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Other brands with the same active ingredient
These brands contain the same active ingredient (Niraparib). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Niragen 100 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Niraparib as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily. Instruct patients to take their dose of Niraparib at approximately the same time each day. Each capsule should be swallowed whole. Niraparib may be taken with or without food. Bedtime administration may be a potential method for managing nausea. Patients should start treatment with Niraparib no later than 8 weeks after their most recent platinum-containing regimen. Niraparib treatment should be continued until disease progression or unacceptable toxicity. In the case of a missed dose of Niraparib, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of Niraparib, an additional dose should not be taken.Niraparib is for oral use. The capsules should be swallowed whole with water. The capsules should not be chewed or crushed. Niraparib can be taken without regard to meals.
Side Effects
In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring > 10% of patients receiving Paribac 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.
Cautions & Contraindications
Warnings & Precautions
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 Paribac or placebo. In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received Paribac (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 Paribac in clinical studies. The duration of Paribac 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 Paribac, treatment should be discontinued and the patient treated appropriately.Hypertension including hypertensive crisis: Hypertension, including hypertensive crisis, has been reported with the use of Paribac. Pre-existing hypertension should be adequately controlled before starting Paribac treatment. Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Paribac. Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Paribac 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 Paribac. In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Paribac dose adjustment. Paribac should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.Pregnancy/contraception: Paribac 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 Paribac. A pregnancy test should be performed on all women of childbearing potential prior to treatment.Lactose: Paribac 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.
Contraindications
Hypersensitivity to the active substance or to any of the excipients & breast-feeding.