General Information
Revision date
2015-07-27
Product name
Feraheme
Product Synonyms
Formulated polyglucose sorbitol carboxymethylether superparamagnetic iron
Chemical name
Iron preparation, semi-synthetic carbohydrate coated superparamagnetic iron oxide
CAS No.
722492-56-0
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ of the substance or mixture packaged in final form for patient use for the treatment of Iron Deficiency mixture and uses Anemia in patients with chronic kidney disease
Emergency telephone
+1 (617) 498-3361 (Available 9 am - 5 pm EST
Icons in SDS
Company Information
company name
AMAG Pharmaceuticals, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
sds@amagpharma.com
GHS Information
Signal word
None
Section 2
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk drug product. SECTION 2 - HAZARDS IDENTIFICATION …continued Globally Harmonized Not classified System [GHS]
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Ferumoxytol is indicated for the intravenous (IV) treatment of iron deficiency anemia in adult patients with chronic kidney disease. Adverse effects reported with high doses of ferumoxytol include gastrointestinal effects, dizziness, hypotension and peripheral edema. Severe allergic reactions have also been reported in some patients. Long-term inhalation exposure to high levels of iron oxide may cause effects on the respiratory system (pneumoconiosis, siderosis). It is unclear if similar effects would occur with inhalation exposure to ferumoxytol. Note This mixture is not classified as hazardous according to Regulation EC No 1272/ 2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA).
