Overview
11 DESCRIPTION Avelumab is a programmed death ligand1 (PD-L1) blocking antibody. Avelumab is a human IgG1 lambda monoclonal antibody produced in Chinese hamster ovary cells and has a molecular weight of approximately 147 kDa. BAVENCIO (avelumab) Injection for intravenous use is a sterile, preservative-free, non-pyrogenic, clear, colorless to slightly yellow solution.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Indications
- 1 INDICATIONS AND USAGE BAVENCIO 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. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. ( 1.2 , 14.2 ) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. ( 1.2 , 14.
Common Doses
- 800 mg
- 5 mg
- 10 mg
- 250 mL
Dosage
2 DOSAGE AND ADMINISTRATION Premedicate for the first 4 infusions and subsequently as needed. ( 2.1 ) Merkel Cell Carcinoma : 800 mg every 2 weeks. ( 2.2 ) Urothelial Carcinoma ; 800 mg every 2 weeks. ( 2.3 ) Renal Cell Carcinoma : 800 mg every 2 weeks in combination with axitinib 5 mg orally twice daily. ( 2.4 ) Administer BAVENCIO as an intravenous infusion over 60 minutes. 2.1 Premedication Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO.
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of allogeneic HSCT [see Warnings and Precautions (5.3) ] Major adverse cardiovascular events [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 20%) in patients were: MCC : Fatigue, musculoskeletal pain, infusion-related reaction, rash, nausea, constipation, cough, and diarrhea. ( 6.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.