Alphanate Adverse Reactions

General: The most common adverse reactions may include urticaria, fever, chills, nausea, vomiting, headache, somnolence, or lethargy.
Occasionally, mild reactions occur following the administration of Antihemophilic Factor/von Willebrand Factor Complex (Human), such as allergic reactions, chills, nausea, or stinging at the infusion site. If a reaction is experienced, and the patient requires additional Antihemophilic Factor/von Willebrand Factor Complex (Human), product from a different lot should be administered.
Massive doses of Antihemophilic Factor/von Willebrand Factor Complex (Human) have rarely resulted in acute hemolytic anemia, increased bleeding tendency or hyperfibrinogenemia. Alphanate contains blood group specific isoagglutinins and, when large and/or frequent doses are required in patients of blood groups A, B, or AB, the patient should be monitored for signs of intravascular hemolysis and falling hematocrit. Should this condition occur, thus leading to progressive hemolytic anemia, the administration of serologically compatible Type O red blood cells should be considered, the administration of Alphanate should be discontinued, and alternative therapy should be considered.
Reports of thromboembolic events in VWD patients with other thrombotic risk factors receiving coagulation factor replacement therapy have been obtained from published literature. Early reports might indicate a higher incidence in females. Caution should be exercised and antithrombotic measures should be considered in all VWD patients in situations of high thrombotic risk.
Adverse Reactions in VWD Patients from Clinical Studies: In clinical studies of Alphanate (A-SD/HT) in patients with VWD, adverse reactions occurred in 6 of 38 (15.8%) subjects and 17 of 299 (5.7%) infusions. The most common adverse events were pruritus, pharyngitis (throat tightness), paresthesia and headache, edema of the face, rash and chills. Except for one instance of pruritus, which was considered moderate in severity, all the adverse events were assessed as mild in severity.
A single incident of pulmonary embolus was reported that was considered to have a possible relationship to the product. This subject received the dose of 60 VWF:RCo IU/kg body weight and the FVIII:C level achieved was 290%.
In the retrospective study, 3 out of 39 subjects (7.7%) experienced 6 adverse drug reactions. Four were considered mild and 2 were considered moderate; and no subject discontinued their treatment due to an adverse reaction. The adverse drug reactions were pruritus, paresthesia (2 events) and hemorrhage (all considered mild), and one event each of moderate hematocrit decrease and orthostatic hypotension.
Only one adverse event (pain) related to the treatment with heat-treated Alphanate (A-SD/HT) was reported on the four pediatric patients with von Willebrand Disease during the course of the prospective study and none of the five subjects in the retrospective clinical study.
Adverse Reaction Information from Spontaneous Reports: The following adverse reactions have been identified during post-approval use of Alphanate (A-SD/HT). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions have been reported as swelling of the parotid gland, urticaria, nausea, shortness of breath, chest tightness, chills, fever, rigors, headache, flushing, vomiting, joint pain, seizure, pulmonary embolus, femoral venous thrombosis, itching and cardiorespiratory arrest.