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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.

Privacy policy


Takeda Website Privacy Policy

Thank you for visiting one of the websites (the "Websites") owned by Takeda Pharmaceuticals North America, Inc., its affiliates or subsidiaries (collectively, "Takeda"). 

This privacy policy (the "Privacy Policy") applies to the personal information collected on Takeda Websites, including those previously owned by TAP Pharmaceutical Products, Inc. ("TAP"). It also applies to Social Security numbers obtained by oral, written or electronic means, as described below in the "Use of Personal Information" section of this Privacy Policy. The term "personal information" as used throughout this Privacy Policy, applies to any information that is used by or on behalf of Takeda to identify an individual.

We have provided this Privacy Policy to describe to you how we collect, use, share and protect the personal information you provide to us at this Website. This Privacy Policy only applies to personal information we collect at our Websites and via the electronic communications technologies that we use. It does not apply to personal information collected through other means, including personal information you provide in email messages you send to us or personal information we may collect from you offline. This Privacy Policy is intended for all visitors of Takeda Websites including consumers, healthcare professionals and Takeda business partners. 

At some of our Websites, we may use personal information in a manner not described in this Privacy Policy. In those instances, the different uses of personal information will be disclosed to you at the web page where your personal information is collected, prior to such collection.

From time to time, our internal processes may change, or we may offer new or altered features at our Websites. If appropriate, we will revise this Privacy Policy. We encourage you to return to this area to read the most recent version of our Privacy Policy. If we alter our practices in a manner that will affect the treatment of the personal information you have already provided, we will attempt to provide visitors who have registered on our Websites with notice of our new Privacy Policy via email. 

Table of Contents

Personal Information Collected

  • Information You Provide

In general, you may browse the Takeda Websites without providing any personal information. At our Websites, we may provide you with opportunities to sign up to receive information or services from us. As part of this process, we ask you to provide us with personal information about you (such as name, address, telephone number or email address). For example, you may choose to register to receive email updates about a Website, information about a particular health condition, or materials relating to products or services offered by Takeda and its product-related co-promotion partners, and you may provide us with your email address to receive such communications. You may always choose not to provide us with your personal information, and we will disclose to you at the time we collect your personal information whether it is required for you to receive the information or services you have requested.

To better understand and address your interests, and to keep the personal information we have about you accurate, we may correct or add to the personal information you provide to us at our Websites with personal information we receive from you offline or from other sources. 

  • Automatically Collected Information -- Cookies and Other Website Information

Like most other commercial websites, we use standard "cookie" and "web beacon" technology and web server logs to collect information about how our Website is used. Web beacons are transparent pixel images that are used in collecting information about Website visitor activities and email response and tracking. For example, if we send you an email message, we (or third parties providing services on our behalf) may collect information through web beacons to determine whether you have opened the email message or clicked on links located within the email message. 

Cookies are pieces of data that a website transfers to a visitor's hard drive for record-keeping purposes. Cookies placed on our Websites may be set directly by our servers or by third parties providing technical services to us. To prevent cookies from tracking you as you navigate our Websites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Please note that some portions of our Websites may not work properly if you refuse cookies.

Information gathered through cookies and by our web server logs may include your IP address, your Internet browser (e.g., Netscape), your operating system (e.g., Windows 2000), the domain name of your internet service provider (e.g., AOL) the date and time of your visits, the pages viewed, the time spent at our Website, and the websites visited just before and just after our Website. This information may be associated with your personal information. 

Your Choices

You have several choices regarding your use of our Websites. You could decide not to submit any personal information at all. Although certain Websites may ask for permission to use your personal information for certain purposes, you can agree or decline to provide your personal information. If you subscribe for particular communications or services such as email updates, you will be able to unsubscribe at any time by: (i) following any opt-out instructions contained in communications you receive from Takeda, (ii) un-subscribing at specific areas of the Websites where you registered, if available, or (iii) sending a written request to the Takeda contact address, which appears at the end of this Privacy Policy. 

As described above, if you wish to prevent cookies from tracking you as you navigate our Websites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Please note, however, that some portions of our Websites may not work properly if you refuse cookies.

Use of Personal Information

Takeda and its service providers will use your personal information to provide information and services to you, including information and services you have requested, or as otherwise disclosed to you in this Privacy Policy or on the web page where you submit your personal information to us. We may also use that information to provide you with materials about products and services offered by Takeda and its product-related co-promotion partners, including new content or services on our Websites. We may provide you with these materials by phone, mail, facsimile or email. We do not share any of your personal information with third parties for their own direct marketing purposes unless we have your consent. 

We may use aggregate information collected from visitors of our Websites to help us better understand visitors’ needs and how they use the Websites. Aggregate information about Website visitors that does not contain personal information may be shared with third parties.

  • Policy on Use of Social Security Numbers

Takeda has a policy which provides for the proper use and protection of Social Security numbers obtained in the course of doing business by Takeda. Such policy protects the confidentiality of Social Security numbers, prohibits unlawful disclosure of Social Security numbers, and limits access to Social Security numbers. This policy applies to all methods of collection of Social Security numbers, including Social Security numbers obtained by oral, written and electronic means.

  • Email-a-Friend or Colleague

On some of the Takeda Websites, you can send a link or email message to a friend or colleague. Email addresses you may provide for a friend or colleague will be used to send your friend or colleague information on your behalf and will not be collected or used by Takeda or other third parties for any other purpose. 

  • Note to Healthcare Professionals and Business Partners

If you have a business or professional relationship with Takeda, we may use your personal information, including personal information we may collect about you from other sources, to develop our business relationship with you and your organization.

Sharing of Personal Information

Takeda may share personal information about you with: (i) various third-party companies or agents working on our behalf to help us engage in the activities described in the "Use of Personal Information" section of this Privacy Policy, including fulfilling business transactions, providing services or information you requested, providing other customer services, sending marketing communications about our products, services and offers, and conducting technological maintenance, and (ii) our parent company, subsidiaries, affiliates and product-related co-promotion partners.

We may also share your personal information with third parties under the following circumstances:

  • if you request or authorize such a disclosure;
  • in connection with the sale, assignment, license or other transfer of our company or our parent company, subsidiaries, affiliates, product-related co-promotion partners or products;
  • to protect our rights, property or safety, or the rights, property or safety of our employees or others;
  • to enforce an agreement we have with you;
  • to comply with the terms of an agreement with a product-related co-promotion partner;
  • to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders or government regulations; or
  • where needed for corporate audits or to investigate or respond to a complaint or security threat.

As a company with global operations, Takeda may share your personal information with parties described in this section who are (1) located in other countries, and (2) subject to other applicable laws, rules and regulations relating to your personal information, that do not offer the same protections as the country in which your personal information was collected. In particular, your personal information may be processed in the United States and subject to applicable US laws, rules and regulations. For more information about how Takeda is committed to protecting your personal information, see the "How We Protect Your Personal Information" section of this Privacy Policy. 

Note: We do not share any of your personal information with third parties for their own direct marketing purposes unless you explicitly give us permission to do so.

Personal Information of Children

Our Websites are not intended or designed to attract children under the age of 18, and we do not believe that our Websites are appealing to children. Therefore, we do not knowingly collect any personal information from anyone under the age of 18 at our Websites.

Links to Other Websites

Our Websites may provide links to other websites as a service to you. The third-party websites are operated by companies that are outside of our control, and your activities at those websites will be governed by the policies and privacy practices of those third parties. We do not recommend or endorse the content of these websites. We encourage you to review the policies and privacy practices of those third parties before disclosing any of your personal information, as we are not responsible for their policies and privacy practices.

How We Protect Your Personal Information

To help protect the privacy and security of personal information you transmit through the use of our Websites, we have implemented reasonable physical, technical and administrative safeguards to help protect your personal information against unauthorized access, disclosure, alteration or destruction.

Changing Your Preferences; Opt-Out of Receiving Communications

When you provide us with your personal information, you will be given some choices about how we use that personal information. You may changes these preferences later. For example, if you sign up for an email newsletter, you may opt out of receiving future email newsletters at any time. Takeda will always provide you with one or more of the following ways to opt out: (i) by following any opt-out instructions contained in communications you receive from Takeda, (ii) by un-subscribing at specific areas of the Website(s) where you registered, if available, or (iii) by sending a written request to the Takeda contact address immediately below.

Questions; Updating Your Personal Information; Takeda Contact Address

If you have any questions about our privacy practices or if you need help accessing your personal information or changing your preferences, please send a written request to us at the following address:

Takeda Pharmaceuticals North America, Inc.
Attn: Privacy Office/Legal Department – Website Communications
1 Takeda Parkway
Deerfield, Illinois 60015

Note: Please make sure to provide the name of the Website(s) applicable to your request, and your name, address, telephone number and email address (if any). If you do not provide us with this information, we may not be able to respond.

  • Note to Employment-Applicant Users of Our Websites

If you wish to modify or update your personal information submitted at one of our Websites in response to an employment opportunity at Takeda, you can do so on the appropriate web page of the Website where you applied.

Effective Date of Privacy Policy

This Privacy Policy is effective as of January 1, 2013.

 

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.