What are the potential complications after a Monoferric (ferric derisomaltose) infusion?

Complications After Monoferric (Ferric Derisomaltose) Infusion

Monoferric has an exceptionally low rate of serious complications, with hypersensitivity reactions occurring in only 0.14% of patients—significantly lower than other IV iron formulations—and treatment-emergent hypophosphatemia being rare compared to ferric carboxymaltose. 1, 2

Hypersensitivity Reactions

Types and Incidence

The vast majority of reactions to Monoferric are non-IgE-mediated infusion reactions (CARPA - Complement Activation-Related Pseudo-Allergy) rather than true allergic reactions 1:

• Serious or severe hypersensitivity reactions occur in only 0.14% of patients receiving ferric derisomaltose, compared to 1.08% with ferric carboxymaltose 2
• True IgE-mediated anaphylaxis is exceedingly rare, occurring in less than 1 in 200,000 administrations 1
• CARPA reactions are self-limited and usually resolve without treatment 1

Clinical Presentation of CARPA

Non-serious infusion reactions typically present with 1:

• Flushing
• Myalgias and/or arthralgias
• Back pain and/or chest pressure
• Most commonly occur at the beginning of infusion
• No symptoms of anaphylaxis (no systemic hypotension, wheezing, peri-orbital edema, respiratory stridor, or gastrointestinal pain)

True Anaphylaxis Warning Signs

Seek immediate intervention if the patient develops 1:

• Airway compromise or respiratory stridor
• Mucosal swelling or peri-orbital edema
• Systemic hypotension
• Wheezing
• Gastrointestinal pain

Hypophosphatemia

Monoferric has a significantly lower risk of hypophosphatemia compared to ferric carboxymaltose 1:

• Hypophosphatemia occurs in only 4% of patients with ferric derisomaltose versus 58% with ferric carboxymaltose 1
• Most episodes are biochemically moderate (serum phosphate 0.32-0.64 mmol/L) and asymptomatic 1
• Phosphorus monitoring following Monoferric administration should be guided by clinical symptoms only—routine monitoring is not required 1
• Severe, symptomatic hypophosphatemia requiring prolonged supplementation is rare 3

When to Monitor Phosphate

Consider phosphate monitoring only in patients with 1:

• Risk factors for hypophosphatemia
• Those receiving long-term or multiple high-dose infusions
• Clinical symptoms suggesting hypophosphatemia (muscle weakness, bone pain, confusion)

Cardiovascular Events

Monoferric is associated with fewer cardiovascular adverse events compared to iron sucrose 4:

• Time to first cardiovascular adverse event was significantly longer with ferric derisomaltose (hazard ratio: 0.59,95% CI: 0.37-0.92) 4
• This safety advantage was consistent in patients both with and without heart failure 4
• Overall cardiovascular adverse events occurred in 4.2% of patients without heart failure and 9.4% in those with heart failure 4

Management Recommendations

Pre-Infusion Preparation

All staff must be educated on recognition and management of infusion reactions 1:

• Resuscitation facilities should be available 1
• Patient education about potential reactions is essential 1
• Premedication should be reserved only for patients at high risk of hypersensitivity reactions 1
• Post-infusion monitoring for 30 minutes is not routinely indicated 1

Infusion Reaction Management

If CARPA occurs during infusion 1:

• Slow or temporarily stop the infusion
• Most reactions resolve without treatment
• Distinguish from true anaphylaxis (which requires epinephrine and emergency management)
• Rechallenge with the same formulation may be attempted after an infusion reaction 1

Laboratory Monitoring

Wait at least 7 days before checking iron parameters after infusion 5:

• Iron initially enters an exchangeable compartment before incorporation into storage pools 5
• Immediate post-infusion labs will be inaccurate 5
• Monitoring frequency depends on the underlying cause of iron deficiency 1

Special Populations

Pregnancy

Monoferric is safe in pregnancy but with specific timing considerations 1:

• Avoid IV iron prior to 13 weeks gestation due to lack of safety data 1
• After 13 weeks, administration is identical to non-pregnant patients 1
• Fetal monitoring during or following IV iron administration is not required and is not recommended 1

Patients with Comorbidities

Patients with comorbidities have a 3.6-fold higher risk of hypersensitivity reactions regardless of IV iron formulation 6:

• This applies to all IV iron preparations, not specific to Monoferric 6
• Close monitoring is warranted in these patients 6

Common Pitfalls to Avoid

• Do not check iron parameters immediately after infusion—wait at least 7 days 5
• Do not routinely premedicate all patients—reserve for high-risk individuals only 1
• Do not confuse CARPA with true anaphylaxis—management differs significantly 1
• Do not withhold treatment in patients with infection unless there is ongoing bacteremia 1
• Do not perform routine phosphate monitoring with Monoferric as you would with ferric carboxymaltose 1