REMICADE

What it is

REMICADE contains 100 mg of infliximab, a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology. REMICADE is presented as a powder for injection, supplied as a white solid with no evidence of meltback and free of foreign particles. The powder is reconstituted with sterile Water for Injections and further diluted in 0.9% sodium chloride solution for infusion.

Approved indications

— Reduction of signs and symptoms and prevention of structural joint damage in rheumatoid arthritis in adults with active disease despite treatment with methotrexate or with active disease who have not previously received methotrexate (used in combination with methotrexate). — Reduction of signs and symptoms and improvement in physical function in ankylosing spondylitis in patients with active disease. — 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 therapy. — Treatment of moderate to severe plaque psoriasis in adult patients for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. — Treatment of moderate to severe Crohn's disease in adults and children and adolescents (6 to 17 years) to reduce signs and symptoms and to induce and maintain clinical remission in patients with inadequate response to conventional therapies. — Reduction of the number of draining enterocutaneous and rectovaginal fistulas and maintenance of fistula closure in refractory fistulising Crohn's disease in adult patients. — Treatment of moderately severe to severe active ulcerative colitis in adults and children and adolescents (6 to 17 years) who have had inadequate response to conventional therapy.

Dosing overview

REMICADE is for intravenous use in adults across all indications and is approved for intravenous use in children and adolescents (6 to 17 years) for Crohn's disease and ulcerative colitis. For adult and paediatric patients, administer the infusion solution over a period of not less than 2 hours. In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.

Key safety warnings

**Infections.** Bacterial, mycobacterial, invasive fungal, viral and opportunistic infections have been observed in patients receiving REMICADE, and some of these infections have been fatal. Tuberculosis, frequently disseminated or extrapulmonary at clinical presentation, has been observed in REMICADE-treated patients, and patients must be evaluated for tuberculosis risk and tested for latent tuberculosis prior to initiation of REMICADE. Treatment with REMICADE must be discontinued if a patient develops a serious infection or sepsis, and close monitoring throughout a period of up to six months is important as REMICADE elimination may take that long. **Infusion and hypersensitivity reactions.** REMICADE has been associated with acute infusion effects and delayed hypersensitivity reactions that differ in their time of onset, with hypersensitivity reactions including urticaria, dyspnea, bronchospasm, laryngeal edema, pharyngeal edema and hypotension occurring during or within 2 hours of infusion. Acute infusion reactions may develop immediately or within a few hours of infusion and are most likely during the first and second infusion, and may be related to the rate of infusion. **Malignancies and lymphoproliferative disorders.** In controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker, and the incidence of lymphoma in REMICADE-treated patients was higher than expected in the general population during clinical trials, though the occurrence was rare. Post-marketing cases of malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) who received TNF-blocking agents including REMICADE, with approximately half the reports being lymphomas. **Congestive heart failure.** Do not initiate therapy in patients with congestive heart failure, and treatment should be discontinued in patients whose congestive heart failure is worsening.

Contraindications

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

PBS listing

REMICADE 100 mg powder for intravenous infusion is listed on the PBS with authority required restriction at an ex-manufacturer price of A$186.16.

Regulatory history

REMICADE infliximab 100 mg powder for injection was first listed on the ARTG on 2 August 2000.