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clotting factor replacements
Factor IX replacement (DNA-derived) to control and prevent bleeding episodes perioperatively or prophylactically in patients with Hemophilia B.
Replaces deficient Factor IX in patients with Hemophilia B.
Decreased incidence and severity of bleeding .
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Used up in clotting process.
Half-life: Adults–86.5 hr; children 12–17 yr–84 hr; children 6–11 yr–72.2 hr; children 2–5 yr–66.4 hr.
TIME/ACTION PROFILE (decreased bleeding/risk of bleeding)
|IV||rapid||unknown||6–48 hr †|
Use Cautiously in:
CV: THROMBEMBOLISM (↑RISK WITH CONTINUOUS INFUSION VIA CENTRAL CATHETER)
GI: perioral paresthesia
Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, production of neutralizing antibodies (inhibitors)
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
One unit/kg increases circulating Factor IX (FIX) level by 1%.
IV: (Adults and Children) Minor and moderate bleeding– amount needed to produce a circulating FIX level of 30–40 IU/dL, repeated every 48 hr as needed; Major bleeding– amount needed to produce a circulating FIX level of 80–100 IU/dL, repeat after 6–10 hr, then every 24 hr for three days, then every 48 hr until healing occurs; Perioperative management (minor procedures)–amount needed to produce a circulating FIX level of 50–80 IU/dL as a single infusion, may be repeated after 24–48 hr until bleeding ceases and healing has occurs; Perioperative management (major procedures)–amount needed to produce a circulating FIX level of 60–100 IU/dL as a single infusion, may be repeated after 6–10 hr and then every 24 for 3 days until bleeding ceases and healing occurs (additional doses may be given every 48 hr if needed);Routine prophylaxis–50 IU/kg once weekly or 100 IU/kg every 10 days. Doses may be modified according to need/response.
Lyophilized powder for IV injection (requires reconstitution): 500 IU vial, 1000 IU vial, 2000 IU vial, 3000 IU vial
Lab Test Considerations:
If expected Factor IX activity levels are not attained or if bleeding is not controlled with recommended dose, perform a Bethesda assay to determine if inhibitors are present.
Control and prevention of bleeding in adults and children with Hemophilia B.
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