Ferric derisomaltose API Manufacturers

General Description:

Ferric derisomaltose, identified by CAS number 1345510-43-1, is a notable compound with significant therapeutic applications. 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. Ferric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to , 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.

Indications:

This drug is primarily indicated for: 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. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Ferric derisomaltose undergoes metabolic processing primarily in: Iron in the circulation is taken up by the plasma by cells of the RES. This binds proteins that form hemosiderin or ferritin, as well transferrin. Following this step, the bound iron replenishes low hemoglobin (Hb) and iron. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Ferric derisomaltose are crucial for its therapeutic efficacy: 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. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Ferric derisomaltose is an important consideration for its dosing schedule: The plasma-half live of intravenous iron is about 1-4 days. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Ferric derisomaltose exhibits a strong affinity for binding with plasma proteins: Iron binds to transferrin, the transport molecule responsible for transporting iron to erythroid precursor cells for the production of hemoglobin. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Ferric derisomaltose from the body primarily occurs through: 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. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Ferric derisomaltose is distributed throughout the body with a volume of distribution of: 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. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Ferric derisomaltose is a critical factor in determining its safe and effective dosage: 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. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Ferric derisomaltose exerts its therapeutic effects through: 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. The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Ferric derisomaltose functions by: 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. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Categories:

Ferric derisomaltose is categorized under the following therapeutic classes: Anemia, Iron-Deficiency, Antianemia Drugs, Antianemic Preparations, Carbohydrates, Iron Compounds, Iron Preparations, Oligosaccharides, Parenteral Iron Replacement, Polysaccharides. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.