Clinical and pharmacological group: & nbsp

Immunosuppressive drugs

Included in the formulation
  • Simsia®
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  • 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.05   Cervolizumab pegol

    Pharmacodynamics:

    Selectively, dose-dependent neutralizes tumor necrosis factor alpha (TNFα), which supports inflammatory processes in Crohn's disease and rheumatoid arthritis. The absence of a crystallizing enzyme in the preparation prevents the formation of antibody-dependent cellular cytotoxicity.

    Certolizumab pegol does not lead to degranulation of neutrophils and does not cause apoptosis of lymphocytes and monocytes.

    Pharmacokinetics:

    After subcutaneous administration, the maximum concentration in the blood plasma is reached after 54-171 hours. Bioavailability - from 76% to 88%. Metabolism in the liver.

    The half-life period is 14 days. Elimination by the kidneys.

    Indications:

    It is used to treat rheumatoid arthritis, Crohn's disease, axial spondylitis, psoriatic and enteropathic arthropathy.

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

    XIII.M05-M14.M05   Seropositive rheumatoid arthritis

    XIII.M05-M14.M07 *   Psoriatic and enteropathic arthropathies

    XIII.M45-M49.M45   Ankylosing spondylitis

    Contraindications:

    Sepsis, chronic infections in the active stage, including tuberculosis; severe heart failure, simultaneous use of abatacept, anakin and etanercept, individual intolerance,children's age till 18 years.

    Carefully:

    Chronic hepatitis, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - category D. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Subcutaneously, 200 mg twice a day on the first, second and fourth day of treatment. Then 200 mg once every 2 weeks or 400 mg once every 4 weeks.

    The highest daily dose: 400 mg.

    The highest single dose: 400 mg.

    Side effects:

    Central and peripheral nervous system: anxiety, mood changes, rarely - suicidal attempts, aggression, delirium.

    Respiratory system: pleural effusion, dyspnea, bronchial asthma, pneumonitis.

    Hemopoietic system: eosinophilia, eosinopenia, leukopenia, anemia, thrombocytopenia, lymphadenopathy, thrombocytosis, rarely - pancytopenia, splenomegaly, erythrocytosis, morphological changes in leukocytes.

    The cardiovascular system: arterial hypertension, heart failure, atrial fibrillation, ischemic heart disease, thrombophlebitis, Reynaud's syndrome, telangiectasia, ecchymosis, stroke, shock.

    Digestive system: dry mouth, painful swallowing, nausea, vomiting, ascites, intestinal obstruction, anal fissures.

    Musculoskeletal system: a violation of the function of muscles and tendons.

    Dermatological reactions: rash, alopecia, photosensitization, nail and nail plate damage, bullous dermatitis, pink lichen, stria.

    Sense organs: tinnitus, vertigo, visual acuity, blepharitis and uveitis, dacryocystitis and dacryoadenitis.

    Urinary system: hematuria, cystitis, urethritis, nephritis.

    Reproductive system: menstrual irregularities, amenorrhea, hemorrhages, balanitis, sexual dysfunction.

    Allergic reactions.

    Overdose:

    Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:

    Clinically significant interactions are not described.

    Special instructions:

    In the treatment it is not recommended to drive vehicles and work with moving mechanisms.

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