Dosing and Administration

Objective

The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/l and aim to be within the reference interval of serum IgG for age

Loading dose (if required)

0.2 to 0.5g/kg. This may need to be divided over several days, with a maximal daily dose of 0.1 to 0.15 g/kg

Maintenance dose

After steady state IgG levels have been attained, maintenance doses are administered to reach a cumulative monthly dose of the order of 0.4-0.8 g/kg

Trough levels

Trough levels should be measured and assessed in conjunction with the incidence of infection

Dose adjustment

To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels

Recommended dose

The recommended dose administered at repeated intervals (approximately once per week) is to reach a cumulative monthly dose of the order of 0.2-0.4 g/kg.

Trough levels

IgG trough levels should be measured and assessed in conjunction with the incidence of infection

Dose adjustment

Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free

Administration route

Cutaquig® should be administered via the subcutaneous route

Infusion frequency

Cutaquig® can be administered at regular intervals from daily up to every other week

Infusion sites

Abdomen, thigh, upper arm, and lateral hip. Infusion sites should be at least 5 cm apart. There is no limit to the number of infusion sites. Each single dose may need to be injected at different anatomic sites

Infusion rate*

Initially 15 mL/h/site. From infusion 7 on, if well tolerated, the infusion rate can be gradually increased to 25 ml/h/site. Recommended infusion rate per hour for all sites combined: 30 ml/h for first 6 infusions, then gradually increase to 50 ml/h and, if well tolerated to 80 ml/h

Infusion volume per site

Infants and children: infusion site may be checked every 5-15 mL. Adults: doses over 30 mL may be divided according to patient preference