ZEJULA 100 MG (NIRAPARIB)

What is Zejula?

Zejula is used as a “maintenance” treatment in adults to keep certain types of cancer from coming back. This includes cancers of the ovary (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).

📌 General Info

• Brand Name : Zejula

• Generic (Salt) : Niraparib

• Drug Class : Oral PARP inhibitor

• Formulation : 100 mg hard capsules

🏥 Indications

1. Maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after response to platinum-based chemotherapy .

2. First-line maintenance in advanced ovarian/fallopian/peritoneal cancer following platinum-response, regardless of BRCA status

3. Treatment of advanced ovarian cancer after ≥3 prior lines (for HRD-positive disease)

💊 Dosage & Administration

• Standard dose: 300 mg once daily (3 capsules)

• Adjusted dose : 200 mg once daily

• Dose modifications:

  • If hematologic toxicity: hold, then reduce to 200 mg → 100 mg → discontinue if necessary

• Continue until disease progression or unacceptable toxicity.

⚠️ Warnings & Precautions

• Hematologic toxicity: Thrombocytopenia (60–66%), anemia (56–64%), neutropenia (31–42%)—dose interruptions in up to 80%

• Myelodysplastic syndrome/AML: Recognized risk—monitor monthly blood counts and discontinue if suspected .

• Hypertension: Occurs in ~18%–17%—monitor BP monthly for the first year, then periodically.

• PRES (posterior reversible encephalopathy): Rare; watch for head pain, seizures, vision changes

• Pregnancy risk: Teratogenic—use contraception during treatment and for ≥6 months after .

• Renal/hepatic: Adjust in severe impairment; ensure monitoring .

⚠️ Common Side Effects

Frequent AEs (≥30%):

• Gastrointestinal: nausea (57–65%), vomiting (22–33%), constipation (39–40%), abdominal pain (35%)

• Fatigue: ~51–55%

• Musculoskeletal: pain in muscles/joints (~36–39%)

• Hematologic lab changes: see above

• Others: headache (26%), insomnia (25%), hypertension (17–18%), dyspnea, cough, dizziness, rash, renal events (~12–13%)

Serious events: Thrombocytopenia, anemia, neutropenia leading to dose pause or hospital care (~32% serious AEs) .

📝 Patient Tips

• Take capsule once daily at the same time, with or without food .

• Missed/vomited dose: Skip and resume next dose; do not double up

• Monitor: Monthly CBCs, BP, signs of PRES; adjust dose as needed .

• Avoid pregnancy: effective contraception for ≥6 months post-treatment

✅ Summary

Zejula is an effective oral PARP inhibitor for maintenance and later-line therapy in ovarian and related cancers, offering PFS benefits in both BRCA-positive and broader populations. Its use necessitates close monitoring for hematologic effects, hypertension, rare neurological complications, and reproductive safety.