emicizumab

Action and Spectrum

Actions and Spectrum: 

emicizumab is a monoclonal antibody used to treat patients with hemophilia A, a bleeding disorder. It works by mimicking the function of clotting factor VIII and allowing the blood to clot more effectively. 

Drug Interaction

Adverse Reaction

>10%: 

Headache (15%) 

Injection site erythema (11%) 

Arthralgia (15%) 

Injection site reaction (22%) 

1-10%: 

Pyrexia (6%) 

Injection site pain (4%) 

Injection site pruritus (4%) 

Diarrhea (6%) 

<1%: 

Rhabdomyolysis 

Black Box Warning

Black Box Warning: 

It is essential to follow the dosage and administration instructions for emicizumab carefully, as an overdose can cause serious side effects. 

Contraindication / Caution

Contraindication/Caution: 

emicizumab should not be used in people hypersensitive to the drug itself. 

Pregnancy / Lactation

Pregnancy consideration:  

Insufficient data regarding the drug’s effect on the fetus during pregnancy is available. 

Breastfeeding warnings:  

No data is available regarding the presence of drugs in human breast milk. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/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 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 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 

emicizumab works by binding to a protein called activated factor IX (FIXa), which is involved in blood clotting. 

By binding to FIXa, emicizumab helps to activate clotting factor X, which can then help to stop bleeding episodes. 

Pharmacokinetics: 

The pharmacokinetics of emicizumab is complex, as it is a large protein eliminated slowly from the body.  

Pharmacodynamics: 

The pharmacodynamics of emicizumab involves its ability to bind to a protein called activated factor IX (FIXa), which is involved in blood clotting. By binding to FIXa, emicizumab helps to activate clotting factor X, which can then help to stop bleeding episodes. 

Absorption 

emicizumab is administered by injection and is rapidly absorbed into the bloodstream. The peak plasma concentration at steady state is 55.1-58.3 mcg/mL.  

Distribution 

After it is absorbed, emicizumab is distributed throughout the body. The volume of distribution is 10.4L.  

Metabolism 

The metabolism of emicizumab occurs primarily in the liver. There it is metabolized into several active and inactive metabolites.  

Elimination and excretion 

These metabolites are then eliminated from the body through the kidneys and feces. The clearance rate is 0.27 ltr/day. The half-life of the drug is 26.9 days.

Adminstartion

Administration: 

The emicizumab is administered through the intravenous route

Patient Information Leaflet

Patient information leaflet 

Generic Name: emicizumab 

Pronounced: emi-si-zu-mab 

Why do we use emicizumab? 

emicizumab helps in the prevention and treatment of hemophilia A