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BAVENCIO

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Avelumab (avelumab) instruction manual

Generic name: avelumab
Trade name: Bavencia
Full names: avelumab, avelumab, bavencia, avelumab, BAVENCIO


Indications:
For the treatment of metastatic Merkel cell carcinoma (MCC) in adults and children ≥12 years old, including those who have not received chemotherapy.


Usage and dosage:
Intravenous infusion lasts for 60 minutes, and 10 mg/kg is given every 2 weeks.


Adverse Reactions:
Common side effects include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and swelling of the extremities (peripheral edema).
The most common serious risk with Bavencio is immune-mediated, in which the body's immune system attacks healthy cells or organs, such as the lungs (pneumonia), liver (hepatitis), colon (colitis), hormone-secreting glands (endocrinopathy), and kidneys (nephritis).
In addition, there may be a risk of serious infusion-related reactions.


Contraindications:
None


Notes:
Immune-mediated pneumonia: Withhold for moderate pneumonia; permanently discontinue for severe, life-threatening or recurrent moderate pneumonia.
Immune-Mediated Hepatitis: Monitor for changes in liver function. Withhold for moderate hepatitis; permanently discontinue for severe or life-threatening hepatitis.
Immune-Mediated Colitis: Withhold for moderate or severe colitis; permanently discontinue for life-threatening or recurrent severe colitis.
Immune-mediated endocrine lesions: Withhold for severe or life-threatening endocrine lesions.
Immune-Mediated Nephritis and Renal Insufficiency: Withhold for moderate or severe nephritis and renal insufficiency; permanently discontinue for life-threatening nephritis or renal insufficiency.
Infusion-Related Reactions: Interrupt or slow the infusion rate for mild or moderate infusion-related reactions. For serious or life-threatening infusion-related reactions, discontinue the infusion and permanently discontinue BAVENCIO.
Embryo-Fetal Toxicity: BAVENCIO may cause fetal harm. Advise on potential risks to the fetus and use of effective contraception.


Storage:
Store in the refrigerator at 36°F to 46°F (2°C to 8°C) in original packaging protected from light.


Mechanism of action:
In animal models, inhibition of PD-L1/PD-1 signaling increases the severity of some infections and enhances inflammatory responses. Mycobacterium tuberculosis -infected PD-1 knockout mice exhibit significantly reduced survival compared with wild-type controls, which is associated with bacterial proliferation and inflammatory responses in these animals. PD-L1 and PD-1 knockout mice and mice receiving PD-L1 blocking antibodies have also been shown to have reduced survival after infection with lymphocytic choriomeningitis virus.


Safety and efficacy:
In the phase II clinical trial of AVELIN Merkel 200, 88 people participated. The objective response rate of avelumab was 33%, of which 11% were complete responses. As with other PD-1 drugs, many patients have relatively durable responses, with 45% of patients responding for one year.