We use cookies to ensure that we give you the best experience on our website. By continuing to browse this site, you are agreeing to our use of cookies.      
Continue     Find out more

smiling woman

Questions About Product Support?

Contact OnePath and get connected with a Case Manager.

Call: 1-866-888-0660

Visit OnePath.com to learn more.

Terms of Use

Shire is pleased to provide you with this web site and its content for general informational purposes. Please carefully read these Terms and Conditions relating to the use of our web site. Shire will use reasonable efforts to ensure that the information is accurate at the time it is added to the web site. Please note, however, that Shire makes no warranties or representations that the information is accurate and accepts no liability for any errors or omissions in the content of the site or any losses or damage that may arise from relying on this information. The information may be changed by Shire at any time. By using this web site, you agree to these Terms and Conditions without limitation or qualification. Use of Materials and Intellectual Property Rights.

The copyright in this web site belongs to Shire. All other intellectual property rights are reserved. Shire authorizes you to copy materials published on this web site for noncommercial use only, provided that any copy of these materials which you make retains all copyright and other proprietary notices.

Links to Third Party Web Sites

The web site may from time to time contain hypertext-links to third parties’ web sites. Shire is not responsible for, and accepts no liability in respect of, any information or opinion contained on any other such web site. As Shire has no control over such web sites and because their content is subject to change without notice to Shire, it is the responsibility of the user of the web site to ensure that any information accessed is accurate and that software which is downloaded from that web site is free of viruses or any other items of a destructive nature. Shire accepts no liability whatsoever in respect of any loss, damage, costs or liability incurred through any such downloaded material.

Information Is No Substitute for Consulting a Health Professional

The information on the Web site is intended only to provide knowledge of disease information. This information should not be considered complete and should not be used in place of a visit, call, consultation, or advice of your physician or other health care provider. Shire does not recommend the self-management of health problems. Should you have any health care-related questions, please call or see your physician or other health care provider promptly. You should never disregard medical advice or delay in seeking it because of something you have read here. Information is not necessarily accurate, complete, or current.

Information accessed on the Web site is not exhaustive. Shire makes reasonable efforts to include accurate and current information, wherever possible, but makes no warranties or representations as to its accuracy or completeness. This information is provided “as is” without warranty of any kind, either express or implied, including but not limited to implied warranty of fitness for a particular purpose. Shire is not responsible for computer damage resulting from using the web site.

Shire makes no representation or warranty that access to the web site will be available on a timely basis, will be uninterrupted, or will be error-free. Shire does not warrant that these pages, or the server that makes them available, are free of viruses or other harmful elements. In no event shall Shire, its affiliates and subsidiaries, and their respective officers directors, employees, agents, representatives, information providers, and licensors and their respective heirs and assigns, be liable for any direct indirect, incidental, consequential, exemplary, special, punitive, or other damages even if informed of the possibility of such damages. The above exclusion may not apply in jurisdictions to the extent that they do not allow the exclusion of implied warranties.

Any personally identifiable information in electronic communications to this web site is governed by Shire’s Privacy Policy. Shire shall be free to use or copy all other information in any such communications, including any ideas, inventions, concepts, techniques or know-how disclosed therein, for any purposes, including disclosure to third parties and/or developing, manufacturing and/or marketing products or services. Information intended for U.S. residents only.

All materials and information appearing on the Web site are intended for U.S. residents only. These Terms and Conditions were last updated: February 4, 2009.

INDICATION

VPRIV® (velaglucerase alfa for injection) is a prescription medication indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

IMPORTANT SAFETY INFORMATION

  • Hypersensitivity reactions, including serious allergic reactions (anaphylaxis) have occurred. VPRIV (velaglucerase alfa for injection) should be administered under the supervision of a healthcare professional. VPRIV is given every other week by intravenous infusion that typically takes up to 60 minutes. Appropriate medical support should be available when VPRIV is administered. The most serious side effects in patients treated with VPRIV were hypersensitivity reactions.
  • Hypersensitivity reactions were the most commonly observed side effects in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, low blood pressure, high blood pressure, nausea, tiredness/weakness, and fever. Hypersensitivity reactions in the clinical trials include any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis. Generally the reactions were mild and, in patients not previously treated, occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
  • If anaphylactic or other acute reactions occur, immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment. A hypersensitivity reaction should be treated based on the severity of the reaction. Your healthcare provider may manage a reaction by slowing the infusion rate or treating with medicine such as antihistamines, fever-reducing agents and/or corticosteroids or possibly stopping the medication and then restarting with a longer infusion time. For patients who have had symptoms of hypersensitivity reaction to enzyme replacement therapy, the doctor may consider treating the patient with antihistamines and/or corticosteroids before an infusion to help prevent such a reaction from happening.
  • The most commonly reported side effects during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, increased time it takes for blood to clot, tiredness/weakness, and fever. In clinical studies, the overall frequency of side effects was generally higher in the patients not previously treated with ERT than in the patients who switched from imiglucerase to VPRIV.
  • VPRIV is classified as pregnancy category B which means that animal reproduction studies did not show a risk to the unborn and there are no adequate and well-controlled studies in pregnant women. Your doctor may prescribe VPRIV to you if you are pregnant, only if it is clearly necessary.
  • The safety and efficacy profiles were similar in pediatric (ages 4 to 17) and adult patients. The safety of VPRIV has not been established in patients under 4 years of age. Side effects more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, increased time it takes for blood to clot, and fever.
  • The side effect profile in elderly patients was generally similar to that seen in pediatric and other adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering other existing medical conditions.
  • As with all therapeutic proteins, there is a potential for developing antibodies to VPRIV. In clinical studies, 1 of 54 patients who had not previously been treated with ERT, who were then treated with VPRIV, developed antibodies. It is unknown if having antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.
  • Please see full prescribing information.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.