INTRAGAM

What it is

Hizentra® AU is a normal immunoglobulin (Human) 20% (20 g/100 mL) subcutaneous injection. It is a 20% solution containing 20 g/100 mL of total human plasma protein with a purity of at least 98% immunoglobulin G (IgG). The distribution of the IgG subclasses is similar to that of normal human plasma (approximate values: 69% IgG1, 26% IgG2, 3% IgG3, 2% IgG4). Hizentra® AU is manufactured from human plasma collected in Australia by Australian Red Cross Lifeblood.

Approved indications

— Replacement therapy in adults and children with Primary Immunodeficiency Disease (PID) — Replacement therapy in adults and children with symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment — Immunomodulatory therapy in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg

Dosing overview

For replacement therapy in PID and symptomatic hypogammaglobulinaemia, a loading dose of at least 0.2 to 0.5 g/kg body weight may be required, followed by maintenance doses to reach a cumulative monthly dose of 0.4 to 0.8 g/kg body weight. For immunomodulatory therapy in CIDP, therapy is initiated 1 week after the last IVIg infusion, with a recommended subcutaneous dose of 0.2 to 0.4 g/kg body weight per week. As the dose is given by body weight and adjusted to the clinical outcome, the dosage regimen is the same in the paediatric population as in adults.

Key safety warnings

Hizentra® AU is for subcutaneous use only; if accidentally administered into a blood vessel, patients could develop shock. Hypersensitivity reactions may occur even in patients who had tolerated previous treatment with human normal immunoglobulin, and severe hypersensitivity or anaphylactic reactions up to shock can particularly occur in patients with known allergies to anti-IgA antibodies. Arterial and venous thromboembolic events have been associated with the use of immunoglobulins, and caution should be taken in patients with pre-existing risk factors such as advanced age, estrogen use, in-dwelling vascular catheters, a history of vascular disease or thrombotic episodes, cardiovascular risk factors, acquired or inherited hypercoagulable states, prolonged periods of immobilisation, severely hypovolaemic patients, and diseases which increase blood viscosity. Aseptic Meningitis Syndrome (AMS) has been reported with use of IVIg or SCIg, usually beginning within several hours to 2 days following IgG treatment, and is characterised by severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.

Contraindications

Hizentra® AU is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to the active substance or to any of its excipients. Hizentra® AU is contraindicated in patients with hyperprolinaemia type I or II.

Regulatory history

Hizentra® AU was first approved on 7 July 2020.