Bavencio 200mg Injection 10ml

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Renal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC. Metastatic Merkel Cell Carcinoma Avelumab (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Locally Advanced or Metastatic Urothelial Carcinoma First-Line Maintenance Treatment of Urothelial Carcinoma Avelumab is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Previously-treated Urothelial Carcinoma Avelumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Advanced Renal Cell Carcinoma Avelumab in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

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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.

Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and may result in solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue Avelumab based on severity of reaction. Complications of allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. Major adverse cardiovascular events: Optimize management of cardiovascular risk factors. Discontinue Avelumab in combination with axitinib for Grade 3-4 events. Embryo-fetal toxicity: Avelumab can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. Severe and Fatal Immune-Mediated Adverse Reactions Avelumab is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. 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 clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions Infusion-related reactions Complications of allogeneic HSCT Major adverse cardiovascular events Most common adverse reactions (≥ 20%) in patients were: MCC: Fatigue, musculoskeletal pain, infusion-related reaction, rash, nausea, constipation, cough, and diarrhea. UC: Maintenance treatment: fatigue, musculoskeletal pain, urinary tract infection, and rash. Previously-treated: fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection. RCC (with axitinib): diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. 5563 or FDA 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 data described in the WARNINGS AND PRECAUTIONS section reflect exposure to Avelumab 10 mg/kg intravenously every 2 weeks as a single agent in 1854 patients enrolled in the JAVELIN Merkel 200 and JAVELIN Solid Tumor trials and to Avelumab 10 mg/kg intravenously every 2 weeks in combination with axitinib 5 mg orally twice daily in 489 patients enrolled in the JAVELIN Renal 100 and JAVELIN Renal 101 trials. In the Avelumab monotherapy population, 25% of patients were exposed for ≥ 6 months and 9% were exposed for ≥ 12 months. The population characteristics of Avelumab in combination with axitinib are shown below. When Avelumab was used in combination with axitinib, 70% of patients were exposed for ≥ 6 months and 31% were exposed for ≥ 12 months. The following criteria were used to classify an adverse reaction as immune-mediated: onset within 90 days after last dose of Avelumab, no spontaneous resolution within 7 days of onset, treatment with corticosteroids or other immunosuppressant or hormone replacement therapy, biopsy consistent with immune-mediated reaction, and no other clear etiology. Metastatic Merkel Cell Carcinoma The safety of Avelumab was evaluated in 204 patients enrolled in the JAVELIN Merkel 200 trial with metastatic MCC. 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.