300-mg pill bottle for RUBRACA with two C3 pills in front.

The recommended dose of RUBRACA is 600 mg (two 300-mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg1

  • Continue treatment with RUBRACA until disease progression or unacceptable toxicity
  • Patients receiving RUBRACA for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
RUBRACA is the ONLY PARPi that can be used as a monotherapy before or after chemotherapy and following ANY ARPI1-4*

*Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

RUBRACA offers dosing flexibility if adjustments are needed1

Dosing modifications are available to help manage adverse reactions (ARs), with 3 dosage strengths available

To manage ARs, consider interrupting treatment or reducing the dose.

64% of patients did not need a dose reduction1

  • The most frequent AR (≥5%) leading to reduction of RUBRACA was anemia (16%) and fatigue/asthenia (8%)
  • Patients with mild to moderate renal and/or hepatic impairment treated with RUBRACA do not need dose modifications

Dose interruptions due to an AR of any grade occurred in 53% of patients receiving RUBRACA1

  • The most frequent ARs (≥5%) leading to treatment interruption of RUBRACA included anemia (24%), fatigue/asthenia (10%), nausea (8%), and increase in ALT (5%)

Missed dose

  • If a patient misses a dose of RUBRACA, instruct the patient to take the next dose at the next scheduled time. Vomited doses should not be replaced

Drug–drug interactions

  • RUBRACA may interact with certain CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates

Please refer to the full Prescribing Information for details.

†Pill images are not actual size.
Doctor explaining to patient couple

Comprehensive support for RUBRACA is available for you
and your patients

find support

ALT, alanine transaminase; ARPI, androgen receptor-pathway inhibitor; mCRPC, metastatic castration-resistant prostate cancer; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor. 

REFERENCES: 1. RUBRACA (rucaparib). Prescribing Information. pharmaand GmbH. 2025. 2. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP. 2025. 3. Akeega (talazoparib). Prescribing Information. Janssen Biotech, Inc. 2024. 4. Talzenna (talazoparib). Prescribing Information. Pfizer Inc. 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.

The information contained in this website is intended for US healthcare professionals only.

By clicking the button below, you acknowledge that you are a US healthcare professional.

I am a US healthcare professional
Cancel

YOU ARE NOW LEAVING RubracaProstateHCP.com

Are you sure you want to leave?

Continue
Cancel and stay
Skip to content
Rubraca® HCP
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.