Nepofer

Nepofer Uses, Dosage, Side Effects, Food Interaction and all others data.

Nepofer solution is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. Nepofer 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.

Nepofer
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Nepofer
Generic	Ferric Pyrophosphate Citrate
Ferric Pyrophosphate Citrate Other Names	Ferric pyrophosphate citrate, Tetraferric nonahydrogen citrate pyrophosphate, Triferic
Weight	27.2mg/5ml
Type	Iv Infusion
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	Incepta Pharmaceuticals Ltd,
Available Country	Bangladesh
Last Updated:	September 19, 2023 at 7:00 am

Uses

Nepofer is used for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Nepofer is also used to associated treatment for these conditions: Iron Deficiency (ID)

How Nepofer 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

Nepofer dosage

Inspect Nepofer ampoule for signs of precipitation prior to mixing with the bicarbonate concentrate. Nepofer should only be added to the bicarbonate concentrate and should not be added to acid concentrate mixtures. Add Nepofer 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 Nepofer 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 Nepofer /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 Nepofer.

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.