Marketing Authorization Holder

Velpharm, LLC (Russia)

ATC Code

B03AC (Parenteral preparations of trivalent iron)

Active Substance

Iron [III] dextran hydroxide (Grouping name)

Dosage Form

Iron [III] dextran hydroxide

Solution for intravenous and intramuscular administration 50 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration dark brown in color, without sediment.

Excipients: diluted hydrochloric acid 10% or sodium hydroxide solution 10%, water for injection.

2 ml – ampoules of dark glass (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules of dark glass (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Iron preparation

Pharmacological Action

The stable complex of iron (III) hydroxide dextran contains iron in a non-ionic water-soluble form and has very low toxicity.

Iron (III) hydroxide dextran is chemically analogous to the physiological complex of ferritin with iron (III) hydroxide.

In the body, ferritin, by binding Fe (III) hydroxide, provides detoxification of toxic iron ions.

Pharmacokinetics

The absorption of iron to replenish its stores in the body and for hemoglobin synthesis begins immediately after the administration of iron (III) hydroxide dextran.

Iron administered intravenously as iron dextran is rapidly absorbed by the system of phagocytic macrophages (SPM), especially by the liver, spleen, and bone marrow.

SPM cells capture iron (III) hydroxide dextran and cleave iron from the carbohydrate compound dextran, making it available to the body.

Elemental iron returns to the plasma, binds to transferrin, and is deposited in the form of ferritin or hemosiderin – physiological forms of iron, and, entering the bone marrow, participates in hemoglobin synthesis.

Serum ferritin levels reach a maximum approximately on days 7-9 after intravenous administration and return to baseline levels approximately after 3 weeks.

Enhanced hematopoiesis can be observed over the subsequent 6-8 weeks.

After intramuscular administration, iron (III) hydroxide dextran enters the bloodstream through capillaries and the lymphatic system.

About 60% of the intramuscularly administered iron dextran (III) is absorbed within 3 days and more than 90% within 3 weeks.

The remaining amount is absorbed over several months.

Two-thirds of the iron is eliminated via the gastrointestinal tract with erythrocytes, bile, and exfoliating epithelial cells.

Due to the size of the complex (165,000 Daltons), it is practically not excreted from the body by the kidneys.

Indications

Severe iron deficiency anemia in cases of intolerance to oral iron preparations and in cases requiring rapid replenishment of iron stores.

ICD codes

Dosage Regimen

Administered intravenously by drip, intravenously slowly, or intramuscularly slowly.

The use of the drug containing iron (III) hydroxide dextran is possible only in a hospital setting with the availability of anti-shock therapy.

Patients must be under close medical supervision during the administration and immediately after it for 1 hour.

The use of this agent must be immediately discontinued upon any manifestations of a hypersensitivity reaction or intolerance detected during administration.

The recommended dose averages 100-200 mg of iron 2-3 times a week depending on the hemoglobin level.

If the clinical situation requires rapid iron replacement, intravenous drip administration of the total dose – up to 20 mg/kg – is possible.

The dose is calculated using special formulas, depending on the indications and clinical situation.

Adverse Reactions

Approximately 5% of patients may experience adverse reactions.

Systemic reactions most frequently – skin itching, shortness of breath; rarely – decreased blood pressure, nausea, dyspepsia, headache, pain in joints and muscles, enlarged lymph nodes, increased bilirubin level, and decreased serum calcium level; possibly – anaphylactoid reactions, up to the development of anaphylactic shock with a fatal outcome.

Local reactions pain and inflammation at the injection site, in addition, with intravenous administration – phlebitis and thrombophlebitis.

Large doses of iron dextran (5 ml and more) impart a brown color to the blood serum taken 4 hours after drug application.

Contraindications

Anemia not associated with iron deficiency (including hemolytic, sideroblastic, lead-induced); iron overload (hemochromatosis, hemosiderosis); bronchial asthma, eczema, or other allergic skin diseases; decompensated liver cirrhosis and hepatitis; infectious diseases; acute renal failure; rheumatoid arthritis with symptoms of active inflammation; first trimester of pregnancy; children and adolescents under 18 years of age; hypersensitivity to preparations containing mono- or disaccharide complexes of iron and dextran.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Use with caution in the second and third trimesters of pregnancy and during breastfeeding.

Use in Hepatic Impairment

Contraindication: decompensated liver cirrhosis and hepatitis.

Use in Renal Impairment

Contraindication: acute renal failure.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Use with caution due to the risk of exacerbation of chronic diseases.

Special Precautions

The use of iron (III) hydroxide dextran, like the use of other iron hydrocarbon complexes, carries a risk of anaphylactic reactions.

During and immediately after the administration of the drug containing iron (III) hydroxide dextran, patients must be under medical supervision.

There is an increased risk for patients with identified allergies.

Acute anaphylactic reactions are extremely rare.

They manifest within the first minutes of application and are usually characterized by a sudden attack of difficulty breathing and/or cardiovascular collapse.

The possibility of anti-shock therapy (0.1% epinephrine (adrenaline) solution, antihistamines and/or corticosteroid drugs) must be available.

Upon the first signs of anaphylactic reactions, the administration of the drug must be immediately discontinued.

Use in patients with autoimmune diseases or inflammatory conditions (systemic lupus erythematosus, rheumatoid arthritis) may cause type III allergic reactions.

With rapid intravenous administration, arterial hypotension is possible.

Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia, and sometimes fever, which may last from several hours to 4 days after drug administration.

Symptoms usually appear within 2-4 days.

Drug Interactions

Not used concomitantly with oral iron preparations, because the absorption of orally taken iron will be reduced.

The interval between the parenteral use of this agent and the start of oral iron forms should be at least 5 days.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.