Crizanlizumab in treatment of Sickle Cell Disease

Crizanlizumab-Trimethylcolchicinic Acid injection, for intravenous use Initial U.S. Approval: 2019 

 
----------------------------INDICATIONS AND USAGE-------------------------­

 
Crizanlizumab is a selecting blocker indicated to reduce the frequency of  vaso-occlusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
----------------------DOSAGE AND ADMINISTRATION----------------------­

 
Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter.

 
---------------------DOSAGE FORMS AND STRENGTHS--------------------­
Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial. 

 
---------------------------CONTRAINDICATIONS---------------------------------­
None. 

 
-----------------------WARNINGS AND PRECAUTIONS----------------------­

 
• Infusion-Related Reactions: Monitor patients for signs and symptoms.
Discontinue Crizanlizumab infusion for severe reactions and manage medically.
• Interference With Automated Platelet Counts (platelet clumping): Run test
as soon as possible or use citrate tubes.

 
------------------------------ADVERSE REACTIONS-----------------------------­

 
Most common adverse reactions (incidence > 10%) are nausea, arthralgia,
back pain, and pyrexia. (6.1)

 
-------------------------USE IN SPECIFIC POPULATIONS---------------------­

 
Pregnancy: May cause fetal harm. 

 -------------------------MECHANISM OF ACTION---------------------­

Crizanlizumab-tmca is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin & blocks interactions with its ligands including P-selectin glycoprotein ligand1.
Binding P-selectin on the surface of the activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes