Olaparix (Olaparib) 50 MG

Breast Cancer: Olaparix (Olaparib) indicate as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before Olaparib treatment is initiated.

Ovarian Cancer: Olaparix (Olaparib) indicate as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum based chemotherapy.

There is a risk of medication errors between Olaparib tablets and Olaparib capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepare and dispense is Olaparib tablets and not Olaparib capsules. Prescribers should specify the formulation and dosage of Olaparib on each prescription.

The recommended total daily dose of Olaparix (Olaparib) tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.

For treatment of ovarian cancer: Patients start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olaparib therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).

It recommend that Olaparib treatment continue until progression of the underlying disease or unacceptable toxicity. Olaparib should not given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that known to inhibit CYP3A should not consume while taking Olaparib.

Pregnancy: Olaparib can cause fetal harm when administered to a pregnant woman base on its mechanism of action and findings in animals. Olaparib wasteratogenic and cause embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. While this drug use during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.

Nursing Mothers: It is not known whether olaparib excrete in human milk. Because many drugs excrete in human milk and because of the potential for serious adverse reactions in nursing infants from olaparib, a decision should made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olaparib, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML confirm.

Pneumonitis: This occurred in patients expose to Olaparib, and some cases fatal. Interrupt treatment if pneumonitis suspected. Discontinue if pneumonitis confirm.

Embryo-Fetal Toxicity: Olaparib can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception