Nirova 100 mg (Capsule)
Unit Price: ৳ 1,095.00 (1 x 6: ৳ 6,570.00)
Strip Price: ৳ 6,570.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Niraparib |
| Company | Beacon pharmaceuticals plc |
Indications
- Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Adult patients
- Complete or partial response to platinum-based chemotherapy
Pharmacology
- Inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes
- Role in DNA repair
- Cytotoxicity induction
- DNA damage, apoptosis, and cell death
- Increased cytotoxicity in tumor cell lines with or without deficiencies in BRCA1/2
- Decreased tumor growth in mouse xenograft models
- Metabolism primarily by carboxylesterases (CEs)
- Excretion in urine and feces
Dosage & Administration
- Recommended dose of 300 mg as monotherapy
- Oral administration once daily
- Swallow whole with water
- Start treatment no later than 8 weeks after platinum-containing regimen
- Continue until disease progression or unacceptable toxicity
Interaction
- Inhibition of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4)
- Caution with concomitant administration of certain active substances
- Induction of CYPs (CYP1A2 and CYP3A4)
- Caution with certain active substances
Contraindications
- Hypersensitivity to the active substance or excipients
- Breast-feeding
Side Effects
- 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
- Dysgeusia
- Serious adverse reactions of thrombocytopenia and anaemia
Pregnancy & Lactation
- Contraception in females
- Pregnancy test for women of childbearing potential
- Effective contraception during therapy and for 1 month after last dose
- Avoid use during pregnancy
- Breast-feeding contraindicated
- Unknown excretion in human milk
- Reversible reduction of spermatogenesis observed in rats and dogs
Precautions & Warnings
- Myelodysplastic syndrome/acute myeloid leukaemia
- Hypertension including hypertensive crisis
- Pre-existing hypertension control
- Monthly blood pressure monitoring for the first year
- Pregnancy/contraception precautions
- Lactose intolerance in patients
- Tartrazine (E102) allergy
Use in Special Populations
- Elderly - no dose adjustment necessary
- Limited clinical data in patients aged 75 or over
- Safety and efficacy not established in children and adolescents below 18 years
- No data in severe renal or hepatic impairment
- Caution in severe renal or hepatic impairment
Overdose Effects
- No specific treatment in case of overdose
- Physicians should follow general supportive measures
- Symptomatic treatment
Therapeutic Class
- Cytotoxic Chemotherapy
Storage Conditions
- Store in a cool and dry place
- Do not store above 30°C
- Avoid exposure to temperatures greater than 40°C or 104°F
- Keep out of the reach and sight of children