For Healthcare Professionals

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”) was updated in connection with Takeda’s merger with TAP Pharmaceutical Products, Inc. (“TAP”), and applies to the personal information collected on Takeda websites, including those previously owned by 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 e-mail 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 e-mail.

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 e-mail address). For example, you may choose to register to receive e-mail 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 e-mail 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 e-mail response and tracking. For example, if we send you an e-mail message, we (or third parties providing services on our behalf) may collect information through web beacons to determine whether you have opened the e-mail message or clicked on links located within the e-mail 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 e-mail 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 e-mail. 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.

  • E-mail-a-Friend or Colleague

On some of the Takeda Websites, you can send a link or e-mail message to a friend or colleague. E-mail 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 e-mail newsletter, you may opt out of receiving future e-mail 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
One 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 e-mail 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 March 26, 2009.

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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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.