CINRYZE

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. Berinert IV is produced as a sterile, pyrogen-free, freeze-dried white powder for intravenous injection and supplied with Water for Injections for reconstitution.

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. If allergic or anaphylactic-type reactions occur, the administration of Berinert IV should stop immediately and an appropriate treatment initiated. 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. Products made from human plasma 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 by two filters, 20 nm and 15 nm, in series, as dedicated virus inactivation and removal steps to reduce the potential for pathogen transmission. The current procedures applied in the manufacture of this product are effective against enveloped viruses such as HIV, hepatitis B and hepatitis C viruses and for the non-enveloped viruses hepatitis A and parvovirus B19.

Contraindications

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

Regulatory history

Berinert IV was first approved on 14 January 2010. An AusPAR (Australian Public Assessment Report) was issued on 2012-03-19 for treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with C1 inhibitor deficiency. Berinert IV 500 IU powder for solution for injection was listed on the ARTG on 2012-04-05.