Product Dossier
CUTAQUIG
Product Dossier for CUTAQUIG (human immunoglobulin G, Octapharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Octapharma
- Active ingredient: human immunoglobulin G
- Therapeutic area: Immunology
- Related brand: XEMBIFY
- Related brand: OCTAGAM
- Same area: COSENTYX
- Same area: HYRIMOZ
What it is
CUTAQUIG is a human normal immunoglobulin 16.5% solution for subcutaneous injection. It is a human normal immunoglobulin solution for subcutaneous injection.
Approved indications
— Replacement therapy in adults and children in primary immunodeficiency diseases (PID). — Replacement therapy in adults and children with symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
Dosing overview
CUTAQUIG is available in six strengths: 1g/6mL, 1.65g/10mL, 2g/12mL, 3.3g/20mL, 4g/24mL and 8g/48mL. Specific dosing information for individual indications is not provided in the available sources.
Key safety warnings
CUTAQUIG is confirmed to provide an effective and safe subcutaneous option for patients. Further safety information specific to CUTAQUIG is not detailed in the available sources.
Regulatory history
The TGA approved CUTAQUIG on 21 April 2021 for its proposed indications. CUTAQUIG was first listed on the ARTG on 3 May 2021, with six strength variants registered. This approval allows CUTAQUIG to be used as a subcutaneous replacement therapy for adults and children with primary immunodeficiency diseases and symptomatic hypogammaglobulinaemia.