Prescription Drug Information: Deferoxamine Mesylate (Page 2 of 2)

OVERDOSAGE

Acute Toxicity

Intravenous LD50 s (mg/kg): mice, 287; rats, 329.

Signs and Symptoms

Inadvertent administration of an overdose or inadvertent intravenous bolus administration/rapid intravenous infusion may be associated with hypotension, tachycardia and gastrointestinal disturbances; acute but transient loss of vision, aphasia, agitation, headache, nausea, pallor, CNS depression including coma, bradycardia and acute renal failure have been reported.

Acute respiratory distress syndrome has been reported following treatment with excessively high intravenous doses of deferoxamine mesylate in patients with acute iron intoxication and in patients with thalassemia.

Treatment

There is no specific antidote. Deferoxamine mesylate should be discontinued and appropriate symptomatic measures undertaken.

Deferoxamine mesylate is readily dialyzable.

DOSAGE AND ADMINISTRATION

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.

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.

For reconstitution instructions for intravenous administration see Table 2. The reconstituted solution is added to physiologic saline, (e.g., 0.9% sodium chloride, 0.45% sodium chloride), 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.

CHRONIC IRON OVERLOAD

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 3.

Intravenous Administration

The standard recommended method of deferoxamine mesylate administration is via slow subcutaneous infusion over 8 – 12 hours. In patients with intravenous access, the daily dose of deferoxamine mesylate can be administered intravenously. The standard dose is 20 – 40 mg/kg/day for children and 40 – 50 mg/kg/day over 8 – 12 hours in adults for 5 – 7 days per week. In children, average doses should not exceed 40 mg/kg/day until growth has ceased. In adults, average doses should not exceed 60 mg/kg/day. The intravenous infusion rate should not exceed 15 mg/kg/hour. For reconstitution instructions for intravenous administration see Table 2.

In patients who are poorly compliant, deferoxamine mesylate may be administered prior to or following same day blood transfusion (for example 1 gram over 4 hours on the day of transfusion); however, the contribution of this mode of administration to iron balance is limited. Deferoxamine mesylate should not be administered concurrently with the blood transfusion as this can lead to errors in interpreting side effects such as rash, anaphylaxis and hypotension.

Intramuscular Administration

A daily dose of 500-1000 mg may be administered intramuscularly. The total daily dose should not exceed 1000 mg. For reconstitution instructions for intramuscular administration see Table 1.

Reconstitution and Preparation

Table 1: Preparation for Intramuscular Administration

RECONSTITUTE DEFEROXAMINE MESYLATE WITH STERILE WATER FOR INJECTION
Vial Size Amount of Sterile Water for Injection Required for Reconstitution Total Drug Content after Reconstitution Final Concentration per mL after Reconstitution
500 mg 2 mL 500 mg/2.35 mL 213 mg/mL
2 grams 8 mL 2 grams/9.4 mL 213 mg/mL

Table 2: Preparation for Intravenous Administrations

RECONSTITUTE DEFEROXAMINE MESYLATE WITH STERILE WATER FOR INJECTION
Vial Size Amount of Sterile Water for Injection Required for Reconstitution Total Drug Content after Reconstitution Final Concentration per mL after Reconstitution
500 mg 5 mL 500 mg/5.3 mL 95 mg/mL
2 grams 20 mL 2 grams/21.1 mL 95 mg/mL

Table 3: Preparation for Subcutaneous Administration

RECONSTITUTE DEFEROXAMINE MESYLATE WITH STERILE WATER FOR INJECTION
Vial Size Amount of Sterile Water for Injection Required for Reconstitution Total Drug Content after Reconstitution Final Concentration per mL after Reconstitution
500 mg 5 mL 500 mg/5.3 mL 95 mg/mL
2 grams 20 mL 2 grams/21.1 mL 95 mg/mL

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

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 room temperature for a maximum period of 24 hours before use. Do not refrigerate reconstituted solution. Reconstituting deferoxamine mesylate for injection in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.

HOW SUPPLIED

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

Carton of 1 vial……………………NDC 47781-623-07
Carton of 4 vials………………..…NDC 47781-623-04

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

Carton of 1 vial……………………NDC 47781-624-07
Carton of 4 vials………………..…NDC 47781-624-04

Each vial is for single dose only.
Discard unused portion.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Manufactured by:
Gland Pharma Limited
Hyderabad — 500043, INDIA.

Distributed by:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

Product of Germany

November 2017
PI623-00

PRINCIPAL DISPLAY PANEL — 500 mg Vial

NDC 47781-623 -07

Deferoxamine Mesylate for Injection, USP

500 mg per vial

For Subcutaneous, Intramuscular or Intravenous Use

Rx only

500mg-vial
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Carton

NDC 47781-623 -07

Deferoxamine Mesylate for Injection, USP

500 mg per vial

For subcutaneous, intramuscular or intravenous administration.

Each vial contains deferoxamine mesylate USP, 500 mg in lyophilized form.

Rx only

500mg-carton
(click image for full-size original)

500mg-vial500mg-carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

NDC 47781-624 -07

Deferoxamine Mesylate for Injection, USP 2 g per vial

For Subcutaneous, Intramuscular or Intravenous Use

For Single-dose only.

Rx only

2g-vial
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

NDC 47781-624 -07

Deferoxamine Mesylate for Injection, USP 2 g per vial

For subcutaneous, intramuscular or intravenous administration

Each vial contains deferoxamine mesylate USP, 2 g in lyophilized form.

Rx only

Dosage: 2 g vial is for single dose only, for full directions see package insert.

2g-mono-carton
(click image for full-size original)
DEFEROXAMINE MESYLATE deferoxamine mesylate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-623
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFEROXAMINE MESYLATE (DEFEROXAMINE) DEFEROXAMINE MESYLATE 500 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-623-07 1 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (47781-623-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207384 03/24/2018 02/01/2020
DEFEROXAMINE MESYLATE deferoxamine mesylate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-624
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFEROXAMINE MESYLATE (DEFEROXAMINE) DEFEROXAMINE MESYLATE 2 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-624-07 1 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (47781-624-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207384 03/24/2018
Labeler — Alvogen Inc. (008057330)

Revised: 05/2021 Alvogen Inc.

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