OVERVIEW
- Important Safety Information to discuss with patients
- Safety profile demonstrated in long-term 6-month and 12-month safety studies1
- No clinically significant changes in serum electrolyte levels in clinical studies2
- Low likelihood of drug-drug interactions (based on in-vitro human microsome studies)1
IMPORTANT SAFETY INFORMATION TO DISCUSS WITH PATIENTS
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.
Please refer to complete Prescribing Information.
CHRONIC IDIOPATHIC CONSTIPATION ADVERSE REACTIONS
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316) in patients with Chronic Idiopathic Constipation, 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%).1
The adverse reactions that occurred in at least 1% of patients who received AMITIZA 24 mcg twice daily and that occurred more frequently with AMITIZA than placebo are shown in this table.1
AMITIZA HAS A DEMONSTRATED SAFETY PROFILE ACROSS ALL AGE GROUPS1
AMITIZA has a demonstrated safety profile with low likelihood of drug-drug interactions (based on in-vitro human microsome studies). Its safety profile was also demonstrated in 6-month and 12-month safety studies (24– to 48–week treatment period). AMITIZA can be effective for appropriate adult patients – it is not recommended for everyone.
DOWNLOAD THE AMITIZA PRESCRIBING INFORMATIONIN DEPTH
SAFETY PROFILE
- Safety profile demonstrated in 6-month and 12-month safety studies1
- 24-week to 48-week treatment period
- Low likelihood of drug-drug interactions (based on in-vitro human microsome studies)1
- No in-vitro interactions observed with cytochrome P450 enzymes
- Metabolism appears to be mediated by microsomal carbonyl reductase
NO CLINICALLY SIGNIFICANT CHANGES IN SERUM ELECTROLYTE LEVELS IN CLINICAL STUDIES2
Data from 24-week (n=490) and 48-week (n=281) safety studies of patients with Chronic Idiopathic Constipation.
*Last treatment assessment.
†Change of < 1% vs. baseline median (no clinical significance).
REFERENCES
- AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
- 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.
Please click here for complete Prescribing Information.
This site is intended for use by U.S. residents only. This site is intended for healthcare professionals.
AMITIZA is a trademark of Sucampo Pharmaceuticals, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
©2011 Takeda Pharmaceuticals North America, Inc.
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