Iron carboxymethyltosate (Ferri carboxymaltosas)

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

Stimulators of hematopoiesis

Included in the formulation
  • Ferinzhect®
    solution in / in 
    Vifor (International) Inc.     Switzerland
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    B.03.A.C   Preparations of iron for parenteral use

    Pharmacodynamics:

    Anti-anemic agent. It is a carboxymethyltosate complex of multinucleated iron (III) hydroxide. After parenteral administration, the macromolecular complex is captured by the reticuloendothelial system and decomposes into iron and carboxymethyltose. The iron enters the bloodstream, where it binds to transport protein transferrin. Iron in combination with transferrin is transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and a large number of enzymes or accumulates in the form of ferritin.

    Pharmacokinetics:

    After parenteral administration, iron is transferred from the blood to the bone marrow and is deposited in the liver and spleen.

    After a single intravenous administration at doses of 100 mg to 1000 mg of iron Cmax serum iron from 37 μg / ml to 333 μg / ml was achieved 0.4-1.21 hours after injection, respectively. Vd The central chamber almost completely corresponds to the volume of the blood plasma - about 3 liters.

    Half-life is 7-12 hours.The average time of the active substance in the body was from 11 to 18 hours. Excretion of iron by the kidneys was practically not observed.

    Indications:

    Iron deficiency anemia in the case when oral iron preparations are ineffective or can not be used.

    The diagnosis should be confirmed by laboratory tests.

    ICD-10

    IV.E50-E64.E61.1   Insufficiency of iron

    III.D50-D53.D50   Iron-deficiency anemia

    Contraindications:

    Anemia not associated with iron deficiency; symptoms of iron overload or iron abnormalities; I trimester of pregnancy; children's age till 14 years; increased sensitivity to iron carboxymaltosis.

    Carefully:

    Caution should be used in hepatic insufficiency, acute or chronic infectious diseases (possibly inhibition of erythropoiesis), bronchial asthma, eczema, atopic allergy.

    Pregnancy and lactation:

    There are no data on pregnancy use. Application in pregnancy is possible only in cases where the potential benefit of therapy for the mother exceeds the risk to the fetus.

    The experience of using the drug in lactation (the period of breastfeeding) is limited.During the treatment period it is recommended to stop breastfeeding.

    Dosing and Administration:

    Enter intravenously (struino or drip) and by direct injection into the venous section of the dialysis system.

    The cumulative dose in mg of elemental iron needed to restore the level of hemoglobin and replenish iron stores is calculated individually according to the general iron deficiency in the body according to a special formula.

    Side effects:

    Most often (3.3%) is a headache.

    Allergic reactions: often - a rash; infrequently - urticaria, hypersensitivity reactions, including anaphylactoid reactions.

    From the nervous system: often - headache; dizziness; infrequently paresthesia.

    From the cardiovascular system: infrequently - lowering blood pressure, "tides" of blood to the skin of the face.

    From the respiratory system: rarely - shortness of breath.

    From the digestive system: often - nausea, abdominal pain, diarrhea, constipation; infrequently - a change in taste, vomiting, dyspepsia, flatulence.

    From the musculoskeletal system: infrequently - myalgia, back pain, arthralgia.

    Common reactions: infrequently - fever, fatigue, chest pain, chills, poor health, peripheral edema.

    Local reactions: often - reactions at the injection site.

    From the laboratory indicators: often - an increase in serum alanine aminotransferase, transient decrease in serum content of phosphate; infrequently - increased activity aspartate aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase.

    Overdose:

    The introduction of the drug in an amount exceeding the body's requirements, can cause an overload with iron, which manifests itself with symptoms of hemosiderosis. Determining such indicators of iron metabolism as serum ferritin and the percentage of transferrin saturation can help in the diagnosis of excessive deposition of iron in the body. If the accumulation of iron is threatened by standard medical practice, the use of a chelating agent for binding iron can be considered.

    Interaction:

    Do not use simultaneously with the medicinal forms of iron for oral administration, as the absorption of iron from the digestive tract decreases.

    The drug is only compatible with 0.9% sodium chloride solution.No other intravenous solutions and medicinal substances should be administered, since there is a potential risk of precipitation and / or interaction.

    Special instructions:

    The drug should not be used for intramuscular or subcutaneous administration.

    Each vial of the drug is intended for single use only.

    Parenterally administered iron preparations can cause hypersensitivity reactions, including anaphylactoid reactions, which can be potentially life-threatening, and appropriate means should be available for cardiopulmonary resuscitation. If hypersensitivity reactions or signs of intolerance occur during the use of the drug, it is necessary to immediately stop treatment.

    Care should be taken with intravenous administration of the drug to prevent penetration of the drug into the circumveneal area, as this can cause skin irritation and possible long-term staining of the tissues at the point of introduction into the brown color. When the drug penetrates into the periovenous space, the drug should be discontinued immediately.

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