Desferal is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.

Acute Iron Intoxication

Desferal is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis.

Chronic Iron Overload

Desferal can promote iron excretion in patients with secondary iron overload frommultiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). Long-termtherapy with Desferal slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis.

Iron mobilization with Desferal is relatively poor in patients under the age of 3 years with relatively little iron overload. The drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated.

Desferal is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.

Acute Iron Intoxication

Intramuscular Administration

This route is preferred and should be used for ALL PATIENTS NOT IN SHOCK.

A dose of 1000 mg should be administered initially. This may be followed by 500 mg every 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours. For reconstitution instructions for intramuscular administration see Table 1 below.

Table 1: Preparation for Intramuscular Administration

The reconstituted Desferal solution is a yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Desferal reconstituted with Sterile Water for Injection IS FOR SINGLE USE ONLY. Discard unused portion.

Intravenous Administration

THIS ROUTE SHOULD BE USED ONLY FOR PATIENTS IN A STATE OF CARDIOVASCULAR COLLAPSE AND THEN ONLY BY SLOW INFUSION. THE RATE OF INFUSION SHOULD NOT EXCEED 15 MG/KG/HR FOR THE FIRST 1000 MG ADMINISTERED. SUBSEQUENT IV DOSING, IF NEEDED, MUST BE AT A SLOWER RATE, NOT TO EXCEED 125 MG/HR.

The reconstituted solution is added to physiologic saline (e.g., 0.9% sodiumchloride, 0.45% sodiumchloride), glucose in water, or Ringer's lactate solution.

An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours.

As soon as the clinical condition of the patient permits, intravenous administration should be discontinued and the drug should be administered intramuscularly. For reconstitution instructions for intravenous administration see Table 2 below.

Table 2: Preparation for Intravenous Administrations

The reconstituted Desferal solution is an isotonic, clear and colorless to slightly yellowish solution. The drug should be completely dissolved before the solution is withdrawn. Desferal reconstituted with Sterile Water for Injection IS FOR SINGLE USE ONLY. Discard unused portion.

Chronic Iron Overload

The more effective of the following routes of administration must be chosen on an individual basis for each patient.

Intramuscular Administration

A daily dose of 500-1000 mg should be administered intramuscularly. In addition, 2000 mg should be administered intravenously with each unit of blood transfused; however, Desferal should be administered separately fromthe blood. The rate of intravenous infusion must not exceed 15 mg/kg/hr. The total daily dose should not exceed 1000 mg in the absence of a transfusion, or 6000 mg even if transfused three or more units of blood or packed red blood cells. For reconstitution instructions for intramuscular administration see Table 3 below.

Table 3: Preparation for Intramuscular Administration

The reconstituted Desferal solution is a yellow-colored solution. The drug should be completely dissolved before the solution is withdrawn. Desferal reconstituted with Sterile Water for Injection IS FOR SINGLE USE ONLY. Discard unused portion

Subcutaneous Administration

A daily dose of 1000-2000 mg (20-40 mg/kg/day) should be administered over 8-24 hours, utilizing a small portable pump capable of providing continuous mini-infusion. The duration of infusion must be individualized. In some patients, as much iron will be excreted after a short infusion of 8-12 hours as with the same dose given over 24 hours. For reconstitution instructions for subcutaneous administration see Table 4 below.

Table 4: Preparation for Subcutaneous Administration

The reconstituted Desferal solution is an isotonic, clear and colorless to slightly yellowish solution. The drug should be completely dissolved before the solution is withdrawn. Desferal reconstituted with Sterile Water for Injection IS FOR SINGLE USE ONLY. Discard unused portion.

Stability after Reconstitution

The product should be used immediately after reconstitution (commencement of treatment within 3 hours) for microbiological safety. When reconstitution is carried out under validated aseptic conditions (in a sterile laminar flow hood using aseptic technique), the product may be stored at roomtemperature for a maximumperiod of 24 hours before use. Do not refrigerate reconstituted solution. Reconstituting Desferal in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.

Vials - each containing 500 mg of sterile, lyophilized deferoxamine mesylate

Cartons of 4 vials……………………………………………NDC 0083-3801-04

Vials - each containing 2 g of sterile, lyophilized deferoxamine mesylate

Cartons of 4 vials……………………………………………NDC 0078-0347-51

Do not store above 25°C (77°F).

Manufactured by: Novartis Pharma Stein AG, Schaffhauserstrasse CH-4332 Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, FDA revision date: 1/19/2007

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