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Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.
Methemoglobin is an isoform of hemoglobin without oxygen carrying properties. Higher levels of methemoglobin may impact oxygen transport of the blood and increase the risk of tissue hypoxia. Methemoglobinemia has been reported as side effect of different drugs such as antibiotics or local anesthetics, but not after iron preparations. There is only one case report of increased levels of methemoglobin following intravenous iron therapy.
Patients with anemia due to iron deficiency can be treated with intravenous iron preparations such as ferric carboxymaltose or ferric derisomaltose. Anemia itself reduces oxygen transport of the blood, increasing the risk of tissue hypoxia due to methemoglobinemia in those patients.
This study aims to assess methemoglobinemia following treatment with intravenous iron in patients with anemia. The report will include case reports of patients with severe anemia who developed methemoglobinemia following treatment with ferric derisomaltose. Furthermore, methemoglobin levels are evaluated before and after intravenous iron administration in a cohort of adult patients with anemia who are scheduled to receive ferric carboxymaltose or ferric derisomaltose in routine care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric derisomaltose | Adult patients with anemia scheduled for administration of ferric derisomaltose as prescribed in routine care. |
| |
| Ferric carboxymaltose | Adult patients with anemia scheduled for administration of ferric carboxymaltose as prescribed in routine care. |
| |
| Case reports | Patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample after treatment | Diagnostic Test | Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in methemoglobin after ferric derisomaltose | Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric derisomaltose. | 30-120 minutes after start of iron administration |
| Difference in methemoglobin after ferric carboxymaltose | Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric carboxymaltose. | 30-120 minutes after start of iron administration |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in methemoglobin depending on drug dosage | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on drug dosage | 30-120 minutes after start of iron administration |
| Difference in methemoglobin depending on age |
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Inclusion Criteria:
for patients in the cohort study:
for patients in the case report:
- patients with severe anemia who developed methemoglobinemia following administration of ferric derisomaltose
Exclusion Criteria:
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All adults (age ≥ 18 years) with anemia that are scheduled for administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose) in the region of Dalarna, Sweden.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Clinical Research Dalarna | Falun | 79182 | Sweden |
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| ID | Term |
|---|---|
| D008708 | Methemoglobinemia |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Case reports | Other | Description of clinical course and methemoglobin levels in patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose. |
|
Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on age. |
| 30-120 minutes after start of iron administration |
| Difference in methemoglobin depending on sex | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on sex. | 30-120 minutes after start of iron administration |
| Difference in methemoglobin depending on hemoglobin level before treatment | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on hemoglobin level before treatment. | 30-120 minutes after start of iron administration |
| Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron. | Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on blood levels of ferritin, transferrin or iron. | 30-120 minutes after start of iron administration |
| Association between difference in methemoglobin and venous lactate | Association between change of methemoglobin (percent) in venous blood and change of lactate in venous blood after compared to before treatment with intravenous iron. | 30-120 minutes after start of iron administration |
| D009750 | Nutritional and Metabolic Diseases |