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Ferric Carboxymaltose
Before starting Ferric Carboxymaltose, it is essential to consult with a healthcare provider, especially in the presence of the following conditions:
- Iron Overload Conditions: Ferric Carboxymaltose is contraindicated in individuals with conditions involving iron overload such as hemochromatosis, hemosiderosis, or other disorders where excess iron accumulates in the body. These patients should not receive iron supplementation.
- Hypersensitivity Reactions: Patients with a known hypersensitivity to Ferric Carboxymaltose or any of its components (including polysaccharides) should avoid its use, as it can trigger allergic reactions, including anaphylaxis.
- Anemia of Unknown Cause: Ferric Carboxymaltose should not be used in patients with anemia that has not been clearly diagnosed or whose iron deficiency is not confirmed, as it may mask other underlying conditions requiring different treatments.
- Pregnancy and Breastfeeding: Ferric Carboxymaltose should only be used during pregnancy if the potential benefits outweigh the risks. It is generally considered safe during breastfeeding, but this should be discussed with a healthcare provider prior to use.
- Liver and Kidney Disorders: Caution is needed in patients with severe liver or kidney impairment, as iron therapy could affect these organs' functioning. A healthcare provider will adjust dosing if necessary and monitor the patient closely.
- Blood Transfusion History: If a patient has had a recent blood transfusion, Ferric Carboxymaltose should only be used after careful consideration, as its combination with blood products can potentially lead to complications or iron overload.
Ferric Carboxymaltose is a form of intravenous iron used to treat or prevent iron deficiency in the following situations:
- Iron Deficiency Anemia: It is indicated for the treatment of iron deficiency anemia in adult patients who cannot tolerate or do not respond adequately to oral iron supplementation. This includes individuals with chronic diseases, post-surgical patients, or those with gastrointestinal conditions that affect iron absorption.
- Chronic Kidney Disease (CKD): Patients with chronic kidney disease who are receiving erythropoiesis-stimulating agents (ESAs) may also benefit from Ferric Carboxymaltose to address iron deficiency associated with CKD.
- Postpartum Iron Deficiency: Women who experience significant iron deficiency after childbirth may be treated with Ferric Carboxymaltose to replenish iron stores.
- Other Conditions Associated with Iron Deficiency: It is used in other situations of iron deficiency anemia related to blood loss, poor diet, or other medical conditions that cause iron depletion.
Ferric Carboxymaltose should not be used in the following situations:
- Iron Overload: It is contraindicated in individuals with hemochromatosis, hemosiderosis, or other disorders involving excess iron stores in the body.
- Severe Hypersensitivity Reactions: Ferric Carboxymaltose should be avoided in patients who have had previous allergic reactions (such as anaphylaxis) to intravenous iron preparations.
- Anemia Not Caused by Iron Deficiency: It is contraindicated in patients with anemia resulting from non-iron-related causes, such as vitamin B12 deficiency, folate deficiency, or bone marrow diseases, where iron supplementation would not be beneficial and could lead to complications.
- Severe Hepatic Disease: It should not be used in patients with severe liver disease, as impaired iron metabolism could cause complications.
Common side effects of Ferric Carboxymaltose include:
- Injection Site Reactions: Pain, redness, swelling, or inflammation at the injection site is common after administration.
- Hypotension: Some patients may experience a drop in blood pressure (hypotension) during or after the infusion, which may require monitoring.
- Headache: Headaches are common, especially during or shortly after administration.
- Dizziness: Some patients may experience dizziness or lightheadedness due to a drop in blood pressure.
- Nausea and Vomiting: Mild nausea or gastrointestinal discomfort may occur following treatment.
- Fatigue: Fatigue or feelings of weakness may occur during the iron repletion process.
- Rashes: Skin rashes, including urticaria (hives), can occur, which may indicate an allergic reaction.
- Allergic Reactions: Rare but severe reactions include anaphylaxis, bronchospasm, or swelling of the throat. Immediate medical attention should be sought if these occur.
- Iron Overload: With prolonged or excessive use, iron overload can occur, leading to damage in organs such as the liver, heart, and pancreas.
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Ferric Carboxymaltose is a polymeric iron complex that is administered intravenously to rapidly replenish iron stores in the body. The mechanism of action involves:
- Iron Delivery: After intravenous administration, the Ferric Carboxymaltose complex releases ferric iron into the bloodstream. This iron is then absorbed by iron transport proteins and delivered to various tissues, including the bone marrow, where it is utilized for hemoglobin synthesis and the production of red blood cells.
- Iron Replenishment: The ferric ion component is essential for the production of hemoglobin and myoglobin, proteins involved in oxygen transport. It helps restore iron levels in individuals with iron deficiency anemia.
- Slow Release: The formulation is designed for a slow release of iron, allowing it to be safely absorbed into the body without causing excessive fluctuations in iron levels.
Ferric Carboxymaltose can interact with several other medications, including:
- Other Iron Supplements: Concomitant use of oral iron supplements or other intravenous iron products is not recommended, as this could increase the risk of iron overload and lead to serious complications.
- Chronic Antacid Use: Long-term use of antacids or medications that reduce stomach acid (e.g., proton pump inhibitors, H2 antagonists) can impair the absorption and efficacy of oral iron, though this is not a significant concern for Ferric Carboxymaltose (which is administered intravenously).
- ACE Inhibitors or Angiotensin II Receptor Antagonists: The use of iron supplementation alongside medications that can affect the renin-angiotensin system, such as ACE inhibitors, may increase the risk of hypotension when receiving intravenous iron, requiring monitoring during administration.
- Chelating Agents: Medications that act as iron chelators, such as deferoxamine, used to treat iron overload, may interfere with Ferric Carboxymaltose therapy or require careful management of iron levels.
- Other Drugs That Affect Hemoglobin Levels: Any drugs that directly impact hemoglobin synthesis or red blood cell production, such as erythropoiesis-stimulating agents, should be closely monitored when combined with Ferric Carboxymaltose.
There are limited data from the use of Ferric Carboxymaltose in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and Ferric Carboxymaltose should not be used during pregnancy unless clearly necessary.
Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Ferric Carboxymaltose should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Animal data suggest that iron released from Ferric Carboxymaltose can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus.
The dosage of Ferric Carboxymaltose depends on the severity of the iron deficiency anemia and the patient's weight. The typical dosing regimen is:
- Initial Dose: A typical initial dose is 15 mg/kg body weight given intravenously, up to a maximum of 1,000 mg per infusion session.
- Repeat Doses: If necessary, additional doses may be administered 7 days apart, depending on the patient's iron levels and clinical response.
- The total dose and frequency of administration may vary based on the severity of iron deficiency anemia and patient factors such as body weight, age, and comorbidities.
Ferric Carboxymaltose is typically not recommended for children under 14 years of age unless specifically indicated and prescribed by a healthcare provider. The safety and efficacy in pediatric populations have not been established, and the dosing regimen may differ from that in adults.
In children who require intravenous iron, alternative formulations may be considered based on age, weight, and clinical need. Always consult a pediatric specialist before administering this medication in younger patients.
For patients with renal impairment, the use of Ferric Carboxymaltose requires caution:
- Moderate Renal Impairment (eGFR 30-59 mL/min/1.73 m²): Dosing should be adjusted, and the patient should be closely monitored during treatment.
- Severe Renal Impairment (eGFR < 30 mL/min/1.73 m²): Ferric Carboxymaltose should be used with caution, and dose adjustments may be necessary. Renal function should be regularly monitored to prevent complications.
IV Preparation
For IV infusion, dilute in up to 250 mL 0.9% NaCl; resulting concentration should be >2 mg/mL
IV Administration
IV push: May administer undiluted at rate of 100 mg/minute
IV infusion: Dilute dose in up to 250 mL 0.9% NaCl and infuse over at least 15 minutes
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