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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.

Savings and coverage

Access, coverage, and savings information

AMITIZA Savings Card

With the AMITIZA Savings Card, appropriate patients pay $0 for 30- or 90- day prescriptions if eligible and can save up to:

  • $75 on 30-day prescriptions
  • $225 on 90-day prescriptions for appropriate patients

Savings card can be used to reduce patient co-pay or for cash-paying patients.

Savings card cannot be used for government programs such as Medicare Part D.

healthy savings card

AMITIZA patients can pay $0 every month for their prescriptions and refills*

*

Eligibility Requirements: This offer cannot be used if you are a beneficiary of, or any part of your prescription is covered by: (1) any federal or state healthcare program (Medicare, Medicaid, TriCARE, etc.), including a state pharmaceutical assistance program, (2) the Medicare Prescription Drug Program (Part D), or if you are currently in the coverage gap, or (3) insurance that is paying the entire cost of the prescription.

Medicare Part D

AMITIZA is accessible and affordable for Medicare Part D patients.

  • 93% of Part D lives are covered
  • 69% of Part D patients pay $10 or less§

Insured lives is intended to show size of insured population and does not imply disease prevalence or appropriate populations for treatment with AMITIZA.

Fingertip Formulary, November 2016.

§IMS Health, FIA PlanTrak, September 2016.

Formulary Tool

AMITIZA has formulary coverage for 83% of all commercially insured lives in the United States.||1 Use this interactive tool to find insurance coverage by ZIP code.

Insured lives is intended to show size of insured population and does not imply disease prevalence or appropriate populations for treatment with AMITIZA.

||Fingertip Formulary, November 2016.

Help At Hand#

Takeda understands that some patients may have financial situations that make it difficult to pay for their prescriptions. Help At Hand provides assistance for people who have no insurance or who do not have enough insurance and need help getting their Takeda medicines.

#Patients must meet Eligibility Requirements.

More ways that may help patients save on AMITIZA

Here are some additional ways your patients may save on AMITIZA prescriptions.

Partnership for Prescription Assistance**

Partnership for Prescription Assistance provides a single point of access to more than 475 public and private patient assistance programs, including more than 180 offered by pharmaceutical companies. Call toll-free 1-888-4PPA-NOW (1-888-477-2669) or go to pparx.org for more information.

**Patients must meet Eligibility Requirements.

Together Rx Access program††

Together Rx Access is a prescription savings program that offers a free, easy way to save on prescription medications. Most cardholders save 25% to 40% on brand-name medicines and also save on a wide range of generic medications.‡‡

††

Eligibility Requirements include household income, not being eligible for Medicare, not having prescription drug coverage (public or private), and being a legal resident of the United States or Puerto Rico. For more information regarding eligibility, contact Together Rx Access at 1-800-444-4106.

‡‡

Each cardholder's savings depend on such factors as the particular drug purchased, amount purchased, and pharmacy where purchased. Participating companies independently set the level of savings offered and the products included in the program. Those decisions are subject to change.

Request AMITIZA materials

We have a variety of materials available that may help you support your patients who may be appropriate candidates for AMITIZA.

 

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.