Medicine information ZEJULA 100mg film-coated tablets

Product code:
W71587006
Quantity:
56
Indicated for:
cancer
Route of administration:
oral
Substance:
niraparib (PARP inhibitor)
ATC
L01XK02 — Antineoplastic and immunomodulating agents | Other antineoplastic agents | Poly (ADP-ribose) polymerase (PARP) inhibitors
Niraparib is a PARP (poly-ADP-ribose polymerase) enzyme inhibitor primarily used for the treatment of recurrent ovarian cancer. This medication is indicated for patients who have responded to platinum-based chemotherapy, serving as a maintenance therapy. Niraparib works by inhibiting DNA repair in cancer cells, leading to their death.

This drug is usually administered orally, once daily, with the dose adjusted based on the patient's weight and individual tolerance. Common side effects include nausea, fatigue, anemia, and constipation. Regular monitoring is essential to assess potential adverse reactions.

Niraparib is contraindicated in patients with hypersensitivity to the active substance or any of its excipients. Additionally, its use during pregnancy and breastfeeding is not recommended, as it may harm the fetus or infant.

This medication represents an important option for patients with ovarian cancer, offering a chance to prolong survival without disease progression. It is crucial that treatment is administered under the supervision of a specialist physician.

General data about ZEJULA 100mg

Substance:
niraparib
Date of latest medicines list:
01-10-2026
Product code:
W71587006
Strength:
100mg
Pharmaceutical form:
film-coated tablets
Quantity:
56
Product type:
Original
Price:
17884.37 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
MILLMOUNT HEALTHCARE LTD. - IRLANDA
Holder:
GLAXOSMITHKLINE TRADING SERVICES LIMITED - IRLANDA
Number:
1235/2017/01
Shelf life:
4 years

Combinations with other substances

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

Added to database:
27/11/2017
Source record updated:
10/06/2026

Warnings:

Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.