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Adalimumab-fkjp 20mg/40mg SC

Brand and Other Names: Hulio
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:

HULIO 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 prefilled pen (HULIO Pen).
•Injection: 40 mg/0.8 mL in a single-dose prefilled plastic syringe. 
•Injection: 20 mg/0.4 mL in a single-dose prefilled plastic syringe.

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

Serious infections: Do not start HULIO during an active infection. If an infection develops, monitor carefully, and stop HULIO if infection becomes serious. 
• Invasive fungal infections: For patients who develop a systemic illness on HULIO, 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 allergic reactions may occur.
•Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HULIO and begin antiviral therapy.
•Demyelinating disease: Exacerbation or new onset, may occur.
•Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HULIO. •Heart failure: Worsening or new onset, may occur.
•Lupus-like syndrome: Stop HULIO if syndrome develops.

See package insert for full prescribing information.