ZYMFENTRA

INFLIXIMAB-DYYB

Manufacturer: CELLTRION USA Inc.

Score: 144.0

Quick Summary

INFLECTRA (INFLIXIMAB-DYYB) is a tumor necrosis factor (TNF) blocker indicated for the treatment of various conditions, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It works by neutralizing the biological activity of TNFα, a substance in the body that causes inflammation and is involved in autoimmune diseases. The recommended dosage of INFLECTRA varies depending on the condition being treated, with typical dosing regimens including an initial induction regimen followed by maintenance dosing. Important safety information includes an increased risk of serious infections, malignancies, and other adverse reactions, as well as contraindications for patients with certain medical conditions or taking certain 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

SERIOUS INFECTIONS and MALIGNANCY

Contraindications

doses >5 mg/kg in moderate or severe heart failure
previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of INFLECTRA or any murine proteins

Adverse Reactions

infections
infusion-related reactions
headache
abdominal pain

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with certain medical conditions or taking certain medications

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

ankylosing spondylitis

Adult Dose

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

Pediatric Dose

Not established

psoriatic arthritis

Adult Dose

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

Pediatric Dose

Not established

plaque psoriasis

Adult Dose

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

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non-biologics
Monoclonal antibodies such as infliximab products are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant

Nursing Mothers

It is not known whether infliximab is excreted in human milk or if it has any effects on the breastfed infant

Pediatric Use

The safety and effectiveness of infliximab products have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of Crohn's disease and ulcerative colitis
The safety and effectiveness of infliximab products in pediatric patients with juvenile rheumatoid arthritis have not been established

Geriatric Use

Of the total number of infliximab-treated patients in RA and Ps clinical studies, 256 (9.6%) were 65 years old and over, while 17 (0.6%) were 75 years old and over
In these trials, no overall differences in safety or effectiveness were observed between geriatric patients and younger adult patients