Generic Name and Formulations:
Rucaparib 200mg, 300mg; tabs.
Indications for RUBRACA:
Monotherapy in patients with deleterious BRCA-mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with ≥2 prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic test.
Swallow whole. 600mg twice daily until disease progression or unacceptable toxicity. Dose modifications or adjustments for adverse reactions: 1st reduction: 500mg twice daily; 2nd reduction: 400mg twice daily; 3rd reduction: 300mg twice daily.
Monitor CBC at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (Grade ≤1). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Embryo-fetal toxicity. Pregnancy; avoid. Females of reproductive potential must obtain pregnancy test prior to initiating therapy. Use effective contraception during therapy and for at least 6 months after last dose. Nursing mothers: not recommended (during and for 2 weeks after last dose).
Poly (ADP-ribose) polymerase (PARP) inhibitor.
Nausea, fatigue, asthenia, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, dyspnea, lab abnormalities (increased: creatinine, ALT/AST, cholesterol; decreased: hemoglobin, lymphocytes, platelets, ANC).