toripalimab

Action and Spectrum

Actions and Spectrum: 

Actions: 

toripalimab, which is a monoclonal antibody that is humanized IgG4, binds to the PD-1 receptor by blocking its action with PD-1 ligands, that is, PD-L1 and PD-L2 which shows its anti-tumor response by releasing its pathway of PD-1 inhibition mediated immune response. 

Spectrum: 

toripalimab is indicated in the first-line therapy for metastatic or recurrent, locally advanced NPC with cisplatin and gemcitabine and as a single agent for previously treated unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy. 

Drug Interaction

Adverse Reaction

Frequency not defined  

Immune-related adverse reactions 

Pneumonitis 

Endocrinopathies 

Colitis 

Hepatitis with no tumor involvement of the liver 

Nephritis with renal dysfunction 

Exfoliative dermatologic conditions 

Myocarditis 

Neurological toxicities  

Infusion-related adverse reactions 

Fever 

Chills 

Rigors 

Pruritis 

Flushing 

Rash 

Hypotension 

Hypoxemia 

rigors 

Black Box Warning

Black Box Warning: 

Patients who are receiving this drug should be in contact with a doctor as it can cause our immune system to attack any normal organs or tissues in the body during therapy. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 

Cautions 

• Immune mediated reactions 
• Infusion related reactions 
• Complications of allogenic HSCT 
• Embro-fetal toxicity 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

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: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

toripalimab, which is a monoclonal antibody that is humanized IgG4, binds to the PD-1 receptor by blocking its action with PD-1 ligands, that is, PD-L1 and PD-L2 which shows its anti-tumor response by releasing its pathway of PD-1 inhibition mediated immune response. 

Pharmacodynamics: 

Limited data available with toripalimab. 

Pharmacokinetics: 

Absorption 

The time to achieve peak effect is seven weeks. 

Distribution 

The volume of distribution of toripalimab is 3.7 L/kg 

Metabolism 

Catabolic pathway metabolism of toripalimab into small peptides. 

Elimination and Excretion 

The half-life is 10+-1.5 days at the first dose and 18+-9.4 days after steady state. 

Clearance after the first dose was 14.9 mL/h, and at steady state, it was 9.5 mL/h. 

Adminstartion

Administration: 

IV administration of diluted solution using inline aseptic filter and should not use other drugs with it through the same IV line. Administration of toripalimab should be before chemotherapy. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: toripalimab 

Pronounced:  TOR-ee-PAH-li-mab 

Why do we use toripalimab?  

toripalimab is indicated in the first-line therapy for metastatic or recurrent, locally advanced NPC with cisplatin and gemcitabine and as a single agent for previously treated unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.