INFED
Generic: IRON DEXTRAN
Basic Information
Manufacturer
Henry Schein, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
INTRAVENOUS
FDA Set ID
99bf34be-cb8a-46d1-9637-5544dc2da287
Indications & Usage
1 INDICATIONS AND USAGE INFeD 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 have had an unsatisfactory response to oral iron.
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)
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)
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Delayed Reactions [see Warnings and Precautions (5.2)] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)] Iron Overload [see Warnings and Precautions (5.4)] Fetal bradycardia [see Use in Specific Populations (8.1)] The following adverse reactions associated with the use of INFeD were identified in clinical studies or postmarketing reports.
Because some of these reactions were 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.
Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy.
Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea.
General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation.
Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – [see Warnings and Precautions (5.3)], myalgia, backache.
Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste.
Psychiatric disorders: Disorientation Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing.
Renal and urinary disorders: Hematuria.
Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating.
Cardiovascular disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction, cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site.
Most common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness.
(6) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because some of these reactions were 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.
Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy.
Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea.
General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation.
Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – [see Warnings and Precautions (5.3)], myalgia, backache.
Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste.
Psychiatric disorders: Disorientation Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing.
Renal and urinary disorders: Hematuria.
Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating.
Cardiovascular disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction, cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site.
Most common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness.
(6) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.