Parib-50

Olaparib INN

Olaparib INN

Composition: Parib-: Each Capsule contains Olaparib INN 50mg.

Indications: 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 germline BRCA-mutated (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.

Dosage and Administration:

Recommended Dosing: The recommended dose of Olaparib is 400 mg (eight 50 mg capsules) taken orally twice daily with or without food, for a total daily dose of 800 mg. Continue treatment until disease progression or unacceptable toxicity. If a patient misses a dose of Olaparib, instruct patients to take their next dose at its scheduled time. Swallow capsule whole. Do not chew, dissolve, or open capsule. Do not take capsules which appear deformed or show evidence of leakage.

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. Because of the potential for serious adverse reactions in

the breastfed infants from Olaparib, lactating woman should be advised not to breastfeed during treatment with Olaparib and for one month after receiving the last dose.

Packing: Parib: Each container contains 112 capsule in a box.

Prescribing Description

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