Pronunciation:
an-teye-hee-moe-feel-ik fak-tor ree-kom-bi-nant eff-cee fyoo-zhun proh-teen
Trade Name(s)
Ther. Class.
hemostatic agents
Pharm. Class.
clotting factor replacements
Control/prevent bleeding episodes, peripoperative management and routine prophylaxis of bleeding episodes in patients with Hemophilia A (congential Factor VIII deficiency).
Replaces deficient antihemophilic factor (AHF, Factor VIII). Produced via recombinant DNA technology, presence of fusion protein delays degradation.
Therapeutic Effect(s):
Decreased incidence and severity of bleeding in patients with Hemophilia A.
Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown; clearance is more rapid in children.
TIME/ACTION PROFILE (effects on hemostasis)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
IV | rapid | end of infusion | 6 hr-5 days† |
Contraindicated in:
Use Cautiously in:
MS: arthralgia
Neuro: malaise
Misc: hypersensitivity reactions including ANAPHYLAXIS, neutralizing antibodies
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Drug-Drug
Anticoagulants, thrombolytics, antiplatelet agents, NSAIDs, SSRIs, and NSRIs may ↑ risk of bleeding.
One unit/kg body weight will ↑ Factor VIII level by 2%.
Control/prevention of bleeding episodes
IV (Adults and Children ≥6 yr): Minor or moderate bleeding (requires Factor VIII level of 40–60% of normal): 20–30 IU/kg every 24–48 hr until bleeding episode is resolved; Major bleeding (requires Factor VIII level of 80–100% of normal): 40–50 IU/kg every 12–24 hr until bleeding episode is resolved (7–10 days).
IV (Children <6 yr): Minor or moderate bleeding (requires Factor VIII level of 40–60% of normal): 20–30 IU/kg every 12 hr un-24 until bleeding episode is resolved; Major bleeding (requires Factor VIII level of 80–100% of normal): 40–50 IU/kg every 8–24 hr until bleeding episode is resolved (7–10 days).
Perioperative Management
IV (Adults and Children ≥6 yr): Minor prodecures (requires Factor VIII level 50–80% of normal): 25–40 IU/kg every 24 hr for 24 hr until healing is achieved; major prodecures (requires Factor VIII level 80–120% of normal): 40–60 IU/kg pre-operatively followed by 40–50 IU/kg after 8–24 hr and then every 24 hr to maintain Factor VIII level in desired range, continued until wound healing and then for at least 7 days to maintain Factor VIII level in desired range.IV (Children <6 yr): Minor prodecures (requires Factor VIII level 50–80% of normal): 25–40 IU/kg every 12–24 hr for 24 hr until healing is achieved; major prodecures (requires Factor VIII level 80–120% of normal): 40–60 IU/kg pre-operatively followed by 40–50 IU/kg after 6–24 hr and then every 24 hr to maintain Factor VIII level in desired range, continued until wound healing and then for at least 7 days to maintain Factor VIII level in desired range.
Routine prophylaxis
IV (Adults and Children): 50 IU/kg every 4 days (range 25–65 IU/kg every 3–5 days), doses up to 80 IU/kg or more frequent doses may be required in children <6 yr.
Lyophilized powder (requires reconsititution with accompanying diluent): 250 IU Factor VIII potency/single use vial, 500 IU Factor VIII potency/single use vial, 750 IU Factor VIII potency/single use vial, 1000 IU Factor VIII potency/single use vial, 1500 IU Factor VIII potency/single use vial, 2000 IU Factor VIII potency/single use vial, 3000 IU Factor VIII potency/single use vial
Lab Test Considerations:
Monitor plasma Factor VIII activity to confirm adequate Factor VIII levels are achieved and maintained.
Decreased incidence and severity of bleeding in patients with Hemophilia A.