Adalimumab

Adalimumab is a medicine used to treat a variety of conditions such as ankylosing spondylitis, rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn’s disease. It provides relief from swelling, pain, and redness associated with various disorders and improves physical function. Adalimumab is given by a healthcare professional and should not be self-administered. You should use it regularly and at the same time each day to get the maximum benefit from it. Continue using it as recommended by your doctor and complete the dose even if you feel better. Some of the common side effects of this medicine include headache, sinus inflammation, rash upper respiratory tract infection, and injection site reactions such as pain, redness, and swelling. Talk to your doctor if any of these side effects do not go away with time or get worse. Your doctor may help with ways to reduce or prevent these symptoms. To make sure the medicine is safe for you, before taking it, let your doctor know if you have any problems with your heart, kidneys, or liver. You should also tell your doctor about all the other medicines you are taking. It is important for pregnant and breastfeeding women to ask the advice of their doctors before taking this medicine. Adalimumab blocks the action of certain chemical messengers that are responsible for inflammation, swelling and redness associated with certain joint diseases.

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

TNF-alpha Inhibitor, Disease-modifying Antirheumatic Drug (DMARD), Immunosuppressant

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

Adalimumab is a recombinant DNA-derived human Ig G1 monoclonal antibody. It binds to human tumour necrosis factor alfa (TNF-alpha), thus interfering w/ cytokine-driven inflammatory processes.

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.

Adalimumab is administered by subcutaneous injection. It is usually given by a healthcare professional. Patients may be trained to self-administer. Clean the injection site with an alcohol swab before injection and rotate injection sites each time

If you miss a dose, inform your doctor as soon as possible. Your doctor will determine when to take the next dose. Do not double the dose.

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

[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.

Hypersensitivity to Adalimumab or any of its components

Increased risk of serious infections w/ other biologic disease-modifying antirheumatic drugs (e.g. abatacept, anakinra), rituximab. May increase immunosuppressant effect w/ tocilizumab, live vaccines.

Consuming alcohol with Adalimumab does not cause any harmful side effects. However, if you have liver problems, you should avoid alcohol.

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.

Adalimumab is probably safe during breastfeeding . Limited human data suggests the drug passes into breast milk in low levels and does not represent a significant risk to the baby. However, no data is available for newborn or preterm infants. Use with caution .

Safety and efficacy of Adalimumab have been established in pediatric patients for JIA (2 years and older) and pediatric Crohn's disease (6 years and older) . Safety and efficacy for other indications have not been established in children

No overall difference in effectiveness was observed between elderly and younger patients. However, the frequency of serious infection and malignancy was higher in patients over 65 . Use with caution in elderly patients due to higher incidence of infections and malignancies in this populatio

Renal Impairment: Limited information is available on the use of Adalimumab in patients with kidney disease. Consult your doctor . Hepatic Impairment: Limited information is available on the use of Adalimumab in patients with liver disease. Consult your doctor .

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 .