Avelumab

Action and Spectrum

Avelumab is an IgG1 monoclonal antibody that targets PD-L1, a protein often present on tumor cells and immune cells within the tumor environment. Normally, when PD-L1 binds to PD-1 or B7.1 receptors on T cells and antigen-presenting cells, it suppresses T-cell function and weakens immune responses. Avelumab blocks this interaction, helping to restore T-cell activity and enhance the body’s immune response against tumors.

Drug Interaction

Adverse Reaction

Adverse drug reactions:  

Frequency defined  

>10%  

Anemia  

Increased AST  

Infusion-related reaction  

Fatigue  

Lymphopenia  

Thrombocytopenia  

Urinary tract infection  

Abdominal pain  

Increased lipase  

Cough  

Constipation  

Dyspnea  

Hyponatremia   

Arthralgia  

Dizziness  

Vomiting/retching  

Hypertension  

Increased GGT   

1-10%  

Abdominal pain  

Musculoskeletal pain  

Fatigue  

Dyspnea  

Colitis   

Pneumonitis   

Constipation  

Arthralgia  

Increased AST  

Pruritus   

Headache   

Increased bilirubin   

Neutropenia  

Thyroid disorders   

Hypertension  

Increased ALT  

Urinary tract infection  

Increased lipase  

Musculoskeletal pain  

Increased creatinine  

Dyspnea  

Decreased appetite  

Increased amylase  

Increased bilirubin  

Thrombocytopenia  

Neutropenia  

<1%  

Adrenal insufficiency  

Type 1 diabetes mellitus  

Hepatitis  

Nephritis  

Black Box Warning

It does not have a U.S. FDA black box warning 

Contraindication / Caution

Contraindication 

None 

Cautions 

Immune-related reactions: May affect any organ; can be severe or fatal. Occur anytime, even after stopping treatment. Prompt evaluation and immunosuppression (e.g., corticosteroids) are essential. 

Pneumonitis: Risk increases with prior chest radiation. 

Colitis: Often presents with diarrhea; monitor for CMV in steroid-refractory cases. 

Hepatitis: Fatal cases reported; monitor liver enzymes, especially with axitinib. 

Endocrinopathies: Can cause adrenal insufficiency, thyroid disorders, diabetes (including DKA), and pituitary issues. Require hormone replacement or insulin therapy. 

Nephritis: May cause renal dysfunction; monitor kidney function. 

Pregnancy / Lactation

Pregnancy warnings:    

• AU TGA pregnancy category: D 
• US FDA pregnancy category: Not assigned 

Breastfeeding warnings: 

• The release of the drug into the human breastmilk is unknown  
• The release of the drug into the animal milk is unknown 
• Therefore, the use of the drug is not recommended 

Pregnancy Categories:      

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first trimester or the later trimester      
• Category B: No evidence shown of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women      
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a result in humans must take care of potential risks in pregnant women      
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits      
• Category X: Drugs listed in this category outweigh risks over benefits Hence these categories of drugs need to be avoided by pregnant women      
• Category N: There is no data available for the drug under this category   

Pharmacology

Pharmacokinetics 

Absorption 

Steady-state concentrations are achieved within 4–6 weeks (typically after 2–3 dosing cycles). 

Distribution 

Volume of distribution (Vd) is approximately 4.72 liters. 

Metabolism 

avelumab is not metabolized by liver enzymes (e.g., CYP450). It undergoes catabolism into small peptides and amino acids via proteolytic enzymes in the reticuloendothelial system. 

Elimination/Excretion 

Terminal half-life is around 6.1 days. 

Pharmacodynamics 

Avelumab is a fully human IgG1 monoclonal antibody that targets PD-L1, a ligand expressed on tumor and immune cells. By blocking PD-L1 from binding to PD-1 and B7.1 receptors, it restores T-cell–mediated immune responses against tumors. Avelumab also retains the ability to induce antibody-dependent cellular cytotoxicity (ADCC), contributing to direct tumor cell killing. Its immunomodulatory effect leads to durable antitumor activity but may also cause immune-related adverse effects due to enhanced immune activation. 

Adminstartion

Avelumab is administered as an intravenous (IV) infusion over 60 minutes using a 0.2-micron, low protein-binding inline filter. It must not be coadministered with other drugs through the same IV line. 

Patient Information Leaflet

Generic name: Avelumab 

Pronunciation: ah-VEL-ue-mab 

Avelumab is the drug used to treat skin cancer, also called Merkel cell carcinoma, in case of metastatic cancer, which has already spread to the other parts of the body. It treats urinary tract cancer.

The drug is cancer-killing; it may also kill healthy cells and organs.

The condition may get serious by threatening organs like the liver, kidney, lungs, pancreas, thyroid gland, adrenal glands, and the intestines.

Consult your doctor if symptoms like cough, fever, muscle debility, chest pain, vision changes, swollen ankles, dysuria, jaundice, hair loss, blood in urine/stools, and diarrhea persist.

Avelumab is contraindicated in pregnancy and lactation, as it is harmful to the ingrowing fetus and breastfed infant.

The drug is intravenously injected through veins once a fortnight by the healthcare provider.

The duration of complete infusion is 60 minutes for the total dose. Medical checkups should be done frequently during the treatment to subside any adverse effects.

There is no chance of overdose as the medication is administered by a healthcare professional.

Avelumab may interact with other drugs and OTC products; therefore, you should consult your physician if taking any medicines.

Keep the medicine away from children and not share the medication with others.