Ferrlecit

Injectable Iron Supplements
Iron Supplements

Prior to and at regular intervals during iron therapy, evaluate serum iron, hemoglobin and hematocrit. Ferritin and transferrin are also recommended monitoring parameters.
Visually inspect solution for particulate matter and discoloration prior to administration whenever solution and container permit.

Sodium ferric gluconate complex:
Administer by intravenous injection or infusion.
Each 5 mL vial of sodium ferric gluconate complex contains 62.5 mg of elemental iron (12.5 mg/mL). The dose of sodium ferric gluconate complex is expressed in terms of elemental iron.[29895]
Intravenous injection
Adults: May administer undiluted, at a rate of 12.5 mg/minute or less to prevent hypotension.
Do not mix or infuse with TPN or any intravenous fluid other than 0.9% Sodium Chloride Injection.[29895]
Intravenous infusion
Dilution:
Adults: Dilute 125 mg of elemental iron in 100 mL of 0.9% Sodium Chloride Injection.
Pediatrics: Dilute each dose in 25 mL of 0.9% Sodium Chloride Injection.
Administer dosage immediately following dilution.
Infuse over 60 minutes. To prevent hypotension and flushing, do not exceed the recommended rate of administration of 2.1 mg/minute.
Do not mix or infuse with TPN or any intravenous fluid other than 0.9% Sodium Chloride Injection.[29895]
 
Ferric pyrophosphate citrate:
Administer undiluted by slow intravenous infusion.
Each 4.5 mL vial of ferric pyrophosphate citrate contains 6.75 mg of elemental iron (1.5 mg/mL).
Each ampule is for single-use only; discard unused portion.
 
Intravenous infusion
Holding the top of the ampule, shake with one single downward movement to remove any solution in the cap. Twist the top of the ampule until the neck breaks off the top.
Attach a 10 mL or 20 mL Luer-lock syringe to the ampule and withdraw the contents (6.75 mg in 4.5 mL).
Connect the syringe to the attached pre-dialyzer infusion line, post-dialyzer infusion line, or to a separate connection to the venous blood line.
Attach the syringe to a syringe pump and administer as a slow continuous infusion over 3 to 4 hours.

Intravascular Administration
Ferric pyrophosphate citrate:
Ferric pyrophosphate citrate should only be added to the bicarbonate concentrate; do not add to acid concentrate mixtures.
Inspect each ampule for signs of precipitation prior to mixing with bicarbonate concentrate. Ferric pyrophosphate citrate should be slightly yellow-green in color.[65183]
Intravascular administration:
Add 27.2 mg (5 mL ampule) to 2.5 gallons of bicarbonate concentrate or 272 mg (50 mL ampule or 1 powder packet) to 25 gallons of bicarbonate concentrate.
The final concentration of iron in the dialysate is 110 mcg/L (2 micromolar).
Multiple ampules may be added to the master bicarbonate mix at each dialysis center at a ratio of 27.2 mg (5 mL ampule) to each 2.5 gallons of bicarbonate concentrate or 272 mg (50 mL ampule or 1 powder packet) to each 25 gallons of bicarbonate concentrate.
Administer at each dialysis session for as long as patients are receiving maintenance hemodialysis therapy for chronic kidney disease.
Hemodialysis solutions should be used within 24 hours of the preparation of the ferric pyrophosphate citrate/bicarbonate concentrate mixture.[65183]

thrombosis / Delayed / 3.0-6.0
hyperkalemia / Delayed / 6.0-6.0
seizures / Delayed / Incidence not known
myocardial infarction / Delayed / Incidence not known
pulmonary edema / Early / Incidence not known
bradycardia / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
Kounis syndrome / Rapid / Incidence not known
hearing loss / Delayed / Incidence not known

hypotension / Rapid / 22.0-41.0
hypertension / Early / 13.0-23.0
sinus tachycardia / Rapid / 5.0-21.0
dyspnea / Early / 6.0-11.0
chest pain (unspecified) / Early / 10.0-10.0
peripheral edema / Delayed / 7.0-7.0
edema / Delayed / 5.0-5.0
bleeding / Early / 3.0-3.0
hypertonia / Delayed / Incidence not known
peripheral vasodilation / Rapid / Incidence not known
fetal bradycardia / Delayed / Incidence not known
angina / Early / Incidence not known
flank pain / Delayed / Incidence not known
melena / Delayed / Incidence not known
constipation / Delayed / Incidence not known
lymphadenopathy / Delayed / Incidence not known
anemia / Delayed / Incidence not known
phlebitis / Rapid / Incidence not known
wheezing / Rapid / Incidence not known
hemosiderosis / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
hypokalemia / Delayed / Incidence not known
hypervolemia / Delayed / Incidence not known
hypoglycemia / Early / Incidence not known

nausea / Early / 6.0-35.0
diarrhea / Early / 8.0-35.0
vomiting / Early / 9.0-35.0
injection site reaction / Rapid / 33.0-33.0
headache / Early / 7.0-29.0
abdominal pain / Early / 3.0-15.0
fever / Early / 3.0-15.0
dizziness / Early / 13.0-13.0
pharyngitis / Delayed / 6.0-12.0
muscle cramps / Delayed / 10.0-10.0
rhinitis / Early / 3.0-9.0
infection / Delayed / 5.0-8.0
asthenia / Delayed / 4.0-7.0
fatigue / Early / 4.0-6.0
paresthesias / Delayed / 6.0-6.0
cough / Delayed / 6.0-6.0
syncope / Early / 6.0-6.0
pruritus / Rapid / 6.0-6.0
back pain / Delayed / 5.0-5.0
weakness / Early / Incidence not known
drowsiness / Early / Incidence not known
hypoesthesia / Delayed / Incidence not known
malaise / Early / Incidence not known
agitation / Early / Incidence not known
flatulence / Early / Incidence not known
anorexia / Delayed / Incidence not known
dyspepsia / Early / Incidence not known
xerostomia / Early / Incidence not known
eructation / Early / Incidence not known
dysgeusia / Early / Incidence not known
leukocytosis / Delayed / Incidence not known
pallor / Early / Incidence not known
urticaria / Rapid / Incidence not known
hyperhidrosis / Delayed / Incidence not known
rash / Early / Incidence not known
skin discoloration / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
musculoskeletal pain / Early / Incidence not known
myalgia / Early / Incidence not known
chills / Rapid / Incidence not known
diaphoresis / Early / Incidence not known
flushing / Rapid / Incidence not known
menorrhagia / Delayed / Incidence not known
diplopia / Early / Incidence not known

Ferrlecit, Nulecit, Triferic

Rx

Iron replacement product
Used to replete iron stores in iron-deficient hemodialysis patients
Ferric pyrophosphate citrate may also be added to bicarbonate dialysate

6.75 mg IV administered by slow IV infusion over 3 to 4 hours at each hemodialysis session. Administer for as long as patients are receiving maintenance hemodialysis therapy for CKD.

Initially, 125 mg IV administered either by IV infusion (over 1 hour) or IV injection (over at least 10 minutes) during each dialysis session. Most patients will require a minimum cumulative dose of 1 g of elemental iron, divided and administered over 8 sequential dialysis sessions to replete iron stores; however, dosage requirements should be based on individual patient assessment and condition.[29895] Patients with a serum ferritin below 100 ng/mL or TSAT less than 18% may need repletion doses of sodium ferric gluconate complex greater than 1 g to achieve optimal hemoglobin response.[25620] Patients may continue to require regular therapy with sodium ferric gluconate complex at the lowest dose necessary to maintain target hemoglobin and hematocrit concentrations and acceptable laboratory parameters of iron storage. Doses of 62.5 mg IV elemental iron twice weekly, weekly, or every 2 weeks has maintained iron stores and reduced the dose of epoetin alfa.[25621] According to the manufacturer, single doses exceeding 125 mg IV may be associated with a higher incidence and/or severity of adverse reactions (e.g., hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesia, and peripheral swelling). Although single doses of 250 mg IV to 500 mg IV have been studied in various populations, adverse reactions were reported in some studies.[36633] [36634] [36635] [36636] [36637] [36638] [36639] Of note, ADRs were more common in patients receiving single doses of 500 mg IV compared to single doses of 250 mg IV.[36638] [36639]

1.5 mg/kg/dose (Max: 125 mg/dose) IV over 1 hour during 8 sequential dialysis sessions.

Patients with hepatic disease should receive sodium ferric gluconate complex; ferric pyrophosphate citrate with caution. The liver is one of the main storage sites for iron, and some patients with chronic liver disease may have excessive iron storage. Specific guidelines for dosage adjustments in hepatic impairment are not available.

Dosage adjustment is not necessary.
 
Intermittent hemodialysis
Sodium ferric gluconate complex is not dialyzable and may be administered during dialysis.

Abacavir; Dolutegravir; Lamivudine: (Moderate) Administer dolutegravir 2 hours before or 6 hours after taking supplements containing iron if given under fasting conditions. When taken with food, dolutegravir and supplements containing iron can be taken at the same time. Simultaneous administration under fasted conditions may result in reduced bioavailability of dolutegravir.
Acetohydroxamic Acid: (Moderate) Acetohydroxamic acid chelates heavy metals, including iron. Absorption of orally administered iron salts or polysaccharide-iron complex and acetohydroxamic acid from the intestinal lumen may be reduced when both drugs are administered concomitantly. If iron therapy is required in a patient currently taking acetohydroxamic acid, intramuscular iron is recommended.
Alendronate: (Moderate) Separate administration of alendronate and iron supplements by at least 30 minutes. Iron will interfere with the absorption of alendronate.
Alendronate; Cholecalciferol: (Moderate) Separate administration of alendronate and iron supplements by at least 30 minutes. Iron will interfere with the absorption of alendronate.
Amoxicillin; Clarithromycin; Omeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Antacids: (Moderate) Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction. Antacids may decrease the absorption of oral iron preparations. At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction. Antacids may decrease the absorption of oral iron preparations. At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed.
Aspirin, ASA; Omeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Bictegravir; Emtricitabine; Tenofovir Alafenamide: (Moderate) Administer bictegravir with food at the same time as iron supplements. Routine administration of bictegravir under fasting conditions simultaneously with, or 2 hours after, iron supplements is not recommended. Iron is a polyvalent cation that can bind bictegravir in the GI tract. Taking these drugs simultaneously without food results in reduced bioavailability of bictegravir. In drug interaction studies, simultaneous administration of bictegravir and ferrous fumarate under fasted conditions decreased the mean AUC of bictegravir by approximately 63%.
Cabotegravir: (Moderate) Administer oral iron at least two hours before or four hours after taking oral cabotegravir. Iron is a polyvalent cation that can bind cabotegravir in the GI tract. Taking these drugs simultaneously may result in reduced oral bioavailability of cabotegravir.
Cabotegravir; Rilpivirine: (Moderate) Administer oral iron at least two hours before or four hours after taking oral cabotegravir. Iron is a polyvalent cation that can bind cabotegravir in the GI tract. Taking these drugs simultaneously may result in reduced oral bioavailability of cabotegravir.
Calcium Carbonate: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction. (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction.
Calcium Carbonate; Simethicone: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction.
Calcium; Vitamin D: (Moderate) Antacids (e.g., calcium carbonate, aluminum hydroxide, or magnesium hydroxide) may decrease the absorption of oral iron preparations (e.g., iron salts or polysaccharide-iron complex). At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction.
Carbidopa; Levodopa: (Moderate) Administration of iron salts, including polysaccharide-iron complex or multivitamins containing iron, should be separated from oral levodopa by at least 2 hours to avoid reduction in levodopa efficacy. Iron salts may reduce the bioavailability of levodopa and carbidopa; levodopa products.
Carbidopa; Levodopa; Entacapone: (Moderate) Administration of iron salts, including polysaccharide-iron complex or multivitamins containing iron, should be separated from oral levodopa by at least 2 hours to avoid reduction in levodopa efficacy. Iron salts may reduce the bioavailability of levodopa and carbidopa; levodopa products.
Cefdinir: (Moderate) Administer cefdinir at least 2 hours before or 2 hours after iron supplements. Cefdinir absorption may be reduced. Coadministration of cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively.
Cholestyramine: (Moderate) Concurrent administration of cholestyramine and oral iron supplements may reduce the oral absorption of iron. To avoid any oral absorption interference, administration of other drugs is recommended 1 hour before or at least 4 to 6 hours after cholestyramine administration.
Cimetidine: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Ciprofloxacin: (Moderate) Administer oral ciprofloxacin at least 2 hours before or 6 hours after oral products that contain iron. Ciprofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
Delafloxacin: (Major) Administer oral delafloxacin at least 2 hours before or 6 hours after oral products that contain iron. Delafloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
Dexlansoprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Didanosine, ddI: (Moderate) Iron salts should not be administered simultaneously with didanosine, ddI chewable tablets or powder for oral solution. Oral absorption of iron supplements is reduced if given with antacids; the buffering agents contained in didanosine tablets and powder likewise reduce iron salt absorption. Administer oral doses of iron salts 1 hour before or 4 hours after didanosine tablet or powder administration. The delayed-release didanosine capsules do not contain a buffering agent and would not be expected to interact with iron salts.
Dimercaprol: (Contraindicated) Dimercaprol forms toxic-chelates with iron. These dimercaprol-metal complexes are more toxic than the metal alone, especially to the kidneys. Iron therapy should not be administered concomitantly with dimercaprol. Therapy with iron should generally be delayed until 24 hours after the cessation of dimercaprol therapy.
Dolutegravir: (Moderate) Administer dolutegravir 2 hours before or 6 hours after taking supplements containing iron if given under fasting conditions. When taken with food, dolutegravir and supplements containing iron can be taken at the same time. Simultaneous administration under fasted conditions may result in reduced bioavailability of dolutegravir.
Dolutegravir; Lamivudine: (Moderate) Administer dolutegravir 2 hours before or 6 hours after taking supplements containing iron if given under fasting conditions. When taken with food, dolutegravir and supplements containing iron can be taken at the same time. Simultaneous administration under fasted conditions may result in reduced bioavailability of dolutegravir.
Dolutegravir; Rilpivirine: (Moderate) Administer dolutegravir 2 hours before or 6 hours after taking supplements containing iron if given under fasting conditions. When taken with food, dolutegravir and supplements containing iron can be taken at the same time. Simultaneous administration under fasted conditions may result in reduced bioavailability of dolutegravir.
Eltrombopag: (Major) Eltrombopag chelates polyvalent cations (e.g., iron) in foods and mineral supplements. In a clinical study, systemic exposure to eltrombopag was decreased by 70% when it was administered with a polyvalent cation-containing antacid. Administer eltrombopag at least 2 hours before or 4 hours after any oral products containing polyvalent cations, such as iron salts, multivitamins that contain iron, or polysaccharide-iron complex.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Moderate) Separate administration of elvitegravir and iron by at least 2 hours. Due to the formation of ionic complexes in the gastrointestinal tract, simultaneous administration results in lower elvitegravir plasma concentrations.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Separate administration of elvitegravir and iron by at least 2 hours. Due to the formation of ionic complexes in the gastrointestinal tract, simultaneous administration results in lower elvitegravir plasma concentrations.
Esomeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Etidronate: (Moderate) Separate administration of oral etidronate and iron supplements by at least 2 hours. Iron will interfere with the absorption of oral etidronate.
Famotidine: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Ferric carboxymaltose: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Ferric Derisomaltose: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Ferumoxytol: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Gemifloxacin: (Major) Administer oral products that contain iron at least 3 hours before or 2 hours after gemifloxacin. Gemifloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
Green Tea: (Major) Green tea has been shown to inhibit the absorption of nonheme iron. When possible, do not consume green tea or green tea extract within 1 hour before or 2 hours after giving iron salts.
H2-blockers: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Hydrochlorothiazide, HCTZ; Methyldopa: (Major) Coadministration of methyldopa with iron salts or polysaccharide-iron complex is not recommended. If iron supplementation is necessary, administer a methyldopa dose at least 2 hours prior to the iron supplement. Iron salts have been reported to dramatically reduce the oral absorption of methyldopa. Several studies demonstrate decreased bioavailability of methyldopa when coadministered with ferrous sulfate or ferrous gluconate. This interaction may result in decreased antihypertensive effect of methyldopa.
Ibandronate: (Moderate) Separate administration of oral ibandronate and iron supplements by at least 1 hour. Iron will interfere with the absorption of oral ibandronate.
Ibritumomab Tiuxetan: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphates by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Ibuprofen; Famotidine: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Iron - Injectable Only: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron Dextran: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron Sucrose, Sucroferric Oxyhydroxide: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Lansoprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Lansoprazole; Amoxicillin; Clarithromycin: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Lanthanum Carbonate: (Major) Oral compounds known to interact with antacids, like iron salts, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
Levodopa: (Moderate) Administration of iron salts, including polysaccharide-iron complex or multivitamins containing iron, should be separated from oral levodopa by at least 2 hours to avoid reduction in levodopa efficacy. Iron salts may reduce the bioavailability of levodopa and carbidopa; levodopa products.
Levofloxacin: (Moderate) Administer oral products that contain iron at least 2 hours before or 2 hours after orally administered levofloxacin. Levofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Chelation of divalent cations with levofloxacin is less than with other quinolones.
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Methyldopa: (Major) Coadministration of methyldopa with iron salts or polysaccharide-iron complex is not recommended. If iron supplementation is necessary, administer a methyldopa dose at least 2 hours prior to the iron supplement. Iron salts have been reported to dramatically reduce the oral absorption of methyldopa. Several studies demonstrate decreased bioavailability of methyldopa when coadministered with ferrous sulfate or ferrous gluconate. This interaction may result in decreased antihypertensive effect of methyldopa.
Moxifloxacin: (Major) Administer oral moxifloxacin at least 4 hours before or 8 hours after oral products that contain iron. Moxifloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
Mycophenolate: (Moderate) Separate administration of mycophenolate and iron by at least 4 hours. Iron may decrease the oral bioavailability of mycophenolate. Mycophenolate recovery was reduced by up to 16% under certain pH conditions in drug interaction studies.
Naproxen; Esomeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Nizatidine: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Ofloxacin: (Moderate) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
Omeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Omeprazole; Amoxicillin; Rifabutin: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Omeprazole; Sodium Bicarbonate: (Moderate) Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction. Antacids may decrease the absorption of oral iron preparations. At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed. (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Pantoprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Penicillamine: (Major) In general, oral mineral supplements should not be given since they may block the oral absorption of penicillamine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and penicillamine each inhibit oral absorption of the other, 2 hours should elapse between administration of penicillamine and iron doses.
Phosphorated Carbohydrate Solution: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphates by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Phosphorus: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphates by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Polyethylene Glycol; Electrolytes: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Polyethylene Glycol; Electrolytes; Ascorbic Acid: (Major) Administer iron at least 2 hours before or 6 hours after administration of magnesium sulfate; potassium sulfate; sodium sulfate. The absorption of iron may be reduced by chelation with magnesium sulfate.
Potassium Phosphate: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphates by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Potassium Phosphate; Sodium Phosphate: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphates by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Proton pump inhibitors: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Rabeprazole: (Moderate) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of proton pump inhibitors can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. Proton pump inhibitors have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Ranitidine: (Minor) The bioavailability of oral iron salts is influenced by gastric pH, and the concomitant administration of H2-blockers can decrease iron absorption. The non-heme ferric form of iron needs an acidic intragastric pH to be reduced to ferrous and to be absorbed. Iron salts and polysaccharide-iron complex provide non-heme iron. H2-blockers have long-lasting effects on the secretion of gastric acid and thus, increase the pH of the stomach. The increase in intragastric pH can interfere with the absorption of iron salts.
Risedronate: (Moderate) Separate administration of oral risedronate and iron supplements by at least 2 hours. Iron will interfere with the absorption of oral risedronate.
Sodium Bicarbonate: (Moderate) Doses of antacids and iron should be taken as far apart as possible to minimize the potential for interaction. Antacids may decrease the absorption of oral iron preparations. At higher pH values, iron is more readily ionized to its ferric state and is more poorly absorbed.
Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: (Moderate) Iron salts may chelate with the magnesium in sodium picosulfate; magnesium oxide; anhydrous citric acid solution. Therefore, products containing iron should be taken at least 2 hours before and not less than 6 hours after the administration of sodium picosulfate; magnesium oxide; anhydrous citric acid solution.
Tetracyclines: (Moderate) Separate administration of tetracyclines and iron by 2 to 3 hours. Iron may decrease the oral bioavailability of tetracyclines.
Thyroid hormones: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after the ingestion of iron supplements. Oral iron salts have been reported to chelate oral thyroid hormones within the GI tract when administered simultaneously, leading to decreased oral absorption of the thyroid hormone. For example, ferrous sulfate likely forms a ferric-thyroxine complex.
Trientine: (Major) In general, oral mineral supplements should not be given since they may block the oral absorption of trientine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and trientine each inhibit oral absorption of the other, 2 hours should elapse between administration of trientine and iron doses.
Vonoprazan; Amoxicillin: (Moderate) Monitor for decreased efficacy of oral iron salts if coadministered with vonoprazan. Vonoprazan reduces intragastric acidity, which may decrease the absorption of iron reducing its efficacy.
Vonoprazan; Amoxicillin; Clarithromycin: (Moderate) Monitor for decreased efficacy of oral iron salts if coadministered with vonoprazan. Vonoprazan reduces intragastric acidity, which may decrease the absorption of iron reducing its efficacy.
Zinc: (Moderate) Orally administered zinc salts compete with iron supplements for absorption from the intestine. To minimize the interaction, separate oral iron and zinc doses by at least 2 hours. The oral receipt of 100 mg of iron as ferrous gluconate with 12 mg zinc in 11 patients with normal iron status and comparable total exchangeable zinc pools yielded a mean zinc absorption of 26.4% +/- 14.4% of the administered dose as compared with 44.5% +/- 22.5% of the dose given without concomitant iron. Concomitant use of iron 400 mg as ferrous gluconate yielded a mean zinc absorption of 22.9% +/- 6.4% of the zinc dose.

Ferrlecit/Iron/Nulecit Intravenous Inj Sol: 1mL, 12.5mg
Triferic Hemodialysis Pwd: 272mg
Triferic Hemodialysis Sol: 1mL, 5.44mg

Sodium ferric gluconate complex:
125 mg/dose IV; higher doses may be associated with higher incidence and/or severity of adverse reactions.
Ferric pyrophosphate citrate:
6.75 mg/dose IV; maximum dosage is not defined for hemodialysate use; dose is dependent on dialysate volume used during hemodialysis session.

Sodium ferric gluconate complex:
125 mg/dose IV; higher doses may be associated with higher incidence and/or severity of adverse reactions.
Ferric pyrophosphate citrate:
6.75 mg/dose IV; maximum dosage is not defined for hemodialysate use; dose is dependent on dialysate volume used during hemodialysis session.

Sodium ferric gluconate complex:
1.5 mg/kg/dose (Max: 125 mg/dose) IV.
Ferric pyrophosphate citrate:
Safety and efficacy have not been established.

Sodium ferric gluconate complex:
6 to 12 years: 1.5 mg/kg/dose (Max: 125 mg/dose) IV.
1 to 5 years: Safety and efficacy have not been established.
Ferric pyrophosphate citrate:
Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Normal erythropoiesis depends on the concentration of iron and erythropoietin available in the plasma, both being decreased in renal failure. Exogenous administration of erythropoietin increases red blood cell production and iron utilization, contributing to iron deficiency in hemodialysis patients. A therapeutic response to treatment with sodium ferric gluconate complex; ferric pyrophosphate citrate is dependent upon the patient's ability to use the iron. Use of iron is influenced by the cause of the deficiency as well as other illnesses that can affect normal erythropoiesis. Protein-energy malnutrition can prevent the incorporation of iron into the erythrocyte regardless of the quantity of iron stored. Only when lean body mass expands will iron be used. Iron therapy alone does not increase red blood cell production. Administration of iron will only improve anemia associated with iron deficiency.
 
There is some concern that intravenously administered iron is not used appropriately by the body and little is available for use in the bone marrow. Both animal and human data indicate the bulk of intravenously administered iron is sequestered in the reticuloendothelial system (i.e. liver, spleen), which could lead to hepatosplenic hemosiderosis (an increase in iron storage without associated tissue damage). Parenterally administered iron predominantly accumulates in the Kupffer cells of the liver's macrophage system, leading to less harm than excess body iron stored in the parenchyma. This information is associated with injectable iron products containing dextran polysaccharides.
 
Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Iron is a component of myoglobin and several heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an essential component of the metalloflavoprotein enzymes and the mitochondrial enzyme alpha-glycerophosphate oxidase. Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Furthermore, iron is a cofactor for enzymes such as aconitase and tryptophan pyrrolase. Iron deficiency not only causes anemia and decreased oxygen delivery, it also reduces the metabolism of muscle and decreases mitochondrial activity. Iron deficiency can also lead to defects in learning or thermoregulation. Thus iron is important to several metabolic functions which are independent of its importance to erythropoesis.

Sodium ferric gluconate complex is administered intravenously; ferric pyrophosphate citrate is administered intravenously or added to a bicarbonate dialysate for hemodialysis therapy.
 
Iron therapy dosage is individualized according to patient goals for serum iron concentrations, iron storage parameters (e.g., ferritin, transferrin saturation), and serum hemoglobin concentrations. Iron toxicity may occur with excessive or unnecessary iron therapy. Systemic iron is stored in compounds called ferritin and hemosiderin, which are used for future use in the production of hemoglobin. The absorption of iron depends upon the route of entry. The tissue that first clears parenterally administered iron from the bloodstream determines the bioavailability. If the reticuloendothelial system clears iron, only small amounts will be available over time to the bone marrow. Transferrin accepts iron from the intestinal tract or from sites of storage or hemoglobin destruction. Iron is then transported in plasma bound to transferrin and distributed to the bone marrow for hemoglobin synthesis, to the reticuloendothelial system for storage, to all cells for enzymes containing iron and to placental cells to meet fetal needs. Transferrin eventually becomes available for reuse. There is no destructive metabolism of iron because it takes place in a closed system. In normal adults, 90% of metabolized iron is conserved and reutilized repeatedly. Very little iron is excreted. In normal, healthy adults, some daily loss of iron occurs through normal skin, hair, and nail loss, and GI losses. Menstruating women have an increased loss as do other persons with loss of blood.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

Sodium ferric gluconate complex:
Multiple, sequential, single-dose, intravenous pharmacokinetic studies were performed on 14 healthy iron-deficient patients. Patients were randomized to receive undiluted sodium ferric gluconate complex by slow IV infusion: either 125 mg (infused over 1 hour) or 62.5 mg (infused over 0.5 hour). Five days after the first stage, each subject was re-randomized to undiluted sodium ferric gluconate complex by rapid IV infusion: either 125 mg (infused over 7 minutes) or 62.5 mg (infused over 4 minutes). Cmax concentrations varied by dosage and rate of administration. The highest Cmax (19 mg/L) was observed in the group who received 125 mg by rapid IV infusion. The initial volume of distribution of 6 L corresponds well to calculated blood volume. The terminal elimination half-life was approximately 1 hour ranging from 0.85 hours for the 62.5 mg rapid IV infusion (4 minutes) group to 1.45 hours for the 125 mg rapid infusion (7 minutes) group. Total clearance was 3.02 to 5.35 L/hour. The AUC for sodium ferric gluconate complex varied by dose from 17.5 mg-hour/L for patients receiving 62.5 mg to 35.6 mg-hour/L for patients receiving 125 mg. The rate of administration did not cause variation in the terminal elimination half-life, clearance, or AUC. Approximately 80% of drug bound iron was delivered to transferrin as a mononuclear ionic iron species within 24 hours of administration in each dosage regimen. Direct movement of iron from sodium ferric gluconate complex was not observed. Mean peak transferrin saturation did not exceed 100% and returned to near baseline by 40 hours after administration of each dosage regimen. Studies in renally competent patients suggest urinary excretion of sodium ferric gluconate complex is clinically insignificant.[29895]
 
Ferric pyrophosphate citrate:
The pharmacokinetics of serum iron were investigated in healthy volunteers administered 2.5, 5, 7.5 and 10 mg ferric pyrophosphate citrate IV over 4 hours, or 15 mg and 20 mg IV over 12 hours. After correcting for the basal iron concentrations, the AUC and Cmax of baseline-corrected serum iron increased in a dose-proportional manner. After intravenous infusion over 4 hours at 2.5, 5, 7.5 and 10 mg doses, serum iron half-life was approximately 1.48 hours, with a mean clearance (CL) ranging from 0.406 to 0.556 L/hour and a volume of distribution (Vz) ranging from 0.765 to 0.859 L; higher mean clearance and volume of distributions were observed after 15 mg (CL = 0.672 L/hour and Vz = 1.66 L) and 20 mg (CL = 0.661 L/hour, Vz = 2.08L) IV over 12 hours.[65183] Following administration of ferric pyrophosphate citrate 6.75 mg via a 3-hour intravenous infusion, the total plasma iron exposure values were 1,260 and 1,230 mcg x hr/dL for administration via pre- and post-dialyzer infusion lines, respectively. Transferrin bound iron exposures were 1,250 and 1,190 mcg x hr/dL, respectively.[58762]

Intravascular Route
Ferric pyrophosphate citrate:
In a study that assessed the impact of different dialysis conditions on iron delivery in patients administered ferric pyrophosphate citrate via hemodialysis, a reduction of the blood and dialysate flow rates (Qb/Qd of 200/400 mL/minute vs. 350 or more/600 or more mL/minute) resulted in a 33% decrease in the median cumulative iron delivered.

Sodium ferric gluconate complex injection contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs. Consider alternative iron replacement therapies without benzyl alcohol during pregnancy. Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions to parenteral iron products, especially during the second and third trimester of pregnancy. Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with sodium ferric gluconate complex injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. In the absence of maternal toxicity, sodium ferric gluconate complex injection was not teratogenic in animal studies at clinically relevant exposures.[29895] There are no available data on the use of ferric pyrophosphate citrate in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. In animal studies with ferric pyrophosphate citrate, developmental toxicity was observed when animals were administered maternally toxic doses that were higher than the maximum theoretical amount of iron administered to humans.[58762] [65183] Untreated iron deficiency anemia in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with iron deficiency anemia include increased risk for preterm delivery and low birth weight.

There are no available data on the presence of sodium ferric gluconate complex injection in human or animal milk, the effects on milk production, or the effects on the breastfed child. Sodium ferric gluconate complex injection contains benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs. Consider alternative iron replacement therapies without benzyl alcohol for use during breast-feeding.[29895] There is no information regarding the presence of ferric pyrophosphate citrate in human milk, the effects on the breast-fed child, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ferric pyrophosphate citrate and any potential adverse effects on the breast-fed child from ferric pyrophosphate citrate or the underlying maternal condition.[58762] [65183]