Applies to the following strength(s): 50 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Ovarian Cancer
Initial dose: 400 mg (eight 50 mg capsules) orally twice a day
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity
Comments: Patients should be selected based on the presence of deleterious or suspected deleterious germline BRCA-mutations, as detected by an approved test.
Use: Monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
Renal Dose Adjustments
-Mild Renal Dysfunction (CrCl 50 to 80 mL/min): No adjustment required, but close monitoring for toxicity recommended
-Moderate and Severe Renal Dysfunction (CrCl less than 50 mL/min): Data not available
Liver Dose Adjustments
Data not available
To manage adverse reactions, consider treatment interruption or dose reduction:
-1st dose reduction: 200 mg (four 50 mg capsules) orally twice a day
-2nd final dose reduction: 100 mg (two 50 mg capsules) orally twice a day
Avoid concomitant use of CYP450 3A inhibitors and consider alternative agents. If concomitant use cannot be avoided:
-Reduce dose to 200 mg (four 50 mg capsules) orally twice a day when used with moderate CYP450 3A inhibitor
-Reduce dose to 150 mg (three 50 mg capsules) orally twice a day when used with strong CYP450 3A inhibitor
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-In the event of a missed dose, advise patients to take their next dose at its scheduled time. Patients should not take an extra dose to make up for the missed dose.
-Advise patients to avoid grapefruit, grapefruit juice, and Seville oranges during treatment as they may increase the level of this drug in the blood.
-Capsules should be swallowed whole; do not chew, dissolve, or open.
-Capsules which appear deformed or show evidence of leakage should not be taken.
-Monitor complete blood count testing at baseline and monthly thereafter.
-For prolonged hematological toxicities, monitor blood counts weekly and interrupt treatment until recovery.
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- Drug class: PARP inhibitors
Other brands: Lynparza