Product Dossier
INTRATECT
Product Dossier for INTRATECT (normal immunoglobulin, Grifols). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Grifols
- Active ingredient: normal immunoglobulin
- Therapeutic area: Immunology
- Related brand: KIOVIG
- Related brand: FLEBOGAMMA
- Related brand: GAMUNEX
- Same area: COSENTYX
- Same area: HYRIMOZ
What it is
INTRATECT is a human normal immunoglobulin solution for intravenous infusion , available in multiple strengths. It is used for replacement therapy in primary immunodeficiency syndromes, including congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies and Wiscott-Aldrich syndrome . It is also indicated for myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, for children with congenital AIDS who have repeated bacterial infections, and provides immunomodulatory effects in idiopathic thrombocytopenic purpura, Guillain-Barré syndrome, Kawasaki disease or allogeneic bone marrow transplant .
Approved indications
— Replacement therapy in primary immunodeficiency syndromes (congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies and Wiscott-Aldrich syndrome) . — Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections . — Children with congenital AIDS who have repeated bacterial infections . — Idiopathic thrombocytopenic purpura (immunomodulatory effect) . — Guillain-Barré syndrome (immunomodulatory effect) . — Kawasaki disease (immunomodulatory effect) . — Allogeneic bone marrow transplant (immunomodulatory effect) .
Regulatory history
INTRATECT was first registered on the ARTG on 16 February 2011 . The TGA approved INTRATECT on 3 February 2011 . The TGA approved INTRATECT for its specified therapeutic uses, concluding that the benefits of the product outweighed the risks after a comprehensive evaluation of quality, nonclinical, and clinical data . Additional ARTG registrations for alternative presentations were listed on 13 October 2016 .