Zejula (Niraparib) – Ovarian Cancer | DengYue Medicine

Zejula Application Scope

Zejula is an oral PARP inhibitor designed to improve progression-free survival in ovarian, fallopian tube, and primary peritoneal cancers.

Characteristics

• Ingredients: Niraparib

• Properties: Oral, once-daily PARP inhibitor targeting DNA repair enzymes PARP‑1/2

• Packaging Specification:

  • Capsules: 100 mg strength

  • Bottles of 30 or 90 capsules (NDC 69656‑103‑30/‑90)

  • Tablets (100, 200, 300 mg) in blister packs of 20

• Storage: Store at room temperature, away from moisture and light

• Expiry Date:

  • Refer to each bottle/pack for the individual expiration date

  • Typical shelf-life 2–3 years

• Executive Standard:

  • Meets FDA-approved drug standards (NDA 208447)

  • EU-approved via EMA epar dossier

• Approval Number:

  • Meets FDA-approved drug standards (NDA 208447)

  • EU-approved via EMA epar dossier

• Date of Revision:

  • US prescribing info updated June 2024

  • Tablet reformulation approved April 26, 2023

• Manufacturer:

  • Originally developed by Tesaro, Inc.

  • marketed and distributed by GlaxoSmithKline (GSK)

Guidelines for the Use of Zejula

• Dosage and Administration:

  • First-line maintenance (after platinum chemo):

    • 200 mg daily for patients <77 kg or platelets <150k/µL

    • 300 mg daily for patients ≥77 kg and platelets ≥150k/µL

  • Recurrent BRCA-mutated maintenance: 300 mg daily

  • Take at the same time each day, with or without food

  • Bedtime dosing may improve nausea control

  • Continue until progression or unacceptable toxicity

 

• Adverse Reactions:

  • Common:

    • fatigue, nausea/vomiting, thrombocytopenia, anemia

    • neutropenia, headache, constipation, hypertension

  • Serious:

    • MDS/AML, PRES, severe myelosuppression, hypertension

    • kidney issues, liver enzyme elevations, allergic reactions to FD&C Yellow No. 5

• Contraindications: None listed in US prescribing information

• Precautions:

  • Monitor CBC weekly for the first month, monthly through year one, then as needed

  • Check blood pressure weekly initially, then monthly

  • Watch for neurologic symptoms (PRES) and discontinue if diagnosed

  • Use contraception; avoid breast-feeding

Zejula Interactions

• Drug Interactions:

  • Metabolized by carboxylesterases and UGT

  • Use caution with enzyme inhibitors or inducers

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.