Miscellaneous coagulation modifiers
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Factor Ix Complex Dosage

Drug Detail:Bebulin vh (Factor ix complex [ fak-tor-nine-kom-plex ])

Drug Class: Miscellaneous coagulation modifiers

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Usual Adult Dose for Factor IX Deficiency

The amount of this drug required to establish hemostasis will vary with each patient and circumstance.

Bebulin(R): 1 international unit (IU) factor IX/kg will increase the plasma level of factor IX by 0.8%.
Profilnine(R): 1 IU factor IX/kg will increase the plasma level of factor IX by 1%.

Minor hemorrhage (e.g., early hemarthrosis, minor epistaxis, gingival bleeding, mild hematuria):
Bebulin(R):

  • Initial dose (desired factor IX level: 20% of normal): 25 to 35 IU/kg IV once; a single dose is usually sufficient; otherwise, a second dose may be given after 24 hours.
Profilnine(R):
  • Initial dose (desired factor IX level: 20% to 30% of normal): 20 to 30 IU/kg IV every 16 to 24 hours for 1 to 2 days until hemorrhage stops and healing has been achieved.

Moderate hemorrhage (e.g., severe joint bleeding, early hematoma, major open bleeding, minor trauma, minor hemoptysis, hematemesis, melena, major hematuria):
Bebulin(R):
  • Initial dose (desired factor IX level: 40% of normal): 50 to 65 IU/kg IV; average duration of treatment is 2 days or until adequate wound healing occurs; more severe hemorrhage will require several doses at approximately 24-hour intervals; for maintenance therapy, two-thirds of the initial dose is usually required.
Profilnine(R):
  • Initial dose (desired factor IX level: 20% to 30% of normal): 20 to 30 IU/kg IV every 16 to 24 hours for 2 to 7 days until hemorrhage stops and healing has been achieved.

Major hemorrhage (e.g., severe hematoma, major trauma, severe hemoptysis, hematemesis, melena):
Bebulin(R):
  • Initial dose (desired factor IX level: 60% of normal or greater): 75 to 90 IU/kg IV; average duration of treatment is 2 to 3 days or until adequate wound healing occurs; more severe hemorrhage will require several doses at approximately 24-hour intervals; for maintenance therapy, two-thirds of the initial dose is usually required.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours.
  • Maintenance dose (desired factor IX level: 20% of normal): 20 IU/kg IV for 3 to 10 days or until healing has been achieved.

Dental surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 40% to 60% of normal): 50 to 75 IU/kg IV 1 hour prior to surgery; one infusion should be sufficient; in case of extraction of several teeth, replacement therapy for up to 1 week may be necessary using the same dose.
Profilnine(R):
  • Initial dose (desired factor IX level: 50% of normal immediately before procedure): 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Minor surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 40% to 60% of normal): 50 to 75 IU/kg IV 1 hour prior to surgery.
  • Initial postoperative dose (week 1 to 2 or until adequate wound healing; desired factor IX level: 20% to 40% of normal): 25 to 65 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Major surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 60% of normal or greater): 75 to 90 IU/kg IV 1 hour prior to surgery.
  • Initial postoperative dose (week 1 to 2; desired factor IX level: 20% to 60% of normal): 25 to 75 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
  • Late postoperative dose (week 3 or until adequate wound healing; desired factor IX level: 20% of normal): 25 to 35 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Usual Adult Dose for Hemophilia B

The amount of this drug required to establish hemostasis will vary with each patient and circumstance.

Bebulin(R): 1 international unit (IU) factor IX/kg will increase the plasma level of factor IX by 0.8%.
Profilnine(R): 1 IU factor IX/kg will increase the plasma level of factor IX by 1%.

Minor hemorrhage (e.g., early hemarthrosis, minor epistaxis, gingival bleeding, mild hematuria):
Bebulin(R):

  • Initial dose (desired factor IX level: 20% of normal): 25 to 35 IU/kg IV once; a single dose is usually sufficient; otherwise, a second dose may be given after 24 hours.
Profilnine(R):
  • Initial dose (desired factor IX level: 20% to 30% of normal): 20 to 30 IU/kg IV every 16 to 24 hours for 1 to 2 days until hemorrhage stops and healing has been achieved.

Moderate hemorrhage (e.g., severe joint bleeding, early hematoma, major open bleeding, minor trauma, minor hemoptysis, hematemesis, melena, major hematuria):
Bebulin(R):
  • Initial dose (desired factor IX level: 40% of normal): 50 to 65 IU/kg IV; average duration of treatment is 2 days or until adequate wound healing occurs; more severe hemorrhage will require several doses at approximately 24-hour intervals; for maintenance therapy, two-thirds of the initial dose is usually required.
Profilnine(R):
  • Initial dose (desired factor IX level: 20% to 30% of normal): 20 to 30 IU/kg IV every 16 to 24 hours for 2 to 7 days until hemorrhage stops and healing has been achieved.

Major hemorrhage (e.g., severe hematoma, major trauma, severe hemoptysis, hematemesis, melena):
Bebulin(R):
  • Initial dose (desired factor IX level: 60% of normal or greater): 75 to 90 IU/kg IV; average duration of treatment is 2 to 3 days or until adequate wound healing occurs; more severe hemorrhage will require several doses at approximately 24-hour intervals; for maintenance therapy, two-thirds of the initial dose is usually required.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours.
  • Maintenance dose (desired factor IX level: 20% of normal): 20 IU/kg IV for 3 to 10 days or until healing has been achieved.

Dental surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 40% to 60% of normal): 50 to 75 IU/kg IV 1 hour prior to surgery; one infusion should be sufficient; in case of extraction of several teeth, replacement therapy for up to 1 week may be necessary using the same dose.
Profilnine(R):
  • Initial dose (desired factor IX level: 50% of normal immediately before procedure): 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Minor surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 40% to 60% of normal): 50 to 75 IU/kg IV 1 hour prior to surgery.
  • Initial postoperative dose (week 1 to 2 or until adequate wound healing; desired factor IX level: 20% to 40% of normal): 25 to 65 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Major surgery:
Bebulin(R):
  • Initial dose (day of operation; desired factor IX level: 60% of normal or greater): 75 to 90 IU/kg IV 1 hour prior to surgery.
  • Initial postoperative dose (week 1 to 2; desired factor IX level: 20% to 60% of normal): 25 to 75 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
  • Late postoperative dose (week 3 or until adequate wound healing; desired factor IX level: 20% of normal): 25 to 35 IU/kg IV; average treatment interval will be 12 hours initially, then every 24 hours later in the postoperative period.
Profilnine(R):
  • Initial dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV prior to surgery.
  • Maintenance dose (desired factor IX level: 30% to 50% of normal): 30 to 50 IU/kg IV every 16 to 24 hours for 7 to 10 days following surgery or until healing has been achieved.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution

Precautions

CONTRAINDICATIONS:

  • Known history of hypersensitivity reactions to the product
  • Known allergy to heparin (heparin-containing formulation)
  • Known history of heparin-induced thrombocytopenia (heparin-containing formulation)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice: The manufacturer product information should be consulted.

Storage requirements: Do not freeze.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Monitoring:

  • Hematologic: Factor IX levels

Patient advice:
  • Inform patients of the early signs and symptoms of hypersensitivity, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Advise patients to discontinue this drug and contact their physician and/or seek immediate emergency care if these symptoms occur.
  • Advise patients to notify their physician of any decrease in effectiveness of this drug as this can indicate development of inhibitors.
  • Advise patients of signs and symptoms of parvovirus B19 infection (e.g., fever, drowsiness, chills, and runny nose followed by a rash and joint pain 2 weeks later), which is especially serious in pregnant women or immune-compromised patients.
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