Millennium Pharmaceuticals, Inc. is pleased to provide you with the materials on this web site for informational purposes. Please carefully read the following paragraphs. By using our web site, you agree to the terms described below. If you do not agree to the terms discussed here, you should exit this web site now.
Millennium maintains this web site from our offices in Cambridge, Massachusetts, United States of America. This web site is intended to be accessed from, and the information contained in the web site is intended to be used within, the United States of America. We make no representations that this web site or materials in our web site are appropriate or available for access or use in other countries. If you access this web site from another country, you do so on your own initiative and are responsible for compliance with laws applicable to such access. We may revise the terms discussed here at any time without notice by updating this posting. You are bound by any revisions and, therefore, should periodically visit this page to review the current terms that apply to your use of our web site.
Intellectual Property Rights
All contents of this web site are protected by copyright and/or other intellectual property rights, and may not be modified, distributed, posted or transmitted without our prior written consent. You may download material from our web site, for your own personal, non-commercial use only. No Copyright notices, other intellectual property or legal notices or other identifying information may be removed from downloaded materials. You may not download material from our web site for any other purpose without our prior written consent.
Millennium and the Millennium logo are trademarks of Millennium Pharmaceuticals, Inc. and/or its affiliates, registered in the U.S. and/or other jurisdictions. Other Millennium product or service names or logos referenced in this document are either trademarks or registered trademarks of Millennium Pharmaceuticals, Inc. and/or its affiliates. The absence of a product or service name or logo from this list does not constitute a waiver of Millennium’s trademark or other intellectual property rights concerning that name or logo.
Other trademarks and product names are the property of their respective owners. Nothing contained in our web site should be construed as granting any license or right to use any trademarks or logos.
Submissions of Information
Any communication or material that you transmit to our site, by electronic mail or otherwise, including any data, questions, comments, suggestions or the like, is, and will be treated as, non-confidential and nonproprietary information.
Millennium may use such communication or material for any purpose whatsoever including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and further posting. Further, Millennium is free, without payment of compensation to you, to use any ideas, concepts, know-how or techniques contained in any communication or material you send to our web site for any purpose whatsoever.
Concerning Your Privacy
Third Party Links
Periodically, our web site may contain links to other web sites. Millennium is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by us of the third-party web site. Millennium has no control over the content on such third party web sites. Millennium does not take any responsibility or assume any liability for information contained on other web sites. Your linking to any other web sites is at your own risk, and you are responsible for learning about and complying with the terms of usage and other conditions posted on those web sites.
Any information posted on our web site related to medical conditions and their treatment is general in nature and is intended only for educational and general information purposes. Should you have a medical condition that may require treatment, or if you have any specific medical questions, promptly see your own doctor or health care provider. Nothing on this web site is substitute for professional medical consultation advice. We do not offer medical diagnosis or treatment from this web site, and none of the information contained on this web site should be construed as providing medical advice or services of any kind. Only your doctor or other health care professional can determine if a particular medical treatment is appropriate for you.
Always seek the advice of your physician or other qualified health care provider before starting any new treatment or with any questions you may have about a medical condition.
Millennium believes that the contents of this web site have come from reliable sources, but we cannot guarantee the information in this web site is accurate, complete or suitable for any purpose. In addition, Millennium cannot guarantee that the contents of this web site have not been affected by technical malfunctions or unauthorized tampering. The contents of this web site are subject to change without notice. We may alter or delete material from this web site at any time.
Your use of this web site and its contents is at your own risk, and neither Millennium nor any party involved in creating or delivering this web site shall be liable for damages of any kind that may result from access to, or use of the information contained on, this web site, including, but not limited to, any such damages arising from errors or omissions, misprints, out-of-date information, inaccuracies, typographical or other errors appearing on this web site, any software that may be downloaded from this web site, or any damage to your computer equipment including, but not limited to, any virus that may infect your computer equipment.
MILLENNIUM MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT, WITH RESPECT TO THE USE OF THIS WEB SITE OR ANY INFORMATION OR SERVICES OBTAINED THROUGH THIS WEB SITE. IN NO EVENT WILL MILLENNIUM BE LIABLE FOR ANY DAMAGES OR LOSSES OF ANY KIND RESULTING DIRECTLY OR INDIRECTLY FROM ANY USE OF THIS WEB SITE OR DEFECT IN THIS WEB SITE OR ANY INFORMATION CONTAINED IN THIS WEB SITE, INCLUDING BUT NOT LIMITED TO CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT DAMAGES.
By using this web site, you assume the risk that the information and materials on this web site may be incomplete, inaccurate, out-of-date, or may not meet your needs or requirements.
Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties.
Export of Information
The United States Export Controls laws prohibit the export of certain technical data and software to certain countries, territories and individuals. No content from this site may be downloaded or otherwise exported in violation of United States law.
Web Site Availability
This web site may be unavailable from time to time due to mechanical, technical, software, hardware or third-party vendor failures, updating or construction. Millennium cannot predict or control when such downtime may occur and cannot control the duration of such downtime.
These Terms and conditions are governed and interpreted pursuant to the laws of the Commonwealth of Massachusetts, United States of America, notwithstanding any principles of conflicts of law that would dictate the application of the law of another jurisdiction. If any part of these terms is unlawful, void, or unenforceable, that part will be deemed severable and will not affect the validity and enforceability of the remaining provisions. Millennium may, at its sole discretion and without notice, revise these terms at any time by updating this posting. This is the entire Agreement between the parties relating to the subject matter herein and shall not be modified except in writing signed by both parties or by a new posting by Millennium, as described above. If you have any questions about the rights and restrictions above, please contact our legal department.
Indications and Important Safety Information for VELCADE® (bortezomib)
INDICATIONS: VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.
CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration.
WARNINGS AND PRECAUTIONS
VELCADE (bortezomib) is for subcutaneous or IV administration only. Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.
Peripheral neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and managed with dose modification or discontinuation. Patients with preexisting symptoms may experience worsening peripheral neuropathy (including≥grade 3). Starting with VELCADE subcutaneously may be considered for patients who either have preexisting or are at high risk for peripheral neuropathy.
Hypotension: Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.
Cardiac toxicity, including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction, has occurred. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing, heart disease should be closely monitored.
Pulmonary toxicity: Acute respiratory distress syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology have occurred (sometimes fatal). Pulmonary hypertension, in the absence of left heart failure or significant pulmonary disease, has been reported. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt and comprehensive diagnostic evaluation is conducted.
Posterior reversible encephalopathy syndrome has occurred. Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.
Gastrointestinal toxicity, including nausea, diarrhea, constipation, and vomiting, has occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement. Interrupt VELCADE (bortezomib) for severe symptoms.
Thrombocytopenia/Neutropenia: Manage with dose and/or schedule modifications. Complete blood counts should be monitored frequently during treatment. There have been reports of gastrointestinal and intracerebral hemorrhage. Transfusions may be considered.
Tumor lysis syndrome: Closely monitor patients with high tumor burden and take appropriate precautions.
Hepatic toxicity: Monitor hepatic enzymes during treatment. Upon occurrence, interrupt therapy with VELCADE to assess reversibility.
Embryo-fetal risk: Women should avoid breast-feeding or becoming pregnant while on VELCADE.
Patients with diabetes may require close monitoring and adjustment of the antidiabetic medications.
DRUG INTERACTIONS: Closely monitor patients receiving VELCADE (bortezomib) in combination with strong CYP3A4 inhibitors. Avoid concomitant use of strong CYP3A4 inducers.
Previously untreated multiple myeloma (MM): In the phase 3 study of VELCADE administered intravenously with melphalan and prednisone (MP) vs MP alone, the most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%).
Relapsed MM and mantle cell lymphoma: In the integrated analysis of 1163 patients in phase 2 and 3 studies of VELCADE (bortezomib) administered intravenously, the most commonly reported ARs were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathy NEC (38%), and thrombocytopenia (32%). A total of 26% of patients experienced serious ARs. The most commonly reported serious ARs included diarrhea, vomiting, and pyrexia (each 3%); nausea, dehydration, and thrombocytopenia (each 2%); and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (each 1%).
Relapsed MM subcutaneous vs IV: In the phase 3 study of VELCADE administered subcutaneously vs intravenously in relapsed MM, safety data were similar between the two treatment groups. The most commonly reported ARs in the subcutaneous vs IV treatment groups were peripheral neuropathy (37% vs 50%) and thrombocytopenia (30% vs 34%). The incidence of serious ARs was similar in the subcutaneous treatment group (20%) and the IV treatment group (19%). The most commonly reported serious ARs were pneumonia and pyrexia (each 2%) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (each 3%) in the IV treatment group.
- Please see full Prescribing Information available at www.VELCADE.com