Trade Names:Advate- Injection, powder for solution antihemophilic factor (AHF) (recombinant) 250 units- Injection, powder for solution AHF (recombinant) 500 units- Injection, powder for solution AHF (recombinant) 1,000 units- Injection, powder for solution AHF (recombinant) 1,500 units- Injection, powder for solution AHF (recombinant) 2,000 units- Injection, powder for solution AHF (recombinant) 3,000 units
Trade Names:Alphanate- Injection, lyophilized powder for solution AHF (human) ≥ 5 units/mg of total protein
Trade Names:Helixate FS- Injection, lyophilized powder for solution AHF (recombinant) 250 units- Injection, lyophilized powder for solution AHF (recombinant) 500 units- Injection, lyophilized powder for solution AHF (recombinant) 1,000 units- Injection, lyophilized powder for solution AHF (recombinant) 2,000 units
Trade Names:Hemofil M- Injection, powder for solution AHF (human) 2 to 20 units/mg of total protein
Trade Names:Koate-DVI- Injection, lyophilized powder for solution 250 units AHF (human)- Injection, lyophilized powder for solution 500 units AHF (human)- Injection, lyophilized powder for solution 1,000 units AHF (human)
Trade Names:Kogenate FS- Injection, lyophilized powder for solution AHF (recombinant) 250 units- Injection, lyophilized powder for solution AHF (recombinant) 500 units- Injection, lyophilized powder for solution AHF (recombinant) 1,000 units- Injection, lyophilized powder for solution AHF (recombinant) 2,000 units
Trade Names:Monoclate-P- Injection, lyophilized powder for solution AHF (human) 250 units- Injection, lyophilized powder for solution AHF (human) 500 units- Injection, lyophilized powder for solution AHF (human) 1,000 units- Injection, lyophilized powder for solution AHF (human) 1,500 units
Trade Names:Recombinate- Injection, lyophilized powder for solution AHF (recombinant) 250 units- Injection, lyophilized powder for solution AHF (recombinant) 500 units- Injection, lyophilized powder for solution AHF (recombinant) 1,000 units
Trade Names:ReFacto- Injection, lyophilized powder for solution AHF (recombinant) 250 units- Injection, lyophilized powder for solution AHF (recombinant) 500 units- Injection, lyophilized powder for solution AHF (recombinant) 1,000 units- Injection, lyophilized powder for solution AHF (recombinant) 2,000 units
Trade Names:Xyntha- Injection, lyophilized powder for solution AHF (recombinant) 250 units- Injection, lyophilized powder for solution AHF (recombinant) 500 units- Injection, lyophilized powder for solution AHF (recombinant) 1,000 units- Injection, lyophilized powder for solution AHF (recombinant) 2,000 units
Increases factor VIII plasma levels, temporarily correcting the coagulation defect caused by factor VIII deficiency in patients with hemophilia A.
Mean C max is 120 units/dL.
Kogenate FSMean C max at 24 weeks is 109 units/dL.
ReFactoMean C max at 12 mo is 2.21 units/mL.
XynthaC max at 6 mo is 1.24 units/mL.
Mean steady-state Vd is 0.47 dL/kg.
Mean half-life is approximately 12 h.
Kogenate FSMean half-life at 24 weeks is 14 h.
Monoclate-PMean half-life is 18 h.
ReFactoMean half-life is 11.4 h.
Control and prevention of bleeding episodes in patients with hemophilia A; surgical prophylaxis of bleeding in patients with hemophilia A. May be of therapeutic value in patients with factor VIII inhibitors not exceeding 10 Bethesda units (BU)/mL.
Kogenate FSFor routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no preexisting joint damage.
ReFactoShort-term prophylaxis to reduce the frequency of spontaneous bleeding episodes.
Hypersensitivity to any component of the product.
Advate , Helixate FS , Kogenate FS , ReFactoKnown hypersensitivity to hamster or mouse proteins.
Advate , Kogenate FSPatients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis.
Hemofil-M , Monoclate-PKnown hypersensitivity to mouse proteins.
RecombinateKnown hypersensitivity to bovine, hamster, or mouse proteins.
XynthaKnown hypersensitivity to hamster proteins.
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. Titrate administered doses to the patient's response. The required dosage can be determined using the following formula:
AHF units required = body weight (kg) × desired factor VIII increase (% normal) × 0.5
Advate , Hemofil-MA peak level of 70% is required in a 40 kg child. See individual product information for dosing guidelines for treatment of hemorrhages and surgical procedures.
Short-Term Routine Prophylaxis ( ReFacto )Adults and Children (all ages including neonates)IV Administer at least 2 times/wk. In some cases, especially in children, shorter dosage intervals or higher doses may be necessary. In clinical studies, the mean dose/infusion for previously treated patients and previously untreated patients was 29 and 53 units/kg, respectively.
Routine Prophylaxis in Children With No Preexisting Joint Damage ( Kogenate FS )ChildrenIV 25 units/kg of body weight every other day.
Store in refrigerator at 36° to 46°F. May be stored at temperatures not exceeding 86°F for 6 mo. Avoid freezing.
AlphanateStore in refrigerator at 36° to 46°F. Do not freeze. May be stored at temperatures not exceeding 86°F for up to 2 mo.
Helixate FS , Kogenate FSStore in refrigerator at 36° to 46°F. Alternatively, may be stored at temperatures not exceeding 77°F for up to 3 mo. Do not freeze. Protect from extreme exposure to light.
Hemofil M , RecombinateStore in refrigerator at 36° to 46°F or at temperatures not exceeding 86°F. Avoid freezing. Administer within 3 h of reconstitution.
Koate-DVIStore in refrigerator at 36° to 46°F. Store lyophilized powder at temperatures of up to 77°F for up to 6 mo. Avoid freezing. Administer within 3 h of reconstitution.
Monoclate-PStore in refrigerator at 36° to 46°F. Alternatively, may be stored at a temperature not exceeding 77°F for up to 6 mo. Avoid freezing.
ReFactoStore in refrigerator at 36° to 46°F. Alternatively, may be stored at temperatures not exceeding 77°F for up to 3 mo. At the end of 3 mo, the product should be used immediately or discarded. Avoid freezing. Avoid prolonged exposure of vial to light. Reconstituted product may be stored at room temperature prior to administration. Use within 3 h after reconstitution.
XynthaStore in refrigerator at 36° to 46°F. Alternatively, may be stored at temperatures not exceeding 77°F for up to 3 mo. The diluent syringe may be stored at 36° to 77°F. Avoid freezing. Avoid prolonged exposure of vial to light.
None well documented.
None well documented.
Slight increase in BP (1%); hypotension (postmarketing).
ReFactoHemorrhage (2%); hypotension, vasodilatation (1%); thrombophlebitis of upper arm (postmarketing).
Headache (29%).
AlphanateHeadache, lethargy, somnolence.
Helixate FSDizziness (2%); depersonalization (1%).
Koate-DVIHeadache.
ReFactoDizziness, headache (4%); asthenia (2%); somnolence (1%); neuropathy (postmarketing).
XynthaHeadache (24%); asthenia (5%).
Urticaria.
Helixate FSRash (2%); pruritus (1%); urticaria (postmarketing).
Kogenate FSPruritus, rash, urticaria (16%).
ReFactoPruritus (2%); rash, urticaria (1%).
Nasopharyngitis (15%); pharyngolaryngeal pain (11%).
Helixate FSRhinitis (1%).
Koate-DVIBlurred vision.
ReFactoTaste perversion (3%).
Nausea, vomiting.
Helixate FSNausea, unusual taste (1%).
Hemofil M , Monoclate-PNausea.
Koate-DVINausea, stomachache.
ReFactoNausea (4%); anorexia, diarrhea, GI hemorrhage (1%).
XynthaNausea (9%); diarrhea, vomiting (5%).
UTI (1%).
Decreased coagulation factor VIII, hematoma.
Kogenate FSFactor VIII inhibition (15%).
ReFactoFactor VIII inhibitor (32%); factor VIII AB lab increase (26%); Chinese hamster ovary AB lab increase (17%); mouse immunoglobulin G AB lab increase (12%).
Allergic reaction.
Helixate FS , Kogenate FSAllergic reactions, anaphylactic reactions (postmarketing).
ReFactoAnaphylactoid reaction (1%).
Increased AST (1%).
Stinging at infusion site.
Helixate FSInjection-site reactions (2%).
Kogenate FSCatheter removal (59%); infusion-site reactions (7%).
ReFactoInjection-site pain (2%); injection-site reaction (1%).
Arthralgia (23%).
ReFactoArthralgia (1%).
Cough (15%).
Helixate FSDyspnea (postmarketing).
ReFactoDyspnea (2%); rhinitis (1%).
Limb injury (35%); pyrexia (17%); accident (15%); fall (13%).
Alphanate , Hemofil MChills, fever.
Koate-DVIJittery feeling; tingling in the arm, ear, and face.
Kogenate FSCentral line infection (19%); pyrexia (3%).
Monoclate-PFactor VIII inhibitors, mild chills.
ReFactoFever (6%); catheter thrombosis, chills, pain (2%); abdominal pain, catheter infection, edema, infection (1%); arm weakness (postmarketing).
XynthaPyrexia (41%).
Category C .
Undetermined.
Studies in previously treated patients younger than 6 yr of age are currently ongoing. A least 54 subjects younger than 16 yr of age have been treated with Advate in phase 2/3 studies.
AlphanateSafety and efficacy not established in children younger than 16 yr of age.
Helixate FS , Kogenate FS , Recombinate , ReFactoAppropriate for use in children of all ages, including neonates.
Koate-DVISafety and efficacy not established in children.
Monoclate-PSafety and efficacy have been demonstrated in 33 children; as in adults, base dosing upon weight.
Studies did not include subjects 65 yr of age and older. Use with caution. Individualize dose selection.
Allergic-type hypersensitivity (including anaphylaxis) reactions may occur.
Bovine/Hamster/Mouse protein antibodiesHemofil M and Monoclate-P contain trace amounts of mouse proteins; therefore, patients may develop hypersensitivity to these proteins. Advate , Helixate FS , Kogenate FS , and ReFacto contain trace amounts of mouse and hamster proteins; therefore, patients may develop hypersensitivity to these proteins. Xyntha contains trace amounts of hamster proteins; therefore, patients may develop hypersensitivity to these proteins. Recombinate contains trace amounts of bovine, hamster, and mouse proteins; therefore, patients may develop hypersensitivity to these proteins.
When large or frequently repeated doses are needed in patients of blood group A, B, or AB, intravascular hemolysis may occur; monitor the hematocrit and direct Coombs tests.
Alphanate , Hemofil M , Koate-DVI , and Monoclate-P are made from human blood, which may contain infectious agents, such as viruses, that can cause disease.
Certain components used in packaging contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.
Neutralizing antibodies (inhibitors) of factor VIII may occur in patients with hemophilia A. Inhibitor titers above 10 BU/mL are likely to make control of hemostasis with AHF concentrates either impossible or impractical because of the large doses required. Alternative means of treating or preventing bleeding may be required.
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time and may seriously affect seronegative pregnant women or immunocompromised individuals.
Not effective in controlling the bleeding of patients with von Willebrand disease.
Massive doses have rarely resulted in acute hemolytic anemia, hyperfibrinogenemia, or increased bleeding tendency.
XynthaNo symptoms of overdose have been reported.
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