Adalimumab injection is a tumor necrosis factor (TNF) inhibitor indicated for the treatment of:

• Rheumatoid Arthritis (RA): Helps reduce signs and symptoms, achieve major clinical response, slow structural damage progression, and improve physical function in adults with moderately to severely active RA.

• Juvenile Idiopathic Arthritis (JIA): Reduces signs and symptoms in children aged 2 years and older with moderately to severely active polyarticular JIA.

• Psoriatic Arthritis (PsA): Reduces signs and symptoms, inhibits structural damage progression, and improves physical function in adults with active PsA.

• Ankylosing Spondylitis (AS): Reduces signs and symptoms in adults with active AS.

• Adult Crohn’s Disease (CD): Reduces signs and symptoms, induces and maintains clinical remission in adults with moderately to severely active Crohn’s disease who have not responded adequately to conventional therapy. Also effective in patients who have lost response to or are intolerant of infliximab.

• Pediatric Crohn’s Disease: Reduces signs and symptoms and induces and maintains clinical remission in patients aged 6 years and older with moderately to severely active Crohn’s disease who have not responded adequately to corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate).

• Ulcerative Colitis (UC): Induces and maintains clinical remission in adults with moderately to severely active UC who have not responded adequately to immunosuppressants (e.g., corticosteroids, azathioprine, or 6-mercaptopurine). Effectiveness has not been established in patients who have lost response to or are intolerant of TNF blockers.

• Plaque Psoriasis (Ps): Treats moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, especially when other systemic therapies are less appropriate.

• Hidradenitis Suppurativa (HS): Treats moderate to severe hidradenitis suppurativa.

Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically targets human tumor necrosis factor (TNF). It binds to TNF-alpha, preventing its interaction with the p55 and p75 TNF receptors on cell surfaces. In vitro, Adalimumab can also induce lysis of cells expressing surface TNF in the presence of complement. TNF is a naturally occurring cytokine that plays a key role in normal inflammatory and immune responses. Elevated TNF levels are observed in the synovial fluid of patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, contributing to both pathological inflammation and joint damage characteristic of these conditions. Increased TNF levels are also found in psoriasis plaques. In patients with Plaque Psoriasis, Adalimumab treatment may reduce epidermal thickness and the infiltration of inflammatory cells.

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 wee

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.

Administered by subcutaneous injection.

Abatacept: May increase the risk of serious infections.

Anakinra: May increase the risk of serious infections.

Live vaccines: Should be avoided during Adalimumab treatment.

Adalimumab must not be given to patients with a known hypersensitivity to Adalimumab or any of its ingredients.

The most common adverse reaction to Adalimumab is injection site reactions, which may include erythema, itching, hemorrhage, pain, or swelling. In patients with Rheumatoid Arthritis, the most frequent adverse reactions leading to discontinuation are clinical flare, rash, and pneumonia. Other reported adverse reactions include:

• Gastrointestinal disorders: Diverticulitis, large bowel perforation (including those associated with diverticulitis), appendiceal perforation associated with appendicitis, pancreatitis.
• General disorders & administration site conditions: Fever (pyrexia).
• Hepato-biliary disorders: Hepatitis, liver failure.
• Immune system disorders: Sarcoidosis.
• Neoplasms (benign, malignant, and unspecified): Merkel cell carcinoma (neuroendocrine carcinoma of the skin).
• Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accidents.
• Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis; pulmonary embolism.
• Skin reactions: Stevens-Johnson syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (including pustular and palmoplantar subtypes), alopecia.
• Vascular disorders: Systemic vasculitis, deep vein thrombosis.

Adalimumab is classified as Pregnancy Category B. Adequate and well-controlled studies in pregnant women have not been conducted. As an IgG1 monoclonal antibody, Adalimumab can cross the placenta, particularly during the third trimester. Limited published data indicate that Adalimumab is present at low levels in human breast milk and is unlikely to be absorbed by a breastfeeding infant. However, there is no information on absorption in newborns or preterm infants. Therefore, caution should be exercised when administering Adalimumab to nursing mothers.

• Serious infections: Adalimumab should not be initiated in patients with active infections. Patients who develop an infection while on therapy should be closely monitored, and treatment should be discontinued if the infection becomes serious.
• Invasive fungal infections: For patients developing systemic illness while on Adalimumab, empiric antifungal therapy should be considered, especially in individuals living in or traveling to regions where endemic mycoses occur.
• Malignancies: The incidence of malignancies has been higher in Adalimumab-treated patients compared to controls.
• Anaphylaxis and serious allergic reactions: May occur during treatment.
• Hepatitis B virus (HBV) reactivation: HBV carriers should be monitored during treatment and for several months after. If reactivation occurs, Adalimumab should be stopped and appropriate antiviral therapy initiated.
• Demyelinating disorders: New-onset or worsening demyelinating diseases may occur.
• Cytopenias and pancytopenia: Patients should seek immediate medical attention if symptoms develop; discontinuation of Adalimumab should be considered.
• Heart failure: Worsening or new-onset heart failure may occur.
• Lupus-like syndrome: Treatment with Adalimumab should be stopped if this syndrome develops.

Pediatric Use: The safety and effectiveness of Adalimumab have not been established in pediatric patients for indications other than polyarticular Juvenile Idiopathic Arthritis (JIA) and pediatric Crohn’s disease.

Geriatric Use: In clinical studies, 519 patients aged 65 years and older (including 107 patients aged 75 and older) received Adalimumab. No overall difference in effectiveness was observed compared to younger patients. However, the frequency of serious infections and malignancies was higher in Adalimumab-treated patients over 65. Because elderly individuals are generally at increased risk for infections and malignancies, caution is advised when treating this population.

The maximum tolerated dose of Adalimumab in humans has not been established. In clinical trials, multiple doses up to 10 mg/kg were administered without dose-limiting toxicities. In the event of an overdose, patients should be closely monitored for any adverse reactions, and appropriate symptomatic treatment should be provided immediately.

Adalimumab belongs to the class of disease-modifying antirheumatic drugs (DMARDs) and acts as an immunosuppressant.

Do not use the medication after the expiration date printed on the container. Adalimumab should be stored in a refrigerator at a temperature between 2°C and 8°C. Do not freeze it. Keep the pre-filled syringe protected from light by storing it in its original carton until it is ready to be used.