REMICADE

INFLIXIMAB

Manufacturer: Janssen Biotech, Inc.

Score: 144.0

Quick Summary

REMICADE (INFLIXIMAB) is a tumor necrosis factor (TNF) blocker used to treat various conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It works by binding to TNF-alpha and preventing it from interacting with its receptors, thereby reducing inflammation. The recommended dosage of REMICADE varies by condition and patient population, and it is administered via intravenous infusion. Important safety information includes an increased risk of serious infections, malignancies, and congenital malformations, as well as potential interactions with other medications. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Crohn's disease
ulcerative colitis
rheumatoid arthritis
ankylosing spondylitis
psoriatic arthritis
plaque psoriasis

Important Safety Information

Warning

Increased risk of serious infections and malignancies

Contraindications

Moderate or severe heart failure
Previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins

Adverse Reactions

Infections
infusion reactions
headache
abdominal pain

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on patient response and tolerability

Crohn's disease

Adult Dose

5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks

Pediatric Dose

5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks for patients 6 years and older

Ulcerative colitis

Adult Dose

5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks

Pediatric Dose

5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks for patients 6 years and older

Rheumatoid arthritis

Adult Dose

3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if potential benefits justify potential risks
Infliximab crosses the placenta and may affect immune response in the in utero exposed infant

Nursing Mothers

Caution advised when administering to nursing mothers
Infliximab is excreted in human milk

Pediatric Use

Safety and effectiveness established for pediatric patients 6 years and older with Crohn's disease and ulcerative colitis
Not established for pediatric patients with rheumatoid arthritis or other conditions