Cuvitru Dosage/Direction for Use

Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Posology: The dose and dose regimen is dependent on the indication.
Replacement therapy: The product should be administered via the subcutaneous route.
In replacement therapy, the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline.
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. A loading dose of at least 0.2 to 0.5 g/kg (1 to 2.5 ml/kg) body weight may be required. This may need to be divided over several days, with a maximal daily dose of 0.1 to 0.15 g/kg. After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.3 to 1.0 g/kg (see Pharmacology: Pharmacokinetics under Actions for details). Each single dose may need to be injected at different anatomic sites.
Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels.
Paediatric population: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the previously mentioned indications.
No clinical trials have been conducted with Cuvitru in children at age 0 - <2 years, but experience with immunoglobulins suggests that no harmful effects on treatment of children at age 0 - <2 years with Cuvitru are to be expected.
Method of administration: For subcutaneous use only.
Cuvitru should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed.
The infusion must be started immediately upon transfer of Cuvitru into the syringe. The administration is foreseen to take up to two hours. Should an administration shorter than two hours not be possible due to required dose or administration rate of Cuvitru, the required dose is to be portioned and administered at different infusion sites. If Cuvitru remains in siliconized syringes for more than two hours, visible particles may form. See Precautions for further details.
Cuvitru must not be diluted.
Subcutaneous infusion should be commenced and initially monitored by a healthcare professional experienced in the guidance of patients for home treatment with regular follow-ups. Infusion pumps appropriate for subcutaneous administration of immunoglobulins can be used. The patient or caregiver must be instructed in the use of a syringe driver, the infusion techniques, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions.
Cuvitru may be injected into sites such as abdomen, thigh, upper arm, and lateral hip.
Adjustment of the infusion rate and infusion volume per site is based on subject tolerability.
It is recommended to use an initial administration speed of 10 ml/h/infusion site. If well tolerated (see Precautions), the rate of administration may be increased at intervals of at least 10 minutes to a maximum of 20 ml/h/infusion site for the initial two infusions. More than one pump can be used simultaneously. The amount of product infused into a particular site varies. In infants and children, infusion site may be changed every 5-15 ml. In adults, doses over 30 ml may be divided according to patient preference. There is no limit to the number of infusion sites.