tetraferric tricitrate decahydrate or ferric citrate

Action and Spectrum

Actions and spectrum: 

tetraferric tricitrate decahydrate is a medication used to chelate (bind) metal ions, particularly iron, in the gastrointestinal tract. It has a high affinity for iron and forms stable complexes with it, preventing its absorption from the gut into the bloodstream. The chelation of iron by tetraferric tricitrate decahydrate is utilized in the management of iron overload conditions, such as hereditary hemochromatosis or transfusional iron overload in patients receiving repeated blood transfusions. 

The spectrum of tetraferric tricitrate decahydrate’s action is focused on reducing iron absorption in the intestine, thereby helping to regulate iron levels in the body. By sequestering excess iron in the gastrointestinal tract and preventing its absorption, it reduces iron overload, which can otherwise lead to various complications and damage to organs. The medication is available in various formulations, including oral solutions and capsules, for different treatment regimens as prescribed by the healthcare provider. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

• abdominal pain 
• Vomiting 
• Hyperkalemia 
• Cough

>10% 

• Discolored feces (22%) 
• constipation (18%) 
• diarrhea (21%) 
• nausea (11%)

Frequency not defined 

• Confusion 
• irregular heartbeat 
• nervousness 
• stomach pain 
• weakness 
• difficulty breathing 
• numbness   
• dark-colored stools 
• difficulty in bowel movement 

Black Box Warning

Black Box Warning: 

There are no specific black box warnings associated with tetraferric tricitrate decahydrate 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: Patients with known hypersensitivity or allergies to tetraferric tricitrate decahydrate or any of its components should avoid its use. 
• Severe Renal Impairment: Individuals may not be suitable candidates for tetraferric tricitrate decahydrate therapy. 
• Drug Interactions: tetraferric tricitrate decahydrate may interact with other medications or substances, and caution should be exercised when using it concomitantly with other drugs. 
• Concomitant Medications: Certain medications or medical conditions may be contraindicated when using tetraferric tricitrate decahydrate, and individualized assessments should be made.

Caution: 

• Renal Function: tetraferric tricitrate decahydrate is excreted through the kidneys. Caution should be used in renal impairment, and dose adjustments may be necessary. 
• Electrolyte Imbalance: tetraferric tricitrate decahydrate can affect electrolyte balance. Patients with electrolyte imbalances or conditions such as hyperkalemia or hypokalaemia should be closely monitored. 
• Hypersensitivity: While rare, allergic reactions to tetraferric tricitrate decahydrate can occur. Patients should be monitored for any signs of hypersensitivity, such as skin rash or difficulty breathing. 
• Concomitant Medications: tetraferric tricitrate decahydrate may interact with other medications or substances. Caution should be exercised when using it concomitantly with other drugs. 
• Pregnancy and Lactation: There may be limited data on the safety of tetraferric tricitrate decahydrate in pregnancy and lactation. 
• Pediatric and Geriatric Use: Safety and efficacy data in pediatric and geriatric populations may be limited. Caution should be exercised when using tetraferric tricitrate decahydrate in these age groups.

Comorbidities: 

• Chronic Kidney Disease (CKD): Patients with CKD are at risk of iron overload due to frequent blood transfusions and impaired iron utilization. 
• Hypertension: Hypertension is prevalent in CKD patients and is often managed with antihypertensive medications. 
• Diabetes: Diabetes is a common comorbidity in CKD patients, and it can further contribute to cardiovascular complications. 
• Hyperkalemia: CKD patients may experience electrolyte imbalances, including elevated potassium levels. 
• Bone and Mineral Disorders: CKD can lead to disturbances in bone and mineral metabolism, resulting in conditions like renal osteodystrophy. 

Pregnancy / Lactation

Pregnancy consideration: Pregnancy Category: not assigned 

Lactation: excreted into breast milk: unknown  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

tetraferric tricitrate decahydrate is a medication used for the treatment of iron overload in patients receiving chronic hemodialysis. It acts as an iron chelator, meaning it binds to excess iron in the body and forms stable complexes that are then excreted through the urine and feces. By removing excess iron, tetraferric tricitrate helps to reduce iron toxicity and prevent iron-related complications.

The chelation process is selective for iron, which minimizes interference with other essential metals in the body. The pharmacology of tetraferric tricitrate decahydrate focuses on its ability to manage iron overload effectively and safely in hemodialysis patients, improving their overall well-being and reducing the risk of iron-related complications.  

Pharmacodynamics: 

• Iron Chelation: tetraferric tricitrate decahydrate acts as an iron chelator, meaning it binds to excess iron in the body. It forms stable complexes with iron, preventing its interaction with other molecules and reducing its toxicity. 
• Selective Iron Binding: The medication selectively binds to iron, minimizing interference with other essential metals in the body. This specificity ensures that other important minerals are not affected during the chelation process. 
• Iron Excretion: Once bound to iron, tetraferric tricitrate decahydrate facilitates the excretion of the iron-chelator complex through the urine and feces. This process effectively removes excess iron from the body. 
• Reduction of Iron Overload: By removing excess iron, tetraferric tricitrate decahydrate helps to reduce iron overload, which is a common concern in patients undergoing chronic hemodialysis. 
• Prevention of Iron-Related Complications: Managing iron overload through chelation therapy with tetraferric tricitrate decahydrate can prevent iron-related complications, such as iron deposition in organs (e.g., liver, heart) and tissues, which can lead to serious health issues. 
• Improvement of Well-Being: By effectively managing iron overload, patients can experience improvements in their overall well-being and quality of life, as the risk of iron-related complications is minimized.

Pharmacokinetics: 

Absorption 

tetraferric tricitrate decahydrate is administered orally. Upon ingestion, it undergoes dissolution in the gastrointestinal tract, and the active iron-chelating component is absorbed into the bloodstream. 

Distribution 

Once absorbed, tetraferric tricitrate decahydrate is distributed throughout the body. It selectively binds to excess iron in the bloodstream and tissues, forming stable complexes. 

Metabolism 

tetraferric tricitrate decahydrate is not metabolized in the body. It remains unchanged as it performs its iron-chelating function. 

Elimination and excretion 

After binding to excess iron, tetraferric tricitrate decahydrate facilitates the excretion of iron-chelator complexes through both the urine and feces. The chelated iron is effectively eliminated from the body. 

Adminstartion

Administration: 

tetraferric tricitrate decahydrate is administered orally as a solution or suspension. The exact dosage and administration may vary based on the medical condition and the product’s formulation. It is commonly prescribed to patients undergoing chronic hemodialysis to manage iron overload. 

Patients should follow their healthcare provider’s instructions regarding the correct dosage and timing of administration. It is essential to take tetraferric tricitrate decahydrate as directed and not to exceed the prescribed dose. If any questions or concerns arise about the administration of this medication, patients should consult their healthcare provider for clarification and guidance. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: tetraferric tricitrate decahydrate 

Pronounced: (teh-truh-FER-ik try-SYE-trate dek-uh-HY-drate)  

Why do we use tetraferric tricitrate decahydrate? 

tetraferric tricitrate decahydrate is primarily used in the treatment of iron overload in patients undergoing chronic hemodialysis. It helps in removing excess iron from the body and prevent iron-related complications that can occur in individuals with end-stage renal disease undergoing frequent blood transfusions.

By chelating excess iron, tetraferric tricitrate decahydrate helps to maintain iron balance and prevent iron-related toxicity in patients with chronic kidney disease. It is an important medication in managing iron overload and improving the overall health and well-being of patients undergoing hemodialysis.