Epidermal growth factor (Recombinant Human Epidermal Growth Factor)

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

Regenerants and reparants

Included in the formulation
  • Eberprot-P®
    lyophilizate for injections 
    Eber Biotech SA     Cuba
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    D.03.A.X   Other drugs that promote normal scarring

    Pharmacodynamics:

    The growth factor epidermal human recombinant is a highly purified peptide consisting of 53 amino acids with a molecular weight of 6054 daltons and an isoelectric point of 4.6.

    Epiedermal growth factor human recombinantth produced by yeast strain Saccharomyces fromerevisiae, into the genome of which by genetic engineering methods a gene epidermal growth factor human recombinant. Epiedermal growth factor human recombinant, obtained on the basis of recombinant DNA technology, is identical in its mechanism of action to the endogenous growth factor of the epidermal growth produced in the body.

    Epiedermal growth factor human recombinantth stimulates the proliferation of fibroblasts, keratinocytes, endothelial and other cells involved in wound healing, promoting epithelization, scarring and restoration of tissue elasticity.

    Pharmacokinetics:

    Epiedermal growth factor human recombinantth in plasma is not detected, but is determined in platelets (approximately 500 mmol / 1012 thrombocytes).

    In most patients, the time to reach the maximum concentration after injection into the affected area was 5 to 15 minutes. The average area under the pharmacokinetic curve after the first administration of the drug at a dose of 75 μg and 27 days after administration is 198 and 243 pg × h / ml, respectively, and the mean maximum concentration was 1040 pg / ml. The half-life and average retention time (MRT) of the drug in the body were close to 1 hour. The total ground clearance takes about 2 hours.

    Indications:

    As part of the complex treatment of diabetic foot syndrome with deep non-healing for 4 weeks or more neuropathic or neuroischemic wounds area more than 1 cm², reaching the tendon, ligament, joint or bone.

    ICD-10

    IV.E10-E14.E11.9   Non-insulin-dependent diabetes mellitus without complications

    IV.E10-E14.E11.8   Non-insulin-dependent diabetes mellitus with unspecified complications

    IV.E10-E14.E11.7   Non-insulin-dependent diabetes mellitus with multiple complications

    IV.E10-E14.E11   Non-insulin-dependent diabetes mellitus

    IV.E10-E14.E10.4   Insulin-dependent diabetes mellitus with neurological complications

    Contraindications:

    Hypersensitivity, pregnancy, breast-feeding, childhood, diabetic coma or diabetic ketoacidosis, chronic cardiac insufficiency III-IV class by NYHA; the presence during the last 3 months of episodes of acute cardiovascular pathology (severe acute cardiovascular conditions) such as acute myocardial infarction, severe angina, acute stroke or transient ischemic attack, and / or thromboembolic events (deep vein thrombosis, pulmonary embolism) ; severe atrioventricular block (grade III), atrial fibrillation with uncontrolled rhythm; malignant neoplasms; renal failure (glomerular filtration rate <30 ml / min); the presence of wound necrosis (before the introduction of the drug, surgical treatment of the wound is necessary); presence of an infectious process, including osteomyelitis (the drug is used after its full resolution); the presence of signs of critical ischemia of the limb (the size of the ankle-brachial index (LPI) ≥ 0.6, but ≤ 1.3 and / or the value of the thumb-brachial index ≥ 0.5, and / or TcP02 <30 mmHg) it is possible to use the drug only after revascularization.)

    Carefully:

    In patients with heart valve disease (eg calcification of aortic valves), severe stenosis of the carotid arteries (<70% NACET), severe uncontrolled arterial hypertension.

    Pregnancy and lactation:

    The category of recommendations for the FDA - D.

    Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    For the treatment of ulcers larger than 10 cm2 should make ten injections of 0.5 ml. Injections should be done in soft tissues with a uniform distribution of the injection site, first of all, by cutting the edges of the wound, and then the bed of the wound. The depth of needle insertion during injection should be about 0.5 cm.

    For the treatment of wounds with an area of ​​less than 10 cm2 per cm2 of the area of ​​the lesion focus, use only one injection in a volume of 0.5 ml of the drug. For example, to treat a 4 cm wound2 Only four injections of 1.25 ml of the drug should be performed.

    To reduce the risk of infection, each injection should be done with a new sterile needle.

    After the injections are completed, the ulcer should be covered with gauze moistened with saline, or a moist bandage applied to create a moist and clean environment.

    Splitting is carried out 3 times a week.Injections of the drug should continue until the formation of granulation tissue covering the entire surface of the wound, or up to 8 weeks (maximum duration of treatment).

    The wound surface should be covered with a neutral atraumatic bandage.

    If, after three weeks of treatment with the drug, granulation tissue in the wound does not begin to form, the presence of a local infection or osteomyelitis should be ruled out.

    Side effects:

    The incidence of side effects (in view of the number of all patients treated with the drug in clinical trials, including in the Russian Federation): 1.2% of patients had headache, 24.3% had tremor, 24.0% had pain place of injection, 17.8% - burning sensation at the injection site, 11.3% - chills, 2.8% - body temperature increase, 4.4% - infection at the injection site.

    Pain or burning at the injection site was observed at a similar frequency in patients who received the drug and placebo. These undesirable phenomena are most likely related to the procedure of injection.

    Approximately 10-30% of patients in all studies observed chills and tremors. These phenomena were often observed shortly after injection and were transient.They were never heavy and did not lead to interruption of treatment. In most cases, their association with treatment was considered to be definite or probable.

    Moderate severity or severe infection of the wound at the site of administration was recorded in 15-18% of patients, both in the treated group and in the placebo group, therefore, these adverse events were not probably related to the use of the drug, but could be associated with the procedure injections.

    Overdose:

    Not described.

    Interaction:

    During the course of treatment with the drug, local use of other drugs is not recommended.

    Special instructions:

    Before the introduction of the drug, surgical treatment of the wound is carried out with observance of all conditions of aseptic and antiseptic.

    Instructions
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