Tetraferric Nonahydrogen Citrate Pyrophosphate
Tetraferric Nonahydrogen Citrate Pyrophosphate Uses, Dosage, Side Effects, Food Interaction and all others data.
Tetraferric Nonahydrogen Citrate Pyrophosphate solution is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. Tetraferric Nonahydrogen Citrate Pyrophosphate solution is a clear, slightly yellow-green color sterile solution containing 27.2 mg iron (III) per 5 mL. Each ampoule contains Iron (7.5-9.0% w/w) Citrate (15-22% w/w) Pyrophosphate (15-22% w/w) Phosphate (< 2% w/w) Sodium (18-25% w/w) Sulfate (20-35%) One ampoule is added to 2.5 gallons (9.46 L) of bicarbonate concentrate.
Iron supplementation typically results in increases in serum iron, transferrin-bound iron, and iron-stored in the form of ferritin in hepatocytes and macrophages. The available iron is usually used in bone marrow for the synthesis of hemoglobin.
Trade Name | Tetraferric Nonahydrogen Citrate Pyrophosphate |
Generic | Ferric Pyrophosphate Citrate |
Ferric Pyrophosphate Citrate Other Names | Ferric pyrophosphate citrate, Tetraferric nonahydrogen citrate pyrophosphate, Triferic |
Type | |
Formula | C18H24Fe4O42P6 |
Weight | Average: 1321.571 Monoisotopic: 1321.556531 |
Protein binding | The main action site of ferric pyrophosphate is in the serum and thus it is highly bound to its targets such as ferritin and hemoglobin. |
Groups | Approved, Investigational |
Therapeutic Class | Parenteral Iron Preparations |
Manufacturer | |
Available Country | |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Tetraferric Nonahydrogen Citrate Pyrophosphate is used for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Tetraferric Nonahydrogen Citrate Pyrophosphate is also used to associated treatment for these conditions: Iron Deficiency (ID)
How Tetraferric Nonahydrogen Citrate Pyrophosphate works
The usage of ferric pyrophosphate is based on the strong complex formation between these two species. Besides, the capacity of pyrophosphate to trigger iron removal from transferrin, enhance iron transfer from transferrin to ferritin and promote iron exchange between transferrin molecules. These properties make it a very suitable compound for parenteral administration, iron delivery into circulation and incorporation into hemoglobin.
Dosage
Tetraferric Nonahydrogen Citrate Pyrophosphate dosage
Inspect Tetraferric Nonahydrogen Citrate Pyrophosphate ampoule for signs of precipitation prior to mixing with the bicarbonate concentrate. Tetraferric Nonahydrogen Citrate Pyrophosphate should only be added to the bicarbonate concentrate and should not be added to acid concentrate mixtures. Add Tetraferric Nonahydrogen Citrate Pyrophosphate to bicarbonate concentrate used for generation of hemodialysate. The final concentration of iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L). Multiple ampoules can be added to the master bicarbonate mix at each center at a ratio of one ampoule to each 2.5 gallons of bicarbonate concentrate.
Administer Tetraferric Nonahydrogen Citrate Pyrophosphate to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.
Hemodialysis solutions should be used within 24 hours of the preparation of the Tetraferric Nonahydrogen Citrate Pyrophosphate /bicarbonate concentrate mixture.
Side Effects
The most common side effects are headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.
Toxicity
Ferric pyrophosphate was showed to be clastogenic in the in vitro chromosomal aberration assay in presence of metabolic activation. It was not showed to have mutagenic or fertility effects and its carcinogenic potential have not been studied yet.
Precaution
Hypersensitivity Reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness and collapse can occur. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until he/she is clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions.
Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
Interaction
Formal drug interaction studies have not been performed for Tetraferric Nonahydrogen Citrate Pyrophosphate.
Food Interaction
No interactions found.Volume of Distribution
The apparent volume of distribution of ferric pyrophosphate after 4 hours of intravenous administration ranged from 0.765 to 0.859 L.
Elimination Route
The results of the present studies show that ferric pyrophosphate is as well absorbed in adults. The absorption of iron depends upon the route of entry. Ferric pyrophosphate has a very high bioavailability of 83-94%. The AUC and Cmax have a dose-dependent pharmacokinetic response, being of 675-1840 mcg.h/dL and 113-261 mcg/dL respectively when given in a dose from 2.5 to 10 mg. The time to reach maximum dose is approximate 4.5 hours.
Half Life
The half-life of ferric pyrophosphate is 1.48 hours.
Clearance
The mean clearance rate of ferric pyrophosphate can range between 0.406 to 0.556 L/hour.
Elimination Route
After metabolism as endogenous iron, the excretion of ferric pyrophosphate follows the same pattern. In the body, iron is retained and in the absence of bleeding the excretion is very small. Most of the iron is absorbed in the gut and does not reach the feces. The excretion of iron can be done in urine, feces, sweat, hair, and nails.
Pregnancy & Breastfeeding use
Pregnant women Category C. Lactating mothers It is not known whether Tetraferric Nonahydrogen Citrate Pyrophosphate is present in human milk or not.
Acute Overdose
No data are available regarding overdose of Tetraferric Nonahydrogen Citrate Pyrophosphate.
Storage Condition
Keep in a cool and dry place, away from light. Keep out of reach of children.
Innovators Monograph
You find simplified version here Tetraferric Nonahydrogen Citrate Pyrophosphate
Tetraferric Nonahydrogen Citrate Pyrophosphate contains Ferric Pyrophosphate Citrate see full prescribing information from innovator Tetraferric Nonahydrogen Citrate Pyrophosphate Monograph, Tetraferric Nonahydrogen Citrate Pyrophosphate MSDS, Tetraferric Nonahydrogen Citrate Pyrophosphate FDA label