Irritable Bowel Syndrome with Constipation

OVERVIEW

The only prescription treatment approved for IBS-C in women 18 years and older
Can help address the global symptoms of IBS-C¹
Global symptoms include abdominal discomfort/pain, bowel habits, and other IBS symptoms

In AMITIZA clinical studies, IBS was defined as:
- Abdominal pain or discomfort occurring over at least 6 months with two or more of the following:
  - Relieved with defecation;
  - Onset associated with a change in stool frequency; and
  - Onset associated with a change in stool form.
Patients were sub-typed as having IBS-C if they also experienced two of three of the following:
- < 3 spontaneous bowel movements per week,
- > 25% hard stools, and
- > 25% spontaneous bowel movements associated with straining.

Safety profile¹
No restriction on duration of use*
- Need for continued therapy should be periodically assessed¹
Recommended by the American College of Gastroenterology (ACG) in 2009. Rated 1B: Strong recommendation. Moderate evidence for IBS-C in women ≥ 18 years old ²

ONLY YOU CAN PRESCRIBE AMITIZA

AMITIZA (8 mcg twice daily) is indicated for the treatment of Irritable Bowel Syndrome with Constipation in women 18 years and older.¹

THE ONLY PRESCRIPTION TREATMENT APPROVED FOR IBS-C
IN WOMEN 18 YEARS AND OLDER

AMITIZA CAN HELP ADDRESS THE GLOBAL SYMPTOMS OF IBS-C¹

AMITIZA (8 mcg twice daily) may help your appropriate patients by addressing the global symptoms of Irritable Bowel Syndrome with Constipation. Global symptoms include abdominal discomfort/pain, bowel habits, and other IBS symptoms.

HOW MIGHT YOUR PATIENTS BENEFIT FROM AMITIZA (8 MCG TWICE DAILY)?

IN 2 CLINICAL STUDIES, THE PRIMARY ENDPOINT WAS OVERALL RESPONSE TO THE QUESTION¹

"How would you rate your relief of symptoms over the past week compared to how you felt before you entered the study?"

Global symptoms were defined as:

Abdominal discomfort/pain, bowel habits, and other IBS symptoms
Overall response was defined as "monthly response" for at least 2 months in the 3-month study¹

SAFETY PROFILE IN IBS-C DEMONSTRATED IN STUDIES UP TO 1 YEAR¹

Studied in 1,011 patients up to 1 year¹
In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%)

NO RESTRICTIONS ON DURATION OF USE*

Based on safety studies up to 52 weeks
Need for continued therapy should be periodically assessed

SAFETY PROFILE¹

Demonstrated in studies up to 52 weeks, including 12- to 16-week, double-blind studies and a 36-week open-label study¹

RECOMMENDED BY THE AMERICAN COLLEGE OF GASTROENTEROLOGY (ACG) IN 2009²

Rated 1B: Strong recommendation. Moderate evidence for IBS-C in women ≥ 18 years old²

*Based on safety studies up to 52 weeks: 12- to 16-week, double-blind studies and a 36-week open-label study.

LEARN MORE ABOUT IRRITABLE BOWEL SYNDROME
WITH CONSTIPATION IN WOMEN 18 YEARS AND OLDER

IN DEPTH

WATCH THE SUGGESTED MECHANISM OF ACTION VIDEO

WATCH VIDEO

REFERENCES

AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011
Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. Am J Gastroenterology. 2009;104:S1-S35.
Data on file, Sucampo Pharma Americas, Inc.

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.

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