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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:
Pharmacology
Niraparib is an inhibitor of the poly (ADP-ribose) polymerase enzymes PARP-1 and PARP-2, which take part in DNA repair. In vitro studies suggest that the cytotoxicity caused by niraparib may involve two things: inhibition of PARP enzymatic activity, and a rise in the formation of PARP-DNA complexes. Together these lead to DNA damage, apoptosis and cell death. The cytotoxic effect of niraparib was greater in tumor cell lines whether or not they had deficiencies in BRCA1/2. Niraparib also slowed tumor growth in mouse xenograft models of human cancer cell lines with BRCA1/2 deficiencies. The same was seen in human patient-derived xenograft tumor models with homologous recombination deficiency, whether the BRCA1/2 was mutated or wild type.
Absorption: The absolute bioavailability of niraparib is approximately 73%. After an oral dose, the peak plasma concentration (Cmax) is reached within 3 hours. A high fat meal (800-1,000 calories, with approximately 50% of the total calories coming from fat) taken together with niraparib did not significantly affect its pharmacokinetics.
Distribution: Niraparib is 83.0% bound to human plasma proteins. The average (±SD) apparent volume of distribution (Vd/F) was 1220 (±1114) L. A population pharmacokinetic analysis gave a Vd/F of 1074 L for niraparib in cancer patients.
Elimination: After multiple daily doses of 300 mg niraparib, the mean half-life (t1/2) is 36 hours. In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib in cancer patients was 16.2 L/h.
Metabolism: Niraparib is metabolized mainly by carboxylesterases (CEs) into a major inactive metabolite, which then undergoes glucuronidation.
Excretion: A single oral 300 mg dose of radio-labeled niraparib was given. Over 21 days, the average recovery of the administered dose was 47.5% in urine (range 33.4% to 60.2%) and 38.8% in feces (range 28.3% to 47.0%). In pooled samples collected over 6 days, unchanged niraparib made up 11% of the administered dose recovered in urine and 19% of the dose recovered in feces.
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 when it is used alone is 300 mg, which is three 100 mg capsules, taken by mouth once daily. Patients should take it at about the same time each day. Swallow each capsule whole with water, and do not chew or crush the capsules. Niraparib can be taken with or without food, and it doesn't matter whether the patient has eaten. Taking the dose at bedtime may help in managing nausea.
Treatment with Niraparib should start no later than 8 weeks after the patient's most recent platinum-containing regimen. It should be continued until the disease progresses or the toxicity becomes unacceptable.
If a dose is missed, the patient should take the next dose at its regular time. If the patient vomits after a dose or misses a dose, an additional dose should not be taken.
Side Effects
In the pivotal ENGOT-OV16 study, more than 10% of patients taking Niraparib alone had adverse reactions (ADRs) such as 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, seen in more than 1% of patients (treatment-emergent frequencies), were thrombocytopenia and anaemia.
Cautions & Contraindications
Warnings & Precautions
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) has been reported in a small number of patients who received Niraparib or placebo, and some of these cases were fatal. In the pivotal Phase 3 international trial (ENGOT-OV16), MDS/AML occurred in 1.4% of patients on Niraparib and 1.1% of patients on placebo, so the two were similar. Across the clinical studies, MDS/AML was reported in 7 out of 751 (0.9%) patients treated with Niraparib. These patients had been taking Niraparib for anything from 1 month to more than 2 years before it developed. The cases were typical of secondary, cancer therapy-related MDS/AML. All of the patients had received multiple platinum-containing chemotherapy regimens, and many had also had other DNA damaging agents and radiotherapy. Some had a history of bone marrow dysplasia. If MDS and/or AML is confirmed during treatment with Niraparib, the treatment should be stopped and the patient treated appropriately. Hypertension, including hypertensive crisis, has been reported with Niraparib. Any existing hypertension should be adequately controlled before Niraparib is started. Blood pressure should be checked monthly for the first year and periodically after that for as long as the patient is on treatment. If hypertension develops, it should be managed medically with antihypertensive medicines, and the Niraparib dose adjusted if necessary. In the clinical programme, blood pressure was measured on Day 1 of each 28-day cycle while the patient stayed on Niraparib. In most cases, standard antihypertensive treatment controlled the hypertension adequately, with or without a change in the Niraparib dose. Niraparib should be stopped in case of hypertensive crisis, or if medically significant hypertension can't be adequately controlled with antihypertensive therapy. Niraparib should not be used during pregnancy. It should also not be used in women of childbearing potential who are not willing to use reliable contraception during therapy and for 1 month after the last dose. A pregnancy test should be done on all women of childbearing potential before treatment starts. 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. This medicine also contains tartrazine (E102), which may cause allergic reactions.
Contraindications
Don't give Niraparib to anyone who is allergic to it or to any of its excipients, or to a woman who is breast-feeding.
Pregnancy & Breastfeeding
Women who could become pregnant should not be pregnant when they start Niraparib, and they should not become pregnant while taking it. A pregnancy test should be done on every woman of childbearing potential before treatment begins. These women must use effective contraception during treatment and for 1 month after the last dose of Niraparib.
Pregnancy: There is little or no data on the use of Niraparib in pregnant women. Animal studies of reproductive and developmental toxicity have not been done. Still, going by how the medicine works, niraparib could harm an embryo or foetus, including embryo-lethal and teratogenic effects, if a pregnant woman takes it. Niraparib should not be used during pregnancy.
Breast-feeding: It isn't known whether niraparib or its metabolites pass into human milk. Breast-feeding is contraindicated while taking Niraparib and for 1 month after the last dose.
Fertility: There are no clinical data on fertility. A reversible reduction of spermatogenesis was seen in rats and dogs.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly: No dose change is needed for elderly patients (over 65 years). There are only 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 haven't been established yet, and no data are available.
Renal impairment: Patients with mild to moderate renal impairment don't need a dose change. There are no data in patients with severe renal impairment, or in end-stage renal disease where the patient is on hemodialysis, so use Niraparib with caution in these patients.
Hepatic impairment: Patients with mild to moderate hepatic impairment don't need a dose change. There are no data in patients with severe hepatic impairment, so use caution in these patients.
Overdose
There's no specific treatment if someone takes too much Niraparib, and the symptoms of an overdose haven't been established. If an overdose happens, doctors should give general supportive care and treat whatever symptoms appear.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Niraparib in a cool, dry place, and don't store it above 30°C. If you think it may have been exposed to temperatures greater than 40°C or 104°F, don't take it. Always keep Niraparib out of the reach and sight of children.
Drug Interactions
Common questions about Niragen 100 100 mg
What is Niragen 100 100 mg Capsule?
Niragen 100 100 mg Capsule is a medicine that contains Niraparib. It is made by General Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Niragen 100 used for?
Niragen 100 is used for: Cancer.
What are the side effects of Niragen 100?
In the pivotal ENGOT-OV16 study, more than 10% of patients taking Niraparib alone had adverse reactions (ADRs) such as 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, seen in more than 1% of patients (treatment-emergent frequencies), were thrombocytopenia and anaemia.
Can I take Niragen 100 during pregnancy or while breastfeeding?
Women who could become pregnant should not be pregnant when they start Niraparib, and they should not become pregnant while taking it. A pregnancy test should be done on every woman of childbearing potential before treatment begins. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Niragen 100?
There's no specific treatment if someone takes too much Niraparib, and the symptoms of an overdose haven't been established. If an overdose happens, doctors should give general supportive care and treat whatever symptoms appear. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Niragen 100?
Keep Niraparib in a cool, dry place, and don't store it above 30°C. If you think it may have been exposed to temperatures greater than 40°C or 104°F, don't take it.
Can I take other medicines with Niragen 100?
Some medicines can interact with Niraparib, for example: Ropinirole, Theophylline, Quetiapine, Clozapine, Tacrolimus, Cyclosporine. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Niragen 100?
Niragen 100 is a prescription (Rx) medicine. Take it as your doctor advises.