Nulecit
Nulecit Uses, Dosage, Side Effects, Food Interaction and all others data.
Nulecit is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 – 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate. It is used in adult and in pediatric patients over the age of 6 years with chronic kidney disease (CKD) receiving hemodialysis and receiving supplemental epoetin therapy.
Nulecit is an exogenous epoetin that acts to restore the body's content of iron, which is essential for normal hemoglobin synthesis, oxygen transport and enzymatic processes. The complex increases red blood cell production and increased iron utilization.
| Trade Name | Nulecit |
| Generic | Sodium ferric gluconate complex |
| Sodium ferric gluconate complex Other Names | Ferric sodium gluconate complex, Sodium ferric gluconate complex |
| Weight | 12.5mg/ml |
| Type | Intravenous, Intravenous Solution |
| Formula | C66H121Fe2NaO65 |
| Weight | Average: 2089.309 Monoisotopic: 2088.47592 |
| Protein binding | It is bind to transferrin, ferritin and hemoglobin. |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Nulecit is an iron complex used for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
Used to replete the total body content of iron during iron deficiency anemia in patients age 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.
Nulecit is also used to associated treatment for these conditions: Anemia, Iron Deficiency Anemia (IDA)
How Nulecit works
The complex is endocytosed by macrophages of the reticuloendothelial system. Within an endosome of the macrophage , lysosome fuses with the endosome creating an acidic environment leading to the cleavage of the complex from iron. Iron is then incorporated in ferritin, transferrin or hemoglobin. Sodium ferric gluconate also normalizes RBC production by binding with hemoglobin
Toxicity
Overdosage of iron causes cardiovascular toxicity and hepatic necrosis. The lowest lethal dose (LDLo) following intravenous administration is 78.8mg/kg in rats and 250mg/kg in dogs. Adverse effects from sodium ferric gluconate therapy include hypersensitivity reactions, nausea, vomiting, diarrhea, pain, peripheral swelling and hypotension. Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis.
Food Interaction
No interactions found.Volume of Distribution
The initial volume of distribution is 6L which correlates well with the calculated blood volume.
Elimination Route
Peak drug levels (Cmax) varied significantly by dosage and by rate of administration. Highest Cmax value is observed in the regimen in which 125 mg was administered in 7 minutes (19.0 mg/L).
Half Life
The terminal elimination half-life for drug bound iron was approximately 1 hour, with the value varying by dose but not by rate of administration. In adults, the shortest terminal elimination half-life of 0.825h occurs with the 62.5 mg/4 min dosing regimen and the longest value of 1.45h is achieved with 125 mg/7 min regimen. In pediatric patients, the half-life was 2 hours following administration of 1.5 mg/kg dose and 2.5 hours following administration of 3.0mg/kg dose.
Clearance
Total clearance ranges from 3.02 to 5.35 L/h in adult patients.
Elimination Route
It is renally eliminated if it is greater than 18,000 Daltons.
Innovators Monograph
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