Indications & Uses
Advixa 40 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg every other week. Some patients with rheumatoid arthritis who are not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. For juvenile idiopathic arthritis, children weighing 10 kg to less than 15 kg receive 10 mg every other week, those weighing 15 kg to less than 30 kg receive 20 mg every other week, and those weighing 30 kg or more receive 40 mg every other week. For adult Crohn's disease and ulcerative colitis, the initial dose on Day 1 is 160 mg, given as four 40 mg injections in one day or as two 40 mg injections per day on two consecutive days. The second dose, given two weeks later on Day 15, is 80 mg. Two weeks after that, on Day 29, the maintenance dose of 40 mg every other week begins. In ulcerative colitis only, adalimumab should be continued solely in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. For paediatric Crohn's disease, children weighing 17 kg to less than 40 kg receive an initial dose of 80 mg on Day 1 (two 40 mg injections in one day), a second dose of 40 mg two weeks later on Day 15, and then a maintenance dose of 20 mg every other week from Day 29. Children weighing 40 kg or more receive an initial dose of 160 mg on Day 1 (four 40 mg injections in one day or two 40 mg injections per day on two consecutive days), a second dose of 80 mg on Day 15 (two 40 mg injections in one day), and then a maintenance dose of 40 mg every other week from Day 29. For plaque psoriasis, the initial dose is 80 mg, followed by 40 mg every other week starting one week after the initial dose. For hidradenitis suppurativa, the initial dose on Day 1 is 160 mg, given as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2. The second dose, given two weeks later on Day 15, is 80 mg (two 40 mg injections in one day). The third dose on Day 29 and all subsequent doses are 40 mg every week.
Side Effects
The most common side effect seen with Advixa was reactions at the injection site, such as redness and/or itching, bleeding, pain or swelling. In rheumatoid arthritis, the side effects that most often led people to stop Advixa were a clinical flare reaction, rash and pneumonia. Other side effects of Advixa include the following. Gastrointestinal disorders: diverticulitis, large bowel perforations (including perforations linked to diverticulitis and appendiceal perforations linked to appendicitis), and pancreatitis. General disorders and administration site conditions: pyrexia (fever). Hepato-biliary disorders: liver failure and hepatitis. Immune system disorders: sarcoidosis. Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel cell carcinoma (a neuroendocrine carcinoma of the skin). Nervous system disorders: demyelinating disorders (for example, optic neuritis and Guillain-Barré syndrome) and cerebrovascular accident (stroke). Respiratory disorders: interstitial lung disease, including pulmonary fibrosis, and pulmonary embolism. Skin reactions: Stevens-Johnson syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types, including pustular and palmoplantar) and alopecia. Vascular disorders: systemic vasculitis and deep vein thrombosis.
Cautions & Contraindications
Warnings & Precautions
Serious infections: Advixa should not be started during an active infection. If an infection develops, the patient should be carefully monitored, and if the infection becomes serious, Advixa should be stopped. Invasive fungal infections: For patients who develop a systemic illness while on Advixa, empiric antifungal therapy should be considered if they live in or have travelled to regions where mycoses are endemic. Malignancies: The incidence of malignancies was higher in Advixa-treated patients than in controls. Allergic reactions: Anaphylaxis or other serious allergic reactions may occur. Hepatitis B virus reactivation: HBV carriers should be monitored during therapy and for several months after it ends. If reactivation occurs, Advixa should be stopped and antiviral therapy should be started. Demyelinating disease: Exacerbation of existing disease or new onset may occur. Cytopenias and pancytopenia: Patients should be advised to seek immediate medical attention if symptoms develop, and stopping Advixa should be considered. Heart failure: Worsening of existing heart failure or new onset may occur. Lupus-like syndrome: Advixa should be stopped if this syndrome develops.
Contraindications
Adalimumab must not be given to anyone who has a known allergy to Adalimumab or to any ingredient in the product.