What are the precautions for Avelumab?

In clinical studies of avelumab (Avelumab), warnings and precautions such as serious and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, major cardiovascular adverse events, embryo-fetal toxicity, etc. have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Serious and fatal immune-mediated adverse reactions: Avelumab is a monoclonal antibody, which belongs to a class of drugs that bind to programmed death receptor 1 (PD-1) or PD ligand 1 (PD-L1), blocking PD-1/PD-L1 pathway. pathways, thus eliminating the suppression of immune responses, potentially damaging peripheral tolerance and inducing immune-mediated adverse reactions, including pneumonia, colitis, hepatitis, adrenal insufficiency, hypothyroidism and hyperthyroidism, diabetes and nephritis, skin adverse reactions, etc.

Immune-mediated adverse reactions can occur at any time after initiating treatment withPD-1/PD-L1 blocking antibodies. Withhold or permanently discontinue avelumab based on severity. Monitor patients closely for signs and symptoms. If avelumab needs to be interrupted or discontinued, administer systemic corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) until improvement to grade 1 or less. When disease improves to grade 1 or less, initiate corticosteroid tapering and continue tapering for at least 1 month. Consider additional systemic immunosuppressants in patients whose immune-mediated adverse effects are not controlled by corticosteroid therapy.

2. Infusion-related reactions: Avelumab can cause serious or life-threatening infusion-related reactions. Premedicate with antihistamines and acetaminophen before the first 4 infusions. Monitor patients for signs and symptoms of infusion-related reactions, including fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. For mild or moderate infusion-related reactions, interrupt or slow down the infusion rate. For serious (Grade 3) or life-threatening (Grade 4) infusion-related reactions, discontinue the infusion and permanently discontinue avelumab.

3. Complications of allogeneic HSCT: Patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with PD-1/PD-L1 blocking antibodies may develop fatal and other serious complications. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after low-intensity conditioning, and febrile syndrome requiring steroids (without an identified infectious cause). These complications may occur despite therapeutic intervention between PD-1/PD-L1 blockade and allogeneic HSCT. Monitor patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits and risks of treatment with PD-1/PD-L1 blocking antibodies before or after allogeneic HSCT.

4. Major adverse cardiovascular events: The combination of avelumab and axitinib can lead to serious and fatal cardiovascular events, such as heart failure. Consider baseline and periodic assessment of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors such as hypertension, diabetes, or dyslipidemia. For grade 3-4 cardiovascular events, discontinue avelumab and axitinib.

5. Embryo-fetal toxicity: Based on its mechanism of action, avelumab can cause fetal damage when administered to pregnant women. Animal studies have shown that inhibition of the PD-1/PD-L1 pathway can lead to an increased risk of immune-mediated rejection in the developing fetus, leading to fetal death. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, inform the patient of the potential risk to the fetus. Advise females of childbearing potential to use effective contraception during treatment with avelumab and for at least one month after the last dose.

Avelumab is an emerging cancer treatment drug. The original drug has not yet been marketed in China, so it cannot be included in medical insurance. The price of Avelumab's generic drug, 200mg/10mL per box, may be more than RMB 10,000 per box (the price may fluctuate due to the exchange rate). We are not aware of any Avelumab generics being produced and put on the market. For specific prices and drug details, please consult Yade's medical consultant.