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Indications:  AMITIZA is for Chronic Idiopathic Constipation (CIC) in adults, Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, and Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years. Effectiveness in patients taking diphenylheptane opioids has not been established.

Indications

AMITIZA is for Chronic Idiopathic Constipation (CIC) in adults, Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, and Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years. Effectiveness in patients taking diphenylheptane opioids has not been established.

Efficacy profile for OIC with chronic, non-cancer pain

AMITIZA is an FDA-approved oral agent for OIC in adults with chronic, non‑cancer pain

The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established.

VIEW STUDIES

Definition of OIC across all 3 clinical studies

In AMITIZA clinical studies 1, 2, and 3, OIC was defined as3

Patients who had been receiving stable opioid therapy for at least 30 days prior to screening, which was to continue throughout the 12-week treatment period.

These patients experienced < 3 SBMs per week, with at least 25% of SBMs associated with one or more of the following conditions:

  • Hard to very hard stool consistency
  • Moderate to very severe straining
  • Having sensation of incomplete evacuation

A comparison of the proportion of overall responders* in clinical study 1

Study design

Study 1 was a randomized, double-blind, placebo-controlled, 12-week study in patients receiving non-diphenylheptane (e.g., non-methadone) opioid therapy for chronic, non-cancer-related pain.3

Proportion of overall responders* in each treatment arm at Week 123

Overall responders in each treatment arm at Week 12

*Overall responders were defined as patients who experienced3

  • ≥ 1 SBM improvement over baseline for all treatment weeks for which data was available, and
  • ≥ 3 SBMs/week for at least 9 of 12 treatment weeks

Mean change from baseline in SBM frequency at Week 8 in studies 2 and 33

Study design

Studies 2 and 3 were randomized, double-blind, placebo-controlled, 12-week studies in patients receiving opioid therapy for chronic, non-cancer pain. Studies 2 and 3 did not exclude patients receiving diphenylheptane opioids (e.g., methadone).3

Mean change from baseline in SBM frequency at Week 8 in studies 2 and 33

Mean Change in SBMs from baseline

||Study 3 did not demonstrate statistically significant improvement in SBM frequency rates at Week 8.3

Efficacy profiles for additional indications

 

Important Safety Information

AMITIZA (lubiprostone) 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 (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with 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 (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.

Hide references

  1. Data on file. Takeda Pharmaceuticals.
  2. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al; American College of Gastroenterology Task Force on Irritable Bowel Syndrome. Am J Gastroenterol. 2009;104(suppl 1):S1-S35.
  3. AMITIZA (lubiprostone) Prescribing Information. Sucampo Pharma Americas, LLC.
  4. Brandt LJ, Prather CM, Quigley EM, Schiller LR, Schoenfeld P, Talley NJ. Am J Gastroenterol. 2005;100(suppl 1):S5-S21.
  5. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Gastroenterology. 2006;130:1480-1491.
  6. Drossman DA, Chey WD, Johanson JF, et al. Aliment Pharmacol Ther. 2009;29:329-341.
  7. Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
  8. Barish CF, Drossman D, Johanson JF, Ueno R. Dig Dis Sci. 2010;55:1090-1097.
  9. Lipecka J, Bali M, Thomas A, et al. Am J Physiol Cell Physiol. 2002;282:C805-C816.
  10. Jentsch TJ, Stein V, Weinreich F, Zdebik AA. Physiol Rev. 2002;82:503-568.
  11. Hall JE. Textbook of Medical Physiology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:773-788.
  12. Keely SJ, Montrose MH, Barrett KE. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. West Sussex, England: John Wiley & Sons Ltd; 2009:330-367.
  13. Data on file. Sucampo Pharma Americas, LLC.
  14. Chey WD, Drossman DA, Johanson JF, Scott C, Panas RM, Ueno R. Aliment Pharmacol Ther. 2012;35:587-599.
  15. Patierno S, Anselmi L, Jaramillo I, Scott D, Garcia R, Sternini C. Gastroenterology. 2011;140:618-626.
  16. Hungin APS, Chang L, Locke GR, et al. Aliment Pharmacol Ther. 2005;21:1365-1375.
  17. Moeser AJ, Nighot PK, Engelke KJ, Ueno R, Blikslager AT. Am J Physiol Gastrointest Liver Physiol. 2007;292:G647-G656.
  18. Cuppoletti J, Malinowska DH, Tewari KP, et al. Am J Physiol Cell Physiol. 2004;287:C1173-C1183.
  19. Camilleri M, Gorman H. Neurogastroenterol Motil. 2007;19:545-552.
  20. Higgins PDR, Johanson JF. Am J Gastroenterol. 2004;99:750-759.
  21. National Digestive Diseases Information Clearinghouse (NDDIC). Constipation (2007).
  22. Furness JB, Nguyen TV, Nurgali K, Shimizu Y. In: Yamada T, Alpers DH, Kalloo AN, Kaplowitz N, Owyang C, Powell DW, eds. Textbook of Gastroenterology. 5th ed. Hoboken, NJ: Wiley Blackwell; 2009:15-36.
  23. Sternini C. Am J Physiol Gastrointest Liver Physiol. 2001;281:G8-G15.
  24. Pappagallo M. Am J Surg. 2001;182:11S-18S.
  25. Brock C, Olesen SS, Olesen AE, Frøkjaer JB, Andresen T, Drewes AM. Drugs. 2012;72:1847-1865.

Important Safety Information

AMITIZA (lubiprostone) 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 (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.

Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.

Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.

Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with 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 (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.

The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Indications

AMITIZA (lubiprostone) capsules are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old (8 mcg twice daily).

Please click here for complete Prescribing Information.