All the Drug Class Drugs
Antihemophilic Agent. Albutrepenonacog Alfa 250, 500, 1000, 2000 IU. VIAL (pwdr. and solvent for sol. for inj.): 1+1. 1 IU of factor IX activ. is equiv. to that quant. of factor IX in 1 ml of normal human plasma.
On demand tmt.: The calculat. of the requir. dose of factor IX is based on the empiric. finding that 1 IU factor IX per kg bdy. wt. is expected to incr. the circulating level of factor IX by an average of 1.3 IU/dl (1.3% of normal) in pts. ≥ 12 yrs. of age and by 1.0 IU/dl (1.0 % of normal) in pts. < 12 yrs. of age. The required dose is determ. using the follow. formulae:
Required dose (IU) = bdy. wt.(kg) x desired factor IX rise (% of normal or IU/dl) x {reciprocal of observed recovery (IU/kg per IU/dl)}
Expected factor IX rise (IU/dl or % of normal) = Dose (IU) x Recovery (IU/dl per IU/kg)/body weight (kg).
The amount to be admin. and the frequen. of admin. should always be oriented to the clinical effectiveness in the individ. case.
Pts.<12 yrs. of age: For an incremental recovery of 1 IU/dl per 1 IU/kg, the dose is calculated as follows: Dose (IU) = bdy. wt (kg) x desired factor IX incr. (IU/dl) x 1 dl/kg. See Lit.
Tmt. and prophylaxis of bleed. in pts. with haemophilia B (congenit. factor IX defic.).
C/I: Hypersens. to the active subst. (recomb. fusion protein linking coagulat. factor IX with albumin (rIX-FP). Known allergic reaction to hamster protein.