TALZENNA Hard capsule (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Talzenna 0.25 mg hard capsules. Talzenna 1 mg hard capsules.
Qualitative and quantitative composition
Talzenna 0.25 mg hard capsules: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. Talzenna 1 mg hard capsules: Each hard capsule contains talazoparib tosylate equivalent ...
Pharmaceutical form
Hard capsule (capsule). Talzenna 0.25 mg hard capsules: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with Pfizer in black) and a white body (printed with TLZ 0.25 in ...
Therapeutic indications
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been ...
Posology and method of administration
Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patients should be selected for the treatment of breast cancer with Talzenna ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
Myelosuppression Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8). Talazoparib should not ...
Interaction with other medicinal products and other forms of interaction
Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound. Agents that may affect talazoparib ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment. ...
Effects on ability to drive and use machines
Talzenna may have a minor influence on the ability to drive and use machines. Fatigue/asthenia or dizziness may occur following administration of talazoparib.
Undesirable effects
Summary of the safety profile The overall safety profile of Talzenna is based on pooled data from 494 patients who received talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 ...
Overdose
There is limited experience of overdose with talazoparib. No adverse reactions were reported in one patient who accidentally self-administered thirty 1-mg capsules of talazoparib on Day 1 and was immediately ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: L01XX60 Mechanism of action Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2. PARP enzymes are involved in cellular DNA damage ...
Pharmacokinetic properties
Talazoparib exposure generally increased proportionally with dose across the range of 0.025 mg to 2 mg after daily administration of multiple doses. Following repeated daily dosing of 1 mg talazoparib ...
Preclinical safety data
Carcinogenicity Carcinogenicity studies have not been conducted with talazoparib. Genotoxicity Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Talazoparib was clastogenic in ...
List of excipients
Capsule content: Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 0.25 mg capsule shell: Hypromellose (HPMC) Yellow iron Oxide (E172) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Talzenna 0.25 mg hard capsules: High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner. Pack size: cartons of 30 capsules in a HDPE bottle. Polyvinyl chloride/polyvinylidene ...
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
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
Talzenna 0.25 mg hard capsules: EU/1/19/1377/001 EU/1/19/1377/002 EU/1/19/1377/003 EU/1/19/1377/004 Talzenna 1 mg hard capsules: EU/1/19/1377/005 EU/1/19/1377/006
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