Olaparib (Olanib) 50/150 mg

About (Olaparib)
Olanib 50mg:
Olanib 50/150 mg is indicate as monotherapy for the treatment of adult patients with deleterious or suspecte deleterious germline BRCA-mutate (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. In addition, patients with hormone receptor (HR)-positive breast cancer should have progressed on or be consider inappropriate for endocrine therapy. Germline BRCA mutation must be confirm before Olanib treatment is initiated. Olanib is 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 platinumbased chemotherapy.

Olanib 150mg:
Olaparib is indicated 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 Olanib 50/150 mg treatment is initiated. Ovarian Cancer: Olanib is indicated 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 platinumbased chemotherapy.

Dosage:

Important Dosage Information: DO NOT substitute Olaparib capsules (50 mg) with Olaparib tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Recommended Dosing: The 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 the capsule. Do not take capsules which appear deformed or show evidence of leakage.

Dosage Modifications for Adverse Reactions:

To manage adverse reactions, consider interruption of treatment or dose reduction. The recommended dose reduction is 200 mg (four 50 mg capsules) taken twice daily, for a total daily dose of 400 mg. If a further dose reduction is required, then reduce to 100 mg (two 50 mg capsules) taken twice daily, for a total daily
dose of 200 mg. Dose Modifications for Use with CYP3A Inhibitors: Avoid concomitant use of strong and moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition. If the
inhibitor cannot be avoided, reduce the Olanib 50/150 mg dose to 150 mg (three 50 mg capsules) taken twice daily for a strong CYP3A inhibitor or 200 mg (four 50 mg capsules) taken twice daily
for a moderate CYP3A inhibitor.
Dose Modifications for Patients with Renal Impairment: Moreover, patients with mild renal impairment (CICr 51-80 mL/min as estimated by Cockcroft-Gault equation) do not require an
adjustment in Olaparib dosing. In patients with moderate renal impairment (CICr 31-50 mL/min) the recommended dose reduction is to 300 mg (six 50 mg capsules) twice daily, for a
total daily dose of 600 mg. Again, the pharmacokinetics of Olaparib have not been evaluate in patients with severe renal impairment or end-stage renal disease (CICr <30 mL/min). Or as
directed by the registered physician.
Pediatric Use: The safety and efficacy of Olaparib has not been establish in pediatric patients.

Side Effects:

1. Dermatitis allergic.
2. Neutrophil count decreased
3. Platelet count decreased
The proportion of patients who permanently discontinued Olanib due to adverse events was 4.9% in the Olanib arm compare
with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olanib in more than one patient.

Storage:
Store in a dry place below 30°C. protect from light. Keep out of the reach of children.