Bavencio 20 mg/mL concentrate for solution for infusion
Merck - Pfizer
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Active ingredient
avelumab
Legal Category
POM: Prescription only medicine
Bavencio 20 mg/mL concentrate for solution for infusion
Each mL of concentrate contains 20 mg of avelumab.
One vial of 10 mL contains 200 mg of avelumab.
Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellow solution. The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.
Posology
The recommended dose of Bavencio is 10 mg/kg body weight administered intravenously over 60 minutes every 2 weeks.
Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity. Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy, could continue treatment.
Premedication
Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio. If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Treatment modifications
Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based
