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Adalimumab-adaz 10mg/20mg/40mg SC

Brand and Other Names: Hyrimoz
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:

HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for treatment of:
•Rheumatoid Arthritis (RA)
•Juvenile Idiopathic Arthritis (JIA)
• Psoriatic Arthritis (PsA)
•Ankylosing Spondylitis (AS)
•Adult Crohn’s Disease (CD)
• Ulcerative Colitis (UC)
•Plaque Psoriasis (Ps) See package insert for complete information.

Route: Subcutaneous
Dose:

• Injection: 40 mg/0.8 mL in a single-dose pre-filled glass syringe (with BD UltraSafe Passive™ Needle Guard)
• Injection: 40 mg/0.8 mL in a single-dose pre-filled pen (Sensoready®Pen).

Adverse Reactions:

The most serious adverse reactions described elsewhere in the labeling include the following:
• Serious Infections [see Warnings and Precautions.]
• Malignancies [see Warnings and Precautions.]

Contraindication:
None
Warnings and Precautions:

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

See package insert for full prescribing information.