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Infliximab (infliximab) instruction manual
Common name: infliximab
Trade name: Remsima
All names: infliximab, infliximab, Remicade, infliximab, Avsola, Inflectra, Remicade, Renflexis, Remsima
Indications:
Rheumatoid arthritis
Crohn's disease in adults and children over 6 years old
Fistula Crohn's disease
Ankylosing spondylitis
Psoriasis
Adult ulcerative colitis
Rheumatoid Arthritis: Give this product 3 mg/kg for the first time, and then give the same dose at the 2nd and 6th weeks after the first dose and every 8 weeks thereafter. This product should be used in combination with methotrexate. For patients with poor efficacy, the dose may be adjusted to 10 mg/kg and/or the medication interval may be adjusted to 4 weeks.
Moderately and severely active Crohn's disease and fistula Crohn's disease: Give this product 5 mg/kg for the first time, and then give the same dose at the 2nd and 6th weeks after the first dose and every 8 weeks thereafter. For patients with poor efficacy, the dose may be considered to be adjusted to 10 mg/kg.
Ankylosing spondylitis: Give this product 5 mg/kg for the first time, and then give the same dose at the 2nd and 6th weeks after the first dose and every 6 weeks thereafter.
Adverse Reactions:
Most common adverse reactions (>10%):
Infections (such as upper respiratory tract, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
Contraindications:
Remicade doses >5 mg/kg are contraindicated in moderate to severe heart failure.
Previous severe hypersensitivity reaction to Remsima or known hypersensitivity to inactive components of Remsima or to any murine protein.
Precautions:
(1) Severe infection - Do not give Remsima during active infection. If infection occurs, monitor carefully and discontinue Remsima if infection becomes severe.
(2) Malignant disease – more common than controls. Lymphoma is more common than in the general population; carefully evaluate the risks and benefits of treatment and monitor for malignancy in children and young adults.
(3) Hepatosplenic T-cell lymphoma – Carefully evaluate risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine therapy.
(4) Hepatitis B virus reactivation – Monitor HBV carriers during and for several months after treatment. If reactivation occurs, discontinue Remsima and initiate antiviral therapy.
(5) Hepatotoxicity – Rare severe liver reactions, some fatal or requiring liver transplantation, discontinue Remicade in case of jaundice and/or significant liver enzyme elevations.
(6) Heart Failure – Monitor patients with heart failure closely and discontinue Remsima if new or worsening symptoms occur.
(7) Cytopenia – If signs and symptoms occur, patients are advised to seek medical advice immediately and consider discontinuing Remsima.
(8) Hypersensitivity – Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.
(9) Demyelinating disease – Consider discontinuing Remsima if it worsens or new attacks occur.
(10) Lupus-like syndrome – Discontinue Remsima if syndrome occurs.
Storage:
Must be kept in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF)
Mechanism of action:
infliximab is a human-mouse chimeric monoclonal antibody that can bind with high affinity to the soluble form and membrane-permeable form of TNFα, inhibiting the binding of TNFα to the receptor, thereby inactivating TNF.