Rubraca

— THERAPEUTIC CATEGORIES —
  • Gynecologic cancers
  • Prostate and other male cancers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Rubraca Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rucaparib 200mg, 250mg, 300mg; tabs.

    Pharmacological Class

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

    How Supplied

    Tabs—60

    Manufacturer

    Clovis Oncology

    Generic Availability

    NO

    Rubraca Indications

    Indications

    Maintenance treatment in adults with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

    Rubraca Dosage and Administration

    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.

    Rubraca Contraindications

    Not Applicable

    Rubraca Boxed Warnings

    Not Applicable

    Rubraca Warnings/Precautions

    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 Pharmacokinetics

    Metabolism

    CYP2D6 (primarily), CYP1A2, CYP3A4.

    Elimination

    Fecal, renal. Half-life: 25.9 hours.

    Rubraca Interactions

    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.

    Rubraca Adverse Reactions

    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).

    Rubraca Clinical Trials

    See Literature

    Rubraca Note

    Not Applicable

    Rubraca Patient Counseling

    See Literature

    Rubraca Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Rucaparib 200mg, 250mg, 300mg; tabs.

    Pharmacological Class

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

    How Supplied

    Tabs—60

    Manufacturer

    Clovis Oncology

    Generic Availability

    NO

    Rubraca Indications

    Indications

    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.

    Rubraca Dosage and Administration

    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.

    Rubraca Contraindications

    Not Applicable

    Rubraca Boxed Warnings

    Not Applicable

    Rubraca Warnings/Precautions

    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 Pharmacokinetics

    Metabolism

    CYP2D6 (primarily), CYP1A2, CYP3A4.

    Elimination

    Fecal, renal. Half-life: 25.9 hours.

    Rubraca Interactions

    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.

    Rubraca Adverse Reactions

    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).

    Rubraca Clinical Trials

    See Literature

    Rubraca Note

    Not Applicable

    Rubraca Patient Counseling

    See Literature

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