INDICATIONS AND USAGE
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
· 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.
Prostate cancer
· for the treatment of adult patients 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. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information for additional Important Safety Information
DOSAGE AND ADMINISTRATION
·
Recommended
dose is 600 mg orally twice daily with or without food.
·
Continue
treatment until disease progression or unacceptable toxicity.
·
For
adverse reactions, consider interruption of treatment or dose reduction.
·
Patients
receiving RUBRACA for mCRPC should also receive a gonadotropin-releasing hormone
(GnRH) analog concurrently or should have had bilateral orchiectomy.
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, 250 mg, and 300
Please see full Prescribing Information for additional Important
Safety Information
CONTRAINDICATIONS
None.
Please see full Prescribing Information for additional Important
Safety Information
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. Interrupt or reduce the dose based on severity
of reaction. Discontinue if MDS/AML is confirmed.
·
Embryo-Fetal
Toxicity: RUBRACA can cause fetal harm. Advise of the potential risk to a fetus
and to use effective contraception.
Please see full Prescribing Information for additional Important
Safety Information
ADVERSE REACTIONS
·
Most
common adverse reactions (≥ 20%) among patients with ovarian cancer 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.)
·
Most
common adverse reactions (≥ 20%) among patients with BRCA- mutated mCRPC
were fatigue (including asthenia), nausea, anemia, ALT/AST increased, decreased
appetite, rash, constipation, thrombocytopenia, vomiting, diarrhea.
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.
Please see full Prescribing Information for additional Important
Safety Information
DRUG INTERACTIONS
·
CYP1A2,
CYP3A, CYP2C9, and CYP2C19 substrates: Adjust dosage of these substrates if clinically
indicated.
Please see full Prescribing Information for additional Important
Safety Information
USE IN SPECIFIC POPULATIONS
·
Lactation:
Advise women not to breastfeed.
Please see full Prescribing Information for additional Important
Safety Information
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PP-RUCA-US-1787 06/2022
Please see full Prescribing Information for additional Important Safety Information