ZEJULA Hard capsule (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zejula 100 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib. Excipients with known effect: Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4). Each ...
Pharmaceutical form
Hard capsule (capsule). Hard capsule of approximately 22 mm × 8 mm; white body with 100 mg printed in black ink and purple cap with Niraparib printed in white ink.
Therapeutic indications
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who ...
Posology and method of administration
Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The dose is three 100 mg hard capsules once daily, equivalent to ...
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
Haematologic adverse reactions In the NOVA study, patients eligible for Zejula therapy had the following baseline haematologic parameters: absolute neutrophil count (ANC) ≥1,500 cells/μL; platelets ≥ 100,000 ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions The combination of niraparib with vaccines or immunosuppressant agents has not been studied. The data on niraparib in combination with cytotoxic medicinal products are limited. ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment. A pregnancy ...
Effects on ability to drive and use machines
Zejula has moderate influence on the ability to drive or use machines. Patients who take Zejula may experience asthenia, fatigue and dizziness. Patients who experience these symptoms should observe caution ...
Undesirable effects
Summary of the safety profile In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring ≥10% of patients receiving Zejula monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, ...
Overdose
There is no specific treatment in the event of Zejula overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: L01XX54 Mechanism of action and pharmacodynamic effects Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 ...
Pharmacokinetic properties
Absorption Following a single-dose administration of 300 mg niraparib under fasting conditions, niraparib was measurable in plasma within 30 minutes and the mean peak plasma concentration (C<sub>max</sub> ...
Preclinical safety data
Secondary pharmacology In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels. In mice, single doses of niraparib increased intracellular levels ...
List of excipients
Capsule content: Magnesium stearate Lactose monohydrate Capsule shell: Titanium dioxide (E171) Gelatin Brilliant blue FCF (E133) Erythrosine (E127) Tartrazine (E102) Printing ink: Shellac (E904) Propylene ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules. Not all pack sizes may be marketed.
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
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/17/1235/001 EU/1/17/1235/002 EU/1/17/1235/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 November 2017
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