Cosmofer (Iron Dextran)
Parenteral iron preparation for intravenous and intramuscular use
Quick Facts About Cosmofer
Key Takeaways About Cosmofer
- Treats iron deficiency anemia: Cosmofer is used when oral iron supplements are not tolerated, not effective, or when rapid iron replenishment is medically required
- Multiple administration routes: Can be given as an intravenous infusion, slow IV injection, or intramuscular injection; IV infusion is the preferred route
- Total dose infusion possible: The entire calculated iron deficit can be given in a single session over 4-6 hours, reducing the need for multiple visits
- Risk of serious allergic reactions: Anaphylaxis can occur; patients must be monitored for at least 30 minutes after every dose in a facility with resuscitation equipment
- Not for children under 14: Cosmofer is approved for use in adults and elderly patients only, due to lack of safety data in younger populations
What Is Cosmofer and What Is It Used For?
Cosmofer is an injectable iron preparation containing iron(III) hydroxide dextran complex, used to treat iron deficiency anemia in adults when oral iron supplements cannot be used or have proven ineffective. It is given by intravenous infusion, slow intravenous injection, or intramuscular injection in a supervised medical setting.
Cosmofer contains a combination of iron and dextran, a long chain of sugar molecules. The type of iron in Cosmofer is structurally similar to ferritin, the body's natural iron storage protein. This molecular similarity allows Cosmofer to be administered in high doses, as the body can process and store the iron efficiently through its natural pathways. Once administered, the iron-dextran complex is taken up by the reticuloendothelial system, where the iron is gradually released and made available for hemoglobin synthesis and replenishment of iron stores.
Iron is an essential mineral that plays a critical role in oxygen transport through hemoglobin in red blood cells. When iron stores become depleted, the body cannot produce sufficient healthy red blood cells, leading to iron deficiency anemia. Symptoms of iron deficiency anemia include fatigue, weakness, pallor, shortness of breath, dizziness, and decreased exercise tolerance. Left untreated, severe iron deficiency can affect cardiovascular function, cognitive performance, and overall quality of life.
Cosmofer is specifically indicated for iron deficiency anemia in the following situations:
- Oral iron intolerance: When patients cannot tolerate oral iron supplements due to gastrointestinal side effects such as nausea, constipation, abdominal pain, or diarrhea
- Oral iron ineffectiveness: When oral iron supplementation has been tried but has not adequately raised iron levels or hemoglobin, as may occur in conditions with impaired iron absorption such as celiac disease or inflammatory bowel disease
- Rapid iron replenishment needed: When the clinical situation requires swift restoration of iron stores, such as in patients with significant blood loss, severe anemia before surgery, or chronic kidney disease patients on dialysis
Common clinical scenarios where Cosmofer is used include chronic kidney disease (particularly in hemodialysis patients), inflammatory bowel disease (Crohn's disease and ulcerative colitis), heavy menstrual bleeding, post-operative anemia, and cancer-associated anemia. In hemodialysis patients, Cosmofer can be administered directly into the blood line on the venous side of the dialyzer during a dialysis session.
Cosmofer should only be used to treat iron deficiency anemia that has been confirmed by appropriate laboratory tests (serum ferritin, transferrin saturation, hemoglobin). It should not be used for anemia that is not caused by iron deficiency, as this could lead to dangerous iron overload.
What Should You Know Before Receiving Cosmofer?
Cosmofer must not be given to patients with known hypersensitivity to the product, a history of severe allergic reactions to injectable iron preparations, non-iron-deficiency anemias, iron overload conditions, active liver disease, untreated infections, or acute kidney failure. A thorough medical history and laboratory assessment are essential before starting treatment.
Contraindications
Cosmofer must not be administered under any of the following conditions:
- Hypersensitivity: Known allergy to Cosmofer, iron dextran, or any of its excipients
- Previous severe allergic reactions: History of serious hypersensitivity reactions to any injectable iron preparation
- Non-iron-deficiency anemia: Anemia not caused by iron deficiency, such as hemolytic anemia, megaloblastic anemia, or anemia of chronic disease without proven iron deficiency
- Iron overload: Conditions involving excess iron in the body, such as hemochromatosis, hemosiderosis, or disorders of iron utilization (e.g., thalassemia, sideroblastic anemia)
- Liver disease: Active hepatic conditions including cirrhosis and hepatitis, as the liver plays a central role in iron metabolism and storage
- Active infection: Bacterial or viral infections, as iron can promote microbial growth and worsen infection outcomes
- Acute kidney failure: Renal conditions requiring acute management, though Cosmofer may be used in stable chronic kidney disease under specialist supervision
Warnings and Precautions
Before receiving Cosmofer, inform your doctor or nurse about any of the following conditions, as they may increase the risk of adverse reactions:
- History of drug allergies: Any previous allergic reaction to medications increases the baseline risk of hypersensitivity to Cosmofer
- Systemic lupus erythematosus (SLE): Autoimmune conditions may be associated with heightened immune reactivity to parenteral iron
- Rheumatoid arthritis: Patients with rheumatoid arthritis may experience exacerbation of joint pain following Cosmofer administration
- Severe asthma, eczema, or other allergies: Atopic individuals have a higher baseline risk of hypersensitivity reactions
Serious and potentially fatal hypersensitivity reactions, including anaphylaxis, can occur with Cosmofer administration. These reactions may develop within minutes of starting the infusion. Cosmofer must only be administered in a clinical setting where trained personnel and resuscitation equipment (including epinephrine) are immediately available. Patients must be closely monitored for signs and symptoms of hypersensitivity during and for at least 30 minutes after each administration.
Cosmofer is intended for use in adults only. It should not be given to children under 14 years of age, as there is insufficient evidence regarding its safety and efficacy in this population. For pediatric patients requiring intravenous iron, alternative formulations with established pediatric safety data should be considered.
Pregnancy and Breastfeeding
Cosmofer has not been formally studied in pregnant women through controlled clinical trials. If you are pregnant, think you may be pregnant, or are planning to become pregnant, it is essential to inform your doctor before receiving treatment. Your physician will carefully weigh the potential benefits of iron replacement against any possible risks to the developing fetus.
Iron deficiency anemia during pregnancy is a common and potentially serious condition that requires appropriate medical management. Untreated maternal anemia is associated with adverse outcomes including preterm birth, low birth weight, and increased maternal morbidity. If Cosmofer is considered necessary during pregnancy, it should be used under close medical supervision, typically during the second or third trimester when the risk-benefit assessment is more favorable.
If you are breastfeeding, consult your physician before receiving Cosmofer. Small amounts of iron from iron dextran may pass into breast milk. However, since iron is a natural component of breast milk and is required for infant growth and development, this is generally not considered a significant concern. Your doctor will advise you based on your individual clinical situation.
Driving and Operating Machinery
Consult your doctor about whether you can drive or operate machinery after receiving Cosmofer. Some patients may experience dizziness, lightheadedness, or fatigue following administration. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness. If you experience any side effects that could impair your ability, refrain from driving until symptoms resolve.
Effect on Laboratory Tests
Cosmofer may affect the results of certain blood tests, including serum bilirubin and serum calcium measurements. If blood tests are scheduled during or shortly after your Cosmofer treatment, inform the laboratory or your doctor so that results can be interpreted accurately.
How Does Cosmofer Interact with Other Drugs?
Cosmofer has relatively few known drug interactions, but the most important is with oral iron supplements, which should not be taken for at least 5 days after the last Cosmofer dose. Inform your doctor about all medications, supplements, and herbal remedies you are taking before receiving Cosmofer.
Drug interactions with Cosmofer are limited but clinically important. The primary interaction involves oral iron preparations, which should be avoided for a specific period after Cosmofer treatment to prevent excessive iron accumulation and ensure accurate monitoring of iron status. Additionally, some medications may affect or be affected by changes in iron status following Cosmofer administration.
| Interacting Substance | Type | Effect | Recommendation |
|---|---|---|---|
| Oral iron supplements | Major | Reduced absorption of oral iron; risk of iron overload with concurrent use | Do not take oral iron for at least 5 days after last Cosmofer dose |
| Vitamins and minerals | Minor | High-dose vitamin C may increase iron absorption and risk of iron toxicity | Inform your doctor about all vitamin and mineral supplements |
| ACE inhibitors | Minor | Increased risk of hypersensitivity reactions reported with some parenteral iron products | Monitor closely; inform your doctor if you take ACE inhibitors |
| Dimercaprol | Major | Dimercaprol chelates with iron forming a toxic complex | Avoid concurrent use; allow adequate washout period |
Always inform your doctor or nurse about all medications you are currently taking or have recently taken. This includes prescription medicines, over-the-counter medications, herbal preparations, and dietary supplements. Your healthcare team can then assess potential interactions and adjust your treatment plan accordingly.
What Is the Correct Dosage of Cosmofer?
The Cosmofer dose is calculated individually based on the patient's body weight, current hemoglobin level, and target hemoglobin level using a specific formula. The usual dose is 100-200 mg iron (2-4 ml) given two to three times per week. Total dose infusion allows the entire calculated deficit to be given in one session.
A trained healthcare professional will administer Cosmofer and calculate the appropriate dose for you. The total cumulative dose is determined based on your hemoglobin value and body weight. The dose and dosing schedule must be tailored individually for each patient based on the calculated total iron deficit.
Dose Calculation Formula
The total iron requirement is calculated using the following formula:
Total dose (mg Fe) = (Body weight in kg × (Target Hb - Actual Hb) in g/L × 0.24) + mg iron for iron stores
The factor 0.24 is derived from: blood volume = 7% of body weight, iron content in hemoglobin = 0.34%. Factor = 0.0034 × 0.07 × 1000.
Iron stores component: Body weight <35 kg = 15 mg/kg; Body weight ≥35 kg = 500 mg.
Adults and Elderly
Standard Dosing
The normal recommended dose is 100-200 mg iron (corresponding to 2-4 ml Cosmofer), administered two or three times per week depending on hemoglobin values. The total number of doses required depends on the calculated total iron deficit.
Administration Methods
| Route | Dose per Session | Dilution | Duration | Notes |
|---|---|---|---|---|
| IV Infusion | 100-200 mg Fe (2-4 ml) | Dilute in 100 ml NaCl 0.9% or glucose 5% | Test dose 25 mg over 15 min; remainder over 30 min | Preferred route; lower risk of hypotension |
| Slow IV Injection | 100-200 mg Fe (2-4 ml) | Dilute in 10-20 ml NaCl 0.9% or glucose 5% | Rate: 0.2 ml/min; test dose 25 mg over 1-2 min | Wait 15 min after test dose before continuing |
| Total Dose Infusion | Up to 20 mg Fe/kg body weight | In 500 ml NaCl 0.9% or glucose 5% | 4-6 hours total; test dose 25 mg over 15 min | Hospital setting only; higher risk of delayed reactions |
| IM Injection | Up to 100 mg Fe (2 ml) per injection | Undiluted | Deep injection using Z-track technique | Upper outer quadrant of buttock only; risk of skin staining |
| Dialysis Administration | 100-200 mg Fe (2-4 ml) | As per IV administration | During hemodialysis session | Administered into venous side of dialyzer blood line |
Children
Cosmofer is not approved for use in children under 14 years of age due to insufficient evidence regarding its safety and efficacy in this population. For pediatric patients with iron deficiency anemia requiring parenteral iron therapy, healthcare providers should consider alternative parenteral iron formulations that have established safety data in children. The decision regarding which parenteral iron preparation to use in pediatric patients should be made by a specialist with experience in managing iron deficiency in children.
Missed Dose
Since Cosmofer is administered by healthcare professionals in a clinical setting, missed doses are managed by your treatment team. If you miss a scheduled appointment, contact your healthcare provider to reschedule. Your doctor will reassess your iron status and adjust the remaining treatment plan as needed. Do not attempt to compensate for a missed dose by receiving a double dose at the next appointment.
Overdose
Cosmofer is administered by trained healthcare professionals who carefully calculate and monitor each dose, making accidental overdose unlikely. However, if too much iron is administered, it can lead to iron overload, which may manifest as hemosiderosis with symptoms including abdominal pain, nausea, vomiting, and potentially organ damage over time. If you suspect that you have received too much Cosmofer, inform your doctor or nurse immediately. Treatment of iron overload may include chelation therapy with agents such as deferoxamine to remove excess iron from the body.
What Are the Side Effects of Cosmofer?
Like all medicines, Cosmofer can cause side effects, although not everyone experiences them. The most serious risk is anaphylaxis, a severe allergic reaction that can occur within minutes. Other side effects range from uncommon local injection site reactions to rare systemic effects. All patients must be monitored for at least 30 minutes after each dose.
Contact medical staff immediately if you experience any of the following signs of a serious allergic reaction: difficulty breathing, hives (urticaria), facial flushing, skin rash, itching, nausea and chills, chest pain (which may be a sign of Kounis syndrome), sudden severe drop in blood pressure, or cardiovascular collapse. In rare cases, fatal anaphylactic reactions have been reported.
Hypersensitivity reactions to Cosmofer can be immediate (occurring within minutes) or delayed (appearing hours to four days after administration). Immediate severe reactions, though occurring in fewer than 1 in 10,000 patients, may involve sudden breathing difficulties, cardiovascular collapse, and in extremely rare cases, death. Delayed reactions typically present as joint or muscle pain, sometimes accompanied by fever.
Uncommon Side Effects
- Abdominal pain and vomiting
- Blurred vision
- Sensation of warmth or flushing
- Muscle cramps
- Numbness or tingling (paresthesia)
Rare Side Effects
- Loss of consciousness
- Altered mental state
- Seizures (convulsions)
- Dizziness, restlessness, fatigue
- Low blood pressure (hypotension)
- Angioedema (severe allergic swelling)
- Irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia)
- Chest pain
- Diarrhea, excessive sweating, tremors
Very Rare Side Effects
- Decreased red blood cell count (hemolysis)
- Headache
- Tingling sensations (formication)
- High blood pressure (hypertension)
- Transient hearing loss (deafness)
- Heart palpitations
- During pregnancy: fetal heart rate deceleration has been reported
Frequency Not Known
- Flu-like illness (fever, muscle and joint aches) occurring hours to days after injection
- Exacerbation of joint pain in patients with rheumatoid arthritis
Injection Site Reactions
After intravenous administration: Local reactions including tenderness, swelling, and inflammation of the vein (phlebitis) may occur at the injection site. These reactions are usually mild and resolve within a few days.
After intramuscular administration: Injection into a muscle may cause skin discoloration (brown staining) at the injection site, bleeding, sterile abscess formation, tissue damage (necrosis or atrophy), and pain. The risk of skin staining can be minimized by using the Z-track injection technique, where the skin is pulled to one side before inserting the needle, and patients should not rub the injection site afterwards.
Reporting Side Effects
Reporting suspected side effects after a medicine has been authorized is important for ongoing safety monitoring. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national medicines regulatory authority. This helps continuously monitor the benefit-risk balance of the medicine.
How Should You Store Cosmofer?
Cosmofer requires no special storage conditions but must not be frozen. Ampoules should be inspected before use for sediment or damage, and only homogeneous solutions without precipitate should be used. The product should be stored out of the sight and reach of children.
Cosmofer does not require any special temperature or light storage conditions under normal circumstances. However, the following guidelines should be observed:
- Do not freeze: Freezing may damage the iron-dextran complex structure and render the product unsafe for use
- Inspect before use: Check each ampoule carefully before administration. Only use ampoules containing a homogeneous brown solution without any visible sediment, precipitate, or damage to the glass
- Keep out of reach of children: Store all medicines in a location not accessible to children
- Check expiry date: Do not use Cosmofer after the expiry date printed on the carton and ampoule (after "EXP"). The expiry date refers to the last day of the indicated month
- Proper disposal: Healthcare personnel are responsible for the correct storage and disposal of Cosmofer according to local pharmaceutical waste regulations
Once diluted for infusion, Cosmofer should be used immediately according to clinical protocols. Any unused solution or waste material should be disposed of in accordance with local requirements for handling pharmaceutical waste.
What Does Cosmofer Contain?
The active substance in Cosmofer is iron(III) hydroxide dextran complex, providing 50 mg of elemental iron per milliliter. Inactive ingredients include water for injections, sodium hydroxide, and hydrochloric acid for pH adjustment. The product is available in 2 ml, 5 ml, and 10 ml ampoules.
Active Ingredient
The active substance is an iron(III) hydroxide dextran complex, in which iron is bound within a dextran matrix. Each milliliter of solution contains 50 mg of iron(III). The iron is in the ferric (Fe3+) oxidation state, complexed with dextran to create a stable colloid suitable for parenteral administration.
Inactive Ingredients (Excipients)
- Water for injections: The vehicle/solvent for the iron-dextran complex
- Sodium hydroxide: Used as a pH adjuster to maintain the correct acidity of the solution
- Hydrochloric acid: Used as a pH adjuster to maintain the correct acidity of the solution
Available Pack Sizes
| Ampoule Size | Iron Content | Pack Sizes Available |
|---|---|---|
| 2 ml | 100 mg iron(III) | 5 × 2 ml, 10 × 2 ml |
| 5 ml | 250 mg iron(III) | 10 × 5 ml |
| 10 ml | 500 mg iron(III) | 2 × 10 ml, 5 × 10 ml |
Cosmofer is packaged in glass ampoules containing a dark brown solution. The appearance should be uniform and homogeneous. Not all pack sizes may be marketed in every country. Cosmofer is manufactured by Pharmacosmos A/S in Holbaek, Denmark.
Availability by Country
Cosmofer is approved within the European Economic Area (EEA) and the United Kingdom (Northern Ireland) under the following names: CosmoFer in Denmark, Estonia, Germany, Ireland, Latvia, Lithuania, Netherlands, Norway, Sweden, and the United Kingdom (Northern Ireland).
Frequently Asked Questions About Cosmofer
Medical References
- European Medicines Agency (EMA). "Cosmofer - Summary of Product Characteristics (SmPC)." European regulatory product information for Cosmofer. Evidence-based prescribing information.
- Auerbach M, Adamson JW (2016). "How we diagnose and treat iron deficiency anemia." American Journal of Hematology. 91(1):31-38. Comprehensive review of iron deficiency anemia diagnosis and treatment strategies including parenteral iron.
- Kidney Disease: Improving Global Outcomes (KDIGO) (2012). "Clinical Practice Guideline for Anemia in Chronic Kidney Disease." Kidney International Supplements. 2(4):279-335. International clinical guideline for managing anemia in CKD patients, including IV iron therapy recommendations.
- Rampton D, et al. (2014). "Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management." Haematologica. 99(11):1671-1676. https://doi.org/10.3324/haematol.2014.111492 Expert consensus on managing hypersensitivity risk with IV iron preparations.
- National Institute for Health and Care Excellence (NICE). "Chronic kidney disease: managing anaemia. NICE guideline [NG8]." NICE Guidance UK national guidelines for managing anemia in CKD, including iron replacement strategies.
- World Health Organization (WHO) (2023). "Model List of Essential Medicines - 23rd List." WHO Essential Medicines Iron dextran is included on the WHO list of essential medicines for treating iron deficiency anemia.
- Avni T, et al. (2015). "The safety of intravenous iron preparations: systematic review and meta-analysis." Mayo Clinic Proceedings. 90(1):12-23. https://doi.org/10.1016/j.mayocp.2014.10.007 Systematic review and meta-analysis evaluating the safety profile of IV iron products including iron dextran.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
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