Prevention and control of hemorrhagic episodes in patients with a deficiency of coagulation factor VIII (antihemophilic factor) associated with hemophilia A (classic hemophilia); designated an orphan drug by FDA for this use.
Because of a decreased risk of transmission of human viruses (e.g., HIV viruses, hepatitis A virus [HAV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and other transmissible disease agents (e.g., agents for Creutzfeldt-Jakob disease [CJD], variant CJD [vCJD]) compared with plasma-derived antihemophilic factor (human), the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation and other experts recommend antihemophilic factor (recombinant) as the preferred preparation when antihemophilic factor therapy is indicated in patients with hemophilia A. Recombinant and plasma-derived preparations of antihemophilic factor produce comparable hemostatic effects.
Antihemophilic factor generally is used in patients with mild to moderate hemophilia A who do not respond adequately to desmopressin or those with moderate to severe hemophilia A and factor VIII level <5% of normal.
Effective in the management of spontaneous or traumatic bleeding episodes (e.g., hemarthrosis, IM hematoma, soft tissue hemorrhage) or acute bleeding events (e.g., GI, retroperitoneal, tonsillar, ocular) in patients with hemophilia A.
Also used for routine prophylaxis (i.e., administration at regular intervals) to prevent or reduce frequency of hemorrhagic events and preserve joint function. MASAC and the World Federation of Hemophilia recommend prophylaxis for patients with severe hemophilia A (factor VIII activity <1%) after careful consideration of risks versus benefits.
Hemophilia A with Inhibitors to Antihemophilic Factor
Prevention and treatment of bleeding in patients with hemophilia A who have developed relatively low levels of inhibitor antibodies to factor VIII. (See Development of Inhibitors to Antihemophilic Factor under Cautions.) Some manufacturers state that antihemophilic factor may be effective in patients with inhibitor levels ≤10 Bethesda units/mL; other clinicians recommend use of these preparations in those with inhibitor levels <5 Bethesda units/mL.
Has been used to induce immune tolerance to further suppress inhibitor production†. Such therapy eliminates risk of anamnesis with continued use of antihemophilic factor.
Generally should not be used for treatment of minor hemorrhage (e.g., cutaneous) in patients with inhibitors and a history of anamnestic response.
MASAC and other clinicians recommend use of a bypassing agent including activated prothrombin complex concentrate (APCC), recombinant factor VIIa, or prothrombin complex concentrates (PCCs) to prevent or control bleeding in patients with inhibitors.
Management of hemophilia A in patients with inhibitors may be difficult and consultation with a hemophilia treatment center is strongly recommended.
Acquired Hemophilia
Has been used to control bleeding in patients without hemophilia A who spontaneously acquire low levels of inhibitors (autoantibodies) to factor VIII. Autoantibodies are similar to but more heterogeneous than the alloantibodies that develop in patients with hemophilia A.
Management of acquired hemophilia† not well established. Antihemophilic factor (recombinant or human) may be effective in patients with low levels of inhibitors. Other treatment options include immunosuppressive therapy, desmopressin, or bypassing agents.
Dosage and Administration
General
Confirm deficiency of factor VIII prior to initiating therapy.
Continue to monitor factor VIII periodically during treatment to individualize dosage and assess response to therapy. (See Laboratory Monitoring under Cautions.)
Administration
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer by slow IV injection or IV infusion over several minutes.
Has been given as a continuous infusion†.
Instructions on reconstitution, dilution, and administration vary according to preparation; consult manufacturers’ labeling for specific information on each antihemophilic factor (recombinant) product.
Reconstitution
Prior to reconstitution, warm lyophilized powders and diluents supplied by the manufacturers to room temperature under ambient conditions (do not exceed 37°C).
Reconstitute and administer drug using tubing, administration sets, vial adapters, and filter needles provided by manufacturer. Use plastic syringes only; antihemophilic factor may adhere to glass.
Gently swirl solution to dissolve powder completely; do not shake vigorously.
Keep reconstituted solutions at room temperature and administer within 3 hours after reconstitution.
Rate of Administration
Individualize infusion rates according to patient response. Monitor pulse before and during infusion. Slow infusion rate or temporarily discontinue therapy if there is a substantial increase in pulse rate, or any other adverse reaction occurs.
Advate®: Administer over 5 minutes or less.
Helixate® FS, Kogenate® FS: Administer over 5–10 minutes or less.
Recombinate®: Administer at a rate ≤10 mL/minute.
ReFacto®: Administer over several minutes; determine rate of administration by the patient’s comfort level.
Dosage
Dosage expressed in terms of international units (IU, units). One unit is approximately equivalent to amount of factor VIII activity in 1 mL of fresh pooled normal human plasma.
Individualize dosage and duration of therapy based on degree of factor VIII deficiency (measuring factor VIII levels prior to and at regular intervals during therapy), desired factor VIII levels, patient’s weight, type and severity of bleeding, presence of inhibitors to factor VIII, and clinical response.
Use the following calculations and dosage guidelines (based on the degree of hemorrhage or type of surgery) for administering the drug. These calculations and suggested dosage regimens are only approximations and should not preclude appropriate laboratory determinations of factor VIII levels.Perform serial assays of factor VIII at suitable intervals as needed to ensure that adequate levels have been attained and maintained. (See Laboratory Monitoring under Cautions.)
If calculated dosage is ineffective in achieving expected factor VIII levels or if bleeding is not controlled, consider the possibility that inhibitors to antihemophilic factor may have developed. (See Development of Inhibitors to Antihemophilic Factor under Cautions.) Higher dosages may be required in such situations.
Administration of 1 unit/kg antihemophilic factor (recombinant) generally increases factor VIII activity by approximately 2%.
Dosage required to achieve desired factor VIII levels:
Dose (units) = body weight (in kg) × 0.5 × desired factor VIII increase (in % of normal)
Approximate % increase in factor VIII levels expected from a given dosage:
Expected factor VIII increase (in % of normal) = [dose (units)/body weight (in kg)] × 2
Pediatric Patients
Hemophilia A
Advate®
IV
Children ≥1 month of age with early hemarthrosis, muscle hemorrhage, or oral bleeding: Use appropriate dosage to achieve a plasma factor VIII level of 20–40% of normal; repeat every 12–24 hours for 1–3 days until bleeding resolves (indicated by pain relief) or healing occurs.
Children ≥1 month of age with moreextensive hemarthrosis, muscle hemorrhage, or hematoma: Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat every 12–24 hours for ≥3 days until pain and disability resolve.
Children ≥1 month of age with life-threatening bleeding (e.g., head injury, throat bleeding, severe abdominal pain): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until bleeding resolves.
Children ≥1 month of age undergoing minor surgery (e.g., tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal within 1 hour of surgery. Repeat dose every 12–24 hours as needed. Consider adjunctive therapy for dental procedures.
Children ≥1 month of age undergoing major surgery: Use appropriate dosage to achieve pre- and postoperative factor VIII levels of 80–120% of normal. Repeat dose every 8–24 hours to desired factor VIII activity and state of wound healing.
Helixate® FS and Kogenate®FS
IV
Children of any age with minor hemorrhage (e.g., superficial, early hemorrhages, bleeding into joints): Initially, 10–20 units/kg to achieve a plasma factor VIII level of 20–40% of normal; repeat if bleeding continues.
Children of any age with moderate to major hemorrhage (hemorrhage into muscles or oral cavity; definite hemarthroses; known trauma): Initially, 15–30 units/kg to achieve a plasma factor VIII level of 30–60% of normal; repeat once at 12–24 hours, if needed.
Children of any age with major to life-threateninghemorrhage (intracranial, intra-abdominal, or intrathoracic hemorrhages; GI bleeding; CNS bleeding; bleeding in retropharyngeal or retroperitoneal spaces or iliopsoas sheath), fractures, head trauma: Initially, 40–50 units/kg to achieve a plasma factor VIII level of 80–100% of normal; give additional doses of 20–25 units/kg every 8–12 hours.
Children of any age undergoing minor surgery: Initially, 15–30 units/kg to achieve a plasma factor VIII level of 30–60% of normal; repeat once at 12–24 hours, if needed.
Children of any age undergoing major surgery: Initially, 50 units/kg preoperatively to achieve a plasma factor VIII level of approximately 100% of normal (must verify 100% factor activity prior to surgery); may repeat after 6–12 hours initially, and for 10–14 days until healing complete.
Children of any age: For prophylaxis of bleeding, may administer on a regular schedule.
Recombinate®
IV
Children of any age with early hemarthrosis, muscle hemorrhage, or oral bleeding: Use appropriate dosage to achieve a plasma factor VIII level of 20–40% of normal; repeat every 12–24 hours for 1–3 days until bleeding resolves (indicated by pain relief) or healing occurs.
Children of any age with moreextensive hemarthrosis, muscle hemorrhage, or hematoma: Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat every 12–24 hours for ≥3 days until pain and disability resolve.
Children of any age with life-threatening bleeding (e.g., head injury, throat bleeding, severe abdominal pain): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until bleeding resolves.
Children of any age undergoing minor surgery (including tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 60–80% of normal. A single infusion in conjunction with oral antifibrinolytic therapy within 1 hour usually sufficient in about 70% of patients.
Children of any age undergoing major surgery: Use appropriate dosage to achieve plasma pre- and postoperative factor VIII levels of 80–100% of normal. Repeat dose every 8–24 hours to desired factor VIII activity and state of wound healing.
ReFacto®
IV
Children of any age with minor hemorrhage (early hemarthrosis, minor muscle hemorrhage, oral bleeding): Use appropriate dosage to achieve a plasma factor VIII level of 20–40% of normal; repeat every 12–24 hours as needed until bleeding resolves. Give at least 1 day of therapy (depending on the severity of hemorrhage).
Children of any age with moderate hemorrhage (muscle hemorrhage, mild trauma capitis, hemorrhage into oral cavity): Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat infusions every 12–24 hours for 3–4 days until local hemostasis achieved.
Children of any age with major hemorrhage (GI, intracranial, intra-abdominal, or intrathoracic hemorrhages) or fractures: Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until bleeding resolves.
Children of any age undergoing minor surgery (e.g., tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat infusions every 12–24 hours for 3–4 days until local hemostasis achieved. For tooth extraction, a single infusion in conjunction with oral antifibrinolytic therapy within 1 hour may be sufficient.
Children of any age undergoing major surgery: Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until local hemostasis achieved.
Children of any age with hemophilia A receiving short-term routine prophylaxis (to prevent or reduce frequency of spontaneous bleeding episodes): Manufacturer recommends administration of drug at least twice weekly to prevent spontaneous musculoskeletal hemorrhages; shorter dosage intervals or higher dosages may be necessary in some pediatric patients. Manufacturer also states that routine prophylaxis 3 times weekly may be associated with a lower risk of bleeding than a twice-weekly regimen. In addition, some experts state that optimum dosage and dosage regimen for short-term routine prophylaxis have not been established.
Adults
Hemophilia A
Advate®
IV
Early hemarthrosis, muscle hemorrhage, or oral bleeding: Use appropriate dosage to achieve a plasma factor VIII level of 20–40% of normal; repeat every 12–24 hours for 1–3 days until bleeding resolves (indicated by pain relief) or healing occurs.
More extensive hemarthrosis, muscle hemorrhage, or hematoma: Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat every 12–24 hours for ≥3 days until pain and disability resolve.
Life-threatening bleeding (e.g., head injury, throat bleeding, severe abdominal pain): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until bleeding resolves.
Minor surgery (e.g., tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal within 1 hour of surgery. Repeat dose every 12–24 hours as needed. Consider adjunctive therapy for dental procedures.
Major surgery: Use appropriate dosage to achieve pre- and postoperative plasma factor VIII levels of 80–120% of normal. Repeat dose every 8–24 hours to desired factor VIII activity and state of wound healing.
Helixate® FS and Kogenate®FS
IV
Minor hemorrhage (e.g., superficial, early hemorrhages, bleeding into joints): Initially, 10–20 units/kg to achieve factor VIII level of 20–40% of normal; repeat if bleeding continues.
Moderate to major hemorrhage (hemorrhage into muscles or oral cavity; definite hemarthroses; known trauma): Initially, 15–30 units/kg to achieve a factor VIII level of 30–60% of normal; repeat once at 12–24 hours, if needed.
Major to life-threatening hemorrhage (intracranial, intra-abdominal, or intrathoracic hemorrhages; GI bleeding; CNS bleeding; bleeding in retropharyngeal or retroperitoneal spaces or iliopsoas sheath), fractures, head trauma: Initially, 40–50 units/kg to achieve a plasma factor VIII level of 80–100% of normal; give additional dosages of 20–25 units/kg every 8–12 hours.
Minor surgery: Initially, 15–30 units/kg to achieve a plasma factor VIII level of 30–60% of normal; repeat once at 12–24 hours, if needed.
Majorsurgery: Initially, 50 units/kg preoperatively to achieve a factor VIII level of approximately 100% of normal (must verify 100% factor activity prior to surgery); may repeat every 6–12 hours initially, and for 10–14 days until healing complete.
For prophylaxis of bleeding, may administer on a regular schedule.
Recombinate®
IV
Early hemarthrosis, muscle hemorrhage, or oral bleeding: Use appropriate dosage to achieve a factor VIII level of 20–40% of normal; repeat every 12–24 hours for 1–3 days until bleeding resolves (indicated by pain relief) or healing occurs.
Moreextensive hemarthrosis, muscle hemorrhage, or hematoma: Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; repeat every 12–24 hours for ≥3 days until pain and disability resolve.
Life-threatening bleeding (e.g., head injury, throat bleeding, severe abdominal pain): Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until bleeding resolves.
Minor surgery (including tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 60–80% of normal. A single infusion in conjunction with oral antifibrinolytic therapy within 1 hour usually sufficient in about 70% of patients.
Major surgery: Use appropriate dosage to achieve pre- and postoperative plasma factor VIII levels of 80–100% of normal. Repeat dose every 8–24 hours to desired factor VIII level and state of wound healing.
ReFacto®
IV
Minor hemorrhage (early hemarthrosis, minor muscle hemorrhage, oral bleeding): Use appropriate dosage to achieve a plasma factor VIII level of 20–40% of normal; repeat every 12–24 hours until bleeding resolves. Give at least 1 day of therapy (depending on the severity of hemorrhage).
Moderate hemorrhage (muscle hemorrhage, mild trauma capitis, hemorrhage into oral cavity): Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; administer infusions every 12–24 hours for 3–4 days until local hemostasis achieved.
Major hemorrhage (GI, intracranial, intra-abdominal, or intrathoracic hemorrhages), fractures: Use appropriate dosage to achieve a plasma factor VIII level of 60–100% of normal; repeat every 8–24 hours until local hemostasis achieved.
Minor surgery (e.g., tooth extraction): Use appropriate dosage to achieve a plasma factor VIII level of 30–60% of normal; administer infusions every 12–24 hours for 3–4 days until local hemostasis achieved. For tooth extraction, a single infusion in conjunction with oral antifibrinolytic therapy within 1 hour may be sufficient.
Major surgery: Use appropriate dosage to achieve a factor VIII level of 60–100% of normal; repeat every 8–24 hours until local hemostasis achieved.
Adults with hemophilia A receiving short-term routine prophylaxis (to prevent or reduce frequency of spontaneous bleeding episodes): Manufacturer recommends administration of drug at least twice weekly to prevent spontaneous musculoskeletal hemorrhages; shorter dosage intervals or higher dosage may be necessary in some patients. Manufacturer also states that routine prophylaxis 3 times weekly may be associated with a lower risk of bleeding than a twice-weekly regimen. Some experts state that optimum dosage and dosage regimen for short-term routine prophylaxis have not been established.
Prescribing Limits
Pediatric Patients
Hemophilia A
IV
Maximum infusion rate of 10 mL/minute.
Adults
Hemophilia A
IV
Maximum infusion rate of 10 mL/minute.
Cautions
Contraindications
Known hypersensitivity to antihemophilic factor (recombinant) or any ingredient in the formulation.
Known hypersensitivity to murine or hamster proteins (Advate®, Helixate® FS, Kogenate®FS, Recombinate®, ReFacto®) or bovine proteins (Recombinate®).
Warnings/Precautions
Warnings
Prior to initiation of antihemophilic factor (recombinant) therapy, appropriate laboratory tests should be performed to confirm that a deficiency in factor VIII exists.
Development of Inhibitors to Antihemophilic Factor
Risk of development of inhibitors (alloantibodies) to factor VIII following antihemophilic factor therapy. Risk of inhibitor development appears to correlate with the severity of hemophilia A and extent of exposure to the drug. Inhibitors usually identified in patients <20 years of age; those <10 years of age appear to be at greatest risk of developing such antibodies.
Inhibitors reported in about 10–30% of patients with hemophilia A, usually within the first 10–20 days of treatment. Inhibitors may diminish or neutralize response to therapy. Anamnestic response and increased levels of inhibitor possible with continued use of drug.
Monitor for development of inhibitors during treatment with clinical observation and appropriate laboratory tests. Perform quantitative test (e.g., Bethesda assay) for inhibitors routinely (e.g., every 3–6 months) and prior to surgery. Screen children every 3–12 months or every 10–20 days following drug exposure, whichever occurs first. Consider the possibility that inhibitors may have developed in patients with treatment failure despite adequate dosages of antihemophilic factor (recombinant) or those with unusually prolonged aPTT.
Consider several factors (e.g., severity and location of bleeding, type and titer of inhibitors, history of anamnestic response, product availability) when treating patients with inhibitors. Consultation with a hemophilia treatment center strongly recommended. Carefully monitor such patients, especially when surgical procedures indicated. Dosage requirements may be variable; use clinical response and factor VIII levels to guide treatment.
Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., hives, generalized urticaria, tightness of the chest, wheezing, hypotension, anaphylaxis) reported rarely with some recombinant factor VIII preparations.
If hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy (e.g., epinephrine, oxygen).
Antibody Formation
Some preparations of antihemophilic factor (recombinant) contain trace amounts of animal proteins (Advate®, Kogenate®, Recombinate®, ReFacto®) which may stimulate antibody production and cause hypersensitivity reactions. Antibodies to such animal proteins reported in a few patients; effect on clinical response not fully elucidated.
Latex Sensitivity
Packaging components for some preparations (e.g., Recombinate®) may contain natural latex proteins; take appropriate precautions if injection is handled by or administered to individuals with a history of natural latex sensitivity.
General Precautions
Risk of Transmissible Agents
Since antihemophilic factor (recombinant) preparations are not prepared using pooled human plasma, they are associated with a decreased risk of transmission of human viruses compared with risk associated with plasma-derived antihemophilic factor (human).
Theoretic but remote risk of transmitting other viruses (e.g., those associated with mammalian cell cultures employed in manufacturing). No such transmission reported to date.
Laboratory Monitoring
Use under supervision of a qualified clinician experienced in treating hemophilia A.
Monitor factor VIII levels prior to and at regular intervals during therapy to guide dosing and ensure adequate therapeutic response.
Monitor factor VIII levels when switching between different factor VIII preparations.
Monitor for development of inhibitors (with Bethesda assay) during treatment, prior to surgery, and when switching between different factor VIII preparations. (See Development of Inhibitors to Antihemophilic Factor under Cautions.)
Sucrose Content
Helixate® FS and Kogenate® FS (250-, 500-, and 1000-unit vials) contain 28 mg of sucrose per vial, while Kogenate® FS 2000-unit vials contain 56 mg of sucrose. The manufacturers state that IV administration of these injections will not affect blood glucose concentrations.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether antihemophilic factor (recombinant) is distributed into human milk. Use only if clearly indicated.
Pediatric Use
Advate®: Safety and efficacy not established in children <1 month of age.
Helixate® FS, Kogenate® FS, Recombinate®, ReFacto®: Have been used in children of all ages without any unusual adverse effects.
Infusion-related reactions (e.g., urticaria, flushing, erythema) occur rarely in previously untreated neonates and children following administration of recombinant factor VIII.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Other reported clinical experience has not identified differences in response between geriatric patients and younger adults. Individualize dosage.
Following IV administration, peak plasma concentrations generally occur 10–15 minutes after end of infusion; may occur up to 1–2 hours later.
Plasma Concentrations
Following IV infusion over 5–15 minutes, plasma concentrations of factor VIII increase by approximately 0.02–0.025 unit/mL per unit/kg administered.
Distribution
Extent
Circulates in plasma; minimally distributed (about 14%) outside the vascular system.
Plasma Binding
Binds noncovalently to von Willebrand factor; stabilizes and protects factor VIII from degradation.
Elimination
Metabolism
Metabolic fate not fully determined.
Elimination Route
Possibly eliminated via reticuloendothelial system.
Half-life
Approximately 8–15 hours.
Stability
Storage
Parenteral
Powder for Infusion
Advate®: 2–8°C (avoid freezing to prevent damage to the diluent vial); may store at room temperature ≤30°C up to 6 months. Do not use beyond expiration date. Do not refrigerate after reconstitution; use solution within 3 hours of reconstitution.
Helixate® FS: 2–8°C (avoid freezing); may store at room temperature ≤25°C up to 3 months. Do not use beyond expiration date. Protect from extreme exposure to light and store lyophilized powder in the carton prior to use. Use solution within 3 hours of reconstitution.
Kogenate® FS: 2–8°C (avoid freezing); may store at room temperature ≤25°C up to 3 months. Do not use beyond expiration date. Protect from extreme exposure to light and store lyophilized powder in the carton prior to use. Use solution within 3 hours of reconstitution.
Recombinate®: 2–8°C (avoid freezing to prevent damage to the diluent vial); may store at room temperature ≤30°C. Do not use beyond expiration date. Do not refrigerate after reconstitution; use solution within 3 hours of reconstitution.
ReFacto®: 2–8°C (avoid freezing to prevent damage to the diluent vial); may store at room temperature ≤25°C up to 3 months. Do not use beyond expiration date. Protect from extreme exposure to light. Use solution within 3 hours of reconstitution.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution Compatibility
Formal compatibility studies have not been performed; manufacturer states antihemophilic factor (recombinant) should not be administered in the same tubing or container with other drugs.
Actions
Antihemophilic factor (recombinant) is structurally similar to and appears to produce the same pharmacologic effects as endogenous human blood coagulation factor VIII.
Factor VIII is essential for blood clotting and maintenance of hemostasis.
Patients with hemophilia A (classic hemophilia) have decreased levels of endogenous factor VIII or dysfunctional factor VIII, resulting in a hemorrhagic tendency and clinical manifestations such as bleeding into soft tissues, muscles, and weight-bearing joints.
The clinical severity and frequency of bleeding in patients with hemophilia A correlate with the degree of deficiency of factor VIII activity. Patients with mild hemophilia A generally have >5% of normal activity, those with moderate disease generally have 1–5% of normal activity, and those with severe disease have <1% of normal activity.
Administration of antihemophilic factor (recombinant) to patients with hemophilia A results in increased plasma levels of factor VIII and temporarily corrects the coagulation defect in these patients.
Although similar in structure and pharmacologic effects to plasma-derived human factor VIII, factor VIII recombinant is associated with substantially reduced risk of transmission of blood-borne human viruses (e.g., HIV, HAV, HBV, HCV).
Prepared by recombinant DNA technology in a mammalian cell expression system using different methods to express, isolate, harvest, and purify factor VIII.
Advice to Patients
Importance of reading manufacturer’s patient information prior to therapy.
Risk for development of inhibitors to factor VIII; importance of informing clinician if usual dosages of factor VIII not able to control bleeding.
Importance of discontinuing therapy and immediately contacting clinician if rash, urticaria, chest tightness, hypotension, wheezing, or other manifestations of hypersensitivity reactions develop.
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Antihemophilic Factor (Recombinant)
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Parenteral
For injection, for IV use
number of units indicated on label
Advate® Plasma/Albumin Free Method (with sterile water for injection diluent; available with transfer and filter needles)
Baxter
Helixate® FS (with sucrose and sterile water for injection diluent; available with transfer and filter needles and an administration set)
CSL Behring, (manufactured by Bayer)
Kogenate® FS (with sucrose and sterile water for injection diluent; available with transfer and filter needles and an administration set)
Bayer
Recombinate® (with albumin [human] and sterile water for injection diluent; available with transfer and filter needles)
Baxter
ReFacto® (with albumin [human] and sodium chloride for injection diluent; available with alcohol swabs, transfer and filter needles, and an administration set)
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
