Paribac 100 mg (Capsule)
Medicine Details
| Category | Details |
|---|---|
| Generic | Niraparib |
| Company | Ziska pharmaceuticals ltd |
| Also available as |
Indications
- Maintenance treatment
- Recurrent epithelial ovarian cancer
- Fallopian tube cancer
- Primary peritoneal cancer
- Platinum-based chemotherapy response
Pharmacology
- PARP-1 enzyme inhibitor
- PARP-2 enzyme inhibitor
- DNA repair
- Cytotoxicity induction
- BRCA1/2 deficiency sensitivity
- Metabolism by carboxylesterases
- Glucuronidation
- Bioavailability
- Plasma protein binding
- Volume of distribution
- Half-life
- Clearance
- Excretion in urine and feces
Dosage & Administration
- Recommended daily dose of 300mg
- Oral administration
- Three 100mg capsules
- Same time daily dosing
- Swallow whole
- With or without food
- Start within 8 weeks after platinum-based regimen
- Continue until disease progression or unacceptable toxicity
Interaction
- CYP enzyme inhibition
- CYP3A4 caution
- CYP1A2 induction caution
Contraindications
- Hypersensitivity to active substance or excipients
- Breastfeeding
Side Effects
- Nausea
- Thrombocytopenia
- Fatigue/asthenia
- Anemia
- Constipation
- Vomiting
- Abdominal pain
- Neutropenia
- Insomnia
- Headache
- Decreased appetite
- Nasopharyngitis
- Diarrhea
- Dyspnea
- Hypertension
- Dyspepsia
- Back pain
- Dizziness
- Cough
- Urinary tract infection
- Arthralgia
- Palpitations
- Dysgeusia
Pregnancy & Lactation
- Pregnancy test before treatment
- Contraception during therapy
- Not for use during pregnancy
- Breastfeeding contraindicated
- Potential embryonic/fetal harm
- Reversible reduction of spermatogenesis
Precautions & Warnings
- Myelodysplastic syndrome/acute myeloid leukemia risk
- Hypertension risk
- Pregnancy/contraception precautions
- Lactose intolerance caution
- Tartrazine allergy caution
Use in Special Populations
- No dose adjustment for elderly patients
- Limited data for patients over 75 years old
- Not established for children and adolescents
- No data for patients with severe renal impairment or end-stage renal disease undergoing hemodialysis
- Caution in patients with severe hepatic impairment
Overdose Effects
- No specific treatment
- Supportive and symptomatic treatment
Therapeutic Class
- Cytotoxic Chemotherapy
Storage Conditions
- Store in cool and dry place
- Do not expose to temperatures above 30°C or 86°F
- Keep out of reach of children