What are the official guidelines for administering FCM (Follicle-Stimulating Hormone) injection in gynaecology?

Guidelines for Administering Ferric Carboxymaltose (FCM) in Gynecology

FCM should be administered intravenously as a diluted infusion over 15-30 minutes with appropriate monitoring for hypersensitivity reactions. 1

Dosing Protocol

• FCM can be administered as a single total dose infusion (TDI) of 1000 mg in Europe and Asia, while in the US it's distributed as 750 mg vials with a recommendation for two doses 1 week apart 1
• The maximum recommended cumulative dose is 1000 mg of iron (20 mL FCM) per week 1
• For gynecological conditions such as heavy menstrual bleeding, the dose should be calculated based on body weight and hemoglobin levels 1

Administration Method

• FCM should be diluted in 100-250 mL of normal saline (0.9% sodium chloride) 1
• Administration time varies by dose:
  • 500 mg should be infused over minimum 6 minutes in 100 mL saline 1
  • 1000 mg should be infused over minimum 15 minutes in 250 mL saline 1
• FCM may be given as an undiluted slow bolus injection or as a diluted infusion, but if given as infusion, it should not be over-diluted as this affects stability 1

Monitoring Requirements

• Patients should be observed for adverse effects for at least 30 minutes following each IV injection 1
• Monitor serum phosphate levels in patients at risk for chronic low serum phosphate, especially those requiring repeat courses of treatment 1
• Check phosphate levels in patients who receive a second course of treatment within 3 months 1

Contraindications

• Hypersensitivity to FCM or any of its excipients 1
• Known serious hypersensitivity to other parenteral iron products 1
• Anemia not attributed to iron deficiency 1
• Evidence of iron overload or disturbances in iron utilization 1

Special Considerations for Gynecological Patients

• FCM is particularly effective for women with heavy menstrual bleeding and postpartum anemia 1, 2
• For postpartum women, FCM has shown significant increases in hemoglobin (mean increase of 4.2 g/dL after 6 weeks) and serum ferritin levels 2
• FCM is superior to iron sucrose in improving hemoglobin and ferritin levels in postpartum anemia 3, 4
• For pregnant women, FCM can be administered in the second and third trimesters with significant hemoglobin improvement (1.25 g/dL in 4 weeks) 5

Risk Management

• FCM should be avoided in patients requiring repeat infusions due to recurrent blood loss or malabsorptive disorders, as it may lead to hypophosphatemia 1
• Patients with abnormal uterine bleeding who require repeated iron infusions are at high risk for developing hypophosphatemia 1
• Alternative iron formulations should be considered for patients at high risk of hypophosphatemia 1
• Patients should be informed to seek medical care if they experience worsening fatigue with myalgias or bone pain following infusion 1

Follow-up Recommendations

• Iron status should be re-evaluated 3 months after administration 1
• Early re-evaluation of iron status (within 4 weeks of administration) should be avoided as ferritin levels increase markedly following IV iron administration 1
• Further iron repletion should be provided as needed based on follow-up testing 1

Safety Profile

• FCM has a favorable safety profile with fewer adverse events compared to oral iron supplementation 3, 6
• The most common adverse reactions include itching and rash, occurring in approximately 4% of patients 5
• FCM is associated with treatment-emergent hypophosphatemia, which can be prolonged and requires monitoring in high-risk patients 1

Remember that while FCM is effective for treating iron deficiency in gynecological conditions, it should be used with caution in patients requiring repeated infusions due to the risk of hypophosphatemia. For these patients, alternative IV iron formulations like ferric derisomaltose (FDI) may be more appropriate 1.