Parib-150

Olaparib INN

Olaparib INN

Composition: Parib-150: Each tablet contains Olaparib INN 150mg.

Indications: First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer: Olaparib is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Olaparib. Maintenance Treatment of Recurrent Ovarian Cancer: Olaparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Advanced gBRCA-mutated Ovarian Cancer After 3 or More Lines of Chemotherapy: Olaparib is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Olaparib. Germline BRCA-mutated HER2-negative Metastatic Breast Cancer: Olaparib is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Olaparib.

Dosage and Administration:

Recommended Dosing: The recommended dose of Olaparib is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. If a patient misses a dose of Olaparib, instruct patient to take their next dose at its scheduled time. Instruct patients to swallow tablets whole. Do not chew, crush, dissolve, or divide tablet. First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer: Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous treatment, can be treated beyond 2 years. Maintenance Treatment of Recurrent Ovarian Cancer: Continue treatment until disease progression or unacceptable toxicity. Advanced gBRCA-mutated Ovarian Cancer: Continue treatment until disease progression or unacceptable toxicity.

Germline BRCA-mutated HER2-negative Metastatic Breast Cancer: Continue treatment until disease progression or unacceptable toxicity.

Use in Pregnancy and Lactation: Based on mechanism of action Olaparib can cause fetal harm when administered to a pregnant woman. There are no available data on Olaparib use in pregnant women to inform the drug associated risk. Pregnant women should be apprised of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Packing: Parib-150: Each container contains 120 tablets in a box.

Prescribing Description

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