Ruparib Tablet

Rucaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer 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. 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. Select patients for therapy based on an FDA-approved companion diagnostic for Rucaparib. Maintenance Treatment of BRCA -mutated Recurrent Ovarian Cancer Rucaparib 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. BRCA -mutated Metastatic Castration-Resistant Prostate Cancer 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.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to Rucaparib, 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: Rucaparib can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. Myelodysplastic Syndrome/Acute Myeloid Leukemia Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rucaparib, 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 Rucaparib 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 Rucaparib, MDS/AML occurred in 9 out of 129 (7%) patients treated with Rucaparib and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with Rucaparib 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 Rucaparib. The duration of therapy with Rucaparib in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years. Do not start Rucaparib 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 Rucaparib or reduce dose according to Table 1 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 Rucaparib. Embryo-Fetal Toxicity Rucaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following serious adverse reactions are discussed elsewhere in the labeling: Myelodysplastic Syndrome/Acute Myeloid Leukemia. Most common adverse reactions (≥10%) among patients with ovarian cancer were nausea, fatigue (including asthenia), anemia, ALT/AST increased, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, blood creatinine increased, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia. Most common adverse reactions (≥10%) among patients with BRCA -mutated mCRPC were fatigue/asthenia, musculoskeletal pain, nausea, anemia, decreased appetite, increased ALT/AST, constipation, diarrhea, vomiting, thrombocytopenia, dyspnea, increased blood creatinine, edema, dizziness, weight decreased, abdominal pain, dysgeusia, rash, neuropathy peripheral, urinary tract infection, cough, headache, hemorrhage, neutropenia, and photosensitivity reaction.. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population for patients with ovarian and prostate cancer in the WARNINGS AND PRECAUTIONS section reflect exposure to Rucaparib at 600 mg orally twice daily in 2141 patients treated on clinical trials including ARIEL3, TRITON2, and TRITON3. In ARIEL3 among the patients who received Rucaparib, 57% of patients were exposed for 6 months or longer and 33% were exposed for greater than one year. In TRITON3 among the patients with BRCA-mutated mCRPC who received Rucaparib, 66% were exposed for 6 months or longer and 34% were exposed for greater than one year. In the pooled safety population for patients with ovarian cancer, the most common adverse reactions in ≥ 10% of patients were nausea (68%), asthenia/fatigue (65%), anemia/hemoglobin decreased (45%), AST/ALT increased (39%), vomiting (36%), diarrhea (29%), decreased appetite (27%), thrombocytopenia/platelet count decreased (25%), dysgeusia (24%), neutropenia/neutrophil count decreased (21%), blood creatinine increased (17%), dyspnea (16%), dizziness (14%), dyspepsia (11%), photosensitivity reaction (10%), and leukopenia/white blood cell count decreased (10%). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.