AURLUMYN

5 WARNINGS AND PRECAUTIONS AURLUMYN may cause symptomatic hypotension. Monitor vital signs while initiating AURLUMYN. Correct hypotension prior to administration of AURLUMYN ( 5.1 ). 5.1 Hypotension AURLUMYN is a systemic vasodilator and may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications while administering AURLUMYN to reduce potential additive hypotensive effects. Consider down-titration or discontinuation of AURLUMYN if hypotension persists despite discontinuation of other antihypertensives and fluid resuscitation.

6 ADVERSE REACTIONS Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension (6.1). To report SUSPECTED ADVERSE REACTIONS, contact BTG International, Inc. at 1-877-377-3748 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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. Adverse events reported with the use of intravenous iloprost in patients with frostbite from the published literature include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension. Pre-marketing safety data on AURLUMYN were obtained from 116 patients with Systemic Sclerosis receiving iloprost in 2 multicenter, double-blind, randomized, placebo-controlled studies in patients with Systemic Sclerosis experiencing symptomatic digital ischemic episodes (Raynaud's Phenomenon). Patients received intravenous AURLUMYN administered as a continuous infusion over 6 hours each day for 5 consecutive days and the dose was adjusted according to individual tolerability within the range of 0.5 to 2.0 ng /kg /min. The observed safety profile in these patients was similar to that observed with IV iloprost.