Thank you for visiting one of the websites (the "Websites") owned by Takeda Pharmaceuticals U.S.A., Inc., its affiliates or subsidiaries (collectively, “Takeda”).
Table of Contents
Personal Information Collected
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.
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.
Use of Personal Information
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
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.
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 change 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 U.S.A., 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.
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%).
Please click here for complete Prescribing Information and Medication Guide for COLCRYS (colchicine, USP) »
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.
Please click here for complete Prescribing Information for ULORIC (febuxostat) »
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.