Dosing and Administration
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Cutaquig® is a ready-to-use liquid solution. It is colourless and may turn to slightly opalescent or pale-yellow during storage1
Cutaquig® must be administered subcutaneously1
An overview of the recommended administration details and dosing schedule is given below1
Primary immunodeficiency syndromes1
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
Secondary immunodeficiencies1
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
The 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
Paediatric population1
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 in replacement therapy indications
Elderly population1
As the dose is given by body weight and adjusted to the clinical outcome of the above-mentioned conditions, the dose in the elderly population is not considered to be different from that in subjects 18 to 65 years of age
In the clinical trials cutaquig® was evaluated in 17 patients older than 65 years
No specific dose-requirements were necessary to achieve the desired serum IgG levels
Administration
Administration route1
Cutaquig® must be administered subcutaneously
Infusion frequency1
Cutaquig® can be administered at regular intervals from daily up to every other week
Infusion sites1
Cutaquig® may be injected into sites such as 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*1
It is recommended to use an initial administration rate of 15 mL/hour/site. For patients already on SCIg therapy and switching to cutaquig® it is recommended to use previously used administration rates for the initial infusions
Then, if well tolerated possible gradual increase by ≈10 mL/h/site every 2-4 weeks in adults (≥ 40 kg) and up to ≈10 mL/h/site every 4 weeks for paediatrics, until reaching a maximum of 67.5 mL/hour/site for adults and 25 mL/hour/site for paediatrics
Infusion volume per site
Infants and children: infusion site may be changed every 5-15 mL. Adults: doses over 30 mL may be divided according to patient preference1
*Please consult your local cutaquig® Summary of Product Characteristics for more detailed instructions1
The low viscosity of cutaquig® makes it easy to use and administer2
Self-infusion guide
Provide your patients with an easy step-by-step guide to administer cutaquig® subcutaneously.
References:
Cutaquig® Summary of Product Characteristics. November 2023.
Gelbmann, N., et al., Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – biochemical characterization, pathogen safety, and stability. Biologicals, 2019. 60:60-67.
This is an international website for cutaquig® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
If you wish to contact Octapharma please use the contact form on our corporate website www.octapharma.com.
