ts with moderately to severely active ulcerativecolitis.
2.4 Rheumatoid Arthritis
The recommended dose of RENFLEXIS is 3 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks
thereafter for the treatment of moderately to severely active rheumatoid arthritis.
RENFLEXIS should be given in combination with methotrexate. For patients who have anincomplete response, consideration may be given to adjusting the dose up to 10 mg/kg ortreating as often as every 4 weeks bearing in mind that risk of serious infections is increasedat higher doses [see Adverse Reactions (6.1)].
2.5 Ankylosing Spondylitis
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks
thereafter for the treatment of active ankylosing spondylitis.
2.6 Psoriatic Arthritis
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks
thereafter for the treatment of psoriatic arthritis. RENFLEXIS can be used with or withoutmethotrexate.
2.7 Plaque Psoriasis
The recommended dose of RENFLEXIS is 5 mg/kg given as an intravenous inductionregimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks
thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) plaquepsoriasis.
2.8 Monitoring to Assess Safety
Prior to initiating RENFLEXIS and periodically during therapy, patients should be eva luatedfor active tuberculosis and tested for latent infection [see Warnings and Precautions (5.1)].
2.9 Administration Instructions Regarding Infusion Reactions
Adverse effects during administration of infliximab products have included flu-likesymptoms, headache, dyspnea, hypotension, transient fever, chills, gastrointestinal symptoms,and skin rashes. Anaphylaxis might occur at any time during RENFLEXIS infusion.
Approximately 20% of patients in all clinical trials of infliximab experienced an infusion reaction compared with 10% of placebo-treated patients [see Adverse Reactions (6.1)].
Priorto infusion with RENFLEXIS, premedication may be administered at the physician’sdiscretion. Premedication could include antihistamines (anti-H1 +/- anti-H2), acetaminophenand/or corticosteroids.
During infusion, mild to moderate infusion reactions may improve following slowing orsuspension of the infusion, and upon resolution of the reaction, reinitiation at a lower infusionrate and/or therapeutic administration of antihistamines, acetaminophen, and/orcorticosteroids. For patients that do not tolerate the infusion following these interventions,RENFLEXIS should be discontinued.
During or following infusion, patients who have severe infusion-related hypersensitivityreactions should be discontinued from further RENFLEXIS treatment. The management ofsevere infusion reactions should be dictated by the signs and symptoms of the reaction.
Appropriate personnel and medication should be available to treat anaphylaxis if it occurs.
2.10 General Considerations and Instructions for Preparation and Administration
RENFLEXIS is intended for use under the guidance and supervision of a physician. Thereconstituted infusion solution should be prepared by a trained medical professional usingaseptic technique by the following |
