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Safety & Tolerability

Safety and Tolerability

Cutaquig® is a high-quality SCIg product that is well tolerated, providing comfortable infusions for patients¹¿⁴⁻⁸

Mother and Daughter dressed as a superhero hugging each other with a dog.

Infusion site reactions

¹⁻⁵ Reactions were almost exclusively (>99%) mild or moderate ¹⁻⁵ Cutaquig® has proven tolerability, with mostly
 mild or moderate infusion site reactions 99%
¹⁻⁵ Cutaquig® has proven tolerability, with mostly mild or moderate infusion site reactions ¹⁻⁵ Reactions were almost exclusively
 (>99%) mild or moderate 99%
In the pivotal clinical study, no infusion site reactions were observed in 77% of cutaquig® infusions ¹ ³ In the extension study, no infusion site reactions were observed in 97% of cutaquig® infusions 77% 97%
¹ In the pivotal clinical study, no infusion site reactions were observed in 77% of cutaquig® infusions ³ In the extension study, no infusion site reactions were observed in 97% of cutaquig® infusions 77% 97%
Incidence in first 4 weeks of the pivotal clinical trial ¹ Incidence in last 4 weeks of the pivotal clinical trial ¹ In the extension study, the incidence was the highest in the 1st and 2nd months (9% of infusions), and decreased over time ³ 9% The incidence of reactions decreased over time 39% 15%
Incidence in last 4 weeks
 of the pivotal clinical trial ¹ ¹ Incidence in first 4 weeks 
 of the pivotal clinical trial The incidence of reactions decreased over time ³ In the extension study, the incidence was the highest in the 1st and 2nd months (9% of infusions), and decreased over time 39% 15% In the extension study, the incidence was the highest in the 1st and 2nd months (9% of infusions), and decreased over time ³ 9%

No serious systemic adverse events were reported in clinical trials*1-5

During clinical trials, no adverse events were reported as leading to subjects withdrawing from treatment ¹⁻⁵ ZERO During clinical trials, no serious systemic adverse drug reactions were reported ¹⁻⁵ ZERO
During clinical trials, no adverse events were reported as leading to subjects withdrawing from treatment ¹⁻⁵ ZERO During clinical trials, no serious systemic adverse drug reactions were reported ¹⁻⁵ ZERO

*excluding infusion site reactions and infections

During the pivotal Phase 3 trial1, 11 (18%) patients experienced mild or moderate systemic adverse events that were considered to be related to cutaquig®

Systemic adverse events

Headache

Abdominal distension

Abdominal pain upper

Vomitting

Myalgia

Pyrexia

Body temparature increased

Coombs direct test positive

Free haemoglobin present

Haemoglobin increased

Haptoglobin decreased

n[%]

2[3.3%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

1[1.6%]

Cutaquig® is a high-quality SCIg product

As an additional safety measure, the cutaquig® manufacturing process includes several steps that remove or inactivate any potential pathogens, such as viruses ⁶ These measures together contribute to the purity and
 quality of cutaquig® Cutaquig® is made from human plasma (a part of blood) that is donated by healthy people who do not have immune deficiencies ⁶ The health status of all donors is checked, and donors and donations are carefully screened for bacteria or viruses ⁶
Cutaquig® is made from human plasma (a part of blood) that is donated by healthy people who do not have immune deficiencies ⁶ The health status of all donors is checked, and donors and donations are carefully screened for bacteria or viruses ⁶ As an additional safety measure, the cutaquig® manufacturing process includes several steps that remove or inactivate any potential pathogens, such as viruses ⁶ These measures together contribute to the purity and
 quality of cutaquig®

Cutaquig® is produced with a
well-established manufacturing process

Removal and inactivation of viruses ⁶ Cold ethanol fractionation Solvent/detergent treatment pH4 treatment Removal of residual coagulation factors ⁶ Chromatography Purification, adjustment of protein concentration and standardisation of the solution ⁶ Ultra- and diafiltration Preservation of native IgG structure and function, and maintenance of osmolality ⁶ Stabilisation with maltose Cutaquig® is produced using the well- established octagam® manufacturing process, including the same virus elimination techniques ¹,⁶ Cutaquig® is manufactured to preserve the integrity of immunoglobulin G (IgG) and has a distribution of IgG subclasses seen in the healthy population ⁶
Cutaquig® is produced using the well-established octagam® manufacturing process, including the same virus elimination techniques ¹,⁶ Cutaquig® is manufactured to preserve the integrity of immunoglobulin G (IgG) and has a distribution of IgG subclasses seen in the healthy population ⁶
Cold ethanol fractionation Solvent/detergent treatment pH4 treatment Removal and inactivation of viruses ⁶ Ultra- and diafiltration Purification, adjustment of protein concentration and standardisation of the solution ⁶ Stabilisation with maltose Preservation of native IgG structure and function, and maintenance of osmolality ⁶ Removal of residual coagulation factors ⁶ Chromatography

References:

  1. 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.

  2. Kobayashi RH, et al. Treatment of children with primary immunodeficiencies with a subcutaneous immunoglobulin 16.5% (cutaquig® [octanorm]). Immunotherapy. 2021;13(10):813–24.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

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