Remicade Infliximab for Injection

1. Indications and Usage
Rheumatoid Arthritis (RA): Treatment of adult patients with moderately to severely active RA, in combination with methotrexate (MTX).
Crohn’s Disease (CD): Treatment of patients with moderately to severely active CD and fistulizing CD.
Ulcerative Colitis (UC): Treatment of adult and pediatric patients with moderately to severely active UC.
Ankylosing Spondylitis (AS): Treatment of adult patients with active AS.
Psoriatic Arthritis (PsA): Treatment of adult patients with active PsA.
Plaque Psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY. Do not administer by IV push or bolus.
Recommended Dosage:
Standard Induction: 5 mg/kg administered at Weeks 0, 2, and 6.
Maintenance: 5 mg/kg every 8 weeks thereafter.
Dose Escalation: For patients who lose response, dose may be increased to 10 mg/kg and/or interval shortened (e.g., every 4 weeks).
RA Specific: 3 mg/kg initially, with subsequent doses at Weeks 2 and 6, then every 8 weeks.
Preparation:
Reconstitute with Sterile Water for Injection and dilute with 0.9% Sodium Chloride Injection.
3. Mechanism of Action
TNF-α Antagonist:
Infliximab binds with high affinity to the soluble and transmembrane forms of TNF-α.
Cell Lysis:
Unlike some other TNF inhibitors, infliximab binds to the transmembrane form of TNF-α on the surface of specific immune cells (like macrophages and T cells), leading to cell lysis (destruction) in vitro.
Anti-inflammatory Effect:
Blocks the interaction of TNF-α with cell surface TNF receptors, preventing downstream inflammatory cascades.
4. Safety and Warnings
Serious Infections (Boxed Warning):
Increased risk of serious bacterial, fungal, and viral infections (e.g., Tuberculosis, invasive fungal infections). Screen for TB prior to initiation.
Malignancy:
Increased risk of malignancies, including hepatosplenic T-cell lymphoma (HSTCL), particularly in adolescents and young adults with IBD.
Infusion Reactions:
Serious hypersensitivity reactions (anaphylaxis, angioedema) can occur during or up to 12 hours after infusion.
Heart Failure:
Contraindicated in patients with moderate to severe (NYHA Class III/IV) heart failure.
Hepatitis B Reactivation:
Monitor for HBV reactivation in carriers.
5.Adverse Reactions
Most Common:
Infusion reactions (dyspnea, flushing, chest pain), upper respiratory tract infections, headache, rash, andIncreased susceptibility to infections.
6.Drug Interactions
Live Vaccines:
Avoid concurrent use with live vaccines.
Anakinra / Abatacept:
Concomitant use is not recommended due to an increased risk of serious infections and no additional clinical benefit.
Methotrexate:
Concomitant use with MTX is recommended to reduce the formation of anti-drug antibodies (immunogenicity) and maintain drug efficacy.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Infliximab.
Available Strength: 100 mg lyophilized powder for IV infusion in a single-dose vial.
Appearance: White to off-white powder.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton.