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American Regent, Inc.
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Shirley, NY 11967
INDICATIONS AND USAGEIMPORTANT SAFETY INFORMATION
Fomepizole Injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis.
Fomepizole Injection should not be administered to patients with a documented serious hypersensitivity reaction to Fomepizole Injection or other pyrazoles.
General: Fomepizole Injection should not be given undiluted or by bolus injection.
Minor allergic reactions have been reported. Patients should be monitored for signs of allergic reactions.
Laboratory Tests: Monitor patient throughout the treatment.
Pregnancy: Pregnancy Category C: Fomepizole should be given to pregnant women only if clearly needed.
Nursing Mothers: Caution should be exercised when fomepizole is administered to a nursing woman.
Pediatric and Geriatric Use: Safety and effectiveness have not been established.
The most frequent adverse events reported as drug-related or unknown relationship to study drug in those who received Fomepizole Injection were headache (14%), nausea (11%), and dizziness, increased drowsiness, and bad taste/metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows:
Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover.
Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension.
Gastrointestinal: Vomiting, diarrhea, dyspepsia, heartburn, decreased appetite, transient transaminitis.
Hemic/Lymphatic: Eosinophilia/hypereosinophilia, lymphangitis, disseminated intravascular coagulation, anemia.
Nervous: Lightheadedness, seizure, agitation, feeling drunk, facial flush, vertigo, nystagmus, anxiety, “felt strange,” decreased environmental awareness.
Respiratory: Hiccups, pharyngitis.
Skin/Appendages: Application site reaction, rash.
Special Senses: Abnormal smell, speech/visual disturbances, transient blurred vision, roar in ear.
USE IN SPECIAL POPULATIONS
Fomepizole Injection has not been studied sufficiently to determine whether the pharmacokinetics differ for geriatric and pediatric populations and between genders.
Renal Insufficiency: The metabolites of fomepizole are excreted renally. Definitive pharmacokinetic studies have not been done to assess pharmacokinetics in patients with renal impairment.
Hepatic Insufficiency: Fomepizole is metabolized through the liver, but no definitive pharmacokinetic studies have been done in subjects with hepatic disease.
OVERDOSAGEFor additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
Nausea, dizziness, and vertigo were noted in healthy volunteers receiving 3 to 6 times the recommended dose. This dose-dependent CNS effect was short-lived in most subjects and lasted up to 30 hours in one subject. Fomepizole is dialyzable, and hemodialysis may be useful in treating cases of overdosage.REF-0838 10/2019