Bavencio (Avelumab)

Brand Name

Bavencio

Generic Name

Avelumab

View Brand Information

FDA approval date: March 23, 2017

Classification: Programmed Death Ligand-1 Blocker

Form: Injection

What is Bavencio (Avelumab)?

BAVENCIO is a programmed death ligand-1 blocking antibody indicated for: Merkel Cell Carcinoma Adults and pediatric patients 12 years and older with metastatic MCC.

Approved To Treat

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Brand Information

BAVENCIO (avelumab)

1DOSAGE FORMS AND STRENGTHS

Injection: 200 mg/10 mL (20 mg/mL), clear, colorless to slightly yellow solution in a single-dose vial.

2CONTRAINDICATIONS

None.

3ADVERSE REACTIONS

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

3.1Clinical 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 BAVENCIO 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 BAVENCIO 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 BAVENCIO monotherapy population, 25% of patients were exposed for ≥ 6 months and 9% were exposed for ≥ 12 months. The population characteristics of BAVENCIO in combination with axitinib are shown below. When BAVENCIO 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 BAVENCIO, 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.

3.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BAVENCIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: neutropenia

Hepatobiliary disorders: sclerosing cholangitis

4DESCRIPTION

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. Each single-dose vial contains 200 mg avelumab in 10 mL (20 mg/mL). Each mL contains 20 mg avelumab, D-mannitol (51 mg), glacial acetic acid (0.6 mg), polysorbate 20 (0.5 mg), sodium hydroxide (0.3 mg), and Water for Injection. The pH range of the solution is 5.0 – 5.6.

5HOW SUPPLIED/STORAGE AND HANDLING

BAVENCIO (avelumab) Injection is a sterile, preservative-free, and clear, colorless to slightly yellow solution for intravenous infusion supplied as a single-dose vial of 200 mg/10 mL (20 mg/mL), individually packed into a carton (NDC 44087-3535-1).

6PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

7PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

NDC 44087-3535-1

BAVENCIO

200 mg/10 mL

For intravenous infusion

Dispense the enclosed

1 vial

Rx only

EMD

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton