BERINERT

What it is

BERINERT IV is a highly purified, freeze-dried C1 esterase inhibitor concentrate derived from human plasma. When reconstituted, the 500 IU presentation contains 500 IU of C1 esterase inhibitor per vial at 50 IU/mL and the 1500 IU presentation contains 1500 IU of C1 esterase inhibitor per vial at 500 IU/mL.

Approved indications —

Treatment of acute attacks in patients with hereditary angioedema (HAE).

Dosing overview

The recommended dose is 20 IU per kg body weight for adult and paediatric patients. BERINERT IV 500 IU is recommended to be administered by slow intravenous injection at a rate of 4 mL/minute. BERINERT IV 1500 IU is recommended to be administered as a bolus intravenous injection.

Key safety warnings

Antihistamines and corticosteroids should be administered prophylactically in patients with a known tendency towards allergies. Patients with laryngeal oedema require particularly careful monitoring. BERINERT IV contains up to 486 mg sodium per 100 mL of solution, which is to be taken into consideration for patients on a controlled sodium diet. This product is made from human plasma and may contain infectious agents such as viruses that can cause disease. The manufacturing process includes pasteurisation (at 60°C for 10 hours), hydrophobic interaction chromatography and virus filtration (also called nanofiltration) by two filters, 20 nm and 15 nm, in series, as dedicated virus inactivation and removal steps to reduce the potential for pathogen transmission.

Contraindications

BERINERT IV is contraindicated in individuals with a known hypersensitivity to any of the components of the product.

Regulatory history

BERINERT IV 500 IU was first approved on 14 January 2010. BERINERT IV 500 IU powder for injection was first listed on the ARTG on 2010-02-05. BERINERT IV 1500 IU powder for injection was first listed on the ARTG on 2017-09-15.