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 in cases of intolerance to oral iron preparations and in cases of need for rapid iron replenishment.

Composition

1 ml of solution for intravenous and intramuscular injection contains:

the active ingredient:

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

auxiliary substances:

Hydrochloric acid or sodium hydroxide to pH 5.5,

water for injection.

How to take, the dosage

CosmoFer is used as an intravenous drip infusion or slow intravenous or intramuscular injections.

The use of CosmoFer is only possible in a hospital setting, with resuscitation and antishock therapy available. Patients must be closely monitored by a physician during and immediately after administration of the drug for 1 hour.

The use of CosmoFer should be discontinued immediately if any hypersensitivity or intolerance reaction is detected during administration.

The usually recommended dose of CosmoFer: 100-200 mg of iron (corresponding to 2-4 ml of the drug) 2-3 times a week depending on the hemoglobin content.
However, if the clinical situation requires rapid iron replacement, an intravenous drip of the total dose of CosmoFer is possible up to 20 mg/kg of the patient body weight.

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.

For intravenous infusions, CosmoFer can only be diluted in 0.9% sodium chloride solution or 5% glucose solution.

For intramuscular injections, the undiluted drug is used (2.0 ml, maximum 4.0 ml) as a series of injections: the volume of each series is usually determined by the patient’s body weight. In patients with a moderately active lifestyle, injections are administered daily, alternating in different buttocks. For inactive patients or bedridden patients, the frequency of injections is reduced to one or two per week.

Interaction

CosmoFer for parenteral use is not prescribed together with oral iron preparations, because the absorption of iron taken orally will be reduced.

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

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

Special Instructions

The use of CosmoFer, like other iron-carbon complexes, carries the risk of anaphylactic reactions. Patients should be supervised by a physician during the administration of the drug and immediately after administration.

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

It must be possible to provide anti-shock therapy (0.1% solution of epinephrine (adrenaline), antihistamines and/or corticosteroids).

In case of the first signs of anaphylactic reactions, the use of CosmoFer should be stopped immediately.

The use of CosmoFera 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 injection. Symptoms usually appear within 2-4 days.

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

Before use, ampoules should be visually inspected for residue and damage. Use only ampoules with a homogeneous solution that does not contain precipitate.

Particulars of action when first used or withdrawn

The first time the drug is used, the recommended starting 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 may be administered.

Impact on the ability to drive vehicles, machinery. Does not affect the ability to operate vehicles and machinery.

Contraindications

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

Side effects

Approximately 5% of patients may have adverse reactions.

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

In rare cases, decreased blood pressure, nausea, dyspeptic disorders, headache, joint and muscle pain, enlarged lymph nodes, increased bilirubin levels, and decreased serum calcium levels may occur.

Local reactions are pain and inflammation at the injection site, in addition, when injected intravenously – phlebitis, thrombophlebitis.

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

Possible anaphylactoid reactions, up to the development of anaphylactic shock with fatal outcome.

Overdose

Symptoms: hemosiderosis (acute iron overload).

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

If a high dose of iron is given repeatedly, excess iron accumulates in the liver and causes an inflammatory process that can lead to fibrosis.

Pregnancy use

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