Can a patient with ulcerative colitis and iron deficiency be treated with intravenous ferric carboxymaltose (Ferinject)?

Yes, intravenous ferric carboxymaltose is appropriate and recommended for treating iron deficiency in patients with ulcerative colitis.

Intravenous ferric carboxymaltose should be considered as first-line treatment for patients with ulcerative colitis who have clinically active disease, previous intolerance to oral iron, hemoglobin below 10 g/dL, or who require erythropoiesis-stimulating agents. 1

Evidence Supporting IV Ferric Carboxymaltose in UC

Guideline-Based Indications

The European Crohn's and Colitis Organisation (ECCO) specifically identifies ferric carboxymaltose as one of the well-studied intravenous iron preparations with large published trials in IBD patients. 1

Key clinical scenarios where IV ferric carboxymaltose is preferred over oral iron: 1

• Active ulcerative colitis - Oral iron can exacerbate intestinal inflammation and alter gut microbiota
• Hemoglobin < 10 g/dL - More rapid correction needed than oral iron can provide
• Previous oral iron intolerance - Common due to gastrointestinal side effects
• Need for erythropoiesis-stimulating agents - IV iron optimizes ESA response

Dosing Advantages

Ferric carboxymaltose offers practical advantages over other IV iron formulations: 1

• Single doses of 500-1000 mg (up to 20 mg/kg body weight)
• 15-minute infusion time - significantly faster than iron sucrose
• No test dose required - unlike iron dextran which carries anaphylaxis risk

Simplified Dosing Regimen

A simple weight and hemoglobin-based dosing scheme has proven more effective than Ganzoni formula calculations: 1

Hemoglobin (g/dL)	Body weight <70 kg	Body weight ≥70 kg
10-12 (women) / 10-13 (men)	1000 mg	1500 mg
7-10	1500 mg	2000 mg

Safety Profile

Ferric carboxymaltose is safe and well-tolerated in IBD patients. 2, 3

• No anaphylaxis reported in initial trials 1
• Drug-related adverse events occur in similar rates to oral iron 2
• Most common side effects: headache, dizziness, nausea (generally mild-to-moderate) 2
• In a large German cohort of 224 IBD patients, no adverse drug reactions or serious adverse events occurred 3

Important Safety Considerations from FDA Label

The FDA label identifies specific risks to monitor: 4

• Hypophosphatemia - Can lead to bone softening and fractures with repeated treatments; check phosphate levels before repeat dosing if within 3 months
• Hypertension - Monitor blood pressure during and after infusion
• Allergic reactions - Observe patient for at least 30 minutes post-infusion with resuscitation facilities available

Clinical Efficacy Data

Multiple studies demonstrate robust efficacy in UC patients: 2, 3, 5

• Hemoglobin increases from baseline of 10.0 to 12.3 g/dL 3
• Ferritin increases from 52 to 103 μg/L 3
• Transferrin saturation increases from 15% to 25% 3
• 63.3% of patients achieved response (Hb normalization or ≥2 g/dL increase) 3
• Quality of life scores improve significantly 2, 3

Treatment Goals and Monitoring

The goal is to normalize hemoglobin levels AND replenish iron stores. 1

• Expect ≥2 g/dL hemoglobin increase within 4 weeks as acceptable response 1
• Target post-treatment ferritin >400 μg/L to prevent recurrence for 1-5 years 1
• Monitor every 3 months for the first year after correction 1
• Re-treat when ferritin drops below 100 μg/L or hemoglobin falls below 12-13 g/dL (gender-dependent) 1

Prevention of Recurrence

Anemia recurs frequently in IBD patients despite treatment: 6

• In a randomized trial, 26.7% of patients given FCM developed recurrent anemia versus 39.4% given placebo within 8 months 6
• Proactive FCM administration when ferritin drops below 100 μg/L significantly delays anemia recurrence (hazard ratio 0.62) 6

Common Pitfall to Avoid

If a patient on IV ferric carboxymaltose develops black stools, investigate for gastrointestinal bleeding rather than attributing it to iron therapy. 7 Unlike oral iron which causes black stools due to unabsorbed iron in the gut, IV iron does not discolor stool since it bypasses the gastrointestinal tract. 7

When Oral Iron May Be Considered

Oral iron may be used only in highly selected UC patients: 1

• Clinically inactive disease
• Mild anemia (Hb 11.0-11.9 g/dL in women, 11.0-12.9 g/dL in men)
• No previous oral iron intolerance
• Maximum 100 mg elemental iron daily if oral route chosen 1

However, oral iron has significant limitations in UC: unabsorbed iron may exacerbate disease activity, induce carcinogenesis, and alter intestinal microbiota. 1