Monofer (Monofer)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron (III) hydroxide oligo isomaltosateIron (III) hydroxide oligo isomaltosate
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  • Monofer
    solution in / in 
    Pharmacosmos A / C     Denmark
    • Dosage form: & nbsp

    Solution for intravenous administration.

    Composition:

    1 ml of the preparation made on the production site Solufarm Pharmacities Erzoignesse GmbH, Germany, contains:

    - active substance: iron [III] hydroxide oligo isomaltosate 417.0 mg (in terms of iron 100.0 mg);

    - Excipients: hydrochloric acid 25% or sodium hydroxide solution 10 M to pH 5.5, water for injection up to 1.0 ml.

    1 ml of the preparation made on the production site Wasserburger Artsclimittelwerk GmbH, Germany, contains:

    - active substance: iron [III] hydroxide oligo isomaltosate 417.0 mg (in terms of iron 100.0 mg);

    - Excipients: 1 M solution of hydrochloric acid or 1 M sodium hydroxide solution to pH 5.5, water for injection up to 1.0 ml.

    Description:

    Dark brown solution.

    Pharmacotherapeutic group:The iron preparation
    ATX: & nbsp

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

    Pharmacodynamics:

    The drug Monofer, the active substance of which is iron [III] hydroxide oligo isomaltosate, is a complex. Iron in the center of the complex is surrounded by an amorphous shell of molecules of oligo isomaltose with a molecular mass of ̴ 1,000 Daltons.This oligoisomaltose complex of ferric hydroxide is structurally similar in structure to ferritin, which protects the body from the toxic effect of unbound iron (III) of an inorganic nature, since it provides a controlled and slow release of bioavailable iron with little risk of free iron formation. In view of the low toxicity of the drug, Monofer can be used in high doses.

    The effectiveness of the drug is noted a few days after the start of treatment and is confirmed by an increase in the number of reticulocytes in the blood.

    The maximum concentration of ferritin in the blood plasma is reached approximately 7-9 days after a single intravenous injection of the drug, and then slowly returns to the initial concentration after 3 weeks.

    Pharmacokinetics:

    After a single intravenous injection of iron monofer (III), the oligoisomaltosate hydroxide is rapidly captured by the cells of the reticuloendothelial system (RES), mainly the liver and spleen, which then gradually release iron into the blood. The half-life (T1/2) is 5 hours for iron in the systemic circulation and 20 hours - in total for the iron bound and located in the systemic blood flow.

    From the vascular bed, iron is utilized by RES cells, which split the oligoisomaltose complex of iron hydroxide (III) on iron and oligoisomaltose. Iron immediately binds to endogenous proteins that transfer (transferrin) and retain iron (ferritin and hemosiderin). Thus, the metabolism of iron in the body is controlled physiologically, and as a result, there is an increase in the concentration of hemoglobin in the blood plasma and the replenishment of iron stores in the depot.

    The monohedral in unchanged form is not excreted by the kidneys because of the large size of the complex.

    Small amounts of iron are excreted by the kidneys and intestines.

    Oligo is also metabolized and excreted.

    Indications:

    Treatment of absolute or functional iron deficiency states in the following cases:

    • in the absence of efficacy of oral iron preparations;
    • if it is necessary to quickly fill iron.

    Contraindications:

    • Hypersensitivity to the active substance and excipients included in the preparation;
    • anemia not related to iron deficiency (eg, hemolytic anemia);
    • presence of signs of iron overload (hemochromatosis, hemosiderosis) or disruption of iron utilization;
    • hepatitis and cirrhosis of the liver in the stage of decompensation;
    • Rheumatoid arthritis with symptoms of inflammatory process activity;
    • bacteremia;
    • children under 18 years of age (due to insufficient data on effectiveness and safety).

    Carefully:

    Iron preparations that are administered parenterally can cause hypersensitivity reactions, including anaphylactic shock.

    In connection with the high risk of allergic reactions in patients with bronchial asthma, eczema, polyvalent allergy, allergic reactions to other parenteral iron preparations, as well as in patients with immune system disorders, for example, in patients with systemic lupus erythematosus, rheumatoid arthritis, acute or chronic infectious diseases.

    At a high rate of drug administration, episodes of a sudden significant decrease in blood pressure are possible.

    Pregnancy and lactation:

    According to preclinical studies, the isomaltose complex has no allergenic activity and does not interact with dextran, which suggests a low immunogenic potential of the Monofer preparation.In studies on animals, a teratogenic and embryotoxic effect was noted when using iron in single doses higher than 125 mg / kg. The maximum recommended dose for clinical use is 20 mg / kg.

    Controlled clinical studies to study the use of the drug Monofer in pregnant women have not been conducted, the use is recommended only in clinically justified cases. It is necessary to carefully evaluate the benefit / risk ratio for the decision on the use of Monofer during pregnancy.

    If the intended benefit to the mother exceeds the possible risk to the fetus, treatment can be carried out only in the II and III trimesters of pregnancy. Application in the I trimester of pregnancy is not recommended.

    Isolation of the drug Monofer with breast milk is not established; the drug can be used during lactation.

    Dosing and Administration:

    The use of Monofer is possible only in a hospital provided that the provision of anti-shock therapy is available. Patients should be under close supervision of medical personnel during the injection and immediately afterwards within 1 hour.

    Determination of total iron deficiency and the required dose:

    Substitution therapy in patients with chronic iron deficiency anemia:

    The dose of the drug Monofer and the scheme of its use are selected for each patient individually, taking into account the definition of total iron deficiency. The optimal target hemoglobin concentration may differ in different patient groups. Follow the recommendations below. The dose of Monofer is expressed in milligrams of elemental iron. The total dose of iron is calculated by the formula Ganzoni:

    Total iron deficiency (mg) = body weight(A) (kg) x (normal concentration Hb - concentration Hb patient)(B) (g / l) x 0.24(C) + deposited iron(D)(mg).

    A) It is recommended to use the ideal body weight of the patient or body weight before pregnancy.

    B) In order to translate Hb (mmol) in Hb (g / l), multiply the value Hb (mmol) per 1.61145.

    C) Coefficient 2.4 = 0.0034 x 0.07 x 10,000
    0,0034 - iron content in hemoglobin (0.34%)
    0.07 - blood volume of 70 ml / kg of body weight (about 7% of body weight)
    10,000 - conversion factor (1 g / l = 10,000 mg / l)

    D) For patients with a body weight above 35 kg, the iron depot is about 500 mg

    Therapy with iron should be replenished as the iron content in hemoglobin, and its stocks in the depot.After the total iron deficiency is adjusted, patients may need to continue therapy with the Monofer drug to maintain the necessary hemoglobin concentration in the blood plasma, as well as other indicators indicative of iron content.

    Filling of the iron during blood loss:

    Replenishment of iron deficiency after hemorrhage with an iron preparation should be equivalent to loss of iron.

    If the concentration of hemoglobin (Hb) is reduced: Use the previous formula, assuming that there is no need to restore the iron depot:

    Total iron dose (mg) = body weight (kg) x (normal concentration of Hb - current concentration of Hb) (g / l) x 2.4.

    If the amount of blood loss is unknown: application of 200 mg of the drug Monofer increases hemoglobin equivalent to 1 U of blood loss.

    The dose of iron for recovery (mg) = The number of blood loss x 200.

    Administration of the drug

    The mono is injected intravenously, either in a jet or in the form of a full dose infusion of the drug or drip, and also through a dialysis system.

    Children. Not recommended for use in children - insufficient data on efficacy and safety.

    Application in adults, including elderly patients. The mono is injected intravenously, either in a jet or in the form of a full dose infusion of the drug or drip, and also through a dialysis system.

    The monofer should not be used concomitantly with other iron preparations, because the absorption of the iron preparation can be reduced.

    Intravenous fluid administration. Monofer can be administered at a dose of 100 to 200 mg intravenously sprayed up to 3 times a week at a rate of up to 50 mg / min. The drug is diluted in 10-20 ml sterile 0.9% solution of sodium chloride.

    Infusion of the full dose of the drug. It is possible to inject completely the entire dose of Monofer as a single infusion.

    In the form of a single intravenous drip infusion, Monofer can be used in a dose of up to 20 mg / kg of body weight.

    The duration of the dose of the drug from 0 to 10 mg / kg is more than 30 minutes.

    Doses of 11-20 mg / kg should be administered more than 60 minutes.

    If the total dose exceeds 20 mg / kg, the dose should be divided into 2 injections with an interval between administrations of at least 1 week. The monofer is diluted in 100 - 500 ml of sterile 0.9% sodium chloride solution.

    Intravenous drip introduction. The monofer should be used at doses of 200-1000 mg once a week until the whole required total dose of iron is introduced.

    The drug in a dose of 0-5 mg / kg is administered for at least 15 minutes.

    The drug in a dose of 6-10 mg / kg is administered for at least 30 minutes.

    The drug in a dose of 11-20 mg / kg is administered for at least 60 minutes.

    The monofer is diluted in 100-500 ml / sterile 0.9% solution of sodium chloride for injection.

    Introduction through the dialysis system. The monoferr can be injected directly into the venous portion of the dialysis system, strictly observing the technique of intravenous injection.

    Side effects:

    Information on the adverse effects of the drug Monofer is limited.

    It is assumed that side effects are observed in more than 1% of patients.

    Parenteral administration of iron-containing drugs may be accompanied by hypersensitivity reactions. In the course of clinical studies of the Monofer drug, there were no allergic reactions.

    The frequency of side effects revealed during the studies was evaluated as follows: very often (> 1/10), often (> 1/100 - <1/10); infrequently (> 1 / 1,000 - <1/100), rarely (> 1 / 10,000 - <1 / 1,000), very rarely (<1 / 10,000), the frequency is unknown (can not be estimated).

    With the use of the Monofer drug, the following side effects were observed:

    From the cardiovascular system: rarely - heart rhythm disturbances, tachycardia, lowering blood pressure; very rarely - increased blood pressure, bradycardia in the fetus, a feeling of palpitations.

    From the side of the blood and lymphatic system: very rarely - hemolysis.

    From the nervous system: infrequently - numbness, dysphonia; rarely - loss of consciousness, convulsions, dizziness, agitation, tremor, increased fatigue, decreased mental ability; very rarely - headache, paresthesia.

    From the side of the organ of vision: infrequent - a violation of the clarity of visual perception.

    From the organ of hearing: very rarely - short-term hearing loss.

    On the part of the respiratory system: infrequently - shortness of breath; rarely - pain in the chest.

    From the gastrointestinal tract: infrequently - nausea, vomiting, abdominal pain, constipation; often diarrhea.

    From the skin: infrequently - "hot flashes", itchy skin, rash; rarely - swelling, increased sweating.

    From the musculoskeletal system: infrequently - muscle cramps; rarely - myalgia, arthralgia.

    From the immune system: infrequently - anaphylactoid reactions; very rarely - anaphylactic shock.

    General disorders and reactions together with injections: infrequently - a feeling of heat, chills, a feeling of malaise, skin flushing, pain and swelling at the injection site, thrombophlebitis.

    Overdose:

    The drug Monofer has low toxicity, good tolerability; the risk of overdose is minimal. Overdose can develop in connection with the cumulation of iron or acute iron overload and manifests itself as symptoms of hemosiderosis. Control of the iron content in the body is carried out by determining the concentration of ferritin. In case of overdose, it is recommended to use symptomatic agents and, if necessary, iron binding substances (chelates).

    Interaction:

    Monofer® should not be given concomitantly with the medicinal forms of iron for oral administration, as their combined use helps to reduce the absorption of iron from the gastrointestinal tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection.

    Special instructions:

    Monofer should be administered only to those patients who are diagnosed with iron deficiency anemia with appropriate laboratory data (for example, serum ferritin or hemoglobin and hematocrit concentrations, erythrocyte count and parameters - mean erythrocyte volume, mean hemoglobin in erythrocyte, or mean hemoglobin concentration in erythrocyte).

    The drug Monofer can be mixed in a single syringe only with a sterile saline solution. No other solutions for intravenous administration and therapeutic agents are added, since there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of other materials than glass, polyethylene and polyvinyl chloride has not been studied.

    Intravenous iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life threatening.

    It is necessary to strictly adhere to the speed of administration of the drug Monofer (with rapid administration of the drug can decrease blood pressure). A higher incidence of undesirable side effects (in particular, lowering blood pressure), which may also be severe, is associated with an increase in the dose. Thus, the time of administration of the drug, given in the section "Dosing and Administration", should be strictly observed, even if the patient does not receive the drug in the maximum tolerated single dose.

    It is necessary to avoid penetration of the drug into the circumveneous area, because getting the drug out of the vessel leads to tissue necrosis and brown staining of the skin.In case of this complication, to accelerate the excretion of iron and prevent its further penetration into surrounding tissues, it is recommended to apply to the injection site of heparin-containing drugs (gel or ointment is applied lightly without rubbing).

    After dilution of the preparation in sterile sodium chloride solution 0.9% for injection, the resulting solution should be stored at room temperature for no more than 24 hours.

    Effect on the ability to drive transp. cf. and fur:

    Studies to study the effect of the drug Monofer on the ability to control vehicles and mechanisms have not been conducted. Against the background of treatment with the drug Monofer it is possible to violate the clarity of visual perception and the development of episodes of increased fatigue, which can have an adverse effect if the patient's work is related to potentially hazardous activities. In case of occurrence of the specified symptomatology it is necessary to refrain from performance of dangerous kinds of works.

    Form release / dosage:

    Solution for intravenous administration, 100 mg / ml.

    Packaging:

    By 1, 2, 5 or 10 ml of the preparation made on the production site Solufarm Pharmacities Erzoignesse GmbH, Germany, in ampoules of a transparent colorless hydrolytic glass of type I (Hebrew F.) with a white point of a break point.

    By 1, 2, 5 or 10 ml of the preparation made on the production site Wasserburger Artzneemittelwerk GmbH, Germany, in bottles of transparent colorless hydrolytic glass type I (Hebrew F), sealed with gray chlorobutyl rubber stoppers and rolled up with aluminum caps equipped with detachable polypropylene disks (FLIP OFF).

    2 ampoules or vials (5 or 10 ml each), or 5 ampoules or vials (1, 2, 5 or 10 ml), or 10 ampoules or vials (1 or 2 ml each) in a pack of cardboard along with the instruction on application.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001499
    Date of registration:13.02.2012
    The owner of the registration certificate:Pharmacosmos A / CPharmacosmos A / C Denmark
    Manufacturer: & nbsp
    Representation: & nbspKOSMOFARM LLCKOSMOFARM LLC
    Information update date: & nbsp13.02.2012
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