iron isomaltoside

Action and Spectrum

Actions and spectrum: 

iron isomaltoside is a medication used to treat iron deficiency anemia that is characterized by a lack of iron in the body. It works by delivering iron to the body to help replenish iron stores and increase the production of red blood cells, ultimately alleviating anemia. 

iron isomaltoside specifically targets iron deficiency anemia, which results from an insufficient amount of iron in the body. It is not used to treat other types of anemia or conditions that are not related to iron deficiency. The medication primarily acts to address this specific deficiency by providing a source of iron that can be utilized by the body to produce hemoglobin and red blood cells. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Hypersensitivity reactions 

Difficulty to swallow 

shortness of breath 

hives 

swollen face 

Black Box Warning

Black Box Warning: 

There is no specific black box warning associated with iron isomaltoside. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Patients with a known hypersensitivity or allergy to iron isomaltoside or any of its components should not use this medication.  
• Infections: iron isomaltoside should not be administered to individuals with active infections, especially systemic infections. Using iron in the presence of infection can worsen the underlying condition. 
• Hemochromatosis: In patients with hereditary hemochromatosis or other conditions leading to iron overload, iron isomaltoside should not be used. It can exacerbate iron overload and related complications. 
• Erythropoietin Treatment: In cases where anemia is being treated with erythropoietin, the cause of the anemia should be thoroughly investigated. iron isomaltoside should only be used in conjunction with erythropoietin if iron deficiency is confirmed. 
• Chronic Kidney Disease: Special caution should be exercised in individuals with chronic kidney disease. The use of iron isomaltoside in this population requires careful assessment and monitoring by a healthcare provider.

Caution: 

• Renal Impairment: Patients with kidney problems should be monitored closely when using iron isomaltoside. Special caution is needed because iron isomaltoside may increase the risk of renal complications. 
• Gastrointestinal Disorders: Patients with active inflammatory bowel disease or other gastrointestinal disorders may not absorb iron isomaltoside efficiently. Careful monitoring is needed to ensure that the medication is effective in these cases. 
• Iron Overload Disorders: Patients with conditions like hemochromatosis or iron overload should not use iron isomaltoside. It can exacerbate iron overload and related complications. 
• Pediatric and Geriatric Patients: The safety and efficacy of iron isomaltoside in pediatric and geriatric populations are not well-established. Use in these populations should be carefully considered, and dosages may need to be adjusted.

Comorbidities: 

• Kidney Disease: Individuals with kidney disease, including chronic kidney disease, should be carefully monitored when receiving iron isomaltoside. Iron therapy may increase the risk of renal complications. 
• Liver Disease: Liver conditions like cirrhosis can affect the metabolism and storage of iron. In patients with severe liver disease, using iron isomaltoside may require dose adjustments or alternative therapies. 
• Hemochromatosis: Hemochromatosis is a hereditary iron overload disorder. Patients with this condition should avoid iron supplementation because it can worsen iron accumulation in the body. 
• Hypertension: Patients with high blood pressure or hypertension may require careful monitoring when receiving iron isomaltoside, as iron can affect blood pressure. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category: not assigned 

Lactation: excreted into human milk: unknown   

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

iron isomaltoside is a medication used to treat iron deficiency anemia. Its pharmacology is centered around iron supplementation. When administered intravenously, iron isomaltoside delivers iron directly into the bloodstream. Iron is a vital component in the production of hemoglobin.

In cases of iron deficiency anemia, the body lacks iron to produce an adequate amount of hemoglobin. iron isomaltoside rapidly increases the iron stores in the body, allowing to produce hemoglobin, improved oxygen-carrying capacity, and the alleviation of anemia symptoms. Its complex structure with isomaltoside enhances stability and controlled release, reducing the risk of adverse reactions often associated with other iron preparations.  

Pharmacodynamics: 

• Hemoglobin Production: Iron is a crucial component in the synthesis of hemoglobin, the protein responsible for transporting oxygen in red blood cells. iron isomaltoside helps increase the production of hemoglobin, improving the oxygen-carrying capacity of the blood. 
• Iron Stores: iron isomaltoside replenishes iron stores in the body, such as ferritin, which serve as a reserve for future hemoglobin production. 
• Correction of Anemia: By addressing iron deficiency, iron isomaltoside alleviates symptoms of anemia, such as fatigue, weakness, and pallor, and helps restore normal red blood cell levels. 
• Enhanced Tissue Oxygenation: Adequate iron levels support proper tissue oxygenation, benefiting overall health and well-being. 
• Minimal Oxidative Stress: iron isomaltoside’s controlled release reduces the risk of oxidative stress and adverse reactions commonly associated with other iron preparations.

Pharmacokinetics: 

Absorption 

iron isomaltoside is typically administered intravenously, bypassing the absorption phase. It enters the bloodstream directly, ensuring precise and rapid delivery of iron. 

Distribution 

After entering the bloodstream, iron isomaltoside is carried by the circulatory system throughout the body. It is distributed to various tissues, where it becomes available for the synthesis of hemoglobin and other iron-dependent proteins. 

Metabolism 

iron isomaltoside does not undergo significant metabolism in the body. It remains in its intact form, with iron ions released gradually as needed for hemoglobin and ferritin production. 

Elimination and excretion 

Excretion of iron isomaltoside occurs primarily through iron homeostatic mechanisms. The body carefully regulates iron levels, so excess iron is neither rapidly excreted nor absorbed. Iron is excreted in small amounts through feces, urine, and sloughed-off skin and mucosal cells. 

Adminstartion

Administration: 

iron isomaltoside is typically administered as a slow intravenous infusion. The specific dosage and infusion rate will depend on the patient’s condition, iron deficiency severity, and the healthcare provider’s recommendations. The IV infusion is typically administered through a catheter inserted into a vein, often in the arm or hand. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: iron isomaltoside 

Pronounced: (EYE-urn eye-soh-MAL-toh-side)  

Why do we use iron isomaltoside? 

iron isomaltoside is often prescribed to individuals with iron-deficiency anemia, a condition characterized by low levels of RBC due to insufficient iron in the body. It helps replenish iron stores and correct anemia. Patients who are undergoing dialysis may develop iron deficiency due to blood loss during dialysis. iron isomaltoside is used to maintain iron levels and prevent anemia in these patients.

Conditions such as Crohn’s disease and ulcerative colitis can lead to chronic gastrointestinal bleeding, causing iron deficiency. iron isomaltoside can be used to address iron deficiency in individuals with these conditions. Women with heavy menstrual bleeding, known as menorrhagia, may experience iron deficiency anemia. iron isomaltoside can help manage this condition by replenishing iron levels.