For Healthcare Professionals

Takeda Website Terms and Conditions of Use

These Terms and Conditions of Use constitute the entire agreement between you and Takeda Pharmaceuticals North America, Inc. and its parent companies, subsidiaries, and affiliates (collectively, “Takeda”), relating to the information on, and your use of, the Websites at which these Terms and Conditions of Use are posted (collectively, the “Websites”). By using our Websites, you are acknowledging your consent to these Terms and Conditions of Use. Do not use our Websites if you do not agree to the following Terms and Conditions of Use. Takeda reserves the right to modify these Terms and Conditions of Use from time to time. These Terms and Conditions of Use should be read in conjunction with our online Privacy Policy.

Notwithstanding anything to the contrary in the foregoing, you may be subject to certain additional agreements with Takeda in addition to these Terms and Conditions of Use, which agreements may impact your ability to use our Websites. In the event that such agreements impose additional obligations on you not described in these Terms and Conditions of Use, those additional obligations will be considered to be a part of these Terms and Conditions of Use.

No Medical Advice

Takeda is not a healthcare provider. It does not render medical advice or services, and the information on our Websites should never be used as a substitute for the advice provided by your physician or other healthcare provider. You should not use this information to diagnose or treat a disease or health problem. You should instead always consult your physician or other healthcare provider for such medical advice or services.

Website Not Intended for Use by Children

This Website is not intended for children under the age of eighteen (18). We will not knowingly collect information from Website visitors under the age of eighteen (18).

Jurisdiction and Choice of Law

Please note that if and when they are available or become available, the products and services referred to on any of our Websites are, or will be, available in the United States and Canada. They may not be available in other countries. The information provided on our Websites is intended for use only by persons in the United States and Canada. Takeda makes no representations that the information on our Websites is appropriate for visitors in countries other than the United States and Canada, which countries may have different legal or regulatory requirements, or indications for, or restrictions on, the sale or use of pharmaceutical products or information. Nothing herein should be considered a solicitation or promotion for any product or an indication for any product that is not permitted by the laws or regulations of the country where a visitor of our Websites resides.

These Terms and Conditions of Use shall be governed by and construed in accordance with the laws of the United States of America and the state of Illinois, without regard to choice of law principles. You agree that jurisdiction and venue for any legal proceeding directly or indirectly arising out of or relating to our Websites shall be in the state or federal courts located in the state of Illinois.

Intellectual Property

Each of our Websites and its content, including art work, graphics, images, screen shots, text, music, digitally downloadable files, copyrights, trademarks, trade dress rights, logos, product and character names, slogans and the compilation of the foregoing (collectively, the “Content”) is the property of either Takeda or its licensors, and is protected in the United States and internationally under trademark, copyright and other intellectual property laws. Third-party content is used by Takeda subject to license, or subject to the fair use provisions of United States trademark and/or copyright laws and applicable provisions in other jurisdictions. Third-party trademarks are the property of their respective owners. All original Content used on our Websites is owned or licensed by Takeda for use only on our Websites and in materials provided to health care professionals. Unless specifically noted, you understand and agree that you may not use any Content or third party content appearing at our Websites, including in any publications, in public performances, for any commercial purpose, including in connection with products or services that are not those of Takeda, in any other manner that is likely to cause confusion among consumers, that disparages or discredits Takeda and/or its licensors, that dilutes the strength of Takeda’s or its licensor’s property, or that otherwise infringes Takeda’s or its licensor’s intellectual property rights. Downloadable files are made available for your use subject to the terms herein, and may be used for personal or non-commercial use, provided that you do not violate any of the terms herein, and provided that the copyright notice of Takeda appears in all copies of such information. With respect to materials provided to health care professionals, such health care professionals agree to comply with the terms described herein, and may only use Content or third-party content located at any of our Websites if approved in writing by us. Unauthorized use of any Content in any context is prohibited. Nothing contained herein shall be construed as conferring any license or right under any patent, copyright, or trademark of Takeda.

Infringement Notification Policy

If you believe that your work has been copied in a way that constitutes copyright or moral rights infringement, please provide Takeda with the following information. Please be advised that to be effective, notification must include ALL of the following:

  1. a physical or electronic signature of the person authorized to act on behalf of the owner of an exclusive copyright that is allegedly infringed;
  2. a description of the copyrighted work that you claim has been infringed, or in respect of which you claim your moral rights have been infringed;
  3. a description of where the material that you claim is infringing is located, including the address of the website where this material is located;
  4. your address, telephone number, and e-mail address and all other information reasonably sufficient to permit us to contact you;
  5. a statement by you that you have a good faith belief that the disputed use is not authorized by the copyright owner, its agent, or the law; and
  6. a statement by you, made under penalty of perjury, that the above information in your notice is accurate and that you are the copyright owner or authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

By Mail:
Takeda Pharmaceuticals North America, Inc.
Attn: Patent Office, Legal Department
One Takeda Parkway
Deerfield, IL 60015

Acknowledgments, Representations and Warranties related to Websites where Information can be Uploaded or Downloaded

You understand and acknowledge that use of any of our Websites is at your own risk. Takeda is not responsible or liable for any visitor postings or third-party content on any of our Websites, including biographical information provided by health care professionals. Takeda is not liable for any Content on any of our Websites. You understand that we expressly disclaim any responsibility for any third-party information or material posted at any of our Websites. We have no responsibility for such content and are merely providing access to such content as a service to you.

We make no representations about the reliability of the features of any of our Websites, and disclaim all liability in the event of any service failure. You acknowledge that any reliance on such material and/or systems will be at your own risk. We make no representations regarding the amount of time any content or information will be preserved.

You participate in or operate and use uploaded information and other Website features at your own risk. If you are dissatisfied with any feature, operability, Content, third-party content, these Terms and Conditions of Use, other agreements we may impose as a condition of usage, or any other component of our Websites, your sole remedy is to discontinue use of our Websites.

DISCLAIMER OF WARRANTIES AND LIMITATIONS OF LIABILITY

OUR WEBSITES ARE PROVIDED ON AN "AS IS, AS AVAILABLE" BASIS. TAKEDA HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT, OR OTHERWISE INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT. SOME JURISDICTIONS MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. IN NO EVENT SHALL TAKEDA BE LIABLE FOR ANY DAMAGES, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFIT) ARISING FROM OR IN CONNECTION WITH THE USE OR EXISTENCE OF ANY OF OUR WEBSITES, THE INABILITY TO USE ANY OF OUR WEBSITES, AND/OR THE INFORMATION THAT ANY OF OUR WEBSITES CONTAIN, REGARDLESS OF WHETHER TAKEDA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. TAKEDA HAS NOT REVIEWED THE THIRD-PARTY WEBSITES THAT MAY BE LINKED TO ANY OF OUR WEBSITES AND DOES NOT ENDORSE AND IS NOT RESPONSIBLE FOR THE CONTENT OF ANY OFF-SITE PAGES OR ANY THIRD-PARTY WEBSITES LINKED TO ANY OF OUR WEBSITES. TAKEDA DOES NOT WARRANT THAT OUR WEBSITES OR THE SERVERS THAT MAKE THEM AVAILABLE ARE FREE FROM ERRORS OF ANY SORT OR FREE FROM COMPUTER VIRUSES.

TAKEDA ALSO DISCLAIMS RESPONSIBILITY FOR ANY DAMAGES WHATSOEVER THAT RESULT FROM MISTAKES, OMISSIONS, INTERRUPTIONS, DELETION OF FILES, ERRORS, DEFECTS, DELAYS IN OPERATION OR TRANSMISSION, OR ANY FAILURE OF PERFORMANCE RELATING TO OUR WEBSITES WHETHER OR NOT CAUSED BY EVENTS BEYOND OUR REASONABLE CONTROL INCLUDING, WITHOUT LIMITATION, ACTS OF ANY OF OUR THIRD-PARTY VENDORS, ACTS OF GOD, COMMUNICATIONS LINE FAILURE, THEFT, DESTRUCTION OR UNAUTHORIZED ACCESS TO THE WEBSITES’ RECORDS, PROGRAMS OR SERVICES. IN NO EVENT SHALL TAKEDA’S TOTAL LIABILITY FOR ALL DAMAGES, LOSSES AND CAUSES OF ACTION EXCEED FIVE DOLLARS ($5.00). SOME JURISDICTIONS DO NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. AS A RESULT, THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.

If any of the above exclusions of warranties is unenforceable in your jurisdiction, the other exclusions listed above will still be given effect to the full extent permitted by that jurisdiction's law.

INDEMNIFICATION

YOU AGREE TO DEFEND, INDEMNIFY, AND HOLD HARMLESS TAKEDA, ITS OFFICERS, DIRECTORS, EMPLOYEES AND THIRD-PARTY VENDORS FROM AND AGAINST ANY LOSSES, DAMAGES, CLAIMS, ACTIONS, DEMANDS OR EXPENSES, INCLUDING REASONABLE ATTORNEY’S FEES, OF ANY PERSON OR ENTITY, INCLUDING PERSONAL INJURY AND DEATH, REGARDLESS OF WHETHER THEY ARISE OUT OF OR ARE ATTRIBUTABLE TO ANY ACT OR OMISSION, NEGLIGENT OR OTHERWISE, OF TAKEDA, ARISING OUT OF OR IN CONNECTION WITH: (i) YOUR USE OF ANY OF OUR WEBSITES, OR ANY CONTRACTS ENTERED INTO OR SERVICES OR PRODUCTS OFFERED, SOLD OR PURCHASED AS A RESULT OF ANY CONTACT INITIATED ON OR THROUGH OUR WEBSITES, (ii) YOUR BREACH OF THESE TERMS AND CONDITIONS OF USE, INCLUDING ANY ABUSIVE OR UNLAWFUL BEHAVIOR ON THE PART OF YOU OR YOUR DEPENDENTS, OR (iii) YOUR INFRINGEMENT OF ANY INTELLECTUAL PROPERTY OR PRIVACY RIGHT OF ANY PERSON. THIS INDEMNIFICATION PROVISION SHALL APPLY TO THIRD-PARTY CLAIMS AS WELL AS CLAIMS BETWEEN THE PARTIES TO THESE TERMS AND CONDITIONS OF USE.

POSSIBLE ERRORS AND CHANGES

THE INFORMATION ON OUR WEBSITES MAY CONTAIN INACCURACIES OR TYPOGRAPHICAL ERRORS. TAKEDA RESERVES THE RIGHT TO MAKE ADDITIONS, DELETIONS, OR MODIFICATIONS TO THE INFORMATION ON ANY OF OUR WEBSITES AT ANY TIME WITHOUT PRIOR NOTICE. TAKEDA ALSO RESERVES THE RIGHT TO WITHDRAW ANY OF OUR WEBSITES OR ANY INFORMATION CONTAINED ON OUR WEBSITES FROM THE INTERNET AT ANY TIME WITHOUT PRIOR NOTICE. ANYONE USING ANY OF OUR WEBSITES OR THE INFORMATION THEY CONTAIN ASSUMES FULL RESPONSIBILITY OF ANY AND ALL RISKS ARISING FROM OR RELATED TO THE USE OF SUCH WEBSITES OR THE INFORMATION THEY CONTAIN.

Visitor Submissions to a Website

If any visitor of our Websites makes any voluntary submission (such as questions, comments, or suggestions) to Takeda, whether oral, written, or electronic, no confidential relationship shall be established between the visitor and Takeda. The visitor's submission, and any information submitted with it, shall be considered non-confidential and shall be considered the sole and exclusive property of Takeda. You agree that such submission constitutes a “work for hire,” under U.S. copyright law. You agree to assign all rights in and to your submission to Takeda. Takeda shall have no obligation of any kind (such as compensation) with respect to the submission or any materials that accompany it. Takeda shall be free to use or transmit to others any ideas, concepts, information, or techniques contained in the visitor's submission and accompanying materials for any purpose whatsoever, including but not limited to research, development, manufacture, use, or sale of any products or ingredients incorporating or relying on such information.

Note: A visitor's personal information is treated in accordance with our online Privacy Policy.

Present or Future Employment with Takeda

Should you become employed with Takeda, none of the information or materials on any of our Websites shall constitute or be considered part of an employment contract or an employee manual or handbook. Nothing stated or represented on any of our Websites shall affect the employment relationships between Takeda and its current, former, or future employees.

Links to Other Websites

Our Websites may from time to time contain links to other third-party websites or other Internet information sources ("Third-Party Sources"). These links are provided as a convenience to visitors and do not constitute an affiliation with such Third-Party Sources or third parties. They are not an endorsement, sponsorship, or recommendation by Takeda of, or make us responsible for: (i) the third parties, (ii) the linked Third-Party Sources, or (iii) any content, services, or products available on or through such Third-Party Sources.

Severability

In the event that any provision of these Terms and Conditions of Use shall, in whole or in part, be determined to be invalid, unenforceable, or void for any reason, the remainder of these Terms and Conditions of Use shall not be affected in any way thereby.

Conditions of Use, Notices and Changes to the Privacy Policy

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 these Terms and Conditions of Use or our Privacy Policy. We reserve the right, to the fullest extent permitted by law, to amend either these Terms and Conditions of Use or our Privacy Policy at any time without notice to you other than the posting of an amended Terms and Conditions of Use or Privacy Policy at our Websites. We encourage you to return to this area to read the most recent version of our Terms and Conditions of Use and Privacy Policy. The personal information you provide on our Websites will be treated in compliance with the Privacy Policy in effect as of the date you provide your personal information to us. However, 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 e-mail.

Indications and Usage
ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.[1]

ACTOplus met is a thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and metformin or who have inadequate glycemic control on a thiazolidinedione alone or metformin alone.[2]

Duetact is a thiazolidinedione and sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and a sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone.[3]

ACTOS, ACTOplus met, and duetact should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.[1-3]

ACTOS has been studied in monotherapy and in combination with a sulfonylurea, metformin, or insulin.[1]

Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.

Important Safety Information

Boxed Warning: Congestive Heart Failure

•  Thiazolidinediones (TZDs), including pioglitazone, which is a component of ACTOplus met and duetact, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation of pioglitazone and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of pioglitazone must be considered.[1-3]
•  Pioglitazone is not recommended in patients with symptomatic heart failure. Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.[1-3]

Boxed Warning for ACTOplus met: Lactic Acidosis

•  Lactic acidosis is a rare but serious metabolic complication that can occur due to metformin accumulation during therapy with ACTOplus met.[2]
•  The reported incidence of lactic acidosis in patients receiving metformin HCl is very low (approximately 0.03 cases/1000 patient-years), but may be fatal in approximately half these instances. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency.[2]
•  Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.[2]
•  The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking ACTOplus met and by use of the minimum effective dose of ACTOplus met. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function.[2]
•  ACTOplus met should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, ACTOplus met should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.[2]
•  Patients should be cautioned against excessive alcohol intake when taking ACTOplus met. In addition, ACTOplus met should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure.[2]
•  The onset of lactic acidosis often is subtle and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Patients should be made aware of the possible importance of such symptoms and instructed to notify their health professional immediately if they occur.[2]

Contraindication
Initiation of pioglitazone in patients with established NYHA Class III or IV heart failure is contraindicated (see Boxed Warning).[1-3]

Additional Contraindications for ACTOplus met
ACTOplus met is contraindicated in patients with:[2]
1. Renal disease or renal dysfunction (serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females]).
2. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

ACTOplus met should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials because such use may result in acute alteration of renal function.[2]

Additional Contraindication for duetact
Diabetic ketoacidosis (DKA), with or without coma. DKA should be treated with insulin.[3]

Warnings and Precautions
Cardiac Effects
Like other TZDs, ACTOS, ACTOplus met, and duetact can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate CHF. Pioglitazone should be used with caution in patients at risk for heart failure. Patients should be monitored for symptoms of heart failure or other adverse events related to fluid retention. In clinical trials, a small number of patients with a history of previously existing cardiac disease were reported to develop CHF when treated with pioglitazone in combination with insulin. Reports of CHF have been received in postmarketing experience in patients with and without previously known heart disease.[1-3]

Additional Cardiac Consideration for duetact
Cardiac Mortality
Glimepiride
The University Group Diabetes Program (UGDP) trial found that tolbutamide, a sulfonylurea, was associated with an increased risk of cardiovascular mortality. Glimepiride was not studied in this trial; however, it is prudent to consider that this warning may apply to all sulfonylureas.[3]

Hepatic Effects
Reports of hepatitis and of hepatic enzyme elevations to three or more times the upper limit of normal (ULN) have been received in postmarketing experience with pioglitazone. Very rarely, these reports have involved hepatic failure with or without fatal outcome, although causality has not been established. Liver enzymes, including serum ALT, should be evaluated in all patients at initiation of therapy with ACTOS, ACTOplus met, and duetact and periodically thereafter per the clinical judgment of the healthcare professional. If ALT is >2.5X ULN at baseline or if the patient exhibits clinical evidence of active liver disease, do not initiate therapy with pioglitazone. If jaundice is observed, pioglitazone should be discontinued.[1-3]

Other Precautions
• ACTOS, ACTOplus met, and duetact may also be associated with hypoglycemia, anemia, and/or weight gain.[1-3]
• ACTOS, ACTOplus met, and duetact should be used with caution in patients with edema. Reports of initiation or worsening of edema have been received in postmarketing experience with pioglitazone.[1-3]
• ACTOS, ACTOplus met, and duetact may be associated with ovulation in premenopausal, anovulatory women. Adequate contraception should be recommended for premenopausal women.[1-3]
• ACTOS, ACTOplus met, and duetact may cause decreases in hemoglobin and hematocrit. [1-3]
• Macular edema has been reported in some diabetic patients receiving TZD therapy, although a causal relationship is unknown. Persons with diabetes should have routine eye exams and be instructed to immediately report any visual changes to their healthcare provider.[1-3]
• An increased incidence of bone fracture was noted in female patients taking pioglitazone. The risk of fracture should be considered in the care of patients treated with TZDs, particularly females, and attention should be given to assessing and maintaining bone health according to current standards of care.[1-3]

Additional Precaution for ACTOplus met
• In clinical trials of metformin, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, has been observed. Such decrease is rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B12 supplementation. Measurement of hematologic parameters on an annual basis is advised in patients on ACTOplus met.[2]

Additional Precautions for duetact
• As with all sulfonylureas, severe hypoglycemia may occur. Elderly, debilitated, or malnourished patients, or patients with adrenal, pituitary, renal, or hepatic insufficiency, may be more sensitive to the glucose-lowering effect of sulfonylureas and should be started on a conservative dose of duetact.[3]
• Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. In postmarketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.

Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ACTOS, ACTOplus met, duetact, or any other antidiabetic drug.[1-3]

Tolerability
In clinical trials using pioglitazone in monotherapy, the most common adverse events (≥5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and pharyngitis.[1]

In clinical trials using pioglitazone in combination with metformin, the most common adverse events (≥5%) were upper respiratory tract infection, diarrhea, nausea, headache, urinary tract infection, sinusitis, dizziness, lower limb edema, and increased weight.[2]

In clinical trials using pioglitazone in combination with a sulfonylurea, the most common adverse events (≥5%) were hypoglycemia, upper respiratory tract infection, weight increase, lower limb edema, headache, urinary tract infection, diarrhea, nausea, and pain in limb.[3]

Pediatric Use
ACTOS, ACTOplus met, and duetact are not recommended, as safety and effectiveness in pediatric patients have not been established.[1-3]

Please see ACTOS Complete Prescribing Information, including boxed warning and Medication Guide.
Please see ACTOplus met Complete Prescribing Information, including boxed warnings and Medication Guide.
Please see duetact Complete Prescribing Information, including boxed warning and Medication Guide.

References:
1. ACTOS package insert, Takeda Pharmaceuticals America, Inc.
2. ACTOplus met package insert, Takeda Pharmaceuticals America, Inc.
3. Duetact package insert, Takeda Pharmaceuticals America, Inc.

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Copyright ©1999, 2010 Takeda Pharmaceuticals North America, Inc.
This site is intended for use by U.S. residents only.
ACTOS, ACTOplus met, and duetact are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.