sintilimab (Pending FDA Approval)

Action and Spectrum

Actions and Spectrum: 

When sintilimab binds to the PD-1 receptor on immune cells like T-cells, it prevents those cells from communicating with the PD-L1 and PD-L2 ligands. Cancer cells have proteins called PD-L1 and PD-L2 on their surface that prevent the immune system from identifying and attacking them. 

After an unsuccessful autologous stem cell transplant (ASCT), sintilimab is recommended for the treatment of classical Hodgkin lymphoma that has relapsed or become resistant. 

Drug Interaction

Adverse Reaction

Frequency defined  

None 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• People with history of severe allergies or hypersensitivity to sintilimab or any of its ingredients should not take it. 

Caution:  

• sintilimab may result in immune-related side effects as endocrinopathies, pneumonitis, colitis, and hepatitis. It is advised to maintain close watch for these adverse events’ signs and symptoms, and appropriate management should be put in place. 
• Infusion-related responses to sintilimab may include fever, chills, rash, itching, light-headedness, and breathing issues. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data 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 the 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

Pharmacology 

sintilimab helps in restoring and enhancing the immune system’s capacity to identify and eradicate cancer cells by preventing the PD-1/PD-L1/L2 interaction. 

Pharmacodynamics 

Treatment with sintilimab may lead to an increase in the production of several cytokines, including interferon-gamma, tumour necrosis factor-alpha, and interleukins. These cytokines are essential for immunological control and for triggering the immune system’s ability to recognise and destroy cancer cells. 

Pharmacokinetics 

Absorption  

sintilimab is given intravenously, its full and quick bioavailability is possible. The medicine enters the systemic circulation without having to first be absorbed through the gastrointestinal tract. 

Distribution  

The body’s distribution of sintilimab is anticipated to include the tumour microenvironment. Blood flow, tissue permeability, and protein binding are some of the variables that affect the distribution pattern. 

Metabolism 

sintilimab, an antibody-based medication, undergoes catabolism as opposed to conventional metabolism. Proteolysis and catabolic mechanisms are generally used to break down antibodies into smaller peptides and amino acids.  

Elimination and Excretion  

The reticuloendothelial system is principally responsible for the body’s removal of sintilimab and its catabolic byproducts. The information that is currently provided does not specify the precise excretion mechanisms, such as renal or hepatic elimination.

Adminstartion

Administration 

sintilimab is administered as an intravenous infusion.  

Patient Information Leaflet

Patient information leaflet 

Generic Name: sintilimab (Pending FDA Approval) 

Why do we use sintilimab? 

For the treatment of relapsed or refractory classical Hodgkin lymphoma (cHL) following the failure of autologous stem cell transplantation (ASCT), sintilimab is approved. 

For the first-line management of advanced squamous non-small cell lung cancer (NSCLC), sintilimab in conjunction with chemotherapy is recommended. 

Advanced Hepatocellular Carcinoma (HCC) is a condition that can be treated with sintilimab in individuals who have already had systemic therapy.