Advixa 40

• Ankylosing spondylitis • Rheumatoid arthritis • Psoriasis • Ulcerative Colitis • Crohn’s disease

Adalimumab is a recombinant human IgG1 monoclonal antibody that binds specifically to human TNF-alpha and blocks its interaction with cell surface TNF receptors. TNF is a pro-inflammatory cytokine that plays an important role in normal immune responses. Elevated TNF levels are found in Rheumatoid Arthritis, Psoriasis, Crohn's disease, and other inflammatory diseases. Adalimumab blocks this excessive TNF activity, reducing inflammation and tissue destruction

Adult Dose: Subcutaneous Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis Adult: 40 mg as a single dose every other wk. May increase to wkly dosing when used as monotherapy. Crohn's disease, Ulcerative colitis Adult: Moderate to severe active disease: Initially, 160 mg (given as four 40-mg inj in 1 day or as two 40-mg inj for 2 consecutive days), then 80 mg 2 wk after the initial dose (day 15). Maintenance: After 2 wk (day 29), 40 mg every other wk, may increase to 40 mg wkly if needed. Review treatment if no response w/in 8 (ulcerative colitis) or 12 (Crohn's disease) wk of therapy. Plaque psoriasis Adult: Initially, 80 mg. Maintenance: 40 mg every other wk beginning 1 wk after 1st dose. Child Dose: Subcutaneous Juvenile idiopathic arthritis Child: >4 yr 15 to 30 kg: 40 mg every other wk.

Common: • Headache • Sinus inflammation • Rash • Upper respiratory tract infection • Injection site reaction

Adalimumab may be used during pregnancy with a doctor's advice (Pregnancy Category B) . IgG1 antibodies cross the placenta and are actively transferred during the third trimester . Data from eight infants suggest adalimumab crosses the placenta and can be detected in infant serum for at least 3 months after birth . Available studies do not reliably establish an association between adalimumab and major birth defects . Use only if clearly needed and with medical advice.

[UNSAFE] Adalimumab may cause side effects which could affect your ability to drive. Adalimumab may cause room spinning sensation and vision disturbances. This may affect your driving ability. It is given by injection under the skin (via subcutaneous). Take it as per the dose and duration suggested by the doctor. Inform your doctor immediately if you notice severe rash, hives, swelling of hands or face and shortness of breath. Store the pen in the refrigerator. When refrigeration is not possible, you can also keep your pen at room temperature (less than 30°C) for up to 2 weeks. Do not freeze it. Do not stop taking the medication suddenly without talking to your doctor first.

The maximum tolerated dose of Adalimumab has not been established in humans. Doses up to 10 mg/kg have been given in clinical trials. In case of overdose, monitor for adverse reactions and provide symptomatic treatment .

Store Adalimumab at 2-8°C in a refrigerator. Do not freeze. Protect from light. Store in the original carton until use. If refrigeration is not possible, can be kept at room temperature (below 30°C) for up to 2 weeks .