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ZEJULA Hard capsule (2020)

Αναφορές

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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