cemiplimab

Action and Spectrum

After being activated by CD28 costimulatory signalling and antigen receptor signalling, T cells mediate antitumor activity. 

Programmed death-1 (PD-1) is one of several T cell immune regulatory checkpoints that control T cell activation and proliferation. 

It expressed on the surface of T cells, PD-1 is an inhibitory co-receptor that prevents T cell activation. 

Drug Interaction

Adverse Reaction

Adverse drug reactions:   

Frequency defined   

>10%    

Fatigue  

Rash  

Diarrhea  

Musculoskeletal pain  

Nausea  

Pruritus  

Cough  

Constipation  

Anemia  

Arthralgia  

Black Box Warning

None

Contraindication / Caution

Contraindication: 

None  

Caution: 

Immune-related adverse events 

Infusion reactions 

Complications of allogeneic hematopoietic stem cell transplantation 

Pregnancy / Lactation

Pregnancy warnings:    

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

Breastfeeding warnings: 

• The release of the drug into the human breastmilk is unknown  

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

Tumor growth is inhibited by cemiplimab through an immune-mediated mechanism. 

Cemiplimab inhibits PD-1 to enhance the T cell-mediated immune response against tumors. 

The growth of tumors was reduced in syngeneic animal tumor models when cemiplimab was used to suppress PD-1 activation. 

As part of a tumor’s adaptive immune response, PD-L1 and PD-L2 are expressed on antigen-presenting cells (APCs) and certain tumor cell types. 

Adminstartion

Examine the solution visually for discoloration and particulate debris. It should be clear to slightly opalescent, colorless to pale yellow, and may contain traces of translucent to white particles. 

350 mg (7 mL) should be removed from the vial and diluted with 0.9% NaCl or D5W to a final concentration of 1–20 mg/mL. 

Gently invert the diluted solution to mix it and do shaking should be avoided. 

Through an IV line with a sterile, in-line or add-on 0.2 to 5-micron filter, infuse for 30 minutes.  

Patient Information Leaflet

Patient information leaflet 

Generic Name: cemiplimab 

Why do we use cemiplimab? 

Cemiplimab is indicated to treat locally advanced or metastatic cutaneous squamous cell carcinoma, locally advanced basal cell carcinoma, and metastatic basal cell carcinoma. 

It is also be used as a first-line treatment for metastatic non-small cell lung cancer in adults when combined with platinum-based chemotherapy. 

In individuals with disease progression during or following platinum-based chemotherapy, it is also recommended for the treatment of recurrent or metastatic cervical cancer.