Adalimumab

What it is and how it works

Mechanism of Action Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases.

Indications

is a tumor necrosis factor (TNF) blocker indicated for: • Rheumatoid Arthritis (RA) : reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA . • Juvenile Idiopathic Arthritis (JIA) : reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. • Psoriatic Arthritis (PsA) : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. • Ankylosing Spondylitis (AS) : reducing signs and symptoms in adult patients with active AS. • Crohn’s Disease (CD) : treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. • Ulcerative Colitis (UC) : treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

Dosage and administration (summary)

• Administer by subcutaneous injection Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis : • Adults: 40 mg every other week. • Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis : Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week • Administer by subcutaneous injection Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis : • Adults: 40 mg every other week.

Contraindications

None. None.

Warnings and precautions

• Serious infections: Do not start IDACIO during an active infection. If an infection develops, monitor carefully, and stop IDACIO if infection becomes serious. • Invasive fungal infections: For patients who develop a systemic illness on IDACIO, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic.

Pregnancy

Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn…

Storage and supply

(adalimumab-aacf) injection is supplied as a preservative-free, sterile, clear and colorless to pale yellow solution for subcutaneous administration. The following packaging configurations are available. • IDACIO Pen Carton - 40 mg/0.8 mL (2 count) IDACIO is supplied in a carton containing 2 alcohol preps and one tray.

Source: Adalimumab-Aacf (Idacio) — US FDA prescribing information, 2024-10-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.