Initial US Approval:
2016
Key Clinical Studies:
TRITON3 (NCT02975934)
Drug Class/Description:
poly (ADP-ribose) polymerase (PARP) inhibitor
Indications and Usage:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
- for the maintenance treatment of adult patients 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.
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. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.
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 mg
Contraindications:
None.
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.
Adverse Reactions:
- Most common adverse reactions (≥ 10%) among patients with ovarian cancer were nausea, fatigue (including asthenia), anemia, increased ALT/AST, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, increase in blood creatinine, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia.
- Most common adverse reactions (≥ 10%) among patients with BRCA-mutated mCRPC were fatigue/asthenia, musculoskeletal pain, nausea, anemia, decreased appetite, increased ALT/AST, constipation, diarrhea, vomiting, thrombocytopenia, dyspnea, increased blood creatinine, edema, dizziness, weight decreased, abdominal pain, dysgeusia, rash, neuropathy peripheral, urinary tract infection, cough, headache, hemorrhage, neutropenia, and photosensitivity reaction.
Use in Specific Populations:
- Lactation: Advise women not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
