Select therapeutic use:

Gynecologic cancers:

Indications for RUBRACA:

Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults with complete or partial response to platinum-based chemotherapy. Treatment of deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have been treated with ≥2 chemotherapies (based on an FDA-approved companion diagnostic test).

Adult:

Confirm presence of a deleterious BRCA mutation. Swallow whole. 600mg twice daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: 1st reduction: 500mg twice daily; 2nd reduction: 400mg twice daily; 3rd reduction: 300mg twice daily.

Children:

Not established.

Warnings/Precautions:

Monitor CBC for cytopenia at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1). Interrupt or reduce dose for prolonged hematological toxicities (>4wks); monitor CBC weekly until recovered. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. 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).

Pharmacologic Class:

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

Interactions:

May potentiate CYP1A2, CYP3A, CYP2C9, CYP2C19 substrates; adjust dose of these if 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.

Elimination:

Half-life: 25.9 hours.

Generic Availability:

NO

How Supplied:

Tabs—60

Pricing for RUBRACA

300mg tablet (Qty: 120)
Appx. price $16809
GoodRx

Prostate and other male cancers:

Indications for RUBRACA:

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

Adult:

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:

Not established.

Warnings/Precautions:

Monitor CBC for cytopenia at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1). Interrupt or reduce dose for prolonged hematological toxicities (>4wks); monitor CBC weekly until recovered. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. 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).

Pharmacologic Class:

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

Interactions:

May potentiate CYP1A2, CYP3A, CYP2C9, CYP2C19 substrates; adjust dose of these if 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.

Elimination:

Half-life: 25.9 hours.

Generic Availability:

NO

How Supplied:

Tabs—60

Pricing for RUBRACA

300mg tablet (Qty: 120)
Appx. price $16809
GoodRx