Hizentra Dosage/Direction for Use

The dose and dose regimen are dependent on the indication.
Posology for adults and children: The dose may need to be individualized for each patient dependent on the clinical response and serum IgG trough levels.
The following dose regimens are given as a guideline: Replacement therapy: 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 to 4.0 ml/kg) body weight (see Pharmacology: Pharmacokinetics under Actions).
For patients switching from intravenous treatment the monthly dose is divided into smaller doses and administered at repeated intervals (see Pharmacology: Pharmacokinetics under Actions).
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.
Immunomodulatory therapy in CIDP patients: The therapy with Hizentra is initiated 1 week after the last IVIg infusion. The recommended subcutaneous dose is 0.2 to 0.4 g/kg bw per week. The weekly dose can be divided into smaller doses and administered by desired number of times per week. For dosing every two weeks, double the weekly Hizentra dose. The dose may need to be adapted to achieve the desired clinical response. Patient's individual clinical response should be the primary consideration in dose adjustment.
If CIDP symptoms worsen on 0.4 g/kg bw per week, re-initiating therapy with IGIV should be considered, while discontinuing HIZENTRA.
Hizentra maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Maintenance therapy beyond these periods should be individualized based upon the patient's response and need for continued therapy.
Paediatric population: As the posology is given by body weight and adjusted to the clinical outcome of the previously mentioned conditions, the dosage regimen is the same in the paediatric population as in adults. Hizentra was evaluated in 68 paediatric subjects with PID, aged 2 to <12 years and in 57 adolescents aged 12 to <18 years. No paediatric-specific dose requriements were necessary to achieve the desired serum IgG levels.
Hizentra was not evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Geriatric population: As the dose is given by body weight and adjusted to the clinical outcome of the previously mentioned conditions, the dose in the geriatric population is not considered to be different from that in subjects 18 to 65 years of age.
In clinical studies, Hizentra was evaluated in 13 subjects with PID >65 years of age and no specific dose adjustments were necessary to achieve the desired serum IgG levels.
In clinical studies, Hizentra was evaluated in 61 subjects with CIDP >65 years of age and no specific dose adjustments were necessary to achieve the desired clinical outcome.
Method of administration: Hizentra must be administered via the subcutaneous route only.
Hizentra may be infused into sites such as abdomen, thigh, upper arm, and/or lateral hip. If large doses are given (>50ml), it is may be advisable to administer the dose at multiple sites. There is no limit to the number of infusion sites administered in parallel. More than one infusion device can be used simultaneously. The volume of product infused into a particular site may vary.
Infusion sites should be at least 5 cm (2 inches) apart. For subsequent administration, the infusion sites should be changed.
Infusion rate: Hizentra can be infused using: an infusion device or by manual push with syringe.
The recommended initial infusion rate depends on the individual patient's needs.
Device-assisted infusion: The initial infusion rate should not exceed 20 ml/hour/site.
If well-tolerated (see also Precautions), the infusion rate can then gradually be increased to 35 ml/hour/site for the subsequent two infusions. Thereafter, the infusion rate can be further increased as per patient's individual tolerability.
Manual push infusion: The recommended initial infusion rate should not exceed 0.5 ml/min/site (30 ml/hour/site).
If well-tolerated, the infusion rate can be increased up to 2.0 ml/min/site (120 ml/hour/site), based on the healthcare professional judgement and patient's individual tolerability.
It is recommended to use needles gauge 24 or larger (i.e. lower gauge number). Using smaller needles (i.e. higher gauge number) may hinder manual push of Hizentra. Only one infusion site per syringe can be infused. If administration with an additional Hizentra syringe is required, a new sterile injection needle should be used and the infusion site changed.
Home-treatment: Subcutaneous infusion for home treatment should be commenced and initially monitored by a healthcare professional. The patient or the caregiver will be instructed in the use of infusion devices, infusion techniques, how to keep a treatment diary, and identification of severe adverse reactions and measures to be taken in case such reactions occur.
For patients at risk, administer Hizentra at the minimum dose and infusion rate practicable (see Precautions).