Chronic Idiopathic Constipation

OVERVIEW

Improvement in spontaneous bowel movement (SBM) frequency vs placebo¹
Improvement of Chronic Idiopathic Constipation symptoms¹
No restrictions on duration of use*
- Need for continued therapy should be periodically assessed¹

ONLY YOU CAN PRESCRIBE AMITIZA

AMITIZA (24 mcg twice daily) is indicated for the treatment of Chronic Idiopathic Constipation in adults¹
AMITIZA (24 mcg twice daily) may be another option for your patients

HOW MIGHT YOUR PATIENTS BENEFIT FROM AMITIZA (24 MCG TWICE DAILY)?

CIC WAS DEFINED AS¹

Average of < 3 SBMs per week, with 1 or more of the following symptoms for at least 6 months:

Very hard stools for at least a quarter of all bowel movements
Sensation of incomplete evacuation following at least a quarter of all bowel movements
Straining with defecation at least a quarter of the time

IMPROVEMENT IN SPONTANEOUS BOWEL MOVEMENT (SBM) FREQUENCY VS PLACEBO¹

In two 4-week clinical studies, the average number of SBMs at Week 1 increased to either 5.7 (n=120) in Pivotal Study 1, or 5.9 (n=119) in Pivotal Study 2 with AMITIZA (24 mcg twice daily) vs 3.5 (n=122) in Pivotal Study 1, or 4.0 (n=118) in Pivotal Study 2 for placebo.^2,3

At Week 4, the average number of SBMs increased to either 5.3 (n=120) in Pivotal Study 1, or 5.4 (n=119) in Pivotal Study 2 per week with AMITIZA (24 mcg twice daily) vs 2.9 (n=122) in Pivotal Study 1, or 3.5 (n=118) in Pivotal Study 2 per week for placebo.^2,3

SBMs were defined as any bowel movements occurring greater than or equal to 24 hours after the use of rescue medication^2,3

IMPROVEMENT OF CIC SYMPTOMS¹

In two 4-week clinical studies, symptoms evaluated were abdominal bloating/discomfort, stool consistency, straining, and constipation severity.

Results were consistent regardless of gender and in patients in a subpopulation analysis ≥ 65¹

NO RESTRICTIONS ON DURATION OF USE*

Need for continued therapy should be periodically assessed¹

*Based on safety studies up to 52 weeks: two 4-week, double-blind studies and a 24- to 48-week, open-label safety study.¹

LEARN MORE ABOUT CHRONIC IDIOPATHIC CONSTIPATION IN ADULTS

IN DEPTH

THE ONLY LOCALLY ACTING CIC-2 CHLORIDE CHANNEL ACTIVATOR¹

AMITIZA (24 mcg twice daily) is a locally acting chloride channel activator approved for the treatment of Chronic Idiopathic Constipation in adults.¹

Chloride channels are key regulators in the intestinal tract, actively transporting chloride ions into the lumen. Sodium ions and fluids passively follow^4,5,6
By regulating fluid absorption and secretion, chloride channels help regulate fluid balance⁷
By increasing intestinal fluid sectretion, AMITIZA increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation¹

WATCH THE MECHANISM OF ACTION VIDEO

WATCH VIDEO

REFERENCES

AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
Barish CF, Drossman D, Johanson JF, Ueno R. Dig Dis Sci. 2010;55:1090-1097.
Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
Jentsch TJ, Stein V, Weinreich F, et al. Physiol Rev. 2002;82:503-568.
Lipecka J, Bali M, Thomas A, et al. Am J Cell Physiol. 2002;282:C805-C816.
Guyton AC, Hall JE. Textbook of Medical Physiology. 9th ed. Philadelphia, Pa: WB Saunders; 1996.
Barrett KE, Keely SJ. Chloride secretion by the intestinal epithelium: molecular basis and regulatory aspects. Annu Rev Physiol. 2000;62:535-572.

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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