Rubraca
(Rucaparib)Dosage & Administration
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Rubraca Prescribing Information
Indications and Usage (BRCA -mutated Recurrent Ovarian CancerRubraca is indicated 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. | 12/2022 |
| Indications and Usage, Treatment of BRCA -mutated Ovarian Cancer after 2 or More Chemotherapies (BRCA -mutated Recurrent Ovarian CancerRubraca is indicated 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. | 06/2022 |
Dosage and Administration (Maintenance Treatment of BRCA -mutated Recurrent Ovarian Cancer Select patients for the maintenance treatment of recurrent ovarian cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) [see Clinical Studies ].An FDA-approved test for the detection of deleterious germline and/or somatic BRCA mutations is not currently available.Treatment of BRCA -mutated mCRPC after Androgen Receptor-directed Therapy and Chemotherapy Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens[see Clinical Studies ]. A negative result from a plasma specimen does not mean that the patient's tumor is negative forBRCA mutations. Should the plasma specimen have a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.Information on the FDA-approved tests for the detection of a BRCA mutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics. | 12/2022 |
| Dosage and Administration, Treatment of BRCA -mutated Ovarian Cancer after 2 or More Chemotherapies (Maintenance Treatment of BRCA -mutated Recurrent Ovarian Cancer Select patients for the maintenance treatment of recurrent ovarian cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) [see Clinical Studies ].An FDA-approved test for the detection of deleterious germline and/or somatic BRCA mutations is not currently available.Treatment of BRCA -mutated mCRPC after Androgen Receptor-directed Therapy and Chemotherapy Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens[see Clinical Studies ]. A negative result from a plasma specimen does not mean that the patient's tumor is negative forBRCA mutations. Should the plasma specimen have a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.Information on the FDA-approved tests for the detection of a BRCA mutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics. | 06/2022 |
Warnings and Precautions (Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1594 treated patients with ovarian cancer [see Adverse Reactions ] , MDS/AML occurred in 32 patients (2%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.9%). 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 a germline and/or somatic BRCA mutation 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 TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation [see Adverse Reactions ]. 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 according to Table 1 [see Dosage and Administration ] 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. | 12/2022 |
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
- for the maintenance treatment of adult patients with a deleteriousBRCAmutation (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. ()
1.1 Maintenance Treatment ofBRCA-mutated Recurrent Ovarian CancerRubraca is indicated for the maintenance treatment of adult patients with a deleteriousBRCAmutation (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.
- for the treatment of adult patients with a deleteriousBRCAmutation (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. (,
1.2BRCA-mutated Metastatic Castration-Resistant Prostate CancerRubraca is indicated for the treatment of adult patients with a deleterious
BRCAmutation (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[see Dosage and Administration ].This indication is approved under accelerated approval based on objective response rate and duration of response
[see Clinical Studies ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.)2.1 Patient SelectionMaintenance Treatment ofBRCA-mutated Recurrent Ovarian CancerSelect patients for the maintenance treatment of recurrent ovarian cancer with Rubraca based on the presence of a deleteriousBRCAmutation (germline and/or somatic) [see Clinical Studies].An FDA-approved test for the detection of deleterious germline and/or somaticBRCAmutations is not currently available.Treatment ofBRCA-mutated mCRPC after Androgen Receptor-directed Therapy and ChemotherapySelect patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious
BRCAmutation (germline and/or somatic) in plasma specimens[see Clinical Studies ].A negative result from a plasma specimen does not mean that the patient's tumor is negative forBRCAmutations. Should the plasma specimen have a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.Information on the FDA-approved tests for the detection of a
BRCAmutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics.
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. (
Rubraca is indicated for the treatment of adult patients with a deleterious
This indication is approved under accelerated approval based on objective response rate and duration of response
- Recommended dose is 600 mg orally twice daily with or without food. ()
2.2 Recommended DoseThe 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 mg.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
- Continue treatment until disease progression or unacceptable toxicity. ()
2.2 Recommended DoseThe 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 mg.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
- For adverse reactions, consider interruption of treatment or dose reduction. ()
2.3 Dose Modifications for Adverse ReactionsTo manage adverse reactions, consider interruption of treatment or dose reduction. Recommended Rubraca dose modifications for adverse reactions are indicated in Table 1.
Table 1. Recommended Dose Modifications for Adverse Reactions Dose ReductionDoseStarting Dose 600 mg twice daily (two 300 mg tablets) First Dose Reduction 500 mg twice daily (two 250 mg tablets) Second Dose Reduction 400 mg twice daily (two 200 mg tablets) Third Dose Reduction 300 mg twice daily (one 300 mg tablet) - Patients receiving RUBRACA for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ()
2.2 Recommended DoseThe 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 mg.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
- Tablets (200 mg): blue, round, immediate-release, film-coated, debossed with “C2”.
- Tablets (250 mg): white, diamond, immediate-release, film-coated, debossed with “C25”.
- Tablets (300 mg): yellow, oval, immediate-release, film-coated, debossed with “C3”.
- Lactation: Advise women not to breastfeed. ()
8.2 LactationRisk SummaryThere is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks following the last dose.
None.