Infliximab (Infliximabum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Immunosuppressive drugs

Included in the formulation
  • Infliximab
    lyophilizate d / infusion 
    BIOCAD, CJSC     Russia
  • Remicade®
    lyophilizate d / infusion 
    MSD FARMASYUTIKALS, LLC     Russia
  • Flammegis®
    lyophilizate d / infusion 
    Selltrion Halcocea Co., Ltd.     The Republic of Korea
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.04.A.B.02   Infliximab

    L.04.A.B   Inhibitors of tumor necrosis factor-α (TNF-α)

    Pharmacodynamics:

    Chimeric mouse-human IgG1 monoclonal antibodies consisting of a variable (Fv) region of high affinity neutralizing mouse monoclonal antibodies to tumor necrosis factor-alpha and a fragment of the IgG molecule1 rights.

    Has a high affinity for the tumor necrosis factor-alpha, forms a stable complex with both soluble and membrane-associated forms of human tumor necrosis factor-alpha, reducing its functional activity. Reduces the concentration (binds and inhibits the synthesis) of interleukin-1, interleukin-6, interleukin-8, monocyte chemoattractant protein-1, nitric oxide, metalloproteinases (collagenase, stromelysin), and other inducers of inflammation and tissue destruction, as well as the level of soluble forms of adhesion molecules - ICAM-1 and E-selectin, reflecting the activation of the vascular endothelium.

    The drug binds to tumor necrosis factor-alpha (with transmembrane and soluble form), forming a stable compound. Thus, the drug has an immunosuppressive effect.

    Pharmacokinetics:

    Vd after a single intravenous injection of 5 mg / kg - 0.04 l / kg (dose-independent). Half-life (after a single intravenous injection of 5 mg / kg, terminal phase) - 9.5 days. Cmax (after a single intravenous injection of 5 mg / kg) - 118 μg / ml. Cmax and AUC are linearly dose-dependent. The drug is completely eliminated from the body within 6 months.

    Indications:

    - rheumatoid arthritis;

    - Crohn's disease;

    - ankylosing spondylitis;

    - psoriasis;

    - psoriatic arthritis;

    - ulcerative colitis.

    ICD-10

    XI.K50-K52.K50   Crohn's disease [regional enteritis]

    XI.K50-K52.K51   Ulcerative colitis

    XII.L40-L45.L40   Psoriasis

    XIII.M05-M14.M05   Seropositive rheumatoid arthritis

    XIII.M05-M14.M06.9   Rheumatoid arthritis, unspecified

    XIII.M05-M14.M07.3 *   Other psoriatic arthropathies (L40.5 +)

    XIII.M45-M49.M45   Ankylosing spondylitis

    Contraindications:

    - severe infectious process (including sepsis, abscess, tuberculosis, opportunistic infections);

    - hypersensitivity;

    - pregnancy and lactation;

    - heart failure of moderate or severe severity;

    - age to 18 years (with Crohn's disease - up to 6 years).

    Carefully:

    Demyelinating diseases of the central nervous system, including CNS lesions in systemic vasculitis, multiple sclerosis,convulsive disorders; chronic viral hepatitis B, blood diseases, cancer history, and tuberculosis.

    Pregnancy and lactation:

    Category FDA - B. The drug is contraindicated in pregnancy and lactation. During the reception, as well as 6 months after the end of the women taking the drug should use reliable methods of contraception.

    Dosing and Administration:

    Intravenously, 2 ml / min for 2 hours. The average single dose is 3-5 mg / kg. The dosing regimen for each patient is set individually by the attending physician.

    Side effects:

    From the nervous system: dizziness, depression, anxiety, apathy, nervousness, headache, fatigue, psychosis, amnesia, drowsiness.

    From the gastrointestinal tract: diarrhea, dyspepsia, gastroesophageal reflux disease, diverticular disease, hepatic dysfunction, nausea, abdominal pain, constipation, cheilitis, cholecystitis.

    From the side of the circulatory system: leukopenia, lymphocytosis, neutropenia, anemia, lymphadenopathy, lymphopenia, thrombocytopenia, flushing, chest pain, hypertension, syncope, bradycardia, vascular spasm,violation of peripheral circulation, edema, petechiae, arterial hypotension, thrombophlebitis, palpitation, cyanosis, arrhythmia, ecchymosis / hematoma, epistaxis.

    From the respiratory system: viral infection (influenza, herpes), upper respiratory infections, pneumonia, pleurisy, pulmonary edema, dyspnea, fever, bronchitis, bronchospasm.

    From the side of the organ of vision: conjunctivitis, endophthalmitis, keratoconjunctivitis.

    From the urinary system: pyelonephritis, urinary tract infection.

    From the skin: skin rash, urticaria, dry skin, seborrhea, warts, periorbital edema, impaired skin pigmentation, alopecia, rash, itching, sweating, fungal dermatitis (onychomycosis, eczema), erysipelas, furunculosis, hyperkeratosis, bullous rashes.

    Other: abscesses, cellulitis, sepsis, myalgia, vaginitis, reaction at the injection site, pain syndrome (chest pain, abdominal pain), fever, myalgia, bacterial and fungal infections, arthralgia, infusion syndrome, allergic reactions, formation of autoantibodies to infliximab, pain in the back, disturbance of the regeneration process, chills, infusion reactions,granulomatous ulcers.

    Overdose:

    Not described, treatment is symptomatic.

    Interaction:

    Do not use simultaneously with methotrexate. In patients with rheumatoid arthritis and Crohn's disease, simultaneous use of methotrexate may reduce the formation of antibodies to infliximab and increase plasma concentrations of plasma.

    Do not combine the drug with an anakin. Infusion solution is incompatible (should not be confused) with other drugs.

    Special instructions:

    The safety and efficacy of the drug for elderly patients, as well as in people with kidney and liver disease is not established.

    When infliximab is used, it is possible to develop acute allergic reactions and allergic reactions of delayed type.

    Some patients may develop antibodies to infliximab, which in rare cases cause the development of severe allergic reactions. In the absence of tolerance to methotrexate or other immunosuppressants of the non-steroidal structure (eg, azathioprine, 6-mercaptopurine) and interruption of their administration before or during infliximab administration, the risk of these antibodies increases.

    Since the withdrawal of infliximab occurs within 6 months, the patient during this period should be under the supervision of a doctor for the timely detection of signs of the infectious process. The use of infliximab should be discontinued in the event of a severe infection or sepsis.

    When symptoms appear during the treatment that resemble a lupus syndrome (persistent rash, fever, joint pain, fatigue), and antibodies to DNA will be detected, infliximab should be canceled.

    Impact on the ability to manage motor transport and other technical devices

    Not found.

    Instructions
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