Bracanat Tablet

Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer - for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Olaparib. - in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: - a deleterious or suspected deleterious BRCA mutation, and/or - genomic instability. - for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Breast cancer - for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. - for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Pancreatic cancer - for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Abridged from the full prescribing information.

---

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): Occurred in approximately 1.2% of patients with various BRCA m, g BRCA m, HRR gene-mutated or HRD-positive cancers exposed to Olaparib and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. - Pneumonitis: Occurred in 1.0% of patients exposed to Olaparib, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. - Venous thromboembolism (VTE), including severe or fatal pulmonary embolism (PE), occurred in patients treated with Olaparib. VTE occurred in 8% of patients with mCRPC. Monitor patients for signs and symptoms of VTE and PE and treat as medically appropriate. - Hepatotoxicity, Including Drug-induced liver injury (DILI): Occurred in patients treated with Olaparib. If DILI is suspected, interrupt Olaparib. If DILI is confirmed, discontinue treatment. - Embryo-Fetal Toxicity: 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) has occurred in patients treated with Olaparib and some cases were fatal. In clinical studies, among 2219 patients with various BRCA m, g BRCA m, HRR gene-mutated or HRD-positive cancers who received Olaparib as a single agent or as part of combination regimen, consistent with approved indications, the cumulative incidence of MDS/AML was approximately 1.2% (26/2219). Of these, 54% (14/26) had a fatal outcome. The median duration of therapy with Olaparib in patients who developed MDS/AML was approximately 2 years (range: < 6 months to > 4 years). All of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy. In SOLO1, patients with newly diagnosed advanced BRCA m ovarian cancer, the incidence of MDS/AML was 1.9% (5/260) in patients who received Olaparib and 0.8% (1/130) in patients who received placebo based on an updated analysis. In PAOLA-1, of patients with newly diagnosed advanced ovarian cancer with HRD-positive status, the incidence of MDS/AML was 1.6% (4/255) in patients who received Olaparib and 2.3% (3/131) in the control arm. In SOLO2, patients with BRCA m platinum-sensitive relapsed ovarian cancer, the incidence of MDS/AML was 8% (15/195) in patients who received Olaparib and 4% (4/99) in patients who received placebo. The duration of Olaparib treatment prior to the diagnosis of MDS/AML ranged from 0.6 years to 4.5 years. Do not start Olaparib until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Abridged from the full prescribing information.

---

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 adverse reactions are discussed elsewhere in the labeling: - Myelodysplastic Syndrome/Acute Myeloid Leukemia - Pneumonitis - Venous Thromboembolism - Hepatotoxicity, Including Drug-Induced Liver Injury Most common adverse reactions (≥10%): - as a single agent were nausea, fatigue (including asthenia), anemia, vomiting, diarrhea, decreased appetite, headache, dysgeusia, cough, neutropenia, dyspnea, dizziness, dyspepsia, leukopenia, and thrombocytopenia. - in combination with bevacizumab were nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, and headache. - in combination with abiraterone and prednisone or prednisolone were anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, and abdominal pain. Clinical Trial 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. Unless otherwise specified, the data described in the WARNINGS AND PRECAUTIONS reflect exposure to Olaparib as a single agent or as part of a combination regimen (SOLO-1, SOLO-2, PAOLA-1, OlympiA, OlympiAD, POLO, PROfound, and PROpel) in 2851 patients that were pooled to conduct safety analyses. Additional data reflect exposure to Olaparib as a single agent in 2901 patients; 2135 patients with exposure to 300 mg twice daily tablet dose including five controlled, randomized, trials (SOLO-1, SOLO-2, OlympiAD, POLO, and PROfound) and to 400 mg twice daily capsule dose in 766 patients in other trials that were pooled to conduct safety analyses. In this pooled single agent safety population, 56% of patients were exposed for 6 months or longer and 28% were exposed for greater than one year in the Olaparib group. In this pooled single agent safety population, the most common adverse reactions in ≥10% of patients were nausea (60%), fatigue (55%), anemia (36%), vomiting (32%), diarrhea (24%), decreased appetite (22%), headache (16%), dysgeusia (15%), cough (15%), neutropenia (14%), dyspnea (14%), dizziness (12%), dyspepsia (12%), leukopenia (11%), and thrombocytopenia (10%). First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer SOLO-1 The safety of Olaparib for the maintenance treatment of patients with BRCA-mutated advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was investigated in SOLO- 1. Abridged from the full prescribing information.

---

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.