Bdenza OS Oral Solution

Enzalutamide ® is indicated for the treatment of patients with: - castration-resistant prostate cancer (CRPC) - metastatic castration-sensitive prostate cancer (mCSPC) - non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) Enzalutamide is an androgen receptor inhibitor indicated for the treatment of patients with: - castration-resistant prostate cancer. - metastatic castration-sensitive prostate cancer. - non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

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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.

• Seizure occurred in 0.6% of patients receiving Enzalutamide. In patients with predisposing factors, seizures were reported in 2.2% of patients. Permanently discontinue Enzalutamide in patients who develop a seizure during treatment. - Posterior reversible encephalopathy syndrome (PRES): Discontinue Enzalutamide. - Hypersensitivity: Discontinue Enzalutamide. - Ischemic Heart Disease: Optimize management of cardiovascular risk factors. Discontinue Enzalutamide for Grade 3-4 adverse reactions - Falls and Fractures: Evaluate patients for fracture and fall risk, and treat patients with bone-targeted agents according to established guidelines. - Embryo-Fetal Toxicity: Enzalutamide can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception. - Severe Dysphagia or Choking Related to Product Size: Consider using smaller Enzalutamide tablet(s) in patients who have difficulty swallowing. Discontinue Enzalutamide for patients who cannot swallow capsules or tablets. - Interference with Immunoassay Measurement of Digoxin: Enzalutamide can interfere with certain digoxin immunoassays, resulting in falsely elevated digoxin plasma concentration results. Seizure Seizure occurred in 0.6% of patients receiving Enzalutamide in eight randomized clinical trials. In these trials, patients with predisposing factors for seizure were generally excluded. Seizure occurred from 13 to 2250 days after initiation of Enzalutamide. Patients experiencing seizure were permanently discontinued from therapy, and all seizure events resolved. In a single-arm trial designed to assess the risk of seizure in patients with pre-disposing factors for seizure, 8 of 366 (2.2%) Enzalutamide-treated patients experienced a seizure. Three of the 8 patients experienced a second seizure during continued treatment with Enzalutamide after their first seizure resolved. It is unknown whether anti-epileptic medications will prevent seizures with Enzalutamide. Patients in the study had one or more of the following pre-disposing factors: the use of medications that may lower the seizure threshold (~ 54%), history of traumatic brain or head injury (~ 28%), history of cerebrovascular accident or transient ischemic attack (~ 24%), and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, past history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection (all < 5%). Approximately 17% of patients had more than one risk factor. Advise patients of the risk of developing a seizure while receiving Enzalutamide and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. 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 adverse reactions are discussed in more detail in other sections of the labeling: - Seizure - Posterior Reversible Encephalopathy Syndrome (PRES) - Hypersensitivity - Ischemic Heart Disease - Falls and Fractures - Dysphagia or Choking The most common adverse reactions (≥ 10%) that occurred more frequently (≥ 2% over placebo) in the Enzalutamide-treated patients are musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. 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. The data in WARNINGS and PRECAUTIONS reflect eight randomized, controlled trials [AFFIRM, PREVAIL, TERRAIN, PROSPER, ARCHES, EMBARK, Asian PREVAIL (NCT02294461), and STRIVE (NCT01664923)] that were pooled to conduct safety analyses in patients with CRPC (N = 3651), mCSPC (N = 754), or nmCSPC with high‑risk BCR (N = 707) treated with Enzalutamide. Patients received Enzalutamide 160 mg (N = 5112) or placebo orally once daily (N = 2829) or bicalutamide 50 mg orally once daily (N = 387). In these eight trials, the median duration of treatment was 22.1 months (range: < 0.1 to 95.0) in patients that received Enzalutamide. In five placebo-controlled trials (AFFIRM, PROSPER, PREVAIL, ARCHES, and EMBARK), the median duration of treatment was 19.4 months (range: < 0.1 to 90.4) in the Enzalutamide group. In these five trials, the most common adverse reactions (≥ 10%) that occurred more frequently (≥ 2% over placebo) in the Enzalutamide-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture and headache. AFFIRM: Enzalutamide versus Placebo in Metastatic CRPC Following Chemotherapy AFFIRM enrolled 1199 patients with metastatic CRPC who had previously received docetaxel. The median duration of treatment was 8.3 months with Enzalutamide and 3.0 months with placebo. During the trial, 48% of patients on the Enzalutamide arm and 46% of patients on the placebo arm received glucocorticoids. Grade 3 and higher adverse reactions were reported among 47% of Enzalutamide-treated patients. Discontinuations due to adverse reactions were reported for 16% of Enzalutamide-treated patients. 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.