Alphanate (Antihemophilic Factor / von Willebrand Factor Complex) is indicated for:

• Management and prevention of bleeding episodes, as well as perioperative care, in both adult and pediatric patients with Factor VIII (FVIII) deficiency associated with Hemophilia A.
• Use during surgical or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) when desmopressin (DDAVP) is either ineffective or contraindicated. However, it is not recommended for patients with severe VWD (Type 3) undergoing major surgical procedures.

Antihemophilic Factor / von Willebrand Factor Complex (Human) contains Factor VIII (FVIII) and von Willebrand Factor (vWF), which are natural components of plasma essential for normal blood clotting. Administration of Alphanate increases plasma FVIII levels temporarily, thereby reducing the risk of bleeding in patients with Hemophilia A.

Factor VIII functions as a critical cofactor in the activation of Factor X, leading to the production of thrombin and formation of fibrin. Von Willebrand Factor supports platelet adhesion and aggregation at the site of vascular injury and also acts as a carrier protein that stabilizes and prolongs the activity of Factor VIII in circulation.

Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand.
Factor: Ristocetin Cofactor activity in IU VWF:RCo/vial.

Hemophilia A: Control and prevention of bleeding episodes

• Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
• Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician

Von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery

• Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed.
• Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.
• Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator.

Pediatric Use-

• Hemophilia A Indication: Clinical trials for safety and effectiveness in pediatric hemophilia A patients 16 years of age and younger have not been conducted.
• VWD Indication: The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo. There were no clinically important differences between pediatric patients and adults.

Geriatric Use: No human or animal data. Use only if clearly needed.

Administration

Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30° C) prior to administration, but administer intravenously within three hours.

Discard any unused contents into the appropriate safety container. Do not administer Alphanate at a rate exceeding 10 mL/minute.

No known drug interactions have been identified.

Alphanate should not be used in patients who have experienced severe or life-threatening hypersensitivity reactions, including anaphylaxis, to this product or any of its ingredients.

The most commonly reported adverse effects (occurring in more than 5% of patients) include respiratory difficulty, itching, skin rash, urticaria, facial swelling, abnormal sensations (paresthesia), pain, fever, chills, joint discomfort, and fatigue.

Pregnancy: There are no adequate data from human or animal studies. Use only if clearly necessary.
Labor and Delivery: No sufficient data available; administer only when clearly needed.
Nursing Mothers: Lack of data; use only if the potential benefit justifies the potential risk.

There is a potential risk of thromboembolic complications and infections. Caution is advised, especially during pregnancy.

Pediatric Use: Safety and efficacy in pediatric patients with Hemophilia A have not been fully established through clinical trials. However, the hemostatic effectiveness has been evaluated in 20 pediatric patients (≤18 years) with VWD. Data analysis indicates that age does not significantly influence the pharmacokinetics of VWF:RCo.

Geriatric Use: There are no sufficient human or animal data available. Use only when clearly necessary.

Hemostatic agents.