Adult Dosing

Hemodialysis associated iron deficiency anemia

• 125 mg of elemental iron diluted in 100 mL of 0.9% NaCl IV infusion over 1 hr each HD; if undiluted, administer 125 mg IV at a rate of 12.5 mg/min
• Max: 125 mg/dose

• Minimum cumulative dose of 1 g of elemental iron x8 dialysis sessions may be required for achieving a favorable hemoglobin or hematocrit response in most patients
• Do not mix with other medications or add to parenteral nutrition solutions for IV infusion

Pediatric Dosing

Hemodialysis associated iron deficiency anemia

• >6 yrs
• 1.5 mg/kg of elemental iron diluted in 25 mL of 0.9% NaCl IV infusion over 1 hr during 8 sequential dialysis sessions
• Max: 125 mg/dose

Note:

• Do not mix with other medications or add to parenteral nutrition solutions for IV infusion

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of iron deficiency anemia in both adult and pediatric patients 6 yrs with chronic kidney disease who are undergoing hemodialysis and receiving supplemental epoetin therapy

• Hypersensitivity to any of the ingredients of the product
• Non-iron deficiency anemia
• Evidence of iron overload
• Neonates
• Hemosiderosis

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Life-threatening and fatal hypersensitivity reactions, including anaphylactic-type reactions have been reported with injectable iron products in postmarketing experience
• Closely monitor patients for signs and symptoms of hypersensitivity during and after dose administration for at least 30 min and until clinically stable after completion of the infusion. Should be administered when facilities and therapies for treatment of anaphylaxis and hypersensitivity reactions are readily available
• Therapy may cause clinically significant hypotension. Hypotensive reactions including lightheadedness, fatigue, malaise, weakness or severe pain in the chest, back, flanks, or groin have been reported in patients receiving intravenous iron. These reactions may or may not be associated with hypersensitivity reactions and usually resolve within 1 to 2 hrs. Monitor patients for signs and symptoms of hypotension during and following administration of this product
• Excessive therapy may lead to excess iron storage with the possibility of iatrogenic hemosiderosis; monitor hematologic and iron parameters regularly during therapy
• Product contains benzyl alcohol as a preservative, which has been associated with serious adverse reactions and death in pediatric patients

Cautions: Use cautiously in

• Patients with iron overload
• Elderly patients
• Hemoglobinopathy
• Refractory anemia

Supplemental Patient Information

• Inform patients to report adverse reactions associated with parenteral iron use such as hypersensitivity, allergic reactions, lightheadedness, dizziness, swelling and breathing problems
• Advise patients that this product may reduce the absorption of concomitantly administered oral iron preparations

Pregnancy Category:B

Breastfeeding: Safety unknown. Manufacturer advises caution.

• CNS: Asthenia, headache, dizziness, agitation, somnolence, malaise, lightheadedness
• CV: Hypotension, chest pain, syncope, tachycardia, bradycardia, vasodilatation, MI, pulmonary edema, hypertension, angina pectoris
• RESP: Dyspnea, coughing, URTI, rhinitis, pneumonia, pharyngitis
• GI: Abdominal pain, nausea, vomiting, diarrhea, anorexia, rectal disorder, dyspepsia, eructation, flatulence, GI disorder, melena
• GU: UTI, menorrhagia
• EENT: Conjunctivitis, diplopia, deafness, rolling of the eyes, watery eyes, puffy eyelids, redness of the eye
• NEURO: Paresthesias
• MUSC: Leg cramps and pain, myalgia, arthralgia, back pain, arm pain
• DERM: Pruritus, rash, increased sweating
• LOCAL: Injection site reactions
• METABOLIC: Hyperkalemia, hypoglycemia, hypervolemia, hypokalemia
• HEMA: Abnormal erythrocytes, anemia, leukocytosis, lymphadenopathy, thrombosis, hemosiderosis
• HYPERSENSITIVITY: Severe hypersensitivity reactions, anaphylactoid reactions
• MISC: Fever, infection, abscess, chills, rigors, carcinoma, flu-like syndrome, sepsis, edema (generalized edema, leg edema, peripheral edema), pain, fatigue

• Hematinic; repletes the total body content of iron, an essential component for normal hemoglobin synthesis, metabolism and various enzymatic processes
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: 1 hr

US Trade Name(s)

• Ferrlecit
• Nulecit

US Availability

sodium ferric gluconate complex (generic)

• INJ: 62.5 mg/5 mL

Ferrlecit

• INJ: 62.5 mg/5 mL (5 mL amp and vial)

Nulecit

• INJ: 62.5 mg/5 mL

Canadian Trade Name(s)

• Ferrlecit

Canadian Availability

Ferrlecit

• INJ: 62.5 mg/5 mL (5 mL amp)

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Nutrition/Electrolytes

Iron Products