Important Safety Information

AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA.

Some patients taking AMITIZA may experience nausea. Take AMITIZA with food and water to reduce the occurrence of nausea.

Do not take AMITIZA if you have severe diarrhea. Some patients taking AMITIZA may experience diarrhea. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms.

The most common side effects of taking AMITIZA 24 mcg twice daily for CIC are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication.

Please click here for complete Prescribing Information.

AMITIZA is a trademark of Mallinckrodt Pharmaceuticals, registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

©2018 Takeda Pharmaceuticals U.S.A., Inc.

USD/LUB/18/0017B    07/18