Indications
Niragen Capsule is used for:
Ovarian Cancer
Adult Dose
Ovarian Cancer
Indicated for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
300 mg PO qDay; continue until disease progression or unacceptable toxicity
Hepatic impairment
Mild: No dose adjustment required
Moderate or severe: Not studied
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl ?30 mL/min): No dose adjustment required
Severe or ESRD: Not studied
Administration
May take with or without food
Initiate niraparib no later than 8 weeks after their most recent platinum-containing regimen
Instruct patient to take dose at about the same time each day
Contra Indications
Precautions
Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with fatal outcome, reported; discontinue drug if MDS/AML is confirmed
May cause bone marrow suppression resulting in hematologic toxicities (eg, thrombocytopenia, anemia, neutropenia); do not initiate until patients have recovered from hematological toxicities caused by previous chemotherapy (grade ≤1); monitor complete blood cell counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time (also see Dosage Modifications)
Hypertension and hypertensive crisis reported; monitor BP and HR monthly for the first year and periodically thereafter during treatment; medically manage hypertension with antihypertensive medications and niraparib dose adjustment
Based on its mechanism of action, can cause fetal harm if administered to a pregnant woman
Pregnancy-Lactation
Pregnancy
Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (eg, bone marrow)
A pregnancy test is recommended for females of reproductive potential prior to initiating drug
Based on animal studies, may impair fertility in males of reproductive potential
Contraception
Advise females of reproductive potential to use effective contraception during treatment for at least 6 months following the last dose
Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise a lactating woman not to breastfeed during treatment and for 1 month after receiving the final dose
Interactions
Side Effects
Side effects of Niraparib :
>10%
Nausea (74%)
Thrombocytopenia (61%)
Fatigue/asthenia (57%)
Anemia (50%)
Constipation (40%)
Vomiting (34%)
Abdominal pain/distention (33%)
Neutropenia (30%)
Thrombocytopenia, grades 3 or 4 (29%)
Insomnia (27%)
Headache (26%)
Anemia, grades 3 or 4 (25%)
Nasopharyngitis (23%)
Rash (21%)
Hypertension (20%)
Neutropenia, grades 3 or 4 (20%)
Mucositis/stomatitis (20%)
Diarrhea (20%)
Dyspepsia (20%)
Myalgia (19%)
Back pain (18%)
Dyspepsia (18%)
Dizziness (18%)
Leukopenia (17%)
Cough (16%)
UTI (13%)
Arthralgia (13%)
Anxiety (11%)
1-10%
Palpitations (10%)
Dry mouth (10%)
AST/ALT elevation (10%)
Dysgeusia (10%)
Hypertension, grade 3 or 4 (9%)
Leukopenia, grades 3 or 4 (5%)
Mode of Action
Poly (ADP-ribose) polymerase (PARP) inhibitor; niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage, apoptosis, and cell death
Note
Niragen 100 mg Capsule generic name is Niraparib. Niragen 100 mg Capsule is manufactured by General Pharmaceuticals Ltd.Niragen is availble in all over Bangladesh.
Mes BD drug index information on Niragen Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.