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Composition:


active ingredient: iron (III) hydroxide sucrose complex;


1 ml of the solution contains iron (III) hydroxide sucrose complex equivalent to Iron (III) 20 mg;


excipients: sodium hydroxide, water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: colloidal solution from Brown to red-brown color.


Pharmacotherapeutic group.


Anti-anemic agents. Iron preparations. ATX code in 3A s.


Pharmacological properties


Pharmacodynamics.


The active component of iron sucrose consists of multinucleated Iron (III) hydroxide centers surrounded externally by a large number of non-covalently bound sucrose molecules. The weight of the complex is the average molecular weight (MV), which is approximately 43 CD, which is a fairly high indicator and does not allow its excretion by the kidneys. The multinucleated iron Center has a structure similar to that of the ferritin Center, which is a physiological iron-containing protein. The complex was designed to provide controlled absorption of iron to transport iron and preserve proteins in the body (transferrin and ferritin, respectively).


After intravenous administration, the multinucleated iron center from the complex is mainly captured by the reticulo-endothelial system of the liver, spleen and bone marrow. In the second stage, iron is used for the synthesis of hemoglobin, myoglobin and other iron-containing enzymes, or stored in the liver as ferritin.


Pharmacokinetics.


Distribution. The ferrokinetics of the iron hydroxide sucrose complex, designated 59Fe and 52fe, was evaluated in 6 patients with anemia and chronic renal failure. During the first 6-8 hours, 52fe is captured by the liver, spleen, and bone marrow. Radioactive iron uptake occurs in macrophages of the reticulo-endothelial system of the spleen.


After intravenous administration of a single dose of the drug containing 100 mg of iron to healthy volunteers, the maximum iron concentration was observed 10 minutes after administration and reached an average value of 538 mmol/L. 


Metabolism. After injection, sucrose almost completely breaks down and the multinucleated iron center is mainly captured by the reticulo-endothelial system of the liver, spleen and bone marrow.


Within 4 weeks after administration, the absorption of iron by red blood cells ranges from 68 to 97 %.


Output. The weight of the iron sucrose complex corresponds to the average molecular weight (MV), which is approximately 43 CD. The weight of the complex is large enough to avoid excretion by the kidneys. Renal iron excretion during the first 4 hours after injection of 100 mg of iron was less than 5% of the dose. After 24 hours, the total serum iron concentration decreased to the initial level (before Administration), and renal sucrose excretion was approximately 75% of the administered dose.


Pharmacokinetics in individual patient groups. It is still unknown whether renal and hepatic insufficiency affects the pharmacological properties of the Iron (III) hydroxide sucrose Complex (see the section "application features").


Clinical characteristics.


Indications.


Iron deficiency in patients who cannot be prescribed oral iron supplements or if they are ineffective in the following cases::


- intolerance to oral iron preparations;


- the presence of inflammatory diseases of the gastrointestinal tract (for example, ulcerative colitis), which can worsen with therapy with oral iron preparations;


- iron deficiency conditions that are resistant to therapy, in the case when the control of these conditions with oral iron preparations is insufficient.


Contraindications.


- Anemia that is not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency, impaired erythropoiesis, bone marrow hypoplasia, anemia caused by lead poisoning);


- diseases accompanied by an oversaturation of the body with iron (hemosiderosis, hemochromatosis) or hereditary disorders of the Iron utilization process (for example, sideroachrestic anemia, cutaneous porphyria, thalassemia);


- hypersensitivity to the active substance or other components of the drug;


- I trimester of pregnancy.


Interactions with other drugs and other types of interactions.


Feroxide is indicated for patients who cannot be prescribed oral iron supplements or if they are ineffective. Like other iron preparations for parenteral use, Feroxide should not be used simultaneously with iron-containing oral agents, since the absorption of iron administered orally decreases. Therefore, treatment with oral iron preparations should begin no earlier than 5 days after the last Feroxide injection.


Application features.


Intravenous use of iron preparations for parenteral administration can lead to immediate hypersensitivity reactions (anaphylactoid/anaphylactic reactions), which can be fatal. Therefore, anti-allergenic treatment should be carried out in a room with appropriate equipment for cardiopulmonary resuscitation. Such reactions have been reported even in cases where the previous use of iron preparations for parenteral administration passed without complications. In patients who have experienced hypersensitivity reactions to other parenteral iron preparations (for example, iron dextran), Feroxide should be used if absolutely necessary, with all precautions taken.


Treatment with Feroxide should be prescribed by a doctor only after accurately determining the indication.


The use of the drug is possible only if there are qualified personnel who can assess the patient's condition and immediately carry out appropriate treatment of anaphylactic reaction and resuscitation measures. Before each use of the drug, the patient should be interviewed about the previous occurrence of adverse reactions associated with the use of iron preparations for intravenous administration.


Typical symptoms of immediate hypersensitivity reactions include: low blood pressure, tachycardia (and even anaphylactic shock), respiratory symptoms (including bronchospasm, laryngeal edema, and pharyngeal edema), gastrointestinal symptoms (including abdominal cramps, vomiting), or skin symptoms (including urticaria, erythema, pruritus).


Each patient should be monitored for at least 30 minutes after taking parenteral iron supplements for timely detection of signs and symptoms of hypersensitivity reactions. In case of allergic reactions or signs of intolerance during use, treatment should be discontinued immediately.


For immediate treatment of acute anaphylactic/anaphylactoid reactions, first of all, the use of epinephrine (for example, at a dose of 0.3 mg intramuscularly) is recommended, then – the use of antihistamines and/or corticosteroids (having a later onset of action).


High risk of hypersensitivity reactions in patients with existing allergies, including drug intolerance, severe bronchial asthma in the Anamnesis, eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations and other forms of atopy, as well as in patients with immunological and inflammatory diseases (such as systemic lupus erythematosus, rheumatoid arthritis).

Use during pregnancy or lactation.


There are some data on the use of Iron (III) hydroxide sucrose complex in pregnant women in the first trimester of pregnancy. Data on the use of Iron (III) hydroxide sucrose complex in pregnant women in the second and third trimesters of pregnancy showed no undesirable effects on the health of the mother and child.


It is still unknown whether the Iron (III) hydroxide sucrose complex passes through the placenta. Iron bound to transferrin does not cross the placental barrier. Iron bound to lactoferrin passes into breast milk.


Studies on the effect on iron levels in newborns have not been conducted.


The drug Feroxide is contraindicated in the first trimester of pregnancy (see the section "contraindications"). It is possible to use the drug in the second and third trimesters of pregnancy only strictly according to indications.


The risk/benefit ratio should be evaluated before using the drug during pregnancy, since hypersensitivity reactions may carry a certain risk for the mother and child (see the section "special instructions for use"). Pre-pregnancy body weight data should be taken into account to calculate the amount of iron needed to avoid overdose.


Data on the excretion of iron in human breast milk after intravenous administration of iron sucrose are limited. During the clinical trial, 10 healthy women with iron deficiency who were breastfed received 100 mg of iron in the form of a sucrose complex. After four days of treatment, the iron content in breast milk was not elevated and did not differ from that in the control group (n = 5). The effect of iron coming from the mother's breast milk on the newborn/infant cannot be excluded, so the risk/benefit ratio should be evaluated.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


There are no relevant studies. It is unlikely to affect the reaction rate when driving vehicles or other mechanisms. However, if you develop adverse reactions, such as dizziness, confusion, you should refrain from driving vehicles or working with other mechanisms until the symptoms disappear.


Dosage and administration.


Feroxide is administered only intravenously. The injection can be performed by slow injection, drip intravenous infusion, or direct injection into the venous area of the dialysis system. The product is not intended for intramuscular or subcutaneous administration.


If the total required dose exceeds the maximum allowed single dose of 200 mg (for injection) or 500 mg (for infusion), it is recommended to administer the drug in parts.


During and after the use of Feroxide, patients should be monitored for signs and symptoms of hypersensitivity reactions. It is necessary to ensure appropriate emergency therapy (see the section "application features").


The cumulative dose of the drug should be calculated for each patient individually and not exceed it. The dose is calculated taking into account the patient's body weight and hemoglobin level.

Standard dosage.


Adults and elderly patients: 5-10 ml of Feroxide (100-200 mg of iron) 1-3 times a week, depending on Hb levels. See the application time and dilution ratio above. 


Children over 3 years of age: there are only limited data on the use of the drug in children. If clinically necessary, it is recommended to administer no more than 0.15 ml of Feroxide (3 mg of iron) per 1 kg of body weight no more than 3 times a week. See the application time and dilution ratio above. 


Maximum tolerated single or weekly dose.


Adults and elderly patients:


For injection: the Maximum Tolerated Dose is 10 ml of Feroxide (200 mg of Iron), no more than 3 times a week, the duration of administration is not less than 10 minutes.


For infusion: the Maximum Tolerated Dose is no more than 1 time per week:


patients weighing more than 70 kg: 500 mg of iron( 25 ml of Feroxide) for at least 3.5 hours;


patients weighing 70 kg or less: 7 mg of iron per kg of body weight for at least 3.5 hours.


The time of administration of the infusion should be strictly observed, even if the patient does not receive the maximum tolerated single dose.


If there is no improvement in hematological parameters (an increase in hemoglobin levels by about 1 g/L of blood per day or about 10-20 G/L 1-2 weeks after the start of treatment), the patient's initial diagnosis should be reviewed and the presence of persistent blood loss should be excluded.


Children.


There are only limited data on the use of the drug in children, see the section ("dosage and administration"). Prescribe the drug to children only for vital indications (for rapid replenishment of the body with iron).


Overdose.


Overdose can lead to acute iron saturation of the body, which can manifest as hemosiderosis. In case of overdose, it is recommended to use symptomatic agents and, if necessary, substances that bind iron (chelates).


Adverse reactions.


The most common adverse reaction to the drug is dysgeusia. Frequent adverse reactions include nausea, hypotension, hypertension, and pain at the infusion site, which occurred with a frequency of 1 to 2 events per 100 people.


The most important serious adverse reactions that have been associated with the use of the drug include hypersensitivity reactions that occurred with a frequency of 0.25 events per 100 people during clinical trials. Immediate hypersensitivity reactions (anaphylactoid/anaphylactic reactions) were rare. In general, anaphylactoid/anaphylactic reactions are very serious adverse reactions that can lead to death (see the section "application features"). Symptoms include circulatory collapse, hypotension, tachycardia, respiratory symptoms (bronchospasm, laryngeal edema, pharyngeal edema, etc.), gastrointestinal symptoms (abdominal pain, vomiting, etc.), and skin symptoms (urticaria, erythema, pruritus, etc.).


Adverse events by frequency are classified into the following categories: very common (> 1/10), often (> 1/100, 1/10), infrequent (> 1/1000, 1/1000), rare (> 1/10 000, 1/1000), very rare (1/10000), unknown (available data do not allow us to estimate the frequency, since such phenomena were reported exclusively during post-marketing studies, and not clinical trials).


Infectious and parasitic diseases.


Rare: pneumonia.


From the blood and lymphatic system.


Infrequently: polycythemia 1.


From the immune system.


Infrequently hypersensitivity reactions.


Unknown: anaphylactoid reactions, angioedema.


Metabolism and eating disorders.


Rare: iron oversaturation.

Storage conditions.


Store in the original packaging at a temperature not exceeding 25 °C.


Do not freeze. Keep out of reach of children.


Incompatibility.


Feroxide can only be mixed with a sterile 0.9% sodium chloride solution. No other intravenous solutions or therapeutic agents should be added, as there is a risk of precipitation and/or other pharmaceutical interactions. Compatibility with polyethylene and polyvinyl chloride containers has not been studied.

Tags: Iron (III) hydroxide sucrose complex