Select therapeutic use:

Gynecologic Cancers:

Prostate and other male cancers:

Indications for: RUBRACA

In adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Adult Dosage:

Confirm presence of a deleterious BRCA mutation. Swallow whole. 600mg twice daily until disease progression or unacceptable toxicity. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. Dose modifications for adverse reactions: 1st reduction: 500mg twice daily; 2nd reduction: 400mg twice daily; 3rd reduction: 300mg twice daily.

Children Dosage:

Not established.

RUBRACA Warnings/Precautions:

Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1). Monitor CBCs for cytopenia at baseline and monthly thereafter. Interrupt or reduce dose for prolonged hematological toxicities (>4wks); monitor CBCs weekly until recovered. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Severe hepatic or renal (CrCl <30mL/min) impairment, on dialysis: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after last dose).

RUBRACA Classification:

Poly (ADP-ribose) polymerase (PARP) inhibitor.

RUBRACA Interactions:

May potentiate CYP1A2, CYP3A, CYP2C9, CYP2C19 substrates; if unavoidable, reduce dose of these as needed. Avoid concomitant warfarin; if unavoidable, monitor INR more frequently.

Adverse Reactions:

Nausea, fatigue, asthenia, vomiting, anemia, dysgeusia, AST/ALT elevation, constipation, decreased appetite, diarrhea, thrombocytopenia, neutropenia, stomatitis, nasopharyngitis/URI, rash, abdominal pain/distention, dyspnea, lab abnormalities (increased: creatinine, liver enzymes, cholesterol; decreased: hemoglobin, platelets, leukocytes, lymphocytes, neutrophils); rare: MDS/AML (may be fatal).

Metabolism:

CYP2D6 (primarily), CYP1A2, CYP3A4.

Drug Elimination:

Fecal, renal. Half-life: 25.9 hours.

Generic Drug Availability:

NO

How Supplied:

Tabs—60