CosmoFer® (LMW Iron Dextran) 50mg/ml, 2 ml x 5 Ampoules

Other Brands: InFeD®, Imferon®, Dexferrum®, Feosol®, Proferdex®, Iron Dextran

What is CosmoFer?

CosmoFer® is a medicinal solution containing iron in the form of iron(III)-hydroxide dextran complex.

This form of iron mimics the natural storage of iron in the body, called ferritin, allowing the medication to be administered in high doses via injection or infusion.

It is primarily used to treat iron deficiency in adults, especially when oral iron supplements are not effective, are not tolerated, or when there is an urgent need to restore iron stores.

When is CosmoFer used?

CosmoFer is prescribed to treat iron deficiency in adults in the following situations:

• When oral iron preparations are unsuitable: This can happen if the patient cannot tolerate oral iron supplements due to gastrointestinal side effects or when the response to oral iron is inadequate.
• When there is a need for rapid iron replenishment: For example, in cases where a patient requires quick restoration of iron stores, such as after significant blood loss or in certain chronic conditions that cause ongoing iron deficiency.

Before starting CosmoFer, the diagnosis of iron deficiency must be confirmed with proper blood tests. These typically include tests for serum ferritin, serum iron, transferrin saturation, and hypochromic red blood cells, ensuring that the patient is truly deficient in iron.

How is CosmoFer administered?

CosmoFer can be given by different methods depending on the clinical need and patient condition. The administration methods include:

• Intravenous drip infusion: This is the preferred route of administration as it reduces the risk of hypotensive episodes (low blood pressure). CosmoFer is diluted in either 0.9% sodium chloride solution (normal saline) or 5% glucose solution. The first 25 mg of iron is infused slowly over 15 minutes to check for any adverse reactions. If tolerated, the rest of the solution is infused at a rate of no more than 100 ml over 30 minutes.

• Intravenous injection: CosmoFer can be administered undiluted or diluted in saline or glucose via a slow intravenous injection (0.2 ml per minute). The first 25 mg of iron is injected over 1-2 minutes, and if there are no adverse reactions within 15 minutes, the rest of the dose is given.

• Intramuscular injection: CosmoFer may also be injected directly into the muscle. The solution is administered undiluted, typically into the upper outer quadrant of the buttock. A "Z-track" injection technique is used to avoid leakage of the solution into subcutaneous tissues, which helps prevent staining or damage to the skin. Care must be taken to avoid injecting into exposed areas like the arm.

Monitoring and Safety: CosmoFer must only be administered by healthcare professionals trained to manage allergic reactions, as there is a risk of hypersensitivity reactions. After each injection, the patient is observed for at least 30 minutes for any adverse effects. Full resuscitation equipment must be available at the time of administration.

What is the dosage of CosmoFer?

The total dose of CosmoFer is based on the patient's haemoglobin levels and body weight, which help determine the iron deficit. The dose schedule should be personalized for each patient. The standard dosage for CosmoFer is 100-200 mg of iron (equivalent to 2-4 ml of CosmoFer solution) two or three times a week. For situations requiring rapid iron replenishment, a total dose infusion (TDI) can be given, providing up to 20 mg of iron per kilogram of body weight.

Special Administration Considerations:

• Total Dose Infusion (TDI): If rapid iron replacement is needed, the total required amount of CosmoFer (based on body weight and haemoglobin level) can be administered as a single infusion over 4 to 6 hours. The first 25 mg of iron is infused over 15 minutes to ensure the patient tolerates it well. TDI should be restricted to hospital use because it has been associated with a higher incidence of adverse reactions, particularly delayed hypersensitivity-like responses.

• Intramuscular injection: CosmoFer should be injected deeply into the muscle to avoid skin staining. The frequency of injections depends on the patient’s activity level. For active patients, injections can be given daily, alternating buttocks. For less active or bedridden patients, injections are given less frequently, typically once or twice a week.

Important: CosmoFer should not be used in children under 14 years of age, as there is no data on its safety and efficacy in this population.

How is the required dose of CosmoFer calculated?

The amount of iron needed depends on the patient’s current haemoglobin level, target haemoglobin, and body weight. The calculation also includes an allowance for replenishing iron stores. Here is the basic formula used to calculate the total dose of iron:

• For haemoglobin levels in grams per litre (g/l):

  $$\text{Total dose (mg Fe)} = (\text{Body weight (kg)} \times (\text{Target Hb} - \text{Actual Hb}) \times 0.24) + \text{Iron for stores}$$

  The factor 0.24 accounts for blood volume and the iron content in haemoglobin.

• For haemoglobin levels in millimoles per litre (mmol/l):

  $$\text{Total dose (mg Fe)} = (\text{Body weight (kg)} \times (\text{Target Hb} - \text{Actual Hb}) \times 3.84) + \text{Iron for stores}$$

A typical target haemoglobin level is 150 g/l (or 9.3 mmol/l), and the calculation usually includes 500 mg of iron to replenish the body’s iron stores. If the total necessary dose exceeds the maximum daily dose, the administration must be split over multiple sessions.

What precautions should be taken with CosmoFer?

CosmoFer should not be administered in the following situations:

• Allergies: If the patient has a known allergy to CosmoFer or other injectable iron products.
• Non-iron deficiency anaemia: Such as haemolytic anaemia, where CosmoFer would not be effective.
• Iron overload: Conditions such as haemochromatosis or haemosiderosis.
• Liver disease: In cases of decompensated cirrhosis or hepatitis, CosmoFer may worsen the condition.
• Acute or chronic infections: Parenteral iron can exacerbate bacterial or viral infections, so CosmoFer should not be used in these cases.

Patients with a history of severe allergies, asthma, or immune conditions such as rheumatoid arthritis should be monitored closely, as they are at higher risk for hypersensitivity reactions.

What are the possible side effects of CosmoFer?

Like any medication, CosmoFer can cause side effects, though not everyone will experience them. About 5% of patients can expect to experience adverse reactions, which are mainly dose-dependent.

Common side effects include:

• Hypersensitivity reactions: Symptoms like urticaria (hives), rashes, itching, nausea, and shivering can occur.

Serious side effects (rare but important):

• Severe allergic (anaphylactic) reactions: These are very rare but can occur within the first few minutes of administration. They are characterized by difficulty breathing, chest pain, and cardiovascular collapse, and they require immediate medical intervention. Fatalities have been reported in extremely rare cases.

• Delayed hypersensitivity reactions: These reactions, such as joint pain, muscle aches, and fever, may occur several hours to four days after treatment and generally resolve on their own or with the use of simple pain relievers.

Other potential side effects:

• Nausea, vomiting, and abdominal pain.
• Dizziness, blurred vision, or headache.
• Pain and swelling at the injection site, particularly if administered intramuscularly.
• Hypotension (low blood pressure) if the intravenous injection is administered too rapidly.
• Skin staining, especially after intramuscular injections, can be permanent if not administered correctly.

Patients with rheumatoid arthritis may experience worsening joint pain. In some cases, an influenza-like illness can occur, with symptoms such as fever and muscle aches appearing a few hours to several days after the injection.

How should CosmoFer be stored?

CosmoFer does not require any special storage conditions but should not be frozen.

Once opened or diluted, it should be used immediately. If necessary, diluted CosmoFer can be stored for up to 24 hours at 2-8°C.

Before use, ampoules should be inspected for sediment or damage.

Only clear, sediment-free solutions should be used. Unused portions of CosmoFer should be disposed of in accordance with local regulations.

What is the Difference Between CosmoFer and Other Iron Supplements Like Ferlatum?

The main difference between CosmoFer and other iron supplements, such as Ferlatum, lies in their composition and method of iron delivery:

CosmoFer contains iron(III)-hydroxide dextran complex, specifically a low molecular weight (LMW) iron dextran. This is a parenteral iron preparation designed for injection or infusion, which allows for direct replenishment of iron stores in the body. The LMW dextran closely mimics the body's natural iron storage protein, ferritin, enabling the efficient delivery of high doses of iron. CosmoFer is often used when oral iron supplements are ineffective, when rapid iron restoration is required, or for patients with gastrointestinal conditions that impair absorption.

Ferlatum, on the other hand, is an oral iron supplement containing ferric protein succinylate. This is a form of iron bound to a protein carrier, which helps improve the stability and absorption of iron when taken orally. The protein binding also helps minimize gastrointestinal irritation, making it more tolerable for many patients. Ferlatum is suitable for cases where iron deficiency can be corrected more gradually through oral intake, and it is preferred for patients who can tolerate oral supplements and do not require immediate iron replacement.

In summary:

• CosmoFer is administered intravenously or intramuscularly, making it ideal for those with severe iron deficiency, malabsorption issues, or situations where oral iron has failed. Its LMW iron dextran formulation allows for rapid and efficient iron replacement with reduced risk of gastrointestinal side effects.

• Ferlatum and other oral iron supplements are less invasive but generally slower in action, requiring consistent dosing over time. They contain ferric protein succinylate, which improves absorption and tolerability for patients who do not need urgent iron replenishment