Niraparib tablets (Zejula) - selected U.S. label sections
- Product / population
- ZEJULA film-coated tablets. This entry does not import an older capsule dosing regimen.
- Renal measure
- Creatinine clearance in mL/min as reported in PK section
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal pharmacokinetic comments
Mild to moderate impairment, reported as CrCl 30-90 mL/min, did not produce clinically significant pharmacokinetic differences. The effects of severe impairment below 30 and ESRD with hemodialysis are unknown.
Dosing boundary
This PK comment is not a complete starting-dose selection algorithm. Use the current indication-, weight-, platelet- and toxicity-specific instructions for the exact product.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7f675e2-159c-490c-b6f4-3f16d9492b7d