RUBRACA® (rucaparib) tablets by Clovis Oncology


Physician Resources: Ovarian
Patient Resources: Ovarian
Physician Resources: Prostate (mCRPC)
Patient Resources: Prostate (mCRPC)
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Indications & Usage

INDICATIONS AND USAGE

 

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

 

Ovarian cancer

·        for the maintenance treatment of adult patients with 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 deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.


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 and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

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.

 

 

Please see full Prescribing Information for additional Important Safety Information

 

Dosage & Administration

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

  

Please see full Prescribing Information for additional Important Safety Information

Contraindications

CONTRAINDICATIONS


None.

  

Please see full Prescribing Information for additional Important Safety Information

Warnings & Precautions

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.

 

Please see full Prescribing Information for additional Important Safety Information

Adverse Reactions

ADVERSE REACTIONS

 

·        Most common adverse reactions (≥ 20%) among patients with ovarian cancer were nausea, fatigue (including asthenia), vomiting, anemia, dysgeusia, AST/ALT elevation, constipation, decreased appetite, diarrhea, thrombocytopenia, neutropenia, stomatitis, nasopharyngitis/URI, rash, abdominal pain/distention, and dyspnea.)

·        Most common adverse reactions (≥ 20%) among patients with BRCA- mutated mCRPC were fatigue (including asthenia), nausea, anemia, ALT/AST increased, decreased appetite, rash, constipation, thrombocytopenia, vomiting, diarrhea.

 

To report SUSPECTED ADVERSE REACTIONS, contact Clovis Oncology, Inc. at 1-844-258-7662 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see full Prescribing Information for additional Important Safety Information

Drug Interactions

DRUG INTERACTIONS

 

·        CYP1A2, CYP3A, CYP2C9, and CYP2C19 substrates: Adjust dosage of these substrates if clinically indicated.

 

Please see full Prescribing Information for additional Important Safety Information

Use in Specific Populations

USE IN SPECIFIC POPULATIONS

 

·        Lactation: Advise women not to breastfeed.

 

Please see full Prescribing Information for additional Important Safety Information

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PP-RUCA-US-1787          08/2021

Please see full Prescribing Information for additional Important Safety Information


 

INDICATIONS

 Rubraca is indicated:

            for the maintenance treatment of adult women with 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 women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

            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 and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. 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.

 

SELECT IMPORTANT SAFETY INFORMATION

 

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 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 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

 

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 its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

 

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%). 

 

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%). 

 

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

 

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. 

 

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 after the last dose.

 

Please click here for full Prescribing Information for Rubraca