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Adalimumab-bwwd 40mg SC

Brand and Other Names: Hadlima
Mechanism of Action:
Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. See package insert for complete information.
Indications:

HADLIMA is a tumor necrosis factor (TNF) blocker indicated for:
•Rheumatoid Arthritis (RA).
•Juvenile Idiopathic Arthritis (JIA).
•Psoriatic Arthritis (PsA).
•Ankylosing Spondylitis (AS).
•Crohn’s Disease (CD).
•Ulcerative Colitis (UC).
•Plaque Psoriasis (Ps).

See package insert for complete information.

Route: Subcutaneous
Dose:

Injection:
•Single-dose prefilled autoinjector (HADLIMA PushTouch): 40 mg/0.8 mL.
•Single-dose prefilled glass syringe: 40 mg/0.8 mL.
•Single-dose glass vial for institutional use only: 40 mg/0.8 mL.

Adverse Reactions:
Most common adverse reactions (>10%): infections (e.g., upper respiratory, sinusitis), injection site reactions, headache and rash.
Contraindication:
None.
Warnings and Precautions:

Serious infections: Do not start HADLIMA during an active infection. If an infection develops, monitor carefully, and stop HADLIMA if infection becomes serious.
•Invasive fungal infections: For patients who develop a systemic illness on HADLIMA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic.
•Malignancies: Incidence of malignancies was greater in adalimumabtreated patients than in controls.
•Anaphylaxis or serious hypersensitivity reactions may occur.
•Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HADLIMA and begin anti- viral therapy.
•Demyelinating disease: Exacerbation or new onset, may occur.
•Cytopenias, pancytopenia: Advise patients to seek immediate medicalattention if symptoms develop, and consider stopping HADLIMA. 
•Heart failure: Worsening or new onset, may occur.
•Lupus-like syndrome: Stop HADLIMA if syndrome develops.

See package insert for full prescribing information.