Patient Support Materials - Amitiza

PHYSICIAN RESOURCES

PATIENT SUPPORT MATERIALS

WEBSITES

AMITIZA.com
The AMITIZA patient site.

The American Gastroenterological Association (AGA) Patient Center
The AGA is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is the oldest medical-specialty society in the United States.

The International Foundation for Functional Gastrointestinal Disorders (IFFGD)
The IFFGD is a nonprofit education and research organization dedicated to informing, assisting, and supporting people affected by gastrointestinal (GI) disorders. Founded in 1991, the IFFGD works with patients, families, physicians, nurses, practitioners, investigators, regulators, employers, and others to improve digestive health in adults and children.

The National Digestive Diseases Information Clearinghouse (NDDIC)
The NDDIC is an information dissemination service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK is part of the National Institutes of Health (NIH), which is part of the U.S. Department of Health and Human Services. NDDIC was established in 1980 to increase knowledge and understanding about digestive diseases among people with these conditions and their families, healthcare professionals, and the general public.

TOOLS

To help your patients more accurately identify and monitor their symptoms, you can provide them with tools like the Bristol Stool Form Scale and the Symptom Tracker. These tools may help patients to assess their symptoms.

CLICK HERE TO DOWNLOAD THE SYMPTOM TRACKER

Indication

AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥ 18 years old.

Important Safety Information

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.
Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.
Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316) in patients with Chronic Idiopathic Constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs < 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Please click here for complete Prescribing Information.