What is cutaquig?

Cutaquig is an immunoglobulin replacement therapy for subcutaneous infusion approved for the treatment of primary immunodeficiencies in patients 2 years of age or older

  • Cutaquig is made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses1
  • Cutaquig is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic Solvent/Detergent (S/D) mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol.1
  • Viral reduction is achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH4 treatment1
  • Other precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as final product testing for viruses1

Find out more about cutaquig production and manufacturing.

Octapharma’s global immunotherapy portfolio offers high-purity human IgG products available in different concentrations and routes of administration in liquid, ready-to-use formulations.

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Deliver the complete package of care

Cutaquig provides adult and pediatric patients with primary immunodeficiency the protection, comfort and independence they need to manage their disease:

  • Zero SBIs in a Phase 3 Clinical Trial1,8
  • Proven Tolerability1,2,8
  • Ease of Administration1,2
  • Low Viscosity & Easy Injectability2,3
  • Favorable Pharmacokinetics1,2,4
  • Manufacturing & Pathogen Safety1,4,7
  • Flexible Storage & Handling1
  • Innovative Patient Support with IgCares

Learn more about the differences between SCIg and IVIg.

Read More

References:
  1. Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.
  2. Kobayashi RH, Gupta S, Melamed I, 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. February 2019 | Volume 10 | Article 40.
  3. Gelbmann N, Zöchling A, Mersich C et al. Cutaquig, Immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – biochemical characterization, pathogen safety and stability. Presented at: 2018 Annual Meeting of the Clinical Immunology Society; Toronto, Canada. Poster Presentation.
  4. Octapharma, Data on File. 2014.
  5. McCormack PL. Immune Globulin Subcutaneous (Human) 20% In Primary Immunodeficiency Disorders. Drugs. 2012; 72 (8): 1087-1097.
  6. Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics: Targets and Therapy.2012:6 277–287.
  7. Buchacher A, Kaar W. Intravenous immunoglobulin G from human plasma–purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley & Sons, Inc; 2013.
  8. Kobayashi RH, Mandujano JF, Rehman SM, et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm]). Immunotherapy. 2021;13(10):813 -824.