BERINERT®

BERINERT is a plasma-derived C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients.

The safety and efficacy of BERINERT for prophylactic therapy have not been established.

BERINERT is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.

Administer BERINERT at a dose of 20 International Units (IU) per kg body weight by intravenous injection.  Doses lower than 20 IU/kg body weight should not be administered. BERINERT is provided as a freeze-dried powder for reconstitution with the Sterile Water for Injection, USP provided.  Store the vial in the original carton in order to protect from light.  Do not freeze.

• Do not mix BERINERT with other medicinal products.  Administer BERINERT by a separate infusion line.
• Use aseptic technique when administering BERINERT.
• Use the silicone-free syringe provided in the administration kit.
• Follow recommended venipuncture guidelines for initiating intravenous therapy.
• Administer BERINERT by slow intravenous injection at a rate of approximately 4 mL per minute.  Please refer to the illustration in step 6 of the self-administration section in the Patient Product Information (PPI) section.
• For self-administration, provide the patient with instructions and training for intravenous injection outside of a clinic setting so patients may self-administer BERINERT upon recognition of symptoms of an HAE attack.
• After administration, immediately discard any unused product and all used disposable supplies in accordance with local requirements.