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Olaparib-
Breast Cancer:
Ovarib is approved as monotherapy for adult patients with HER2-negative metastatic breast cancer harboring confirmed or suspected harmful germline BRCA mutations (gBRCAm). Candidates should have previously undergone chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. For hormone receptor-positive cases, disease progression during or unsuitability for endocrine therapy must be confirmed.
Ovarian Cancer:
Indicated for maintenance therapy in adult patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy.
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✅ Description:
Olaparib is a PARP (poly ADP-ribose polymerase) enzyme inhibitor targeting PARP1, PARP2, and PARP3, which are involved in DNA repair, transcription, and cell cycle control. Inhibiting these enzymes, particularly in BRCA-deficient cells, induces DNA damage and promotes the death of cancer cells. Preclinical studies demonstrate tumor suppression in models both alone and after platinum chemotherapy.
Absorption: Rapid; peak levels in 1–3 hours post-dose. High-fat meals delay peak time by ~2 hours but only modestly increase overall exposure (~20% increase in AUC).
Distribution: Mean volume of distribution ~167 L. Plasma protein binding ~82%.
Metabolism: Mainly via CYP3A4/5. The majority of the circulating drug is unchanged Olaparib. Extensively metabolized to oxidized and conjugated forms.
Excretion: Half-life ~12 hours. ~44% eliminated via urine and 42% via feces, mostly as metabolites.
✔️ Dosage & Administration
Recommended Dose: 400 mg (eight 50 mg capsules) twice daily (total 800 mg/day), with or without food. Continue until disease progression or intolerable toxicity.
Missed Dose: If you miss a dose, skip it and take the next scheduled dose. Do not double-dose.
Administration Notes: Swallow capsules whole; do not chew, dissolve, or open.
Dose Adjustments:
Adverse Reactions:
- 1st reduction: 200 mg twice daily
- 2nd reduction: 100 mg twice daily
With CYP3A Inhibitors:
- Strong inhibitors: 150 mg twice daily
- Moderate inhibitors: 200 mg twice daily
Renal Impairment:
- Mild: No adjustment needed
- Moderate: 300 mg twice daily
- Severe: Not studied
✔️ Side Effects
Common Serious ADRs: Anemia (2.4%), neutropenia, and thrombocytopenia.
Discontinuation Rate: 4.9% in Ovarib arm vs 7.7% with chemotherapy.
Other Effects: Fatigue, nausea, vomiting, loss of appetite, diarrhea.
✔️ Interactions
Increased Levels: Strong CYP3A inhibitors (e.g., itraconazole) can significantly raise Olaparib levels. Avoid co-use; reduce dose if unavoidable. Also, avoid grapefruit and Seville oranges.
Decreased Levels: Strong CYP3A inducers (e.g., rifampicin) may lower efficacy by reducing plasma levels. Avoid co-administration.
✔️ Contraindications
Known hypersensitivity to Olaparib or any component of the formulation.
✔️ Use in Pregnancy & Lactation
Pregnancy: May harm the fetus based on the mechanism and animal studies. Avoid during pregnancy.
Lactation: Unknown if excreted in breast milk. Breastfeeding is not recommended during treatment.
✔️ Precautions & Warnings
MDS/AML Risk: <1.5% incidence. Monitor CBC at baseline and monthly. Discontinue if confirmed.
Pneumonitis: Rare but potentially fatal. Discontinue if confirmed and manage appropriately.
✔️ Storage:
Store below 30°C in a dry place away from light. Keep out of reach of children.
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
