roo-KAP-a-rib

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

• Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have experienced a complete or partial response to platinum-based chemotherapy.
• Deleterious BRCA mutation-associated metastatic, castration-resistant prostate cancer in patients who have been treated with androgen-receptor directed therapy and a taxane-based chemotherapy regimen.

• Acts as a poly (ADP-ribose) polymerase (PARP) inhibitor, thereby disrupting DNA transcription, cell cycle regulation and DNA repair.

• Decreased growth and spread of epithelial ovarian, fallopian tube, primary peritoneal, or prostate cancer.

Absorption: 30–45% absorbed following oral administration; bioavailability increased but delayed with high-fat meal.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Extensively metabolized primarily by the CYP2D6 isoenzyme and to a lesser extent by the CYP1A2 and CYP3A4 isoenzymes; information regarding mode of elimination unknown.

Half-life: 17–19 hr.

(plasma concentrations)

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Severe hepatic impairment
• Severe renal impairment or dialysis
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

Derm: photosensitivity, rash, palmar-plantar erythrodysaesthesia syndrome, pruritus.

Endo: hypercholesterolemia.

GI: ↓ appetite, ↑ liver function tests, abdominal pain, constipation, diarrhea, nausea, vomiting.

GU: ↑ serum creatinine.

Hemat: anemia, lymphocytopenia, neutropenia, thrombocytopenia, MYELODYSPLASTIC SYNDROME/ACUTE MYELOID LEUKEMIA.

Neuro: dizziness, dysgeusia, fatigue.

Resp: dyspnea.

Misc: fever.

Drug-Drug:

• May ↑ levels and toxicity of CYP1A2 substrates, CYP2C9 substrates, CYP2C19 substrates, and CYP3A substrates; if concurrent administration unavoidable, consider ↓ dose of CYP1A2, CYP2C9, CYP2C19, or CYP3A substrate; if concurrent administration with warfarin unavoidable, monitor INR more frequently.

• PO (Adults): 600 mg twice daily until disease progression or unacceptable toxicity.

• Tablets: 200 mg; 250 mg; 300 mg;

• Monitor for signs and symptoms of myelodysplastic syndrome/acute myeloid leukemia during therapy. May require discontinuation of therapy.

• Select patients for maintenance treatment of recurrent ovarian cancer or for maintenance treatment of recurrent ovarian cancer based on the presence of a deleterious BRCA mutation (germline and/or somatic). For patient selection for BRCA-mutated ovarian cancer, information on the FDA-approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer is available at: www.fda.gov/CompanionDiagnostics.Verify negative pregnancy test prior to starting therapy.Monitor CBC prior to and monthly during therapy. Do not start rucaparib until hematologic toxicity from previous chemotherapy has recovered to ≤Grade 1. For prolonged hematologic toxicities, interrupt rucaparib and monitor CBC weekly until recovery. If levels have not recovered to ≤Grade 1 after 4 wk, refer patient to hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If myelodysplastic syndrome/acute myeloid leukemia is confirmed, discontinue rucaparib.
  • May cause anemia, thrombocytopenia, lymphocytopenia, and neutropenia.
  • May cause ↑ serum creatinine, ALT, AST, and cholesterol.

• Patients receiving rucaparib for metastatic, castration-resistant prostate cancer should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
• Recommended Dose Modifications for Adverse Reactions: Starting dose: 600 mg twice daily. 1st dose reduction: 500 mg twice daily. 2nd dose reduction: 400 mg twice daily. 3rd dose reduction: 300 mg twice daily.
• PO: Administer 2 tablets twice daily approximately 12 hr apart, without regard to food.

• Instruct patient to take rucaparib as directed. If a dose is missed, omit and take next dose at scheduled time. Do not replace vomited doses.
• Advise patient to notify health care professional if signs and symptoms of myelodysplastic syndrome/acute myeloid leukemia (weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool) occur.
• Advise patient to wear protective clothing and sunscreen to prevent photosensitivity reactions.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo following last dose of rucaparib and to avoid breast feeding during and for 2 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. Advise males to avoid donating sperm during therapy and for 3 mo after last dose.

• Decrease in growth and spread of ovarian, fallopian tube, primary peritoneal, or prostate cancer.

Rubraca

NDC Code^*

• 69660- Clovis Oncology, Inc.
  • 69660-201- Rubraca
    • 69660-201-91- 60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)

• 69660- Clovis Oncology, Inc.
  • 69660-202- Rubraca
    • 69660-202-91- 60 TABLET, FILM COATED in 1 BOTTLE (69660-202-91)

• 69660- Clovis Oncology, Inc.
  • 69660-203- Rubraca
    • 69660-203-91- 60 TABLET, FILM COATED in 1 BOTTLE (69660-203-91)