Safety and Tolerability

Cutaquig® is well tolerated, providing comfortable infusions for patients

Cutaquig® has proven tolerability, with mostly mild or moderate infusion site reactions1,2

No serious systemic adverse drug reactions were reported in the clinical trials 1,2

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

This included (n [%]): headache (2 [3.3]), abdominal distension (1 [1.6]), abdominal pain upper (1[1.6]), vomiting (1 [1.6]), myalgia (1 [1.6]), pyrexia (1 [1.6]), body temperature increased (1 [1.6]), Coombs direct test positive (1 [1.6]), free haemoglobin present (2 [3.3]), haemoglobin increased (1[1.6]), haptoglobin decreased (1 [1.6]).

Cutaquig® is a high-quality SCIg product

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. 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.
3. 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.
4. Cutaquig® European Public Assessment Report (PAR). DE/H/4903/001/DC. May 2019. Available here

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).

▼ This medicinal product is subject to additional monitoring.