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Lynparza Tablets Dosage

Generic name: OLAPARIB 100mg
Dosage form: tablet, film coated

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The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Important Administration Instructions

Lynparza is also available as a 50 mg capsule. DO NOT substitute Lynparza tablets (100 mg and 150 mg) with Lynparza capsules (50 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation [see Clinical Pharmacology (12.3)]. Refer to the full prescribing information for Lynparza capsules for specific capsule dosing.

Recommended Dosing

The recommended dose of Lynparza 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.

Continue treatment until disease progression or unacceptable toxicity.

If a patient misses a dose of Lynparza, instruct patient to take their next dose at its scheduled time.

Swallow tablets whole. Do not chew, crush, dissolve, or divide tablet [see How Supplied/Storage and Handling (16.2)].

Patient Selection for gBRCA-mutated Advanced Ovarian Cancer

Select patients for the treatment of advanced ovarian cancer with Lynparza based on the presence of deleterious or suspected deleterious BRCA-mutations [see Indications and Usage (1.2) and Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of BRCA-mutations is available at http://www.fda.gov/companiondiagnostics.

Dose Adjustments for Adverse Reactions

To manage adverse reactions, consider interruption of treatment or dose reduction.

The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) taken twice daily, for a total daily dose of 500 mg.

If a further dose reduction is required, then reduce to 200 mg (two 100 mg tablets) taken twice daily, for a total daily dose of 400 mg.

Dose Modifications for Use with CYP3A Inhibitors

Avoid concomitant use of strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition. If a strong CYP3A inhibitor must be co-administered, reduce the Lynparza dose to 100 mg (one 100 mg tablet) taken twice daily (equivalent to a total daily dose of 200 mg). If a moderate CYP3A inhibitor must be co-administered, reduce the Lynparza dose to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg) [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Dose Modifications for Patients with Renal Impairment

Patients with mild renal impairment (CLcr 51-80 mL/min as estimated by Cockcroft-Gault equation) do not require an adjustment in Lynparza dosing. In patients with moderate renal impairment (CLcr 31-50 ml/min) the recommended dose reduction is to 200 mg (two 100 mg tablets) twice daily, for a total daily dose of 400 mg. The pharmacokinetics of Lynparza have not been evaluated in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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