Clinical and pharmacological group: & nbsp

Antineoplastic agents - monoclonal antibodies

Included in the formulation
  • Tecentric®
    concentrate d / infusion 
    Hoffmann-La Roche Ltd.     Switzerland
  • АТХ:

    L.01.X.C   Monoclonal antibodies

    Pharmacodynamics:

    Monoclonal antibody, immunoglobulin IgG 1 kappa. It binds PD-L1 receptors, which are expressed on cancer cells and membranes of immune cells surrounding the tumor. This prevents interaction with the receptors PD-1 and B7.1, which are located in T-lymphocytes and antigen-presenting cells. Activates the immune response without attracting anti-lethal 551 cellular cytotoxicity.

    Pharmacokinetics:

    After intravenous administration, T ½ with monotherapy is 27 days. Achieves equilibrium concentration after 6-9 weeks (2-3 cycles) with repeated dosing. Subjected to tissue catabolism up to amino acids. Penetrates through the placental and blood-brain barrier.

    Indications:

    Used to treat urothelial carcinoma in the background or after treatment with platinum drugs, as well as for neoadjuvant and adjuvant chemotherapy. Used for metastatic non-small cell lung cancer during or after platinum-containing chemotherapy.

    II.C30-C39.C34.9   Malignant neoplasm of bronchus or lung, unspecified

    II.C64-C68.C67.9   Malignant neoplasm of urinary bladder, part unspecified

    Contraindications:

    Age to 18 years, acute infection, pregnancy and lactation, individual intolerance.

    Carefully:

    Systemic lupus erythematosus, the presence of a transplanted organ, severe hepatic insufficiency, myasthenia gravis, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - Category C. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Intravenously, slowly, 1200 mg for 60 minutes every 3 weeks until the disease progresses or the toxicity threshold is reached.

    The highest daily dose: 1200 mg.

    The highest single dose: 1200 mg.

    Side effects:

    Central and peripheral nervous system: headache, dizziness, hallucinations, convulsions.

    Respiratory system: shortness of breath, dry cough.

    Hemopoietic system: anemia, thrombopenia, leukopenia.

    The cardiovascular system: arterial hypertension, peripheral edema.

    Sense organs: photophobia, diplopia.

    Digestive system: nausea, vomiting, diarrhea, bleeding in the gastrointestinal tract.

    Musculoskeletal system: convulsions.

    Dermatological reactions: alopecia.

    urinary system: frequent urination, darkening of urine.

    Allergic reactions.

    Overdose:

    Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:

    Clinically significant interactions are not described.

    Special instructions:

    During the treatment period and 5 months after the last injection, people of reproductive age are recommended to use reliable methods of contraception.

    When taking the drug is not recommended driving and working with moving machinery.

    Instructions
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