Concizumab (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INJECTION.
Brand Names
- ALHEMO
Indications and Usage
Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: •hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors •hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors
Contraindications
Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients [see Warnings and Precautions ( 5.1)and Description (11)].
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: •Thromboembolic Events [see Warnings and Precautions (5.1)] •Hypersensitivity Reactions [see Warnings and Precautions (5.2)] •Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2 [see Warnings and Precautions (5.3)]
Mechanism of Action
Concizumab-mtci is a monoclonal antibody antagonist of endogenous Tissue Factor Pathway Inhibitor (TFPI). Through the inhibition of TFPI, concizumab-mtci acts to enhance FXa production during the initiation phase of coagulation which leads to improved thrombin generation and clot formation with the goal of achieving hemostasis in patients with Hemophilia A or B regardless of their inhibitor status. The effect of concizumab-mtci is not influenced by the presence of inhibitory antibodies to FVIII or FIX. There is no structural relationship or sequence homology between concizumab-mtci and FVIII or FIX and, as such, treatment with concizumab-mtci does not induce or enhance the development of direct inhibitors to FVIII or FIX.