RUBRACA has demonstrated a well-established safety profile in BRCA-mutated mCRPC, supported by data from hundreds of patients across the TRITON2 and TRITON3 studies1

Adverse reactions (ARs) in ≥10% of patients with BRCA-mutated mCRPC1

General disorders/administration site conditions Musculoskeletal and connective tissue disorders Gastrointestinal disorders Fatigue/asthenia Edema* 61 18 7 0 65 20 10 0 61 19 ARPI or docetaxel
 (N=97) RUBRACA
 (N=373) TRITON2 +
 TRITON3 pooled Grades 
 1-4 (%) Grades 
 3-4 (%) Grades 
 1-4 (%) Grades
 3-4 (%) Grades 
 1-4 (%) TRITON3 RUBRACA
 (N=201) Metabolism and nutrition disorders Respiratory, thoracic, and mediastinal disorders Investigations Skin and subcutaneous tissue disorders Nervous system disorders Infections and infestations 53 51 31 7 2 2 57 22 29 8 1 1 52 52 27 31 25 2 1 17 10 1 1 30 26 17 34 1 1 10 20 1 2 15 35 13 19 12 1 1 1 6 13 0 0 1 0 13 20 10 16 1 13 0 16 Musculoskeletal pain* Nausea Diarrhea Constipation Vomiting Abdominal pain* Decreased appetite  Rash* Dyspnea* Photosensitivity reaction* Weight decreased Dysgeusia* Dizziness* Headache* Peripheral neuropathy* Urinary tract infection* 18 16 0 1 12 9 0 0 15 19 12 12 0 1 9 26 0 1 12 13 10 3 4 1 13
Gastrointestinal disorders Metabolism and nutrition disorders Skin and subcutaneous tissue disorders Infections and infestations Fatigue/asthenia Edema* Nausea Diarrhea Constipation Vomiting Abdominal pain* Decreased appetite  Rash* Photosensitivity reaction* * Urinary tract infection RUBRACA
 (N=201) Grades 
 1-4 (%) Grades 
 1-4 (%) General disorders/administration site conditions ARPI or docetaxel
 (N=97) TRITON3 61 65 20 22 29 17 10 10 20 6 0 4 18 51 31 31 25 17 34 13 12 10 Nervous system disorders Dysgeusia* Dizziness* Headache* Peripheral
 neuropathy* 12 9 9 26 18 16 12 12 Respiratory, thoracic, and mediastinal disorders Dyspnea* 13 19 Musculoskeletal and connective tissue disorders Musculoskeletal pain* 57 53 Investigations Weight decreased 13 16

*Includes multiple related terms.

Laboratory abnormalities in ≥25% of patients with BRCA-mutated mCRPC1

TRITON3 study participant characteristics at baseline.

†Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available for 192 to 201 patients in the RUBRACA arm and 94 to 97 patients in the ARPI or docetaxel arm.
‡NCI CTCAE version 5.0: decrease in phosphate is graded using NCI CTCAE version 4.03.

73% of patients did not have any serious ARs1

  • Serious ARs occurred in 27% of patients receiving RUBRACA. Serious ARs in ≥ 2% of patients included anemia (4%), pneumonia (4%), 
urinary tract infection (3%), acute kidney injury (3%), myocardial ischemia/infarction (2%), and pulmonary embolism (2%)

86% of patients remained on RUBRACA without discontinuing due to ARs1

  • ARs which led to permanent discontinuation of RUBRACA in ≥ 2% of patients included anemia (6%), fatigue/asthenia (3%), thrombocytopenia/platelet count decreased (3%), and nausea (2%)
Fatal ARs occurred in 1.5% of RUBRACA patients, including cardiac failure, myocardial ischemia, and sepsis (1 patient each)

RUBRACA’s discontinuation rate due to ARs was 8%

  • None of the ARs leading to discontinuation of RUBRACA occurred in more than 1 patient (<1%)
  • Other clinically relevant ARs that occurred in <20% of patients included dyspnea, dizziness, bleeding, urinary tract infection, dysgeusia, dyspepsia, hypersensitivity (including flushing, asthma, choking sensation, periorbital swelling, swelling face, and wheezing), pneumonia, sepsis, ischemic cardiovascular events, renal failure, venous thromboembolism, and stomatitis

LEARN ABOUT RUBRACA'S TWICE-DAILY ORAL DOSING

VIEW DOSING DETAILS

ALT, alanine aminotransferase; AST, aspartate transaminase; BRCA, BReast CAncer gene; CTCAE, Common Terminology Criteria for Adverse Events; mCRPC, metastatic castration-resistant prostate cancer; NCI, National Cancer Institute.

REFERENCE: 1. RUBRACA (rucaparib). Prescribing Information. pharmaand GmbH. 2025.

Tap for safety information

 

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 2141 treated patients with ovarian and prostate cancer, MDS/AML occurred in 34 patients (1.6%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.7%).

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 ARIEL3, of patients with ovarian cancer associated with a germline and/or somatic BRCA mutation who were treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

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.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities
(> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after
4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.

If MDS/AML is confirmed, discontinue RUBRACA.

Based on findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of 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 select laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA
in TRITON3 (≥ 25%, Grade 1-4) were increased ALT (68%), decreased neutrophils
(67%), decreased phosphate (64%), decreased hemoglobin (60%), increased AST (59%), increased creatinine (56%), increased glucose (45%), decreased lymphocytes (43%), decreased sodium (35%), decreased platelets (34%), and increased calcium (29%).

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%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

Full Prescribing Information available at: https://www.rubracahcp.com.

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.

Please see full Prescribing Information for RUBRACA.

EXPANDED INDICATION

NOW APPROVED FOR USE 
BEFORE OR AFTER CHEMOTHERAPY

for the treatment of BRCA-mutated mCRPC1

  • ⁨⁨Backed by new clinical data from the Phase 3 trial, TRITON3
  • The first and only PARPi studied head-to-head with chemotherapy2
  • Can be used after ANY ARPI

Learn more about the updated indication in the full Prescribing Information

View Updated Prescribing Information

ARPI, androgen receptor pathway inhibitor; BRCA, BReast CAncer gene; mCRPC, metastatic castration-resistant prostate cancer;

PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor.

REFERENCES: 1. RUBRACA (rucaparib). Prescribing Information. pharmaand GmbH. 2025. 2. Fizazi K, Piulats JM, Reaume MN, et al. Rucaparib or physician’s choice in metastatic prostate cancer. N Engl J Med. 2023;388(8):719-732.

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