What are the adverse effects of IV FCM (Fludarabine, Cyclophosphamide, Mitoxantrone) infusion?

Adverse Effects During IV Ferric Carboxymaltose (FCM) Infusion

The most common adverse effects during IV ferric carboxymaltose infusion include dizziness, headache, hypertension, hypophosphatemia, injection-site reactions, and nausea, occurring in 1-10% of patients, with a low risk of hypersensitivity reactions (0.1-1%). 1, 2

Common Adverse Effects

• Mild and transient effects (1-10% frequency):

  • Dizziness
  • Headache
  • Hypertension
  • Hypophosphatemia
  • Injection-site reactions
  • Nausea
  • Vomiting 1, 2, 3

• Less common effects (0.1-1% frequency):

  • Hypersensitivity reactions
  • Skin discoloration at infusion site (if extravasation occurs) 1, 2

Risk Factors for Adverse Reactions

Patients with the following conditions are at higher risk for adverse reactions:

• Known drug allergies
• History of severe asthma, eczema, or other atopic allergies
• Immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis) 1

Monitoring and Management

During Administration

1. Observation requirement: Patients must be observed for adverse effects for at least 30 minutes following each IV injection 1

2. Vital sign monitoring: Check blood pressure, heart rate, and respiratory rate before, during, and after administration 1

3. Extravasation management: If paravenous leakage occurs, the administration of FCM must be stopped immediately to prevent skin staining/discoloration 1

Post-Administration Monitoring

• Iron status: Re-evaluate 3 months after administration (early re-evaluation within 4 weeks should be avoided as serum ferritin increases markedly following IV iron administration) 1

• Phosphate levels: Monitor serum phosphate in patients at risk for chronic low serum phosphate or those requiring repeat courses of treatment 2

Administration Guidelines to Minimize Adverse Effects

• Maximum dose: The maximum recommended cumulative dose is 1000 mg iron/week 1

• Administration methods:

  • Undiluted slow bolus injection (100 mg/min)
  • Diluted infusion according to specific dilution plan:
    • 500 mg in 100 mL saline over minimum 6 minutes
    • 1000 mg in 250 mL saline over minimum 15 minutes 1, 2

• Dilution caution: FCM should not be over-diluted as this affects the stability of the drug 1

Contraindications

FCM is contraindicated in patients with:

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

Clinical Pearls

1. Unlike iron dextran, FCM does not require a test dose before administration, making it more convenient and potentially safer 2

2. Administration should be performed in settings where staff are trained to monitor for and manage hypersensitivity reactions 1

3. The safety profile of FCM is generally favorable compared to older IV iron preparations, with a lower risk of severe hypersensitivity reactions 2, 4

4. Hypophosphatemia can occur particularly with repeated dosing, so monitoring phosphate levels may be important in certain patients 2

By following proper administration guidelines and monitoring protocols, the risk of adverse effects during IV FCM infusion can be minimized while effectively treating iron deficiency.