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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.
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here information is for informational purposes only.
The information contained herein should NOT be used as a substitute
for the advice of a qualified physician. This may not cover
everything about particular health conditions,
lab tests, medicines, all possible side effects, drug interactions,
warnings, alerts, etc. Please consult your healthcare professional
and discuss all your queries related to any disease or medicine. We
intend to support, not replace, the doctor-patient relationship.
