About cutaquig®
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Cutaquig® is a 16.5% liquid preparation of highly purified human normal IgG, derived from large pools of human plasma. Human normal Immunoglobulin contains mainly IgG, with a broad spectrum of antibodies active against infectious agents.1
Cutaquig® is currently indicated for lg replacement therapy in adults, children and adolescents (0-18 years) with PID syndromes with impaired antibody production and SID patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or a serum IgG level of <4 g/L.1
Cutaquig® has lower viscosity than 20% SCIg products, and was shown to require less injection force to administer.2 This is particularly important for the elderly or people with dexterity issues.
Each batch of cutaquig® is made from a pool of plasma donations. Therefore, cutaquig® contains a broad spectrum of opsonising and neutralising IgG antibodies, which represent a distribution of Ig subclasses similar to that in native human plasma, active against a wide variety of pathogens.2
Cutaquig® is produced using the well-established Octagam® manufacturing process, Octagam® has a long history as a well-tolerated IVIg product, with thousands of patients treated over the last 3 decades.2
Cutaquig® availabilities
Cutaquig® is supplied in a single-use vial containing the labelled amount of functionally active IgG. The components used in the packaging of cutaquig® are latex free.1
The following dosage forms are available:
References:
Cutaquig® European Summary of Product Characteristics. November 2023.
Frenzel W, et al. Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials. Int J Clin Pharmacol Ther. 2016;54(11):847–55.
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.
Kobayashi, R.H., et al., Clinical efficacy, safety and tolerability of a new subcutaneous immunoglobulin 16.5% (octanorm [cutaquig®]) in the treatment of patients with primary immunodeficiencies. Front Immunol, 2019. 10:40.
Kobayashi RH, et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm]). Immunotherapy. 2021;13(10):813–24.
Kobayashi RH, et al. Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig®) in the treatment of patients with primary immunodeficiencies. Clin Exp Immunol. 2022;210(2):91-103.
Latysheva E, et al. Efficacy and safety of octanorm (cutaquig®) in adults with primary immunodeficiencies with predominant antibody deficiency: a prospective, open-label study. Immunotherapy. 2020;12(5):299–309.
Gupta S, et al. Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. J Clin Immunol. 2023; 43(6):1414-1425.
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.
