CosmoFer, 50 mg/ml 2 ml, 5 pcs.

CosmoFer contains iron in the form of a stable iron (III) complex – dextran hydroxide, suitable for both intravenous and intramuscular use. An important advantage of the preparation is that the iron in the complex is in a non-ionic water-soluble form and has very low toxicity.

The complex of iron (III) – dextran hydroxide by its chemical structure is analogous to the physiological complex of ferritin with iron (III) – hydroxide. In the body ferritin, by binding Fe (III) hydroxide, provides neutralization of toxic iron ions.

Pharmacokinetics

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

Iron administered intravenously in the form of iron dextran is rapidly absorbed by the phagocytic macrophage system (PFM), especially the liver, spleen and bone marrow. SFM cells take up iron (III) hydroxide dextran and detach the iron from the dextran carbohydrate compound, making it available to the body. Elemental iron returns to the plasma, binds with transferrin and is deposited as ferritin or hemosiderin – physiological forms of iron, and entering the bone marrow, participates in hemoglobin synthesis.

The serum ferritin content reaches a maximum on about day 7-9 after intravenous administration and returns to baseline levels after about 3 weeks.

Elevated hematopoiesis can be observed over the next 6-8 weeks.

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

About 60% of the intramuscularly administered drug is absorbed within 3 days and more than 90% within 3 weeks. The remaining amount is absorbed within several months. 2/3 of the iron is removed through the gastrointestinal tract with red blood cells, bile and exfoliating epithelial cells.

Because of the size of the complex (165,000 Da), it is almost never eliminated from the body by the kidneys.

Indications

Severe iron deficiency anemia with intolerance to oral iron supplements and in cases where rapid replenishment of iron reserves is necessary.

Pharmacological effect

CosmoFer contains iron in the form of a stable iron (III) complex – dextran hydroxide, suitable for both intravenous and intramuscular use. An important advantage of the drug is that the iron in the complex is presented in a non-ionic water-soluble form and has very low toxicity.

The iron (III) complex – dextran hydroxide in its chemical structure is an analogue of the physiological complex of ferritin with iron (III) – hydroxide. In the body, ferritin, by binding Fe(III) hydroxide, ensures the neutralization of toxic iron ions.

Pharmacokinetics

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

Iron administered intravenously as iron dextran is rapidly taken up by the phagocytic macrophage (PMS) system, especially the liver, spleen, and bone marrow. SFM cells take up 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 when entering the bone marrow, it participates in the synthesis of hemoglobin.

Serum ferritin levels peak approximately 7–9 days after intravenous administration and return to baseline levels after approximately 3 weeks.

Increased hematopoiesis can be observed over the next 6–8 weeks.

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

About 60% of the intramuscularly administered drug is absorbed within 3 days and more than 90% within 3 weeks. The remaining amount is absorbed over several months. 2/3 of iron is removed through the gastrointestinal tract with red blood cells, bile and exfoliating epithelial cells.

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

Special instructions

The use of CosmoFer, like other iron hydrocarbon complexes, carries a risk of anaphylactic reactions. During administration of the drug and immediately after administration, patients should be under medical supervision.

There is an increased risk for patients with known allergies. Acute anaphylactic reactions are extremely rare. They appear within the first minutes of use and are usually characterized by a sudden onset of difficulty breathing and/or cardiovascular collapse.

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

When the first signs of anaphylactic reactions appear, the use of CosmoFer should be stopped immediately.

The use of CosmoFer in patients with autoimmune diseases or inflammatory conditions (systemic lupus erythematosus, rheumatoid arthritis) may cause type III allergic reactions. Cases of arterial hypotension may occur if the IV injection is given too quickly.

Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia and sometimes fever, which can last from several hours to 4 days after drug administration. Symptoms usually appear within 2–4 days.

The diagnosis of iron deficiency should be based on appropriate laboratory tests (serum ferritin, serum iron, transferrin saturation with iron).

Before use, you should check the ampoules visually for sediment and damage. Use only ampoules with a homogeneous solution that does not contain sediment.

Features of the drug’s effect upon first use or upon withdrawal

When using the drug for the first time, the recommended initial dose is 25 mg of iron or 0.5 ml of solution. If no adverse reactions occur within the next 60 minutes, the remaining dose can be administered.

Influence on the ability to drive vehicles and machinery. Does not affect the ability to drive vehicles and machinery.

Active ingredient

Iron[III]hydroxide dextran

Composition

1 ml of solution for intravenous and intramuscular administration contains:

active ingredient:

iron (III) – dextran hydroxide complex 312.5 mg (equivalent to 50 mg of elemental iron);

excipients:

hydrochloric acid or sodium hydroxide to pH 5.5,

water for injections.

Pregnancy

It should not be prescribed during the first trimester of pregnancy, but can be used with caution during the second and third trimesters and during lactation.

Contraindications

hypersensitivity to drugs containing mono- or disaccharide complexes of iron and dextran;
anemia not associated with iron deficiency (including hemolytic, sideroblastic, lead);
iron overload (hemochromatosis, hemosiderosis);
bronchial asthma;
allergic skin diseases (including eczema);
decompensated liver cirrhosis and hepatitis;
infectious diseases;
acute renal failure;
rheumatoid arthritis with symptoms of active inflammation;
pregnancy (first trimester);
children’s age (up to 14 years).

With caution: impaired renal function; pregnancy (II–III trimesters); lactation period.

Side Effects

Approximately 5% of patients may experience adverse reactions.

The most common adverse reactions are skin itching and shortness of breath.

In rare cases, possible: decreased blood pressure, nausea, dyspeptic disorders, headache, pain in joints and muscles, swollen lymph nodes, increased bilirubin levels and decreased calcium levels in the blood serum.

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

Large doses of iron dextran (5 ml or more) give a brown color to blood serum taken 4 hours after administration of the drug.

Anaphylactoid reactions are possible, including the development of anaphylactic shock with a fatal outcome.

Interaction

CosmoFer for parenteral use is not prescribed in conjunction with oral iron supplements, because absorption of iron taken orally will be reduced.

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

CosmoFer must be mixed only with 0.9% sodium chloride solution or 5% glucose solution. Do not mix with solutions of other drugs.

Overdose

Symptoms: hemosiderosis (acute iron overload).

Treatment: administration of complexing drugs (chelators) that bind iron into a chelate complex.

With constantly repeated administration of iron in a large dose, its excess accumulates in the liver and causes an inflammatory process that can lead to fibrosis.

Storage conditions

In a dry place, at a temperature not exceeding 25°C.

Shelf life

30 months

Manufacturer

Sky A/S, Denmark