Ferric citrate approved for the treatment of hyperphosphatemia in September 2014

Company: Keryx Biopharma

Approval status: approved in September 2014.

Indication: for hyperphosphatemia in patients with chronic kidney disease. 

Mechanism of action: ferric iron binds to the dietary phosphate in the gastrointestinal tract and precipitates as ferric phosphate. This ferric phosphate is insoluble and gets excreted out through feces. So, the phosphate levels in serum are reduced by ferric citrate through binding phosphate in the GIT and by decreasing its absorption. It lowers phosphate levels without raising calcium or aluminium concentrations. 

Dosing form: tablet 210mg ferric iron (equivalent to 1g ferric citrate). It is a film coated, peach colored oval shaped tablet.

Dosage and administration: Starting dose is 2 tablets (420mg) orally TID and is taken with meals. Dose is adjusted by 1 or 2 tablets as needed in order to maintain serum phosphorus at target levels. Dose can be titrated at 1 week or longer intervals. Not more than 12 tablets per should be consumed.

Pregnancy category: B.

Lactation: data from the rat studies have shown the that there is a transfer of iron into milk by divalent metal transporter- 1 and ferroportin- 1. That means infant can be exposed to ferric citrate if administered to a nursing mother.

Pediatric use: safety and efficacy has not been established. 

Contraindications: ferric citrate is contraindicated in people with an iron overload syndrome e.g. hemochromatosis (a hereditary disorder in which iron salts get deposited into the tissues, and leads to liver damage, diabetes mellitus,  bronze discoloration of the skin). 

Precautions:  iron absorption from ferric citrate may lead to elevations in iron stores.

Accidental overdose of Iron: to prevent accidental overdose, it should be kept out of reach of children. 

Drug interactions: the following oral drugs can be administered concomitantly with ferric citrate

a. aspirin

b.clopidogrel

c. digoxin

d. amlodipine

e. atorvastatin

f. enalapril

g. calcitriol

h. doxercalciferol

I. levofloxacin

j. warfarin

k. propranolol

l. metoprolol

m. fluvastatin

n. pravastatin

o. sitagliptin.

oral drug which cannot be given with ferric citrate is doxycycline. Ferric citrate decreases the levels and effects of doxycycline by drug binding in GI tract. So doxycycline should be administered at least 1 hour before taking the ferric citrate tablets.

Carcinogenesis, impaired fertility,  mutagenesis: studies showed that ferric citrate is not carcinogenic in mice and rats when given subcutaneously or intramuscularly. It was also not mutagenic in the bacterial reverse mutation assay. It was also not found to be clastogenic in the chromosomal aberration test in Chinese hambster fibroblasts.

Side effects: diarrhea,  nausea, vomiting, cough, discolored (dark) stools.

Storage: should be stored at 20 degrees celsius. The drug should be protected from moisture.

The above given drug information is from various medical journal articles, presentations and company’s website.

 

 

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