Generic name: rucaparib camsylate 200mg
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on Oct 12, 2020.
2.1 Patient Selection
Treatment of BRCA-mutated Ovarian Cancer after 2 or More Chemotherapies
Select patients for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) [see Clinical Studies (14.1)].
Treatment of BRCA-mutated mCRPC after Androgen Receptor-directed Therapy and Chemotherapy
Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens [see Clinical Studies (14.2)]. A negative result from a plasma specimen does not mean that the patient's tumor is negative for BRCA mutations. Should the plasma specimen have a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.
Information on the FDA-approved tests for the detection of a BRCA mutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dose
The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
2.3 Dose Modifications for Adverse Reactions
To manage adverse reactions, consider interruption of treatment or dose reduction. Recommended Rubraca dose modifications for adverse reactions are indicated in Table 1.
|Starting Dose||600 mg twice daily (two 300 mg tablets)|
|First Dose Reduction||500 mg twice daily (two 250 mg tablets)|
|Second Dose Reduction||400 mg twice daily (two 200 mg tablets)|
|Third Dose Reduction||300 mg twice daily (one 300 mg tablet)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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