Introduction
Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life.
Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.
Uses
Ferric derisomaltose is an iron injection used in the treatment of iron deficiency anemia.
This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease. In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.
Associated Conditions
Pharmacodynamics
Ferric derisomaltase increases the reticulocyte count and ultimately increases hemoglobin, treating iron deficiency anemia and its various symptoms. Parenteral iron, such as ferric derisomaltose, may cause false elevations in serum bilirubin levels and falsely reduced serum calcium.
Mechanism of Action
This drug is a complex made of iron (III) hydroxide and derisomaltose, which is an iron carbohydrate oligosaccharide that works to releases iron. The released iron then binds to the transport protein, transferrin, and is taken to erythroid precursor cells for incorporation into the hemoglobin molecule.
Absorption
After a single 1000 mg dose, the Cmax and AUC of serum iron were 408 μg/mL and 17730 μg.h /mL, respectively. Serum ferritin concentrations reach their peak about 7 days after a single dose of intravenous ferric derisomaltose.
A note on concomitant oral iron
The absorption of oral iron is decreased when administered with intravenous iron. The administration of oral iron should be delayed until at least 5 days after the last ferric derisomaltose injection.
Volume of Distribution
Ferric derisomaltose or released iron that was released is found in cells of the reticuloendothelial system (RES). It is found to be highly concentrated in the liver and spleen. The volume of distribution of other forms of intravenous iron is 3L, on average, in a 70 kg adult. Though the specific volume of distribution of ferric derisomaltose is not readily available in the literature, it is likely similar to other intravenous forms of iron.
Protein Binding
Iron binds to transferrin, the transport molecule responsible for transporting iron to erythroid precursor cells for the production of hemoglobin.
Route of Elimination
Renal elimination was not a significant route of elimination in single-dose pharmacokinetic studies. Iron can often accumulate in the body leading to iron overload followed by toxic effects. Small amounts of ferric derisomaltose are excreted in the urine and feces.
Half Life
The plasma-half live of intravenous iron is about 1-4 days.
Clearance
Intravenous iron is cleared from the plasma. Ferric derisomaltose is not eliminated via the kidneys, as the size of the complex is large and cannot be excreted via the nephron.
Toxicity
LD50 information for ferric derisomaltose is not readily available in the literature, however, the LD50 for iron sucrose (another form of intravenous iron) was 140 mg/kg in male rats. An overdose with ferric derisomaltose may lead to accumulation of stored iron, causing hemosiderosis. Symptoms may include abdominal pain, weakness, and lethargy, among others. Serum ferritin should be monitored. Employ supportive treatment including chelating agents.
Food Interactions
No interactions found.
Dosage
For patients weighing less than 50 kg: Administer Derisofer IV Injection 500 mg/5 ml as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.
The dosage of Derisofer IV Injection 500 mg/5 ml is expressed in mg of elemental iron. Each mL of Derisofer IV Injection 500 mg/5 ml contains 100 mg of elemental iron. Only administer Derisofer IV Injection 500 mg/5 ml when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
