AVSOLA

INFLIXIMAB-AXXQ

Manufacturer: Amgen Inc

Score: 144.0

Quick Summary

AVSOLA (INFLIXIMAB-AXXQ) 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 neutralizing the biological activity of TNFα, a substance in the body that causes inflammation and is involved in autoimmune diseases. The recommended dosage varies depending on the condition being treated, with most conditions requiring an initial induction regimen followed by maintenance dosing. Important safety information includes an increased risk of serious infections, malignancies, and hypersensitivity reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring and dose adjustments as needed.

Key Clinical Findings and Indications

Treatment of Crohn's disease
Treatment of ulcerative colitis
Treatment of rheumatoid arthritis
Treatment of ankylosing spondylitis
Treatment of psoriatic arthritis
Treatment of 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 products or any of the inactive ingredients of AVSOLA or any murine proteins

Adverse Reactions

Infusion-related reactions
Infections
Malignancies
Hypersensitivity reactions

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

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

Use during pregnancy only if potential benefits justify potential risks
Monitor for adverse reactions and adjust dose as needed

Nursing Mothers

Use with caution in nursing mothers
Monitor infant for adverse reactions

Pediatric Use

Established for use in pediatric patients 6 years and older with Crohn's disease and ulcerative colitis
Not established for use in pediatric patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis