Ferric Carboxymaltose

# Ferric carboxymaltose ## Overview - **Classification**: Iron replacement product, parenteral iron - **Mechanism**: Replenishes body iron stores and increases hemoglobin levels. Iron is delivered as a stable iron-carbohydrate complex for cellular uptake. ## Primary Indications 1. **Iron Deficiency Anemia (IDA)**: In adult patients with intolerance or unsatisfactory response to oral iron. 2. **Iron Deficiency Anemia (IDA)**: In adult patients with non-dialysis dependent chronic kidney disease (CKD). 3. **Iron Deficiency Anemia (IDA)**: In pediatric patients ≥ 1 year of age with intolerance or unsatisfactory response to oral iron. ## Adult Dosing ### Standard Dosing **Iron Deficiency Anemia** - **Dose**: Individualized based on baseline hemoglobin (Hb) and body weight. - **≥35 kg**: **750 mg** IV. - **<35 kg**: **15 mg/kg** IV. - **Frequency**: Administer a second dose at least **7 days** after the first dose. - Total cumulative dose: **1000 mg** to **1500 mg** per treatment course. - **Route**: Intravenous (IV) infusion over at least **15 minutes**. - **Duration**: Two doses given at least 7 days apart. Do not exceed **1000 mg** per week. ### Dose Adjustments - **Renal Impairment**: No specific dose adjustment recommended. Use caution in CKD patients due to potential for hypotension. - **Hepatic Impairment**: No specific dose adjustment recommended. Use with caution. - **Elderly Patients**: No specific dose adjustment needed. Administer with caution and monitor for adverse reactions. ## Pediatric Dosing ### Neonates (0-28 days) - **Not Recommended**: Safety and efficacy have not been established. ### Infants (1-12 months) - **Not Recommended**: Safety and efficacy have not been established. ### Children (1-12 years) **Iron Deficiency Anemia** - **Dose**: **15 mg/kg** IV. - **Frequency**: Administer as a single dose. A second dose may be given at least **7 days** later if needed. - **Maximum**: Max single dose **750 mg**. Cumulative maximum dose **1500 mg**. - **Special Notes**: For patients with body weight **<35 kg**. For patients ≥35 kg, refer to adult dosing. ### Adolescents (13-18 years) **Iron Deficiency Anemia** - **Dose**: For patients ≥35 kg, follow adult dosing: **750 mg** IV. - **Frequency**: Administer a second dose at least **7 days** after the first dose. - **Maximum**: Max single dose **750 mg**. Cumulative maximum dose **1500 mg**. ## Safety Information ### Contraindications - **Absolute**: Hypersensitivity to ferric carboxymaltose or excipients. - **Absolute**: Anemia not caused by iron deficiency (e.g., hemolytic anemia). - **Absolute**: Iron overload or disturbances in iron utilization. ### Common Adverse Effects - **Very Common (>10%)**: Headache, nausea, hypertension, injection site reactions. - **Common (1-10%)**: Dizziness, flushing, hypophosphatemia, abdominal pain, diarrhea, rash, arthralgia. - **Serious but Rare**: Anaphylaxis/hypersensitivity reactions (life-threatening), severe hypotension, iron overload. ### Key Drug Interactions - **Oral Iron Preparations**: Reduce absorption of oral iron. - **Oral Iron Preparations**: Start at least **5 days** after the last FCM dose. - **Other Parenteral Iron**: Do not administer concomitantly with other IV iron products. - **ACE Inhibitors**: May enhance hypotensive effect. Monitor BP. ## Monitoring & Follow-up - **Before Treatment**: Confirm IDA (ferritin <30 ng/mL or TSAT <20%). Obtain baseline Hb. - **During Treatment**: Monitor for hypersensitivity during and for at least **30 minutes** after infusion. Monitor BP and pulse. - **Clinical Signs**: Watch for dizziness, swelling, rash, breathing difficulty (anaphylaxis). - **After Treatment**: Re-evaluate iron status (Hb, ferritin, TSAT) at least **4 weeks** after the last dose. ## Clinical Pearls - 💡 **Tip 1**: Administer **slowly** over at least **15 minutes** to minimize risk of hypotension and infusion reactions. - 💡 **Tip 2**: Have resuscitation equipment and trained personnel ready for severe hypersensitivity reactions. - 💡 **Tip 3**: Transient hypophosphatemia is common; usually asymptomatic but monitor in high-risk patients. - 💡 **Tip 4**: Avoid extravasation; it can cause long-lasting brown skin discoloration. > **⚠️ Important**: This information is for educational purposes only. Always consult current prescribing information, local guidelines, and clinical judgment before prescribing.