Humira Adalimumab Injection

1. Indications and Usage
Rheumatoid Arthritis (RA): Treatment of adult patients with moderately to severely active RA, usually in combination with methotrexate (MTX).
Psoriatic Arthritis (PsA): Treatment of adult patients with active PsA, as monotherapy or in combination with MTX.
Ankylosing Spondylitis (AS): Treatment of adult patients with active AS.
Crohn’s Disease (CD) & Ulcerative Colitis (UC): Treatment of moderately to severely active IBD in adults and pediatric patients.
Plaque Psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis.
Uveitis: Treatment of non-infectious intermediate, posterior, and panuveitis.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Standard Dose (RA, PsA, AS, Psoriasis): 40 mg administered every other week.
Dose Escalation: In patients not receiving MTX, the dose may be increased to 40 mg every week.
IBD Dosing: 160 mg at Week 0, 80 mg at Week 2, followed by 40 mg every other week starting at Week 4.
Administration:
Patients may self-inject if their physician determines it is appropriate and they receive proper training.
3. Mechanism of Action
TNF-α Antagonist:
Adalimumab is a recombinant human IgG1 monoclonal antibody that binds specifically to TNF-α.
Blocking Inflammation:
It blocks the interaction of TNF-α with cell surface TNF receptors (p55 and p75), effectively neutralizing the biological activity of TNF-α.
Cell Lysis:
Adalimumab also lyses surface TNF-α-positive T cells and monocytes in vitro, reversing inflammation and preventing tissue damage.
4. Safety and Warnings
Serious Infections (Boxed Warning):
Patients are at increased risk for serious infections involving various organs and body systems (e.g., Tuberculosis, invasive fungal infections, sepsis). Screen for TB prior to initiation.
Malignancy:
Increased risk of malignancies, including lymphoma and hepatosplenic T-cell lymphoma (HSTCL), particularly in adolescents and young adults.
Hepatitis B Reactivation:
Cases of HBV reactivation have occurred in carriers. Monitor liver function and HBV viral load.
Heart Failure:
New or worsening heart failure has been reported; use with caution in patients with a history of heart failure.
Demyelinating Disease:
Use with caution in patients with central nervous system demyelinating disorders (e.g., MS).
5.Adverse Reactions
Most Common:
Injection site reactions (rash, pruritus, erythema, pain), upper respiratory tract infections, headache, and rash.
6.Drug Interactions
Live Vaccines:
Avoid concurrent use with live vaccines (e.g., MMR, BCG).
Anakinra / Abatacept:
Contraindicated/Not Recommended. Concomitant use with anakinra or abatacept is not recommended due to an increased risk of serious infections and no additional clinical benefit.
Methotrexate:
Concomitant use with MTX may reduce the formation of anti-adalimumab antibodies, thereby increasing adalimumab exposure and efficacy.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Adalimumab.
Available Strength: 40 mg/0.8 mL or 0.4 mL prefilled syringes or pens.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Storage: Store in original carton at 2°C to 8°C (36°F to 46°F).