Description

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.

None known.

Alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

The most frequent adverse events reported with Alphanate in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue

Pregnancy: No human or animal data. Use only if clearly needed Labor and Delivery: No human or animal data. Use only if clearly needed Nursing Mothers: No human or animal data. Use only if clearly needed

Risk of thromboembolic events & infections. Pregnancy.

Pediatric Use: Clinical trials for safety and effectiveness in pediatric hemophilia A patients have not been conducted. 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 Geriatric Use: No human or animal data. Use only if clearly needed