VENCLYXTO Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Venclyxto 10 mg film-coated tablets. Venclyxto 50 mg film-coated tablets. Venclyxto 100 mg film-coated tablets.
Qualitative and quantitative composition
Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of venetoclax. Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of venetoclax. Venclyxto 100 mg film-coated ...
Pharmaceutical form
Film-coated tablet (tablet). Venclyxto 10 mg film-coated tablet: Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other. Venclyxto 50 mg film-coated tablet: ...
Therapeutic indications
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). Venclyxto in combination with ...
Posology and method of administration
Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology Dose-titration schedule The starting dose is 20 mg of venetoclax ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase (see sections 4.2 ...
Special warnings and precautions for use
Tumour lysis syndrome Tumour lysis syndrome, including fatal events, has occurred in patients with CLL with high tumour burden when treated with venetoclax (see section 4.8). Venetoclax can cause rapid ...
Interaction with other medicinal products and other forms of interaction
Venetoclax is predominantly metabolised by CYP3A. Agents that may alter venetoclax plasma concentrations CYP3A inhibitors Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment. Therefore, women of childbearing potential ...
Effects on ability to drive and use machines
Venclyxto has no or negligible influence on the ability to drive and use machines. Fatigue has been reported in some patients taking venetoclax and should be considered when assessing a patients ability ...
Undesirable effects
Summary of safety profile The overall safety profile of Venclyxto is based on data from 758 patients with CLL treated in clinical trials with venetoclax in combination with obinutuzumab or rituximab or ...
Overdose
There is no specific antidote for venetoclax. Patients who experience overdose should be closely monitored and appropriate supportive treatment provided. During dose-titration phase, treatment should be ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: L01XX52 Mechanism of action Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein. Overexpression ...
Pharmacokinetic properties
Absorption Following multiple oral administrations, maximum plasma concentration of venetoclax was reached 5-8 hours after dose. Venetoclax steady state AUC increased proportionally over the dose range ...
Preclinical safety data
Toxicities observed in animal studies with venetoclax included dose-dependent reductions in lymphocytes and red blood cell mass. Both effects were reversible after cessation of dosing with venetoclax, ...
List of excipients
Venclyxto 10 mg film-coated tablets Tablet core: Copovidone (K28) Colloidal anhydrous silica (E551) Polysorbate 80 (E433) Sodium stearyl fumarate Anhydrous calcium hydrogen phosphate (E341 (ii)) Film-coating: ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Venclyxto 10 mg film-coated tablets: 2 years. Venclyxto 50 mg film-coated tablets: 2 years. Venclyxto 100 mg film-coated tablets: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets. Venclyxto 10 mg tablets: The film-coated tablets are supplied in cartons ...
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
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Marketing authorization number(s)
EU/1/16/1138/001 (10 mg, 10 tablets) EU/1/16/1138/002 (10 mg, 14 tablets) EU/1/16/1138/003 (50 mg, 5 tablets) EU/1/16/1138/004 (50 mg, 7 tablets) EU/1/16/1138/005 (100 mg 7 tablets) EU/1/16/1138/006 (100 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 5 December 2016 Date of latest renewal: 6 September 2018
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