Deoxynate® (Desoxynatum®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for intramuscular and subcutaneous administration
Composition:
Active substance:
Deoxynate® (sodium deoxyribonucleate) 5 mg
Excipients:
sodium chloride - 9.0 mg, water for injection - up to 1 ml
Description:
Colorless transparent liquid.
Pharmacotherapeutic group:Immunomodulating agent
ATX: & nbsp
  • Immunostimulators
    • Pharmacodynamics:Deoxynate ® has an immunomodulatory effect on the cellular and humoral levels. Activates antiviral, antifungal and antimicrobial immunity. It has a radioprotective effect, stimulates regeneration: accelerates the healing of wounds and ulcerative necrotic lesions of the skin and mucous membranes, activates the growth of granulations and epithelium. Regulates hemopoiesis (normalizes the number of leukocytes, granulocytes, phagocytes, lymphocytes, platelets).
    Deoxynate®, according to experimental data, has a curative effect in acute radiation sickness II-III severity in hypo- and aplastic states of the blood system caused by radiation or polychemotherapy. A rapid leukostimulating effect after a single intramuscular injection of Desoxynate ® is observed in cancer patients with leukopenia III and life-threatening IV degree ("Febrile neutropenia") caused by the use of polychemotherapy or combined polychemorabine treatment.In the first place, an increase in the content in periphyric blood of an absolute number of granulocytes by 5-7 times is observed. Simultaneously, under the influence of the drug, an increase in the absolute number of lymphocytes and a normalization of the content of platelets in the peripheral blood during thrombocytopenia of I-IV degrees of the same origin were noted. Deoxynate ® does not affect tumor growth and the therapeutic effect of cytostatics or chemoradiotherapy, does not cause immediate or delayed side effects, does not show mutagenic, carcinogenic or allergic properties.
    One-time intramuscular injection of Desoxynate® during the first 24 hours after the total exposure of ionizing radiation to the body facilitates the clinical course of radiation sickness in the experiment, accelerates the onset and rate of recovery of stem cells in the bone marrow, as well as myeloid, lymphoid and platelet germs of hematopoiesis. Deoxynate ® increases the likelihood of favorable outcomes of radiation sickness. The positive therapeutic effect of the drug Dezoksinat® is manifested with primary and late radiation ulcers, acute pharyngeal syndrome, with thermal burns, with complications associated with cytotoxic therapy.
    Pharmacokinetics:

    Absorption and distribution.

    The drug is rapidly absorbed and distributed in organs and tissues. Has a high tropism to the organs of the hematopoietic system, takes an active part in cellular metabolism, integrating into cellular structures. In the phase of intensive drug delivery to the blood, a redistribution occurs between the plasma and the formed elements of the blood, in parallel with the metabolism and excretion. After a one-time injection, all pharmacokinetic curves describing the change in drug concentration in the organs and tissues studied are characterized by a rapid increase phase and a fast phase of decreasing concentration in the time interval 5-24 hours. The half-life (T 1/2) when administered intramuscularly 72,3 hours. Deoxynate ® is quickly distributed throughout the body, in the course of daily course use is cumulated in organs and tissues: maximum - in the bone marrow, lymph nodes, spleen, thymus; to a lesser extent - in the liver, brain, stomach, small and large intestine. The maximum concentration in the bone marrow is determined by 5 hours, after the administration of the drug. The drug overcomes the hemato-encephalic barrier.The maximum concentration of the drug in the brain is reached through 30 minutes.

    Metabolism and excretion.

    Deoxynate® is metabolized in the body. The final metabolites are xanthine, hypoxanthine, beta-alanine, acetic, propionic and uric acids, which are excreted from the digestive tract. Excreted from the body (in the form of metabolites) by the kidneys by bi-exponential dependence and, in part, through the gastrointestinal tract.

    Indications:

    The drug is prescribed to cancer patients with severe myelodepression (leukopenia and thrombocytopenia) caused by cytostatics (mono- or polychemotherapy) or combined chemoradiotherapy.

    Deoxynate® can be used prophylactically before the beginning of a cycle of chemotherapy or chemoradiotherapy, especially repeated, during or after it. Indication for preventive use of the drug is the presence of leukopenic (less 3,5∙109/ l) and thrombocytopenic (less, 150∙109/l) background before the beginning of specific therapy, expressed leuko- and thrombocytopenia, which developed during the previous cycle of chemo- or chemoradiotherapy. In the case of leukopenia and / or thrombocytopenia,emerged during the course of chemotherapy (chemoradiotherapy) or after its termination, indications for the purpose of the drug is the reduction of the content of leukocytes in the peripheral blood to 2,0∙109/l, thrombocytes - 100∙109/ l and less.

    According to experimental data, Deoxynate® is also shown to persons exposed to acute ionizing radiation at doses that cause the development of radiation sickness II-III severity.

    Contraindications:
    Hypersensitivity to sodium deoxyribonucleate or any other component of the drug.
    If you have any of the listed conditions, always consult a doctor before taking the drug.
    Pregnancy and lactation:
    Consultation of the doctor is necessary. If it is necessary to prescribe the drug during pregnancy, the expected benefit for the mother and the potential risk to the fetus should be assessed. In the lactation period, use strictly according to the doctor's prescription.
    Dosing and Administration:Deoxynate ® is administered to adults and children (regardless of age!) Once intramuscularly or subcutaneously in the form of a solution of 5.0 mg / ml in a volume of 15 ml (75 mg of active substance).It is allowed to re-use during the next cycles of chemotherapy, radiation or chemoradiotherapy in cancer patients. Before the introduction, the drug stored in the refrigerator is heated to body temperature. For the treatment of acute radiation sickness Dezoksinat® is applied no later than 24 hours after irradiation.
    Side effects:
    The introduction of the drug does not cause complications. In rare cases, after 4-24 hours, there is a short (2-4 h) rise in body temperature from the low-grade digits to 38.5 0C, usually without disturbing the patient's condition (chills, etc.) and not requiring correction. With the forced introduction of the drug, there is a short pain at the injection site, which does not need medical treatment.
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:There were no negative effects from an overdose.
    Interaction:
    Deoxynate® increases the effectiveness of antitumor antibiotics of the anthracycline series, cytostatics.
    In the event that you are taking other medicines, be sure to consult a doctor before taking the drug.
    Special instructions:
    Intravenous administration of the drug is not allowed!
    Effect on the ability to drive transp. cf. and fur:
    Data on the adverse effect of the drug on the ability to manage vehicles and mechanisms are absent.
    Form release / dosage:Solution for intramuscular and subcutaneous administration, 5 mg / ml.
    Packaging:
    5 ml into neutral glass ampoules. 5 ampoules per contour cell pack of polyvinyl chloride film.
    2 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:
    In a dry, protected from light place at a temperature of 2 to 8 ° C.
    Keep out of the reach of children.
    Shelf life:
    3 years.
    The drug should not be used after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002541
    Date of registration:22.07.2014
    Expiration Date:22.07.2019
    The owner of the registration certificate:FARMZASCHITA NPC, FSUE FARMZASCHITA NPC, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.03.2017
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