Medically reviewed on July 21, 2017.
Applies to the following strengths: 200 mg; 250 mg; 300 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Ovarian Cancer
600 mg orally twice a day
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity.
-Administer each dose about 12 hours apart, with or without food.
-Select patients based on the results of the approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer; the test is available at http://www.fda.gov/CompanionDiagnostics.
Use: Monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with 2 or more chemotherapies.
Renal Dose Adjustments
-Mild to Moderate Renal Impairment (CrCl 30 to 89 mL/min): No starting dose adjustment recommended.
-Severe Renal Impairment (CrCl less than 30 mL/min): Data not available.
Liver Dose Adjustments
-Mild Hepatic Impairment (total bilirubin equal to ULN or less AND AST greater than ULN, OR total bilirubin between 1 to 1.5 x ULN AND any AST): No starting dose adjustment recommended.
-Moderate to Severe Hepatic Impairment (total bilirubin greater than 1.5 x ULN): Data not available.
Adverse Reactions: Consider treatment interruption or dose reduction.
-First Dose Reduction: 500 mg orally twice a day
-Second Dose Reduction: 400 mg orally twice a day
-Third Dose Reduction: 300 mg orally twice a day
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, instruct patients to take the next dose at the usual scheduled time; vomited doses should not be replaced and extra doses should not be taken to make up for missed doses.
-Store at room temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit).
-The indication for this drug is under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
-Overdosage: Symptoms are not established and there is no specific treatment; use general supportive measures and treat symptomatically.
-Oncologic: CBC (baseline and monthly thereafter; weekly for prolonged hematological toxicities)
-This drug may make your skin more sun-sensitive; avoid spending time in sunlight during treatment.
-When outdoors in sunlight during treatment with this drug, use sunscreen and wear a hat and clothes that cover your skin to help protect against sunburn.
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Other brands: Rubraca