Olaparib: Brands, Price & Uses in Bangladesh

Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor approved for several BRCA-mutated or homologous-recombination-deficient (HRD) cancers, most often as maintenance therapy after response to chemotherapy. Indications are classified below by strength of evidence.

FDA-Approved / Established Uses

• Ovarian cancer: First-line maintenance treatment of BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have achieved a complete or partial response to first-line platinum-based chemotherapy; maintenance treatment of BRCA-mutated recurrent ovarian cancer in response to platinum-based chemotherapy.
• Ovarian cancer (combination/adjunct use): First-line maintenance treatment of HRD-positive advanced ovarian cancer, used in combination with bevacizumab, in patients responding to first-line platinum-based chemotherapy plus bevacizumab.
• Breast cancer: Adjuvant treatment of germline BRCA-mutated, HER2-negative high-risk early breast cancer after neoadjuvant or adjuvant chemotherapy; treatment of germline BRCA-mutated, HER2-negative metastatic breast cancer in patients previously treated with chemotherapy (hormone-receptor-positive disease requires prior endocrine therapy or is considered ineligible for it).
• Pancreatic cancer: First-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma in patients whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.
• Prostate cancer: Treatment of germline or somatic homologous-recombination-repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) that has progressed after prior treatment with enzalutamide or abiraterone.
• Prostate cancer (combination use): Treatment of BRCA-mutated mCRPC, used in combination with abiraterone and prednisone/prednisolone.

All indications require documented BRCA mutation, HRR gene mutation, or HRD status (confirmed by an approved companion diagnostic test) unless otherwise specified. Use of Olaparib outside these confirmed biomarker settings is not supported by current evidence.

The recommended dose of Olaparib (tablet formulation) is 300 mg taken orally twice daily, with or without food, for most approved indications. Tablets must be swallowed whole and should not be chewed, crushed, dissolved, or divided.

Dose Adjustments

• Renal impairment (moderate, creatinine clearance 31–50 mL/min): Reduce to 200 mg twice daily. Not recommended in severe renal impairment or end-stage renal disease due to lack of data.
• Hepatic impairment: No dose adjustment needed in mild impairment; not well studied in moderate-to-severe hepatic impairment — use with caution.
• Adverse reactions: Dose may be reduced stepwise (e.g., to 250 mg, then 200 mg twice daily) or interrupted, per physician assessment.
• Drug interactions: See Interactions section for CYP3A-based dose adjustments.

Any dose change must be made only under a physician's direction; patients should never adjust their own Olaparib dose.

Side effects of Olaparib range from common, generally manageable effects to rare but serious reactions requiring urgent medical attention.

Common Side Effects

• Nausea and vomiting
• Fatigue and weakness (asthenia)
• Anemia
• Diarrhea
• Decreased appetite
• Headache and dizziness
• Altered taste (dysgeusia)
• Cough and shortness of breath
• Low blood cell counts: neutropenia, leukopenia, thrombocytopenia

Serious Side Effects (Seek Medical Attention)

• Signs of myelodysplastic syndrome/acute myeloid leukemia (unusual bruising or bleeding, prolonged fever, persistent fatigue) — see Precautions and Warnings.
• Signs of pneumonitis (new or worsening shortness of breath, cough, fever) — see Precautions and Warnings.
• Signs of blood clots (leg swelling/pain, sudden chest pain, breathlessness).
• Signs of liver injury (yellowing of skin/eyes, dark urine, severe fatigue).

Patients should report any severe or persistent side effect to their physician promptly.