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 (VWD) in whom desmopressin is either ineffective or contraindicated, except type 3 patients undergoing major surgery.
Dosage/Direction for Use
IV Hemophilia A Individualised dose. Dose is based on initial response of 2% of normal FVIII:C increase per FVIII:C IU/kg. Major hemorrhage (joint & muscle hemorrhage, major trauma, hematuria, intracranial & IP bleeding) 40-50 FVIII IU/kg bid for at least 3-5 days. Following this treatment period, maintain FVIII levels at 25 FVIII IU/kg bid until healing has been achieved or up to 10 days. Moderate hemorrhage (nose, mouth & gum bleeds, dental extractions, hematuria) 25 FVIII IU/kg bid until healing has been achieved (ave 2-7 days). Minor hemorrhage (bruises, cuts or scrapes, uncomplicated joint hemorrhage) 15 FVIII IU/kg bid until hemorrhage stops & healing has been achieved (1-2 days). Surgery 40-50 FVIII IU/kg bid prior to surgery. Maintain FVIII levels at 25-50 FVIII IU/kg bid for the next 7-10 days, or until healing has been achieved. Prophylaxis during surgery & invasive procedure of VWD (except type 3 patients undergoing major surgery) Adult Pre-op dose: 60 VWF:RCo IU/kg. Subsequent infusions: 40-60 VWF:RCo IU/kg at 8-12 hr intervals as needed. May be reduced after 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 3rd post-op day. Continue treatment until healing is complete.
Special Precautions
Discontinue use if early symptoms & signs of hypersensitivity reactions occur. Increased incidence of thromboembolic events in females. Risk of transmitting infectious agents eg, viruses, & Creutzfeldt-Jakob disease. Viral infection eg, hepatitis C, parvovirus B19 (in seronegative pregnant women & immunocompromised patients) or hepatitis A. Development of factor VIII inhibitors. VWD patients w/ high thrombotic risk; consider antithrombotic measures. Consider hepatitis A & B vaccination in patients w/ hemophilia at birth or at the time of diagnosis. Carefully monitor management of bleeding in patients w/ factor VIII inhibitors especially in surgical procedures. Pregnancy. Ped ≤16 yr (w/ hemophilia A).
Adverse Reactions
Urticaria, fever, chills, nausea, vomiting, headache, somnolence, lethargy. Pruritus, pharyngitis, paresthesia, face edema, rash. Mild hemorrhage, moderate decreased hematocrit, orthostatic hypotension, pain. Parotid gland swelling, shortness of breath, chest tightness, rigors, flushing, joint pain, seizure, pulmonary embolus, femoral venous thrombosis, itching, cardioresp arrest.
MIMS Class
Haemostatics
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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