Usual Adult Dose for Factor IX Deficiency

For intravenous use after reconstitution only.

AlphaNine SD(R): number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (%) x 1 IU/kg; adjust dose based on clinical response

Alprolix(R): number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 hours if further evidence of bleeding
Major bleeding: 80 to 100 IU/dL (or % of normal); repeat dose after 6 to 10 hours, then every 24 hours for the first 3 days.

• Because of this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding is stopped and healing is achieved.

Perioperative management, minor surgery (including uncomplicated dental extraction): 50 to 80 IU/dL (or % of normal); a single dose may be sufficient; repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved.
Perioperative management, major surgery: 60 to 100 IU/dL (or % of normal); consider repeat dosing after 6 to 10 hours, then every 24 hours for the first 3 days.

• Due to this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

Routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10 days; adjust based on individual response.

BeneFIX(R), Rixubis(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Average recovery: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.8 IU/dL (range 0.4 to 1.2 IU/dL)

Idelvion(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 to 72 hours until healing is achieved; a single dose is sufficient for most minor surgeries
Major bleeding: 60 to 100 IU/dL (or % of normal); repeat every 48 to 72 hours for the first week until bleeding stops or healing is achieved; maintenance dose is 1 to 2 times per week.
Perioperative management, minor surgery (uncomplicated hemarthrosis, muscle bleeding other than iliopsoas, oral bleeding): 30 to 60 IU/dL (or % of normal); a single dose is usually sufficient.
Perioperative management, major surgery (life or limb threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal): 60 to 100 IU/dL (or % of normal); repeat dose every 48 to 72 hours for 7 to 14 days until bleeding stops and healing is achieved; maintenance dose is 1 to 2 times weekly.
Routine prophylaxis: 25 to 40 IU/kg once weekly; well controlled patients may be switched to 50 to 75 IU/kg every 14 days.

• Adjust dose based on individual response.

Ixinity(R):
Initial dose: number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.02 dL/kg

Mononine(R): number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x 1 IU/kg (per IU/dL)

Rebinyn(R):
Minor and moderate bleeding: 40 IU/kg

• A single dose should be sufficient for minor and moderate bleeds; additional 40 IU/kg doses may be given

Major bleeding: 80 IU/kg; additional 40 IU/kg doses may be given
Perioperative management, minor surgical procedure (e.g. implanting subcutaneous pumps, skin biopsy, simple dental procedures): 40 IU/kg

• A single dose should be sufficient for minor procedures; additional doses may be given as needed

Perioperative management, major surgical procedure (e.g. body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, normal anatomy is operatively altered): 80 IU/kg for pre-operative dose

• Additional 40 IU/kg doses at 1- to 3-day intervals within the first week after surgery may be given as clinically needed for perioperative bleeding management.
• Due to this products long half-life, post-surgical dosing may be extended to once weekly after the first week until bleeding stops and healing is achieved.

Comments:

• Dosage and treatment duration depend on the severity of factor IX deficiency, bleeding location and extent, patient clinical condition, age, and pharmacokinetics of factor IX.

Usual Adult Dose for Hemophilia B

For intravenous use after reconstitution only.

AlphaNine SD(R): number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (%) x 1 IU/kg; adjust dose based on clinical response

Alprolix(R): number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 hours if further evidence of bleeding
Major bleeding: 80 to 100 IU/dL (or % of normal); repeat dose after 6 to 10 hours, then every 24 hours for the first 3 days.

• Because of this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding is stopped and healing is achieved.

Perioperative management, minor surgery (including uncomplicated dental extraction): 50 to 80 IU/dL (or % of normal); a single dose may be sufficient; repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved.
Perioperative management, major surgery: 60 to 100 IU/dL (or % of normal); consider repeat dosing after 6 to 10 hours, then every 24 hours for the first 3 days.

• Due to this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

Routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10 days; adjust based on individual response.

BeneFIX(R), Rixubis(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Average recovery: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.8 IU/dL (range 0.4 to 1.2 IU/dL)

Idelvion(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 to 72 hours until healing is achieved; a single dose is sufficient for most minor surgeries
Major bleeding: 60 to 100 IU/dL (or % of normal); repeat every 48 to 72 hours for the first week until bleeding stops or healing is achieved; maintenance dose is 1 to 2 times per week.
Perioperative management, minor surgery (uncomplicated hemarthrosis, muscle bleeding other than iliopsoas, oral bleeding): 30 to 60 IU/dL (or % of normal); a single dose is usually sufficient.
Perioperative management, major surgery (life or limb threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal): 60 to 100 IU/dL (or % of normal); repeat dose every 48 to 72 hours for 7 to 14 days until bleeding stops and healing is achieved; maintenance dose is 1 to 2 times weekly.
Routine prophylaxis: 25 to 40 IU/kg once weekly; well controlled patients may be switched to 50 to 75 IU/kg every 14 days.

• Adjust dose based on individual response.

Ixinity(R):
Initial dose: number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.02 dL/kg

Mononine(R): number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x 1 IU/kg (per IU/dL)

Rebinyn(R):
Minor and moderate bleeding: 40 IU/kg

• A single dose should be sufficient for minor and moderate bleeds; additional 40 IU/kg doses may be given

Major bleeding: 80 IU/kg; additional 40 IU/kg doses may be given
Perioperative management, minor surgical procedure (e.g. implanting subcutaneous pumps, skin biopsy, simple dental procedures): 40 IU/kg

• A single dose should be sufficient for minor procedures; additional doses may be given as needed

Perioperative management, major surgical procedure (e.g. body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, normal anatomy is operatively altered): 80 IU/kg for pre-operative dose

• Additional 40 IU/kg doses at 1- to 3-day intervals within the first week after surgery may be given as clinically needed for perioperative bleeding management.
• Due to this products long half-life, post-surgical dosing may be extended to once weekly after the first week until bleeding stops and healing is achieved.

Comments:

• Dosage and treatment duration depend on the severity of factor IX deficiency, bleeding location and extent, patient clinical condition, age, and pharmacokinetics of factor IX.

Usual Pediatric Dose for Factor IX Deficiency

For intravenous use after reconstitution only.

Alprolix(R): number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 hours if further evidence of bleeding
Major bleeding: 80 to 100 IU/dL (or % of normal); repeat dose after 6 to 10 hours, then every 24 hours for the first 3 days.

• Because of this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding is stopped and healing is achieved.

Perioperative management, minor surgery (including uncomplicated dental extraction): 50 to 80 IU/dL (or % of normal); a single dose may be sufficient; repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved.
Perioperative management, major surgery: 60 to 100 IU/dL (or % of normal); consider repeat dosing after 6 to 10 hours, then every 24 hours for the first 3 days.

• Due to this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

Routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10 days; adjust based on individual response.

• In patients under 12 years old recovery may be lower and body weight adjusted clearance may be higher; adjust dose as needed.

BeneFIX(R):
Initial dose: number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Average recovery:
15 years and older: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.8 IU/dL (range 0.4 to 1.2 IU/dL) in adult patients

Under 15 years: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.3 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.7 IU/dL (range 0.2 to 2.1 IU/dL) in pediatric patients

Idelvion(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 to 72 hours until healing is achieved; a single dose is sufficient for most minor surgeries
Major bleeding: 60 to 100 IU/dL (or % of normal); repeat every 48 to 72 hours for the first week until bleeding stops or healing is achieved; maintenance dose is 1 to 2 times per week.
Perioperative management, minor surgery (uncomplicated hemarthrosis, muscle bleeding other than iliopsoas, oral bleeding): 30 to 60 IU/dL (or % of normal); a single dose is usually sufficient.
Perioperative management, major surgery (life or limb threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal): 60 to 100 IU/dL (or % of normal); repeat dose every 48 to 72 hours for 7 to 14 days until bleeding stops and healing is achieved; maintenance dose is 1 to 2 times weekly.
Routine prophylaxis, 12 and older: 25 to 40 IU/kg once weekly; well controlled patients may be switched to 50 to 75 IU/kg every 14 days.
Routine prophylaxis, under 12 years old: 40 to 55 IU/kg once weekly

• Adjust dose based on individual response.

Ixinity(R):
12 years and older:
Initial dose: number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.02 dL/kg

Mononine(R): number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x 1 IU/kg (per IU/dL)

Rebinyn(R):
Minor and moderate bleeding: 40 IU/kg

• A single dose should be sufficient for minor and moderate bleeds; additional 40 IU/kg doses may be given

Major bleeding: 80 IU/kg; additional 40 IU/kg doses may be given
Perioperative management, minor surgical procedure (e.g. implanting subcutaneous pumps, skin biopsy, simple dental procedures): 40 IU/kg

• A single dose should be sufficient for minor procedures; additional doses may be given as needed

Perioperative management, major surgical procedure (e.g. body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, normal anatomy is operatively altered): 80 IU/kg for pre-operative dose

• Additional 40 IU/kg doses at 1- to 3-day intervals within the first week after surgery may be given as clinically needed for perioperative bleeding management.
• Due to this products long half-life, post-surgical dosing may be extended to once weekly after the first week until bleeding stops and healing is achieved.

Rixubis(R):
Initial dose: number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients:
12 years and older: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.1 dL/kg (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.9 IU/dL in adult patients

Under 12 years: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.7 IU/dL (range 0.2 to 2.1 IU/dL) in pediatric patients

Comments:

• Dosage and treatment duration depend on the severity of factor IX deficiency, bleeding location and extent, patient clinical condition, age, and pharmacokinetics of factor IX.

Usual Pediatric Dose for Hemophilia B

For intravenous use after reconstitution only.

Alprolix(R): number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 hours if further evidence of bleeding
Major bleeding: 80 to 100 IU/dL (or % of normal); repeat dose after 6 to 10 hours, then every 24 hours for the first 3 days.

• Because of this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding is stopped and healing is achieved.

Perioperative management, minor surgery (including uncomplicated dental extraction): 50 to 80 IU/dL (or % of normal); a single dose may be sufficient; repeat as needed after 24 to 48 hours until bleeding stops and healing is achieved.
Perioperative management, major surgery: 60 to 100 IU/dL (or % of normal); consider repeat dosing after 6 to 10 hours, then every 24 hours for the first 3 days.

• Due to this products long half-life, dose may be reduced and dosing frequency extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.

Routine prophylaxis: 50 IU/kg once weekly or 100 IU/kg once every 10 days; adjust based on individual response.

• In patients under 12 years old recovery may be lower and body weight adjusted clearance may be higher; adjust dose as needed.

BeneFIX(R):
Initial dose: number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Average recovery:
15 years and older: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.8 IU/dL (range 0.4 to 1.2 IU/dL) in adult patients

Under 15 years: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.3 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.7 IU/dL (range 0.2 to 2.1 IU/dL) in pediatric patients

Idelvion(R):
Initial dose: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Minor to moderate bleeding: 30 to 60 IU/dL (or % of normal); repeat every 48 to 72 hours until healing is achieved; a single dose is sufficient for most minor surgeries
Major bleeding: 60 to 100 IU/dL (or % of normal); repeat every 48 to 72 hours for the first week until bleeding stops or healing is achieved; maintenance dose is 1 to 2 times per week.
Perioperative management, minor surgery (uncomplicated hemarthrosis, muscle bleeding other than iliopsoas, oral bleeding): 30 to 60 IU/dL (or % of normal); a single dose is usually sufficient.
Perioperative management, major surgery (life or limb threatening hemorrhage, deep muscle bleeding including iliopsoas, intracranial, retropharyngeal): 60 to 100 IU/dL (or % of normal); repeat dose every 48 to 72 hours for 7 to 14 days until bleeding stops and healing is achieved; maintenance dose is 1 to 2 times weekly.
Routine prophylaxis, 12 and older: 25 to 40 IU/kg once weekly; well controlled patients may be switched to 50 to 75 IU/kg every 14 days.
Routine prophylaxis, under 12 years old: 40 to 55 IU/kg once weekly

• Adjust dose based on individual response.

Ixinity(R):
12 years and older:
Initial dose: number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.02 dL/kg

Mononine(R): number of factor IX required in IU = body weight (kg) x desired factor IX increase (% or IU/dL) x 1 IU/kg (per IU/dL)

Rebinyn(R):
Minor and moderate bleeding: 40 IU/kg

• A single dose should be sufficient for minor and moderate bleeds; additional 40 IU/kg doses may be given

Major bleeding: 80 IU/kg; additional 40 IU/kg doses may be given
Perioperative management, minor surgical procedure (e.g. implanting subcutaneous pumps, skin biopsy, simple dental procedures): 40 IU/kg

• A single dose should be sufficient for minor procedures; additional doses may be given as needed

Perioperative management, major surgical procedure (e.g. body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, normal anatomy is operatively altered): 80 IU/kg for pre-operative dose

• Additional 40 IU/kg doses at 1- to 3-day intervals within the first week after surgery may be given as clinically needed for perioperative bleeding management.
• Due to this products long half-life, post-surgical dosing may be extended to once weekly after the first week until bleeding stops and healing is achieved.

Rixubis(R):
Initial dose: number of factor IX required in international units (IU) = body weight in kg x desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg or IU/dL)
Incremental recovery in previously treated patients:
12 years and older: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.1 dL/kg (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.9 IU/dL in adult patients

Under 12 years: number of factor IX required in IU = body weight in kg x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg or IU/dL)

• On average, one IU/kg increased circulating activity of factor IX by 0.7 IU/dL (range 0.2 to 2.1 IU/dL) in pediatric patients

Comments:

• Dosage and treatment duration depend on the severity of factor IX deficiency, bleeding location and extent, patient clinical condition, age, and pharmacokinetics of factor IX.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Life-threatening immediate hypersensitivity (including anaphylaxis) to any of the ingredients, including hamster protein

Consult WARNINGS section for additional precautions.

Dialysis

Data not available