Rubraca (rucaparib)

Rubraca is a prescription medicine used for:

• the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy.
• the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer.

Your healthcare provider will perform a test to make sure Rubraca is right for you.

It is not known if Rubraca is safe and effective in children.

Rubraca may cause serious side effects.

The most common side effects of Rubraca include:

• nausea
• tiredness or weakness
• vomiting
• decrease in hemoglobin (anemia)
• changes in how food tastes
• constipation
• decreased appetite
• diarrhea
• low blood cell counts
• mouth sores
• upper respiratory tract infection
• shortness of breath
• rash
• changes in liver or kidney function blood tests
• stomach (abdomen) pain
• increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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). Information on the FDA-approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer is available at: http://www.fda.gov/CompanionDiagnostics.

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). An FDA-approved test for the detection of BRCA1/BRCA2 mutations in patients with mCRPC is not currently available.

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, the patient should wait 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

Effect Of Rucaparib On Cytochrome P450 (CYP) Substrates

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs.

Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

• Based on findings from animal studies and its mechanism of action, Rubraca can cause fetal harm when administered to pregnant women.
• There are no available data in pregnant women to inform the drug-associated risk.
• There is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child.
• Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks following the last dose.