Dilution Sodium Ferric Gluconate - Ferrlecit ®

Sodium Ferric Gluconate Complex (Ferrlecit ®)

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Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

--Intravenous dilution: --
[125 mg ] [100 ml] [60 minutes]

--Undiluted--
Ferrlecit® may be administered undiluted as a SLOW IV injection (at a rate of up to 12.5 mg/min).

Stability / Miscellaneous

EXP: If diluted in saline, use immediately after dilution.

Supplied: [62.5 mg/ 5 ml ampule]

INDICATIONS
Ferrlecit® (sodium ferric gluconate complex in sucrose injection) is indicated for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.

OVERDOSE
Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis. Periodic monitoring of laboratory parameters of iron storage may assist in recognition of iron accumulation. Ferrlecit® should not be administered in patients with iron overload.

Serum iron levels greater than 300 µg/dLmay indicate iron poisoning which is characterized by abdominal pain, diarrhea, or vomiting which progresses to pallor or cyanosis, lassitude, drowsiness, hyperventilation due to acidosis, and cardiovascular collapse. Caution should be exercised in interpreting serum iron levels in the 24 hours following the administration of Ferrlecit® since many laboratory assays will falsely overestimate serum or transferrin bound iron by measuring iron still bound to the Ferrlecit® complex. Additionally, in the assessment of iron overload, caution should be exercised in interpreting serum ferritin levels in the week following Ferrlecit® administration since, in clinical studies, serum ferritin exhibited a nonspecific rise which persisted for five days.

The Ferrlecit® iron complex is not dialyzable.

Ferrlecit® at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths to mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events based on information from postmarketing spontaneous reports. These adverse events included hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesia, and peripheral swelling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

CONTRAINDICATIONS
-All anemias not associated with iron deficiency.
-Hypersensitivity to Ferrlecit® or any of its inactive components.
-Evidence of iron overload.

DOSAGE AND ADMINISTRATION
The dosage of Ferrlecit® is expressed in terms of mg of elemental iron. Each 5 mL ampule contains 62.5 mg of elemental iron (12.5 mg/mL).

The recommended dosage of Ferrlecit® for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit® (125 mg of elemental iron). Ferrlecit® may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour. Ferrlecit® may also be administered undiluted as a slow IV injection (at a rate of up to 12.5 mg/min). Most patients will require a minimum cumulative dose of 1.0 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits. Ferrlecit® has been administered at sequential dialysis sessions by infusion or by slow IV injection during the dialysis session itself.

Data from Ferrlecit® postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events. See OVERDOSAGE.

Pediatric Dosage: The recommended pediatric dosage of Ferrlecit® for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit® (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour at eight sequential dialysis sessions. The maximum dosage should not exceed 125 mg per dose.

Note: Do not mix Ferrlecit® with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of Ferrlecit® with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit.

If diluted in saline, use immediately after dilution.

HOW SUPPLIED
NDC 52544-922-26

Ferrlecit® is supplied in colorless glass ampules. Each ampule contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 ampules.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze. See USP Controlled Room Temperature.

Source: [package insert]