Dosing Rates and Administration Details Berinert is a lyophilized concentrate (500 IU) that requires reconstitution with 10 mL of sterile water (included). No refrigeration is required. Treatment is given as an intravenous infusion, via self-administration or by a healthcare professional.

The recommended Berinert dosage is 20 units (U) per kilogram body weight, with a recommended infusion rate of 4 mL/minute. For example, a 70-kg patient would require 1400 U, infused over 7 minutes.

Preparation and Reconstitution

Each Berinert kit consists of 1 carton containing 1 single-use vial of Berinert, one 10-mL vial of diluent (sterile water), 1 Mix2Vial® transfer set, and 1 alcohol swab.

The Mix2Vial transfer set enables reconstitution to occur. It automatically transfers the right amount of diluent into the Berinert vial. For step-by-step instructions on how to prepare Berinert for administration, please see the self-administration step-by-step guide, video, or full prescribing information for Berinert.

Mix2Vial is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

Save on Co-Pays: The Berinert Co-Pay BENefit™ may cover up to $12,000 of your eligible out-of-pocket expenses per year.

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It is important for patients to undergo training from a healthcare professional before patients can self-administer Berinert.

Home Dosing and Administration
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Important Safety Information

Berinert®, C1 Esterase Inhibitor (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established.

Berinert is contraindicated in individuals with a history of life-threatening systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).

Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of Berinert and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.

Serious arterial and venous thromboembolic events have been reported at recommended doses of C1 Esterase Inhibitor (Human) products, including Berinert, following administration to patients with HAE. Risk factors may include having an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after Berinert administration. TE events also have been reported with C1 Esterase Inhibitor (Human) products when used off-label at higher than labeled doses.

Patients able to recognize signs and symptoms of HAE attack and comprehend necessary training can self-administer Berinert. Patients should not attempt to self-administer unless they have been trained and determined to be capable by healthcare provider. Advise patients to seek medical attention immediately following self-administration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of Berinert.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.

Berinert has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. The safety and efficacy of Berinert have not been established in children (ages 0 through 12) or in the geriatric population. In clinical trials, the half-life of Berinert was shorter and clearance was faster in children than in adults; the clinical implication is not known.

Please see full prescribing information for Berinert, including the patient product information.

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