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COMPOSITION Olanib 150 Tablet: Each flim coated tablet contains Olaparib INN 150mg.
INDICATIONS AND USAGE Olaparib is a poly (ADP-ribose)polymerase(PARP)inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germ line BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
DOSAGE AND ADMINISTRATION
The recommended dose of Olaparib is 300 mg (two 150 mg tablets) taken twice daily,equivalent to a total daily dose of 600 mg. It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.Patients with platinum-sensitive relapsed(PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy should start treatment with Olaparib no later than 8 weeks after completion of their final dose of the platinum-con taining regimen. Important differences in posology between Olaparib tablets and capsules Olaparib tablets(100 mg and 150 mg)should not be substituted for Olaparib capsules(50 mg)on milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Therefore, the specific dose recommendations for each formulation should be followed. Missing dose If a patient misses a dose of Olaparib, they should take their next normal dose at its scheduled time. Dose adjustments for adverse reactions Treatment may be interrupted to manage adverse reactions such as nausea, vomiting,diarrhoea and anaemia and dose reduction can be considered The recommended dose reduction is to 250 mg twice daily(equivalent to a total daily dose of 500 mg) If a further dose reduction is required, then reduction to 200 mg twice daily (equivalent to a total daily dose of 400 mg) is recommended. Dose adjustments for co-administration with CYP3A inhibitors Concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternative agents should beconsidered.lfa strong CYP3A inhibitor must be co-administered the recommended Olaparib dose reduction is to 100 mg takentwice daily (equivalent to a total daily dose of 200 mg).If a moderate CYP3A inhibitor must be co-administeredthe recommended Olaparib dose reduction is to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg).
Most common adverse reactions (>20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngitis/URI, cough, arthralgia/musculoskeletal pain, myalgia, back pain,dermatitis rash and abdominal pain/discomfort. Most common laboratory abnormalities (>25%) were increase in creatinine, mean corpuscular volume elevation,decrease in hemoglobin, decrease in lymphocytes,decrease in leucocytes, decrease in absolute neutrophil count and decrease in platelets.