Feraheme Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] • Hypotension [ see Warnings and Precautions ( 5.2 ) ] • Iron Overload [ see Warnings and Precautions ( 5.3 ) ] • Magnetic Resonance (MR) Imaging Test Interference [ see Warnings and Precautions ( 5.4 ) ] The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS with Feraheme, contact AMAG Pharmaceuticals, Inc.

at 1-877-411-2510, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, 3,968 subjects were exposed to Feraheme.

Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years).

The data described below reflect exposure to Feraheme in 997 patients exposed to a 1.02 g course of ferumoxytol administered as two 510 mg intravenous (IV) doses: 992 subjects (99.5%) received at least 1 complete dose of ferumoxytol and 946 subjects (94.9%) received 2 complete doses.

The mean cumulative IV Iron exposure was 993.80 ±119.085 mg.

The safety of Feraheme was studied in a randomized, multicenter, double-blind clinical trial in patients with IDA (IDA Trial 3), [ see Clinical Studies ( 14.1 ) ].

In this trial, patients were randomized to two intravenous infusions of 510 mg (1.02 g) of Feraheme (n=997), or two intravenous infusions of 750 mg (1.500 g) of ferric carboxymaltose (FCM) (n=1000).