Indications and Important Safety Information

ALPHANATE^® (antihemophilic factor/von Willebrand factor complex [human])

ALPHANATE is indicated for:

• Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor VIII (FVIII) deficiency due to hemophilia A
• Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (type 3) undergoing major surgery

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

Anaphylaxis and severe hypersensitivity reactions are possible with ALPHANATE. Discontinue use of ALPHANATE if hypersensitivity symptoms occur, and initiate appropriate treatment.

Development of procoagulant activity-neutralizing antibodies (inhibitors) has been detected in patients receiving FVIII-containing products. Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests.

Thromboembolic events have been reported with AHF/VWF complex (human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may occur with infusion of large doses of AHF/VWF complex (human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Because ALPHANATE is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

Monitor for development of FVIII and VWF inhibitors. Perform appropriate assays to determine if FVIII and/or VWF inhibitor(s) are present if bleeding is not controlled with expected dose of ALPHANATE.

The most frequent adverse drug reactions reported with ALPHANATE in >1% of infusions were pruritus, headache, back pain, paresthesia, respiratory distress, facial edema, pain, rash, and chills.

Please see full Prescribing Information for ALPHANATE.

AlphaNine^® SD (coagulation factor IX [human])

AlphaNine is indicated for the prevention and control of bleeding in patients with factor IX deficiency due to hemophilia B.

AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

Incidences of thrombosis or disseminated intravascular coagulation (DIC) have been reported following administration of factor IX complex concentrates which contain high amounts of factor II, VII and X. AlphaNine SD contains low, nontherapeutic levels of factor II, VII and X.

Following administration in surgery patients and individuals with known liver disease, the physician should closely observe the patient for signs and symptoms of potential disseminated intravascular coagulation.

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.

Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to factor IX.

In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed.

AlphaNine SD should not be administered at a rate exceeding 10 mL/minute. Rapid administration may result in vasomotor reactions.

Please see full Prescribing Information for AlphaNine SD.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.