Advixa

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.

Juvenile Idiopathic Arthritis:

• 10 kg to <15 kg: 10 mg every other week
• 15 kg to < 30 kg: 20 mg every other week
• ≥ 30 kg: 40 mg every other week

Adult Crohn's Disease and Ulcerative Colitis:

• Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days).
• Second dose two weeks later (Day 15): 80 mg.
• Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
• For patients with Ulcerative Colitis only: Adalimumab should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Pediatric Crohn’s Disease:

• 17 kg to < 40 kg: Initial dose (Day 1): 80 mg (two 40 mg injections in one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later (Day 29): Maintenance dose of 20 mg every other week.
• ≥ 40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) , Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two weeks later (Day 29): Maintenance dose of 40 mg every other week.

Plaque Psoriasis:

• 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
• Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2, Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day), Third (Day 29) and subsequent doses: 40 mg every week.

The most common adverse reaction with Advixa was injection site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most common adverse reactions leading to discontinuation of Advixa in rheumatoid arthritis were clinical flare reaction, rash and pneumonia.

• Other adverse reactions of Advixa includes- Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis.
• General disorders and administration site conditions: Pyrexia.
• Hepato-biliary disorders: Liver failure, hepatitis.
• Immune system disorders: Sarcoidosis.
• Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin). 
• Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome).
• Cerebrovascular accident Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis.
• Pulmonary embolism Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia.
• Vascular disorders: Systemic vasculitis, deep vein thrombosis.

Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). 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. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Plaque Psoriasis, treatment with Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.

Disease-modifying antirheumatic drugs (DMARDs), Immunosuppressant