HELIXATE FS- antihemophilic factor, recombinant
CSL Behring LLC
1 INDICATIONS AND USAGE
Helixate� FS is a recombinant antihemophilic factor indicated for:
�
On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
�
Perioperative management of bleeding in adults and children with hemophilia A.
�
Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
�
Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.
Helixate FS is not indicated for the treatment of von Willebrand disease.
2 DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
2.1 Dose
Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
Each vial of Helixate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.
The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:
Dosage (units) = body weight (kg) � desired factor VIII rise (IU/dL or % of normal) � 0.5 (IU/kg per IU/dL)
or
IU/dL (or % normal) = Total Dose (IU)/body weight (kg) � 2 [IU/dL]/[IU/kg]
Titrate dose to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Helixate FS.2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
On-Demand Treatment and Control of Bleeding Episodes
