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).
Elimination:
Half-life: 25.9 hours.
Generic Availability:
NO
How Supplied:
Tabs—60
Pricing for RUBRACA
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).
Elimination:
Half-life: 25.9 hours.
Generic Availability:
NO
How Supplied:
Tabs—60
