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TASIGNA 50/200mg Hard capsule (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tasigna 50 mg hard capsules. Tasigna 200 mg hard capsules.

Qualitative and quantitative composition

Tasigna 50 mg hard capsules: One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate). Excipient with known effect: One hard capsule contains 39.03 mg lactose monohydrate. Tasigna 200 mg ...

Pharmaceutical form

Hard capsule. Tasigna 50 mg hard capsules: White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint NVR/ABL on cap. Tasigna 200 ...

Therapeutic indications

Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML. Posology Treatment should be continued as long as clinical benefit is observed or until unacceptable ...

Contraindications

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

Special warnings and precautions for use

Myelosuppression Treatment with nilotinib is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia. Occurrence is more frequent in patients ...

Interaction with other medicinal products and other forms of interaction

Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated. It may be given with hydroxyurea ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception Women of childbearing potential have to use highly effective contraception during treatment with nilotinib and for up to two weeks after ending treatment. ...

Effects on ability to drive and use machines

Tasigna has no or negligible influence on the ability to drive and use machines. However, it is recommended that patients experiencing dizziness, fatigue, visual impairment or other undesirable effects ...

Undesirable effects

Summary of the safety profile The data described below reflect exposure to nilotinib in a total of 737 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic ...

Overdose

Isolated reports of intentional overdose with nilotinib were reported, where an unspecified number of Tasigna hard capsules were ingested in combination with alcohol and other medicinal products. Events ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE08 Mechanism of action Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein ...

Pharmacokinetic properties

Absorption Peak concentrations of nilotinib are reached 3 hours after oral administration. Nilotinib absorption following oral administration was approximately 30%. The absolute bioavailability of nilotinib ...

Preclinical safety data

Nilotinib has been evaluated in safety pharmacology, repeated-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity (rats and mice) studies. Safety pharmacology studies ...

List of excipients

Tasigna 50 mg hard capsules Capsule content: Lactose monohydrate Crospovidone Type A Poloxamer 188 Colloidal anhydrous silica Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Red iron ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Tasigna is available in the following pack sizes: Tasigna 50 mg hard capsules: PVC/PVDC/Alu blisters: Pack containing 120 (3 packs of 40) hard capsules. Tasigna 200 mg hard capsules PVC/PVDC/Alu blisters: ...

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)

Tasigna 50 mg hard capsules: EU/1/07/422/015 Tasigna 200 mg hard capsules: EU/1/07/422/001-004 EU/1/07/422/007-008 EU/1/07/422/011-012 EU/1/07/422/014

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 November 2007 Date of latest renewal: 19 November 2012

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