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
Assess for allergic reaction (angioedema, dyspnea, wheezing, tachycardia, urticaria, hives, chest tightness, pruritus). If symptoms occur discontinue infusion immediately and treat symtomatically.
Lab Test Considerations:
Monitor plasma Factor VIII activity to confirm adequate Factor VIII levels are achieved and maintained.
Instruct patient to notify health care professional or go to nearest emergency department immediately if signs and symptoms of hypersensitivity reactions occur.
Decreased incidence and severity of bleeding in patients with Hemophilia A.