Adalimumab

HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: 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 rheumatoid arthritis. Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Reducing signs and symptoms in adult patients with active ankylosing spondylitis. Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab does 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. Increased concentrations of TNF are also found in psoriasis plaques. In Ps, treatment with HUMIRA may reduce the epidermal thickness and infiltration of inflammatory cells.

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 or Pediatric Uveitis: 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 Crohn's Disease: Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15, and 40 mg every other week starting on Day 29.

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Boxed warning (serious infections and malignancy serious infections): Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Serious infections: Do not start HUMIRA during an active infection. If an infection develops, monitor carefully, and stop HUMIRA if infection becomes serious. Invasive fungal infections: For patients who develop a systemic illness on HUMIRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. Malignancies: Incidence of malignancies was greater in HUMIRA-treated patients than in controls.

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections Malignancies Hypersensitivity Reactions Hepatitis B Virus Reactivation Neurologic Reactions Hematological Reactions Heart Failure Autoimmunity Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

Abatacept: Increased risk of serious infection. Anakinra: Increased risk of serious infection. Live vaccines: Avoid use with HUMIRA.

HUMIRA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray. Storage and Stability Do not use beyond the expiration date on the container. Store in original carton until time of administration to protect from light. Do not store HUMIRA in extreme heat or cold.