| BLEEDING DISORDER TREATMENTS: HEMOPHILIA B | |||
|---|---|---|---|
| Brand | Strength | Form | Dose |
| ANTI-INHIBITOR COAGULANT COMPLEX | |||
| Feiba1,2 | 500 units,1000 units, 2500 units | lyophilized pwd for IV infusion after reconstitution | Adults and Children: Joint hemorrhage: 50–100units/kg every 12hrs until improved. Mucous membrane bleed: 50–100units/kg every 6hrs for ≥1 day or until resolved. Soft tissue hemorrhage: 100units/kg every 12hrs until resolved. Other severe hemorrhage (eg, CNS bleeds): 100units/kg every 6–12hrs until resolved. Pre-op: 50–100units/kg once immediately prior to surgery. Post-op: 50–100units/kg every 6–12hrs until resolved and healed. Routine prophylaxis: 85units/kg every other day. All: Max 200units/kg/day (100units/kg/dose). |
| COAGULATION FACTOR IX | |||
| AlphaNine SD7 | 250 IU, 500 IU, 1000 IU, 1500 IU | lyophilized concentrate for IV infusion after reconstitution | Adults: Dose (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. Individualize. Mild hemorrhage: increase FIX 20–30% (20–30 IU/kg twice daily) for 1–2 days or until resolved. Moderate hemorrhage: increase FIX 25–50% (25–50 IU/kg twice daily) for 2–7 days. Major hemorrhage: increase FIX 50% (30–50 IU/kg twice daily) for 3–5 days then maintain at 20% (20 IU/kg twice daily) for up to 10 days. Surgery: pre-op: increase FIX 50–100% (50–100 IU/kg twice daily), then maintain at 50–100% for 7–10 days or until healed. Max infusion rate: 10mL/min. Children: See full labeling. |
| BeneFix3 | 250 IU, 500 IU, 1000 IU, 2000 IU | lyophilized pwd for IV infusion after reconstitution | Adults: Dose (IU) = Body Weight (kg) × Desired Factor IX increase × 1.3 IU/kg. Minor hemorrhage: 20–30% increase every 12–24hrs for 1–2 days. Moderate hemorrhage: 25–50% increase every 12–24hrs for 2–7 days until resolved. Major hemorrhage: 50–100% increase every 12–24 hrs for 7–10 days. Children: <15yrs: see full labeling. Dose (IU) = body weight (kg) × % FIX increase × 1.4 IU/kg. |
| Mononine3 | 500 IU, 1000 IU | lyophilized pwd for IV infusion after reconstitution | Adults and Children: Dose (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. Individualize. Minor spontaneous hemorrhage, prophylaxis: increase FIX 15–25%; give up to 20–30 IU/kg once; may repeat in 24hrs if needed. Major trauma, surgery: increase FIX 25–50%; give up to 75 IU/kg every 18–30hrs for up to 10 days. |
| Rebinyn4 | 500 IU, 1000 IU, 2000 IU | lyophilized pwd for IV infusion after reconstitution | Adults and Children: Minor/moderate bleed: 40 IU/kg as single dose. Major bleed: 80 IU/kg as single dose. Both: may give additional doses of 40 IU/kg. Peri-op: Minor: 40 IU/kg as single dose; repeat if needed; Major: 80 IU/kg as single dose; if needed, repeat doses of 40 IU/kg (in 1–3 day intervals) within first week, then may extend to once weekly until bleeding stops and healing achieved. |
| Rixubis | 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU | lyophilized pwd for IV infusion after reconstitution | Adults: Initial dose = body weight (kg) x desired FIX increase × reciprocal of observed recovery (IU/dL per IU/kg). Dose in previously treated patients (IU) = body weight (kg) x desired FIX increase × 1.1 dL/kg. Individualize. Minor bleed: 20–30% required every 12–24hrs for ≥1 day until healing achieved. Moderate bleed: 25–50% required every 12–24hrs for 2–7 days until bleeding stops and healing achieved. Major bleed: 50–100% required every 12–24hrs for 7–10 days until bleeding stops and healing achieved. Peri-op: Minor: 30–60% required every 24hrs for ≥1 day until healing achieved; Major: 80–100% required every 8–24hrs for 7–10 days until bleeding stops and healing achieved. Routine prophylaxis (PTPs): 40–60 IU/kg twice weekly; titrate if needed. Max infusion rate 10mL/min. Children: Initial dose = body weight (kg) x desired FIX increase × reciprocal of observed recovery (IU/dL per IU/kg). Dose in PTPs (IU) = body weight (kg) x desired FIX increase x 1.4 dL/kg. Individualize. Minor, moderate, major bleed: see Adults: Peri-op: see Adults: Routine prophylaxis (PTPs): 60–80 IU/kg twice weekly; titrate if needed. Max infusion rate 10mL/min. |
| COAGULATION FACTOR IX/ALBUMIN FUSION PROTEIN | |||
| Idelvion5 | 250 IU, 500 IU, 1000 IU, 2000 IU | lyophilized pwd for IV inj after reconstitution | Adults and Children: Dose (IU) = body weight (kg) × desired FIX increase x reciprocal of recovery (IU/dL per IU/kg). Individualize. Minor/moderate bleed: 30–60% required; repeat every 48–72hrs for ≥1 day until bleeding stops and healing achieved. Major bleed: 60–100% required; repeat every 48–72hrs for 7–14 days until bleeding stops and healing achieved; give maintenance dose weekly. Peri-op: Minor: 50–80% required; repeat every 48–72hrs for ≥1 day or until healing achieved; Major: initially 60–100% required every 48–72hrs for 7–14 days or until bleeding stops and healing achieved; may repeat every 48–72hrs for the 1st week or until healing achieved; give maintenance dose 1–2 times weekly. Routine prophylaxis (<12yrs): 40–55 IU/kg every 7 days; (≥12yrs): 25–40 IU/kg every 7 days (may give 50–75 IU/kg every 14 days if well tolerated). Max infusion rate: 10mL/min. |
| COAGULATION FACTOR IX/Fc FUSION PROTEIN | |||
| Alprolix6 | 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU, 4000 IU | lyophilized pwd for IV inj after reconstitution | Adults and Children: Dose (IU) = body weight (kg) × desired FIX increase x reciprocal of recovery (IU/kg per IU/dL). Individualize. Minor/moderate bleed: 30–60% required; repeat every 48hrs if needed. Major bleed: 80–100% required; consider repeat dose after 6–10hrs, then every 24hrs for the 1st 3 days; then may reduce dose and frequency to every 48hrs or longer until bleeding stops and healing achieved. Peri-op: Minor: 50–80% required as single dose; repeat as needed after 24–48hrs until bleeding stops and healing achieved; Major: initially 60–100% required; consider repeat dose after 6–10hrs, then every 24hrs for the 1st 3 days; then may reduce dose and frequency to every 48hrs or longer until bleeding stops and healing achieved. Routine prophylaxis (<12yrs): initially 60 IU/kg once weekly; (≥12yrs): initially 50 IU/kg once weekly or 100 IU/kg once every 10 days. Max infusion rate 10mL/min. |
| COAGULATION FACTOR IX COMPLEX | |||
| Bebulin7,8 | 500 –700 IU | freeze-dried concentrate for IV infusion after reconstitution | Adults and Children: Dose (IU) = Body Weight (kg) × Desired Factor IX increase × 1.2 IU/kg. Minor bleed: 20% increase (25–35 IU/kg) for 1 dose. Moderate bleed: 40% increase (40–55 IU/kg) once, give 2nd dose after 24hrs (continue until resolved). Major bleed: ≥60% increase (60–70 IU/kg) once daily for 2–3 days or until healed. Surgery: give loading dose 1hr prior to surgery; may repeat every 12hrs initially then every 24hrs in late post-op period. Minor: initially 40–60% (50–60 IU/kg), then 20–40% (25–55 IU/kg) for 1–2wks. Major: initially ≥60% increase (70–95 IU/kg) then 20–60% (35–75 IU/kg) for 1–2wks, then 20% (25–35 IU/kg) until healed. Prophylaxis: 20–30 IU/kg 1–2 times weekly. Max infusion rate: 2mL/min. |
| Profilnine SD7 | 500 IU, 1000 IU, 1500 IU | lyophilized concentrate for IV infusion after reconstitution | Adults: Dose (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. Individualize. Mild to moderate hemorrhage: increase FIX 20–30% as single dose. Serious hemorrhage: increase FIX 30–50% once daily. Surgery: increase FIX 30–50% for ≥1wk post-op. Dental extraction: increase FIX 50% immediately prior to procedure; may give additional doses if bleeding recurs. Max infusion rate: 10mL/min. Children: See full labeling. |
| COAGULATION FACTOR VIIa | |||
| NovoSeven RT1 | 1mg, 2mg, 5mg, 8mg | lyophilized pwd for IV inj after recon-stitution | Adults and Children: Give by IV bolus only. Individualize. Bleeding: 90mcg/kg every 2hrs, adjust until hemostasis achieved; post-hemostatic dose: continue at 3–6hrs intervals for severe bleeds. Peri-op: initially 90mcg/kg prior to surgery, repeat at 2hr intervals during surgery. Post-op: Minor: every 2hrs for 48hrs, then every 2–6hrs until healed; Major: every 2hrs for 5 days, then every 4hrs until healed. |
| NOTES | |||
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Key: FIX = Factor IX; PTP = previously treated patients 1 For Hemophilia B with inhibitors. 2 Contains Factors II, IX, X (non-activated); Factor VII (activated); Factor VIII inhibitor bypassing activity; Prothrombin Complex Factors. 3 May need higher doses if FIX inhibitors present or low FIX recovery. 4 GlycoPEGylated. 5 Dose adjustment may be needed in children <12yrs. 6 More frequent or higher doses may be needed in children <12yrs (esp. <6yrs). 7 Contains Factor II, Factor VII, Factor X (non-therapeutic levels in AlphaNine). 8 Contains heparin. Not an inclusive list of medications and/or official indications. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Created 4/2018) |
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