IXIFI

What it is

IXIFI (infliximab) 100 mg powder for injection is a biosimilar medicine approved by the TGA on 20 September 2024. IXIFI is an approved biosimilar to the reference product REMICADE (infliximab). Comparability in safety, efficacy and quality between IXIFI and REMICADE has been established.

Approved indications

— Rheumatoid arthritis in adults: reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in patients with active disease despite treatment with methotrexate and in patients with active disease who have not previously received methotrexate. — Ankylosing spondylitis: reduction of signs and symptoms and improvement in physical function in patients with active disease. — Psoriatic arthritis: treatment of signs and symptoms and improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (DMARD) therapy. — Psoriasis: treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate; safety and efficacy beyond 12 months have not been established. — Crohn's disease in adults and in children and adolescents (6 to 17 years): treatment of moderate to severe Crohn's disease to reduce signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. — Refractory fistulising Crohn's disease: reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. — Ulcerative colitis in adults and in children and adolescents (6 to 17 years): treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Dosing overview

IXIFI 100 mg powder for injection is for intravenous use in adults across all indications. IXIFI is approved for intravenous use in children and adolescents (6 to 17 years) for the indication of Crohn's disease and ulcerative colitis. For adult and paediatric patients, the infusion solution is to be administered over a period of not less than 2 hours. For rheumatoid arthritis in adults not previously treated with IXIFI: initially 3 mg/kg intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For ankylosing spondylitis: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 weeks thereafter. For psoriatic arthritis: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For psoriasis: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For moderate to severe Crohn's disease in adults and children and adolescents (6 to 17 years), for optimal long-term symptom control: 5 mg/kg given as a single intravenous infusion as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For refractory fistulising Crohn's disease: 5 mg/kg given as a single intravenous infusion as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For ulcerative colitis in adults and children and adolescents (6 to 17 years): 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Key safety warnings

Bacterial infections (including sepsis and pneumonia), mycobacterial infections (including tuberculosis, frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, viral infections and other opportunistic infections have been observed in patients receiving infliximab, and some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of more than 5 per cent include pneumocystosis, candidiasis, listeriosis and aspergillosis. Infliximab should not be given to patients with a clinically important, active infection. Patients must be evaluated for the risk of tuberculosis prior to initiation of infliximab, and appropriate screening tests including tuberculin skin test and chest x-ray should be performed in all patients. Infliximab has been associated with acute infusion effects, systemic injection reactions, anaphylactic shock and delayed hypersensitivity reactions; hypersensitivity reactions, which include urticaria, dyspnoea and/or bronchospasm, laryngeal oedema, pharyngeal oedema and hypotension, have occurred during or within 2 hours of infliximab infusion. Antibodies to infliximab may develop in some patients; these antibodies have been associated with an increased frequency of infusion reactions and may be associated with an increased risk of serious infusion reactions. Treatment with infliximab may result in the formation of autoantibodies and in the development of a lupus-like syndrome; the relative deficiency of TNF alpha caused by anti-TNF therapy may result in the initiation of an autoimmune process in a subgroup of genetically susceptible patients. Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab, and isolated cases of liver failure resulting in liver transplantation or death have occurred. In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared with control patients; during clinical trials of infliximab in patients with rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, psoriasis and ulcerative colitis, the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population.

Contraindications

IXIFI is contraindicated in patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections. IXIFI should not be given to patients with a history of hypersensitivity to infliximab, to other murine proteins or to any excipient of the product. Concurrent administration of IXIFI and anakinra (an interleukin-1 receptor antagonist) is contraindicated. Do not initiate therapy in patients with congestive heart failure.

Regulatory history

IXIFI was approved by the TGA on 20 September 2024 as a new biosimilar medicine. IXIFI infliximab 100 mg powder for injection vial was first listed on the ARTG on 27 September 2024.