These highlights do not include all the information needed to use RUBRACA safely and effectively. See full prescribing information for RUBRACA.
RUBRACA � (rucaparib) tablets, for oral use
Initial U.S. Approval: 2016
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2) 04/2018
Dosing and Administration (2.3) 04/2018
Warnings and Precautions (5.1) 04/2018
INDICATIONS AND USAGE
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. (1.1)
for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. (1.2, 2.3)
DOSAGE AND ADMINISTRATION
Recommended dose is 600 mg orally twice daily with or without food. (2.1)
Continue treatment until disease progression or unacceptable toxicity. (2.1)
For adverse reactions, consider interruption of treatment or dose reduction. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, 250 mg, and 300 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to RUBRACA, and some cases were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. (5.1)
Embryo-Fetal Toxicity: RUBRACA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.2, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (? 20%) were nausea, fatigue (including asthenia), vomiting, anemia, dysgeusia, AST/ALT elevation, constipation, decreased appetite, diarrhea, thrombocytopenia, neutropenia, stomatitis, nasopharyngitis/URI, rash, abdominal pain/distention, and dyspnea (6.1)
Most common laboratory abnormalities (? 25%) were increase in creatinine, increase in ALT, increase in AST, increase in alkaline phosphatase, decrease in hemoglobin, increase in cholesterol, decrease in platelets, decrease in leukocytes, decrease in lymphocytes, and decrease in neutrophils. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Clovis Oncology, Inc. at 1-844-258-7662 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP1A2, CYP3A, CYP2C9, and CYP2C19 substrates: Adjust dosage if clinically indicated. (7)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2018
