SPL Set ID: 34036fc0-6832-d066-e063-6394a90a18a4

AURLUMYN contains iloprost, a synthetic analog of prostacyclin PGI 2 . The chemical name for iloprost is (5 E )-[3a S ,4 R ,5 R ,6a S )-5-hydroxy-4-[(1 E )-(3 S ,4 RS )-3-hydroxy-4-methyloct-1-en-6-ynyl]-hexahydropentalen-2(1 H )-ylidene]pentanoic acid. Iloprost consists of a mixture of the 4R and 4S diastereoisomers at a ratio of approximately 53:47. Iloprost is an oily substance, which is soluble in methanol, ethanol, ethyl acetate, acetone, and pH 7 buffer, sparingly soluble in buffer pH 9, and very slightly soluble in distilled water, buffer pH 3, and buffer pH 5. The molecular formula of iloprost is C 22 H 32 O 4 and its molecular weight is 360.49. The structural formula is shown below: AURLUMYN (iloprost) injection is a clear, colorless, sterile solution formulated for intravenous use. AURLUMYN is supplied in single-use glass vials containing 1-mL per vial. Each mL of the solution contains 100 mcg (0.1 mg) of iloprost as the active ingredient and the following inactive ingredients: 8.1 mg ethanol, 9 mg sodium chloride, and 0.242 mg tromethamine. Hydrochloric acid and sodium hydroxide is added to adjust pH to 8.3. The solution contains no preservatives. Chemical Structure