Posology : מינונים

4.2   Posology and method of administration

Posology for adults and children
The dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response and serum IgG trough levels. The following dose regimens are given as a guideline.

The dose regimen using the subcutaneous route should achieve a sustained level of IgG. A loading dose of at least 0.2 to 0.5 g/kg (1.0 to 2.5 ml/kg) body weight may be required. This may need to be divided over several days. After steady state IgG levels have been attained, maintenance doses are divided into smaller doses and administered at repeated intervals to reach a cumulative monthly dose in the order of 0.4 to 0.8 g/kg (2.0 - 4.0 ml/kg) body weight (see section “Pharmacokinetics").

For patients switching from intravenous to subcutaneous treatment the monthly dose is divided into smaller doses and administered at repeated intervals (see section “Pharmacokinetics").

Trough levels should be measured and assessed in conjunction with the patient’s clinical response. Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.

Posology for children and adolescents
The posology is given by body weight like in adults.
Hizentra was evaluated in 21 children aged 2 to 11 years and 12 adolescents aged 12 to 16 years in two clinical studies.


Method of administration
Hizentra must be administered via the subcutaneous route only.

Hizentra may be injected into sites such as abdomen, thigh, upper arm, and lateral hip (see figure 1).
Figure 1: Possible infusion sites for Hizentra

If large doses are given (>25 ml), it is advisable to administer them at multiple sites. Up to 4 infusion sites can be used simultaneously.


Infusion for home treatment should be commenced and initially supervised and monitored by a healthcare professional. The healthcare professional should already be experienced in the guidance of home treatment of patients with primary immunodeficiency syndromes. The patient must be instructed in the using an infusion pump, infusion techniques, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions.


Infusion rate
The recommended initial infusion rate depends on individual needs of the patient and should not exceed 15 ml/hour/site.
If well-tolerated , the infusion rate can then gradually be increased to 25 ml/hour/site.