Ixifi

Ixifi Dosage/Direction for Use

infliximab

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Posology: Crohn's Disease: The recommended dose of Ixifi is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulizing Crohn's disease. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Ixifi in these patients.
Pediatric Crohn's Disease: The recommended dose of Ixifi for pediatric patients 6 years and older with moderately to severely active Crohn's disease is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
The safety and efficacy of infliximab products have not been studied in children with Crohn's disease below the age of 6 years and no recommendation on a posology can be made.
Ulcerative Colitis: The recommended dose of Ixifi is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active UC.
Pediatric Ulcerative Colitis: The recommended dose of Ixifi for pediatric patients 6 years and older with moderately to severely active UC is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
The safety and efficacy of infliximab products have not been studied in children with UC below the age of 6 years and no recommendation on a posology can be made.
Rheumatoid Arthritis: The recommended dose of Ixifi is 3 mg/kg given as an IV induction regimen 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 RA. Ixifi should be given in combination with MTX. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses (see Adverse Reactions).
Ankylosing Spondylitis: The recommended dose of Ixifi is 5 mg/kg given as an IV induction regimen 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.
Psoriatic Arthritis: The recommended dose of Ixifi is 5 mg/kg given as an IV induction regimen 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. Ixifi can be used with or without MTX.
Plaque Psoriasis: The recommended dose of Ixifi is 5 mg/kg given as an IV induction regimen 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) plaque psoriasis.
Juvenile Rheumatoid Arthritis: The safety and efficacy of infliximab products in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis (JRA) have not been established and no recommendation on a posology can be made.
Method of Administration: Administration Instructions Regarding Infusion Reactions: Adverse effects during administration of infliximab products have included flu-like symptoms, headache, dyspnea, hypotension, transient fever, chills, gastrointestinal symptoms, and skin rashes. Anaphylaxis might occur at any time during Ixifi infusion. Approximately 20% of infliximab-treated patients in all clinical trials experienced an infusion reaction compared with 10% of placebo-treated patients (see Adverse Reactions). Prior to infusion with Ixifi, premedication may be administered at the physician's discretion. Premedication could include antihistamines (anti-H1 +/- anti-H2), acetaminophen, and/or corticosteroids.
During infusion, mild to moderate infusion reactions may improve following slowing or suspension of the infusion, and upon resolution of the reaction, reinitiation at a lower infusion rate and/or therapeutic administration of antihistamines, acetaminophen, and/or corticosteroids. For patients that do not tolerate the infusion following these interventions, Ixifi should be discontinued (see Precautions and Adverse Reactions).
During or following infusion, patients who have severe infusion-related hypersensitivity reactions should be discontinued from further Ixifi treatment. The management of severe 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 (see Precautions and Adverse Reactions).
For preparation and administration instructions, see Special precautions for disposal and other handling under Cautions for Usage.
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