization / renewal of the authorization

22 August 2017

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