Cutaquig SCIg Therapy | Proven Safety & Tolerability

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For Both Adults and Pediatric Patients 2 Years of Age and Older, Most Local Infusion Site Reactions were Mild or Moderate

98% of Infusion Site Reactions Were Mild (88%) or Moderate (10%)1*

  • Across all infusion, ZERO infusions site reactions were observed for over 85% of infusions (6151 or 7239)1
  • 73% of adult and pediatric patients experienced at least once infusion site reaction1
  • The most frequent infusion site reactions were redness, swelling, and itching1

* Mild local reaction was defined as a transient adverse reaction causing discomfort but not interfering with routine activities; moderate local reaction was defined as an adverse reaction causing sufficient discomfort to interfere with routine activities.

Of 7,239 total infusions, there were only 0.15 local reactions per infusion

The Incident of Local Reactions Decreased Over Time1,2,3


Adverse Reactions (ARs) in ≥5% of Patients and Rate Per Infusion in the Pivotal and Extension Trials1,4†

Adults (N=43) Who Received 3956 Infusions
ARs % Patients with ARs % ARs Per Infusion†
Local
(infusion site)		 72.1% 16.4%
Systemic
Headache 18.6% 0.20%
Dermatitis 11.6% 0.20%
Fever 11.6% 0.20%
Diarrhea 11.6% 0.20%
Muscle Spasms 9.3% 0.10%
Back Pain 9.3% 0.10%
Arthralgia 7.0% 0.10%
Children/Adolescents (N=38) Who Received 3282 Infusions
ARs % Patients with ARs % ARs Per Infusion†
Local
(infusion site)		 73.7% 16.4%
Systemic
Asthma 10.5% 0.20%
Cough 10.5% 0.20%
Vomiting 10.5% 0.20%
Nasal Congestion 7.9% 0.20%
Fever 7.9% 0.10%
Headache 7.9% 0.10%
ALT Increased 7.9% 0.10%
Leukopenia 7.9% 0.10%
Neutropenia 7.9% 0.10%
Dermatitis 5.9% 0.10%
Oropharyngeal Pain 5.3% 0.10%
Urticaria 5.3% 0.10%
AST Increased 5.3% 0.10%
Abdominal Pain 5.3% 0.10%
Ear Pain 5.3% 0.10%

ALT: alanine aminotransferase; AST: aspartate aminotransferase

†Excluding infections, defined as ARs occurring during or within 72 hours of infusion or any ARs otherwise causally related.

*Rate = total number of ARs divided by total number of infusions.

ZERO WITHDRAWLS

Due to adverse reactions in the phase 3 pivotal and extension studies1,2

Review the recommended dosing, administration and usage of cutaquig.

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References:
  1. 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.
  2. Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.
  3. Kobayashi RH, et al. Immunotherapy. 2021;13(10):813–824.
  4. 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, Clinical and Experimental Immunology. 2022; 210: 91–103.