Evogam - Human Normal Immunoglobulin

The distribution of the IgG subclasses closely resembles that found in normal human plasma (approximate ranges for Evogam*: 47.8-58.1% IgGi, 38.8^9.3% IgG2, 0.9-1.4% IgG3, 1.4-2.1% IgG4).

Evogam® contains only trace amounts of IgA, typically

The pH value of the ready-to-use solution is 5.5.

Evogams is manufactured from human plasma collected by Australian Red Cross Lifeblood.

Evogam& contains 2.25 g of glycine per 100 mL as a stabiliser.

PHARMACEUTICAL FORM
Solution for subcutaneous administration.

CLINICAL PARTICULARS

Therapeutic indications

Evogam® is indicated in adults and children for replacement therapy in:

• Primary Immunodeficiency Diseases (PID) and
• symptomatic hypogammaglobulinemia secondary to underlying disease or treatment.

Dose and method of administration

Evogam® must be administered SUBCUTANEOUSLY.

Treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.

Dosage
The dose and dosage interval must be individualised for each patient based on their measured IgG trough levels and ongoing clinical response. The following dose regimens are given as a guideline.

A weekly dose in the range 0.05-0.15 g/kg body weight is recommended (this corresponds to a total monthly dose of Evogam* in the range of 0.2-0.6 g/kg body weight).

As the dose is given by body weight and adjusted to clinical outcome, the dose in the paediatric population is not considered to be different to that of adults.