Rubraca Dosage

Generic name: RUCAPARIB CAMSYLATE 200mg
Dosage form: tablet, film coated
Drug class: PARP inhibitors

Medically reviewed by Drugs.com. Last updated on Feb 21, 2024.

Patient Selection

Maintenance Treatment ofBRCA-mutated Recurrent Ovarian Cancer

Select patients for the maintenance treatment of recurrent ovarian cancer with Rubraca based on the presence of a deleterious BRCAmutation (germline and/or somatic) [ see Clinical Studies ( 14.1) ].

An FDA-approved test for the detection of deleterious germline and/or somatic BRCAmutations is not currently available.

Treatment ofBRCA-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 BRCAmutation (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 BRCAmutations. 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 BRCAmutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics.

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.

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.

Table 1. Recommended Dose Modifications for Adverse Reactions
Dose Reduction	Dose
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)