Can be used as a monotherapy for BRCA-mutated mCRPC before or after chemotherapy and following any ARPI†
To be used as a
monotherapy following
enzalutamide
or abiraterone in
HRR-mutated mCRPC
To be used in combination
with abiraterone and
either prednisone or prednisolone
in BRCA-mutated mCRPC
To be used in combination with enzalutamide in HRR-mutated mCRPC
To be used as a fixed combination with abiraterone in BRCA-mutated mCRPC, taken in combination with prednisone
Direct clinical comparisons between PARPis cannot be made in the absence of a head-to-head trial.
*Based on in vitro studies.
†Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
ELIGARD® (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.7
ELIGARD may impair fertility in males of reproductive potential.
For Important Safety Information and full Prescribing Information for ELIGARD, visit EligardHCP.com.
ARPI, androgen receptor-pathway inhibitor; BRCA, BReast CAncer gene; DNA, deoxyribonucleic acid; DSB, double-strand break; HRR, homologous recombination repair; LuPSMA, Lutetium-177-PSMA-617; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; PARPi, poly adenosine diphosphate-ribose polymerase inhibitor; PCa, prostate cancer; RLT, radioligand therapy; SSB, single-strand break.
RUBRACA® (rucaparib) is indicated 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.
The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/
cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/
or other DNA damaging agents.
In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.
If MDS/AML is confirmed, discontinue RUBRACA.
Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).
Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).
Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).
If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.
For medical information inquiries within the U.S., contact pharma& at medinfo.us@pharmaand.com.
You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/
medwatch.
Alternatively, to report an adverse event or reaction, contact pharma& at pv@pharmaand.com.
To report a product complaint, contact pharma& at complaints@pharmaand.com.
for the treatment of BRCA-mutated mCRPC1
Learn more about the updated indication in the full Prescribing Information
ARPI, androgen receptor pathway inhibitor; BRCA, BReast CAncer gene; mCRPC, metastatic castration-resistant prostate cancer;
PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor.