Adalimab

Adalimab

Adalimumab

40 mg/ 0.8 ml Injection

Biotech and Oncology

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.

Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). It 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 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. These elevated levels play a critical role in both the pathologic inflammation and joint destruction characteristic of these diseases.

Increased TNF levels are also present in psoriasis plaques. In Plaque Psoriasis, treatment with Adalimumab may reduce epidermal thickness and the infiltration of inflammatory cells.

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

Rheumatoid Arthritis (RA): Reduces signs and symptoms, induces major clinical response, inhibits the progression of structural damage, and
improves physical function in adult patients with moderately to severely active RA.

Juvenile Idiopathic Arthritis (JIA): Reduces signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

Psoriatic Arthritis (PsA): Reduces signs and symptoms, inhibits the progression of structural damage, and improves physical function in adult patients with active PsA.

Ankylosing Spondylitis (AS): Reduces signs and symptoms in adult patients with active AS.

Adult Crohn’s Disease (CD): Reduces signs and symptoms and induces and maintains clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Also used for patients who have lost response to or are intolerant to infliximab.

Pediatric Crohn’s Disease: Reduces signs and symptoms and induces and maintains clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis (UC): Induces and sustains clinical remission in adult patients with moderately to severely active UC who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine (6-MP). The effectiveness of Adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis (Ps): Treats adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, particularly when other systemic therapies are medically less appropriate.

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

Administered by subcutaneous injection.

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

Juvenile Idiopathic Arthritis:

10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week
15 kg (33 lbs) to <30 kg (66 lbs): 20 mg every other week
≥30 kg (66 lbs): 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 (Day 15): 80 mg
Maintenance dose (Day 29): 40 mg every other week
For Ulcerative Colitis: Adalimumab should only be continued in patients who have shown clinical remission by eight weeks (Day 57).

Pediatric Crohn’s Disease:

17 kg (37 lbs) to <40 kg (88 lbs): Initial dose 80 mg, followed by 40 mg (Day 15), then 20 mg every other week (Day 29).
≥40 kg (88 lbs): Initial dose 160 mg, followed by 80 mg (Day 15), then 40 mg every other week (Day 29).
Plaque Psoriasis or Adult Uveitis: 80 mg initial dose, followed by 40 mg every other week starting one week after the initial dose.

Hidradenitis Suppurativa:

Adults: Initial dose 160 mg, followed by 80 mg (Day 15), then 40 mg weekly (Day 29).
Adolescents (≥12 years, ≥60 kg/132 lbs): Same as adults.
Adolescents (30-60 kg/66-132 lbs): Initial dose 80 mg, then 40 mg every other week (Day 8).

Adalimumab should not be used in patients with hypersensitivity to Adalimumab or any component of the formulation. It is contraindicated in cases of sepsis or risk of sepsis. Treatment should not be initiated in patients with serious active infections, including chronic or localized infections.

Serious Infections: Do not start Adalimumab during an active infection. Discontinue if an infection becomes serious.
Invasive Fungal Infections: Consider empiric antifungal therapy for at-risk patients.
Malignancies: Higher incidence reported in Adalimumab-treated patients.
Anaphylaxis and Allergic Reactions: May occur.
Hepatitis B Reactivation: Monitor HBV carriers before, during, and after treatment.
Demyelinating Disease: Risk of new onset or exacerbation.
Cytopenias, Pancytopenia: Immediate medical attention required if symptoms appear.
Heart Failure: Risk of worsening or new-onset heart failure.
Lupus-like Syndrome: Discontinue if symptoms develop.
Tuberculosis: Pre-treatment screening required. Report any symptoms promptly.
Blood Disorders: Persistent fever, bruising, or paleness should be reported.
Chickenpox Exposure: Consult a doctor for preventive treatment.
Latex Sensitivity: The needle cover contains latex.
Alcohol Abuse: Not recommended for alcohol-related hepatitis.
Wegener’s Granulomatosis: Not recommended for this condition.
Diabetes Medications: May require dose adjustments.

Common side effects include injection site reactions (redness, itching, swelling), rash, pneumonia, fever, and gastrointestinal disorders. Serious side effects include liver failure, demyelinating disorders, deep vein thrombosis, Stevens-Johnson Syndrome, and pulmonary embolism.