Clinical Information
Gen. Code and Des.
1609 iron dextran complex INJECTION VIAL 100 MG/2ML
GCN and Des.
4420 iron dextran complex INJECTION VIAL 100 MG/2ML
Strength
100MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
20040400 IRON PREPARATIONS
Active Ingredients
832 iron dextran complex 9004664
INFeD® (iron dextran injection), for intravenous or intramuscular use
Initial U.S. Approval: 1974
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS
See full prescribing information for complete boxed warning.
Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. (5.1)
Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.
Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose.
During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated.
Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD. (5.3)
INDICATIONS AND USAGE
INFeD, an iron replacement product, is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for weight-based dosing and administration information. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/2 mL (50 mg/mL) in single-dose vials (3)
CONTRAINDICATIONS
Known hypersensitivity to INFeD (4)
WARNINGS AND PRECAUTIONS
Delayed Reactions: May occur with large intravenous doses. (5.2)
Increased Risk of Toxicity in Patients with Underlying Conditions: Monitor for toxicity in these patients. (5.3)
Iron Overload: Excessive therapy can lead to iatrogenic hemosiderosis. Do not administer to patients with iron overload. Periodically monitor hematologic and iron parameters. (5.4)
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Risk of hypersensitivity reaction which may have serious consequences for the fetus. (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2021