Indications & Uses
Bavencio is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Premedication: Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of Avelumab. Premedication should be administered for subsequent Avelumab doses based upon clinical judgment and presence/severity of prior infusion reactions.Recommended Dosage for MCC: The recommended dosage of Avelumab is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.Recommended Dosage for UC: The recommended dosage of Avelumab is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.Recommended Dosage for RCC: The recommended dosage of Avelumab is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. When axitinib is used in combination with Avelumab, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of two weeks or longer.
Side Effects
The following clinically significant adverse reactions are: Severe and fatal immune-mediated adverse reactions Infusion-related reactions Complications of allogeneic HSCT Major adverse cardiovascular events
Cautions & Contraindications
Warnings & Precautions
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: immunemediated 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 Bavencio 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 Bavencio in combination with axitinib for Grade 3-4 events.Embryo-fetal toxicity: Bavencio can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.