Alphanate

Alphanate

factor viii + von willebrand factor

Manufacturer:

Grifols

Distributor:

DKSH
Concise Prescribing Info
Contents
Antihemophilic factor/von Willebrand factor complex (human), solvent detergent & heat treated
Indications/Uses
Prevention & control of bleeding in patients w/ factor VIII deficiency due to hemophilia A or acquired factor VIII deficiency. Surgical &/or invasive procedure in patients w/ von Willebrand disease in whom desmopressin is either ineffective or contraindicated, except type 3 patients undergoing major surgery.
Dosage/Direction for Use
IV Hemophilia A Individualised dosage. Dose is based on initial response of 2% of normal FVIII:C increase per FVIII:C IU/kg. Minor hemorrhage (bruises, cuts or scrapes, uncomplicated joint hemorrhage) 15 FVIII IU/kg bid until hemorrhage stops & healing has been achieved. Moderate hemorrhage (nose, mouth & gum bleeds, dental extractions, hematuria) 25 FVIII IU/kg bid until healing has been achieved. Major hemorrhage (joint & muscle hemorrhage, major trauma, hematuria, intracranial & IP bleeding) 40-50 FVIII IU/kg bid. Following this treatment period, FVIII levels should be maintained at 25 FVIII IU/kg bid until healing has been achieved. Major hemorrhage may require treatment for up to 10 days. Surgery Prior to surgery, FVIII:C levels should be brought to 40-50 FVIII IU/kg. For the next 7-10 days, or until healing has been achieved, the patient should be maintained at 25-50 FVIII IU/kg bid. Prophylaxis during surgery & invasive procedure of von Willebrand disease (except type 3 patients undergoing major surgery) Adult Pre-op dosage: 60 VWF:RCo IU/kg. Subsequent infusions: 40-60 VWF:RCo IU/kg at 8-12 hr intervals as needed. May be reduced after the 3rd post-op day. Continue treatment until healing is complete. Minor procedure: VWF activity of 40-50% during 1-3 days post-op. Major procedure: VWF activity of 40-50% during at least 3-7 days post-op. Ped Initially, 75 VWF:RCo IU/kg. Subsequent infusions: 50-75 VWF:RCo IU/kg at 8-12 hr intervals as needed. May be reduced after the 3rd post-op day. Continue treatment until healing is complete.
Special Precautions
Discontinue use in the presence of hypersensitivity reactions. Patients w/ known risk factors for thrombosis. Consider antithrombotic measures in patients w/ high thrombotic risk. May carry risk of transmitting infectious agents eg, viruses, & Creutzfeldt-Jakob disease. Patients w/ hemophilia should have hepatitis A & B vaccination. Inhibitor formation. Carefully monitor management of bleeding in patients w/ inhibitors especially in surgical procedures. Viral infection eg, parvovirus B19 or hepatitis A in immunocompromised & pregnant patients. Pregnancy. Ped patients ≤16 yr w/ hemophilia A.
Adverse Reactions
Urticaria, fever, chills, nausea, vomiting, headache, somnolence, lethargy. Pruritus, pharyngitis, paresthesia, face edema, rash. Hemorrhage, decreased hematocrit, orthostatic hypotension, pain. Parotid gland swelling, shortness of breath, chest tightness, rigors, flushing, joint pain, seizure, pulmonary embolus, femoral venous thrombosis, itching, cardiorespiratory arrest.
MIMS Class
ATC Classification
B02BD06 - von Willebrand factor and coagulation factor VIII in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Alphanate inj 250 IU
Packing/Price
1's
Form
Alphanate inj 500 IU
Packing/Price
1's
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