Terms and conditions of use
Takeda Website Terms and Conditions of Use
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. 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. Takeda makes no representations that the information on our Websites is appropriate for visitors in countries other than the United States. 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.
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:
- a physical or electronic signature of the person authorized to act on behalf of the owner of an exclusive copyright that is allegedly infringed;
- 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;
- a description of where the material that you claim is infringing is located, including the address of the website where this material is located;
- your address, telephone number, and e-mail address and all other information reasonably sufficient to permit us to contact you;
- 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
- 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.
Takeda Pharmaceuticals U.S.A., 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.
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.
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.
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.
This Terms and Conditions of Use is effective as of March 5, 2012.
Important Safety Information for COLCRYS (colchicine, USP)
- COLCRYS is contraindicated in patients with renal or hepatic impairment who are currently prescribed P-gp inhibitors or strong inhibitors of CYP3A4. In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors in patients with normal renal and hepatic function.
- Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.
- Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported in patients taking colchicine at therapeutic doses.
- Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk.
- Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
- The most common adverse reactions in clinical trials were diarrhea (23%) and pharyngolaryngeal pain (3%).
COLCRYS (colchicine, USP) 0.6 mg tablets are indicated in adults for the prophylaxis of gout flares and treatment of acute gout flares when taken at the first sign of a flare.
COLCRYS is not an analgesic medication and should not be used to treat pain from other causes.
Important Safety Information for ULORIC (febuxostat)
- ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
- An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.
- Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of MI and stroke.
Hepatic Effects: Postmarketing reports of hepatic failure, sometimes fatal, have been received. Causality cannot be excluded. During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in ULORIC and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
Obtain liver tests before starting treatment with ULORIC. Use caution in patients with liver disease. If liver injury is detected, promptly interrupt ULORIC and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart treatment if liver injury is confirmed and no alternate etiology can be found.
- Adverse reactions occurring in at least 1% of ULORIC-treated patients, and at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash. Patients should be instructed to inform their healthcare professional if they develop a rash or have any side effect that bothers them or does not go away.
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.
- Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum. 2011;63:3136-3141.
- Helmick CG, Felson DT, Lawrence RC, et al; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58:15-25.
- Edwards NL. Clinical gout. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology. 6th ed. Philadelphia, PA: Mosby Elsevier; 2014:1569-1574.
- Wortmann RL. Gout and hyperuricemia. In: Firestein GS, Budd RC, Harris ED Jr, McInnes IB, Ruddy S, Sergent JS, eds. Kelley’s Textbook of Rheumatology. Vol 2. 8th ed. Philadelphia, PA: Saunders Elsevier; 2009:1481-1506.
- Becker MA, Jolly M. Clinical gout and the pathogenesis of hyperuricemia. In: Koopman WJ, Moreland LW, eds. Arthritis and Allied Conditions: A Textbook of Rheumatology. Vol 2. 15th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:2303-2339.
- McCarthy GM, Barthelemy CR, Veum JA, Wortmann RL. Influence of antihyperuricemic therapy on the clinical and radiographic progression of gout. Arthritis Rheum. 1991;34:1489-1494.
- Pascual E, Batlle-Gualda E, Martínez A, Rosas J, Vela P. Synovial fluid analysis for diagnosis of intercritical gout. Ann Intern Med. 1999;131:756-759.
- Pascual E, Pedraz T. Gout. Curr Opin Rheumatol. 2004;16:282-286.
- Edwards NL. Gout. A. Clinical features. In: Klippel JH, Stone JH, Crofford LJ, White PH, eds. Primer on the Rheumatic Diseases. 13th ed. New York, NY: Springer Science+Business Media, LLC; 2008:241-249.
- Schumacher HR Jr. The pathogenesis of gout. Cleve Clin J Med. 2008;75(suppl 5):S2-S4.
- Pascual E. Persistence of monosodium urate crystals and low-grade inflammation in the synovial fluid of patients with untreated gout. Arthritis Rheum. 1991;34:141-145.
- McLean L, Becker MA. Etiology and pathogenesis of gout. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology. 5th ed. Philadelphia, PA: Mosby Elsevier; 2011:1841-1857.
- Neogi T. Clinical practice. Gout. N Engl J Med. 2011;364:443-452.
- Busso N, So A. Mechanisms of inflammation in gout. Arthritis Res Ther. 2010;12:206.
- Rose DM, Liu-Bryan R. Innate immunity in triggering and resolution of acute gouty inflammation. Curr Rheumatol Rep. 2006;8:209-214.
- Liu-Bryan R, Scott P, Sydlaske A, Rose DM, Terkeltaub R. Innate immunity conferred by Toll-like receptors 2 and 4 and myeloid differentiation factor 88 expression is pivotal to monosodium urate monohydrate crystal-induced inflammation. Arthritis Rheum. 2005;52:2936-2946.
- Cronstein BN, Terkeltaub R. The inflammatory process of gout and its treatment. Arthritis Res Ther. 2006;8(suppl 1):S3.
- Phelps P. Polymorphonuclear leukocyte motility in vitro. IV. Colchicine inhibition of chemotactic activity formation after phagocytosis of urate crystals. Arthritis Rheum. 1970;13:1-9.
- Pope RM, Tschopp J. The role of interleukin-1 and the inflammasome in gout: implications for therapy. Arthritis Rheum. 2007;56:3183-3188.
- COLCRYS (colchicine, USP) Prescribing Information and Medication Guide. Takeda Pharmaceuticals.
- Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010;62:1060-1068.
- Terkeltaub R, Edwards NL. Gout: Diagnosis and Management of Gouty Arthritis and Hyperuricemia. 2nd ed. West Islip, NY: Professional Communications, Inc.; 2011:15-231.
- Dore RK. The gout diagnosis. Cleve Clin J Med. 2008;75(suppl 5):S17-S21.
- ULORIC (febuxostat) Prescribing Information. Takeda Pharmaceuticals.
- Allopurinol full prescribing information, October 2009.
- Hamburger M, Baraf HSB, Adamson TC, et al. 2011 recommendations for the diagnosis and management of gout and hyperuricemia. Phys Sportsmed. 2011;39:98-123.
- Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004;31:2429-2432.
- Shoji A, Yamanaka H, Kamatani N. A retrospective study of the relationship between serum urate level and recurrent attacks of gouty arthritis: evidence for reduction of recurrent gouty arthritis with antihyperuricemic therapy. Arthritis Rheum. 2004;51:321-325.
- Loeb JN. The influence of temperature on the solubility of monosodium urate. Arthritis Rheum. 1972;15:189-192.
- Li-Yu J, Clayburne G, Sieck M, et al. Treatment of chronic gout. Can we determine when urate stores are depleted enough to prevent attacks of gout? J Rheumatol. 2001;28:577-580.
- Perez-Ruiz F, Calabozo M, Pijoan JI, Herrero-Beites AM, Ruibal A. Effect of urate-lowering therapy on the velocity of size reduction of tophi in chronic gout. Arthritis Rheum. 2002;47:356-360.
- Data on file, Takeda Pharmaceuticals U.S.A., Inc.
- Khanna D, Khanna P, Fitzgerald J, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64:1447-1461.
- Khanna D, Fitzgerald J, Khanna P, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012;64:1431-1446.
- Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006;65:1312-1324.
- Schumacher HR, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008;59:1540-1548.
- Becker MA, Schumacher HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353:2450-2461.
- Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res. 2010;12:R63.