Usual Adult Dose for Bleeding

General Dosage Guidelines:
50 to 100 units/kg IV

Comments:

• Patients with a factor VIII inhibitor titer less than 5 Bethesda units (BU) may be successfully treated with antihemophilic factor. Patients with a titer between 5 and 10 BU may be treated with antihemophilic factor or this drug. Patients with a titer greater than 10 BU have generally been refractory to treatment with antihemophilic factor.
• Patients receiving more than 100 units/kg must be monitored for the development of disseminated intravascular coagulation (DIC) and/or symptoms of acute coronary ischemia. High doses should only be given if necessary to stop bleeding.

Use: Control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.

Joint Hemorrhage:
50 units/kg IV every 12 hours until clear signs of clinical improvement appear (e.g., relief of pain, reduction of swelling, or mobilization of the joint). Dose may be increased to 100 units/kg if hemorrhage does not stop.

Maximum dose: Two administrations of 100 units/kg a day or a total daily dose of 200 units/kg should not normally be exceeded.

Mucous Membrane Bleeding:
50 units/kg IV every 6 hours. Dose may be increased to 100 units/kg if hemorrhage does not stop.

Maximum dose: Two administrations of 100 units/kg a day or a daily total dose of 200 units/kg should not be exceeded.

Comments: Monitor the patient carefully (i.e., examine for cessation of visible bleeding) and perform repeated measurements of hemoglobin/hematocrit.

Soft Tissue Hemorrhage:
100 units/kg IV every 12 hours

Maximum dose: Total daily dose of 200 units/kg should not be exceeded.

Other Severe Hemorrhage:
100 units/kg IV every 6 to 12 hours

Maximum dose: Single doses of 100 units/kg and a daily dose of 200 units/kg should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses.

Comments: May be indicated at 6-hour intervals until clear clinical improvement is achieved.

Usual Pediatric Dose for Bleeding

Safety and efficacy have not been established in neonates.

General Dosage Guidelines:
50 to 100 units/kg IV

Comments:

• Patients with a factor VIII inhibitor titer less than 5 Bethesda units (BU) may be successfully treated with antihemophilic factor. Patients with a titer between 5 and 10 BU may be treated with antihemophilic factor or this drug. Patients with a titer greater than 10 BU have generally been refractory to treatment with antihemophilic factor.
• Patients receiving more than 100 units/kg must be monitored for the development of disseminated intravascular coagulation (DIC) and/or symptoms of acute coronary ischemia. High doses should only be given if necessary to stop bleeding.

Use: Control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.

Joint Hemorrhage:
50 units/kg IV every 12 hours until clear signs of clinical improvement appear (e.g., relief of pain, reduction of swelling, or mobilization of the joint). Dose may be increased to 100 units/kg if hemorrhage does not stop.

Maximum dose: Two administrations of 100 units/kg a day or a total daily dose of 200 units/kg should not normally be exceeded.

Mucous Membrane Bleeding:
50 units/kg IV every 6 hours. Dose may be increased to 100 units/kg if hemorrhage does not stop.

Maximum dose: Two administrations of 100 units/kg a day or a daily total dose of 200 units/kg should not be exceeded.

Comments: Monitor the patient carefully (i.e., examine for cessation of visible bleeding) and perform repeated measurements of hemoglobin/hematocrit.

Soft Tissue Hemorrhage:
100 units/kg IV every 12 hours

Maximum dose: Total daily dose of 200 units/kg should not be exceeded.

Other Severe Hemorrhage:
100 units/kg IV every 6 to 12 hours

Maximum dose: Single doses of 100 units/kg and a daily dose of 200 units/kg should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses.

Comments: May be indicated at 6-hour intervals until clear clinical improvement is achieved.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Use with caution

Precautions

US BOXED WARNING:

• THROMBOTIC/THROMBOEMBOLIC EVENTS: Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of this drug, particularly following the administration of high doses and/or in patients with thrombotic risk factors. Monitor patients receiving this drug for signs and symptoms of thromboembolic events.

Safety and efficacy have not been established in neonates.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available