Proven Tolerability, with Mostly Mild or Moderate Infusion Site Reactions

More than 99% of local reactions were mild (89.4%) or moderate (10.3%)1,2

  • Zero infusion site reactions were observed in over 3/4 of infusions (76.7%)
  • 46 of 61 patients (75.4%) experienced at least one infusion site reaction

No serious systemic adverse drug reactions were reported1,2

  • Rate of related systemic adverse event (AE) per infusion was 0.004
  • No AE resulted in withdrawal of subjects from the study
  • No AE resulted in discontinuation of the study medication
  • No AE required a dose change
  • There was no incidence of thrombosis during the study. However, thrombosis may occur with immune globulin products, including cutaquig

11 of 61 patients (18%) Experienced Non-Serious Systemic Adverse Events that Were Considered Related to cutaquig1,2

Adverse reactions and rate per infusion2

Adverse reactions* in ≥ 5% of subject and rate per infusion6

Adverse ReactionsNumber (%) of Patients (N=61)Number (Rate)
of ARs (N=3,497)
Local reaction46 (75.4)814 (0.23)
Systemic ARs
Headache7 (11.5)8 (0.0023)
Fever5 (8.2)6 (0.0017)
Diarrhea5 (8.2)8 (0.0023)
Dermatitis5 (8.2)6 (0.0017)
Asthma4 (6.6)5 (0.0014)
Skin Abrasion4 (6.6)4 (0.0011)

AR=Adverse reaction.
*
Excluding infections.
Rate = total number of ARs divided by total number of infusions./p>

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® (Immune Globulin Subcutaneous (Human) – hipp), 16.5% solution. Full Prescribing Information. Octapharma USA, December 2019.