Transfusion medicine handbook

5. Fractionated Products

5.5.1 BERINERT (C1-esterase inhibitor)

Berinert was approved by Medsafe in August 2025 [26]. Until a New Zealand datasheet is approved, further information is available from Germany at Berinert | FDA

Berinert is a C1-esterase inhibitor concentrate supplied as 500 IU per vial (50 IU/mL). Berinert is intended for slow intravenous injection or infusion.

Indications for Use

Berinert is indicated for:

• The management of patients with C1-esterase inhibitor deficiency and/or hereditary angioedema (HAE).

Treatment should be initiated under the supervision of a physician experienced in the management of C1-esterase inhibitor deficiency.

The treatment of capillary leak syndrome with Berinert is not advised.

Dosage and Administration

The recommended dose is 20 IU per kilogram body weight, rounded to the nearest 500 IU. An additional dose may be required in less than 5% of patients with persistent or worsening clinical condition within a few hours of administration of the initial dose. It is recommended that Berinert be administered by slow intravenous injection 4 mL/minute.