INFLECTRA

What it is

INFLECTRA (infliximab) is an approved biosimilar to the reference product REMICADE (infliximab). Comparability in safety, efficacy and quality between INFLECTRA and REMICADE has been established. Each vial contains infliximab 100 mg. It is a powder for injection.

Approved indications

— Rheumatoid arthritis in adults with active disease despite treatment with methotrexate or with active disease who have not previously received methotrexate, in combination with methotrexate, for the reduction of signs and symptoms and prevention of structural joint damage. — Ankylosing spondylitis for the reduction of signs and symptoms and improvement in physical function in patients with active disease. — Psoriatic arthritis for the treatment of the 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 therapy. — Psoriasis for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. — Crohn's disease in adults and in children and adolescents (6 to 17 years) for the treatment of moderate to severe Crohn's disease, to reduce the 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 in adult patients for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure. — Ulcerative colitis in adults and in children and adolescents (6 to 17 years) for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Dosing overview

For rheumatoid arthritis, patients not previously treated with INFLECTRA receive an initial dose of 3 mg/kg intravenous infusion over a 2-hour period followed with additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter, given in combination with methotrexate. The dose may be adjusted in increments of 1.5 mg/kg up to a maximum of 7.5 mg/kg. For ankylosing spondylitis, INFLECTRA is given as 5 mg/kg intravenous infusion over a 2-hour period 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, INFLECTRA is given as 5 mg/kg intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For psoriasis, INFLECTRA is given as 5 mg/kg intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusions 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), INFLECTRA is given as 5 mg/kg as a single intravenous infusion over a 2-hour period as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For patients who have an incomplete response during maintenance treatment, consideration may be given to adjusting the dose up to 10 mg/kg. For refractory fistulising Crohn's disease, INFLECTRA is given as 5 mg/kg as a single intravenous infusion over a 2-hour period 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), INFLECTRA is given as 5 mg/kg intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion dose at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Key safety warnings

Infliximab has been associated with acute infusion effects and a delayed hypersensitivity reaction. 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. Acute infusion reactions may develop immediately or within a few hours of infusion and are most likely to occur during the first and second 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. In the controlled portions of clinical trials of tumour necrosis factor-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, but the occurrence of lymphoma was rare. Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including infliximab. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Bacterial (including sepsis and pneumonia), mycobacterial (including tuberculosis), invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab. Some of these infections have been fatal. Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving infliximab. Patients must be evaluated for the risk of tuberculosis and tested for latent tuberculosis prior to initiation of infliximab. Appropriate screening tests, including tuberculin skin test and chest x-ray, should be performed in all patients. Treatment with infliximab may result in the formation of autoantibodies and in the development of a lupus-like syndrome. If drug-induced lupus is suspected, patients being treated with infliximab should have regular measurements of antinuclear antibodies (ANA) and double-stranded DNA (dsDNA) antibodies. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, treatment should be discontinued.

Contraindications

INFLECTRA is contraindicated in patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections. INFLECTRA 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 INFLECTRA and anakinra (an interleukin-1 receptor antagonist) is contraindicated. Do not initiate therapy in patients with congestive heart failure.

PBS listing

INFLECTRA powder for intravenous infusion 100 mg is listed on the PBS with 54 items, restricted to authority required, with an ex-manufacturer price of A$186.16.

Regulatory history

INFLECTRA infliximab (rmc) 100 mg powder for injection was first listed on the ARTG on 19 August 2015. An AusPAR (Australian Public Assessment Report) was approved on 5 August 2015, covering indications in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease, refractory fistulising Crohn's disease, and ulcerative colitis. In March 2019, the PBAC recommended a change to increase the maximum quantity of vials from 4 to 5 for severe Crohn disease, complex refractory fistulising Crohn disease, moderate to severe Crohn disease, moderate to severe ulcerative colitis, ankylosing spondylitis, severe psoriatic arthritis, and severe chronic plaque psoriasis.