Bevacizumab (Bevacizumabum)

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

Antineoplastic agents - monoclonal antibodies

Included in the formulation
  • Avastin®
    solution in / in 
    Hoffmann-La Roche Ltd.     Switzerland
  • Avegra® BIOCAD
    concentrate d / infusion 
    BIOCAD, CJSC     Russia
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.01.X   Other antineoplastic agents

    Pharmacodynamics:

    The preparation is a recombinant hyperchimeric monoclonal antibody that binds to the vascular endothelial growth factor, ndiscouraging its interaction with receptors on the surface of endothelial cells. As a result, vascularization and tumor growth decrease.

    Pharmacokinetics:

    It is similar to that of the natural IgG molecule. When intravenous the introduction of bevacizumab in the dose range of 1 to 10 mg / kg for 90 minutes, its pharmacokinetics was linear. The initial half-life period is 1-4 days, the final half-life is 20/19 days for men / women, thus the final elimination half-life is 18-23 days, which corresponds to the final half-life of human endogenous IgG.

    Indications:

    Metastatic colorectal cancer, local-recurrent or metastatic breast cancer, common inoperable, metastatic or recurrent non-small cell non-small cell lung cancer, common and / or metastatic renal cell carcinoma, glioblastoma.

    ICD-10

    II.C15-C26.C18   Malignant neoplasm of colon

    II.C15-C26.C19   Malignant neoplasm of rectosigmoidal joint

    II.C15-C26.C20   Malignant neoplasm of rectum

    II.C30-C39.C34.1   Malignant neoplasm of upper lobe, bronchus or lung

    II.C30-C39.C34.2   Malignant neoplasm of middle lobe, bronchus or lung

    II.C30-C39.C34.3   Malignant neoplasm of lower lobe, bronchus or lung

    II.C50.C50   Malignant neoplasm of breast

    II.C64-C68.C64   Malignant neoplasm of kidney, except for renal pelvis

    II.C76-C80.C79.0   Secondary malignant neoplasm of kidney and renal pelvis

    II.C76-C80.C79.8   Secondary malignant neoplasm of other specified localizations

    Contraindications:

    Hypersensitivity, impaired renal / liver function, pregnancy / lactation, children's age, metastases in the central nervous system.

    Carefully:

    Arterial thromboembolism, venous thromboembolism; age over 65 years, perforation of the gastrointestinal tract, bleeding, Arterial hypertension, clinically significant cardiovascular disease or congestive heart failure in history; neutropenia; proteinuria; congenital hemorrhagic diathesis;acquired coagulopathy; reception of high doses of anticoagulants; syndrome of reversible late leukoencephalopathy.

    Pregnancy and lactation:

    Action category for the fetus by Food and Drug Administration (US Food and Drug Administration) - C. Controlled studies on humans are not conducted. Can be used in pregnancy only if the potential benefits exceed the potential risk to the fetus. Since the effect of bevacizumab can persist for a long time after its withdrawal, it is recommended that women and men of reproductive age be treated with bevacizumab and after it is canceled (within 6 months) it is recommended to use contraceptives. There is no information on the penetration of bevacizumab into breast milk. In view of the potential risk to the child, it is recommended to stop breastfeeding during treatment and for a long time (6 months) after the cancellation of bevacizumab.

    Dosing and Administration:

    Dosing regimen is individual. Enter intravenously drip. As first-line therapy: 5 mg / kg 1 time in 2 a week or 7.5 mg / kg once every 3 weeks as intravenous infusion, long. As second-line therapy: 10 mg / kg 1 time in 2 weeks or 15 mg / kg once every 3 weeks as intravenous infusion, long.

    Side effects:

    The most serious: perforations gastrointestinal tract, hemorrhage, including pulmonary hemorrhage / hemoptysis (more common in patients with non-small cell lung cancer), arterial thromboembolism.

    From the side gastrointestinal tract: bleeding, vomiting, diarrhea, colitis, asthenia, intestinal obstruction, abdominal pain.

    From the respiratory system: rhinitis, shortness of breath, epistaxis, pulmonary thromboembolism, hypoxia, infection, respiratory failure.

    On the part of the blood system: neutropenia, leukopenia, febrile neutropenia, proteinuria, thrombocytopenia, anemia, hypokalemia, hyperbilirubinemia.

    From the skin: dry skin, wound healing, skin discoloration, exfoliative dermatitis, palmar-plantar syndrome.

    From the cardiovascular system: disturbance of the heart rhythm (supraventricular tachycardia), arterial thromboembolism (including myocardial infarction, stroke, transient ischemic attack and other arterial embolisms), deep vein thrombosis, congestive heart failure, hypertension, bleeding.

    From the nervous system: peripheral sensory neuropathy, taste perversion, headache, stroke, syncope, drowsiness.

    From the side of the vision system: impaired visual function, increased lacrimation.

    From the musculoskeletal system: arthralgia, muscle weakness, myalgia.

    From the urinary system: proteinuria, infection of the urinary tract.

    Local reactions: pain in the injection site.

    Other: asthenia, increased fatigue, increased body temperature, inhibition, pain of different localization, attachment of secondary infections, abscess, sepsis, dehydration.

    Disorders from laboratory indicators of the 3rd and 4th degree of severity, observed in patients who received bevacizumab with or without chemotherapy: hyperglycemia, decreased hemoglobin, hypokalemia, hyponatremia, leukopenia, neutropenia, thrombocytopenia, proteinuria, increased prothrombin time, an increase in the international normalized relationship.

    Overdose:

    Increased side effects, migraines. Treatment is symptomatic.

    Interaction:

    Irinotecan, calcium folinate, fluorouracil - an increase in the incidence of leukopenia and diarrhea, neutropenia.

    When bevacizumab was used in combination with sunitinib (50 mg, daily), cases of development of microangiopathic hemolytic anemia were recorded in patients with metastatic renal cell carcinoma (it belongs to the subgroup of hemolytic anemia, which can be manifested by erythrocyte fragmentation, anemia and thrombocytopenia). In some cases, neurologic disorders, elevated levels of creatinine, hypertension, including hypertensive crisis, are also noted. These symptoms were reversible after discontinuation of therapy with bevacizumab and sunitinib.

    Pharmaceutically incompatible with dextrose.

    Special instructions:

    Treatment only under the supervision of a doctor, who has experience in the use of antitumor therapy.

    In case of progression of the disease should stop taking the drug.

    At treatment the risk of occurrence of perforation is great gastrointestinal tract, in connection with which you should monitor the treatment process and stop it if necessary.

    Monitoring of blood pressure (every 2-3 weeks), daily proteinuria.

    In elderly patients (over 65 years) with the use of bevacizumab, the risk of arterialthromboembolism (including stroke, transient ischemic attack, myocardial infarction), leukopenia 3-4 degrees of severity and thrombocytopenia, as well as neutropenia (all degrees of severity), diarrhea, nausea, headache and asthenia.

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