Transfusion medicine handbook

5. Fractionated Products

5.5.1 BERINERT (C1-esterase inhibitor)

Berinert does not have full New Zealand registration and so consultation with a NZBS Transfusion Medicine Specialist/Medical Officer is required prior to release of this product. It is supplied by NZBS under Section 29, a provision in the Medicines Act 1981, whereby a medical practitioner can prescribe a medicine that is not registered with Medsafe. 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.