Description

Hypersensitivity to the active substance or to any of the excipients & breast-feeding.

In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring > 10% of patients receiving Niraparib monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhoea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia. The most common serious adverse reactions >1% (treatment-emergent frequencies) were thrombocytopenia and anaemia.

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 test should be performed on all women of childbearing potential prior to treatment. Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Niraparib. Pregnancy: There are no or limited amount of data from the use of Niraparib in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted. However, based on its mechanism of action, niraparib could cause embryonic or foetal harm, including embryo-lethal and teratogenic effects, when administered to a pregnant woman. Niraparib should not be used during pregnancy. Breast-feeding: It is unknown whether niraparib or its metabolites are excreted in human milk. Breast-feeding is contraindicated during administration of Niraparib and for 1 month after receiving the last dose. Fertility: There are no clinical data on fertility. A reversible reduction of spermatogenesis was observed in rats and dogs.

Myelodysplastic syndrome/acute myeloid leukaemia: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Niraparib or placebo. In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4%) was similar to that in patients who received placebo (1.1%). Overall, MDS/AML has been reported in 7 out of 751 (0.9%) patients treated with Niraparib in clinical studies. The duration of Niraparib treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years. The cases were typical of secondary, cancer therapy-related MDS/AML. All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy. Some of the patients had a history of bone marrow dysplasia. If MDS and/or AML are confirmed while on treatment with Niraparib, treatment should be discontinued and the patient treated appropriately. Hypertension including hypertensive crisis: Hypertension, including hypertensive crisis, has been reported with the use of Niraparib. Pre-existing hypertension should be adequately controlled before starting Niraparib treatment. Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Niraparib. Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Niraparib dose, if necessary. In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Niraparib. In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Niraparib dose adjustment. Niraparib should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy. Pregnancy/contraception: Niraparib should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of Niraparib. A pregnancy test should be performed on all women of childbearing potential prior to treatment. Lactose: Niraparib hard capsules contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Tartrazine (E102): This medicinal product contains tartrazine (E 102), which may cause allergic reactions.

Elderly: No dose adjustment is necessary for elderly patients (> 65 years). There are limited clinical data in patients aged 75 or over. Paediatric population: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established. No data are available. Renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment. There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis; use with caution in these patients. Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. There are no data in patients with severe hepatic impairment; use with caution in these patients.

There is no specific treatment in the event of Niraparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.