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Videx and Zerit treatment phased out

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Bristol-Myers Squibb |
Bristol-Myers Squibb would like to inform you that the sale and distribution of  all strengths of ZERIT® (stavudine) Capsules and Powder for Oral Solution (OS) Videx® (didanosine) will be phased out globally and in New Zealand, effective by March 2017.

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​15 December 2016:  Bristol-Myers Squibb would like to inform you that the sale and distribution of

    • all strengths of ZERIT® (stavudine) Capsules and Powder for Oral Solution (OS)
    • Videx® (didanosine)

will be phased out globally. The discontinuation in New Zealand is planned to be effective by March 2017. In Australia, it is planned to be effective by September 2017. This action is voluntary and is not the result of any quality, safety or efficacy issues regarding the product.

The use of ZERIT® (stavudine) and Videx® (didanosine) has been decreasing significantly over time, and are no longer considered a first- or second-line treatment for HIV-1. Guidelines authored by organizations such as the U.S. Department of Health and Human Services (DHHS), the World Health Organization (WHO) and the European AIDS Clinical Society (EACS) do not recommend didanosine nor stavudine for the initial treatment of HIV-1.

    • The current 2016 EMA publication does not recommend the use of stavudine and it states that when used, stavudine should be taken for as short a time as possible and only when other antiviral medicines are not available.
    • In March 2014, WHO recommended to phase out didanosine as a second line regimen for adults and children, recommending the transition of patients to more optimal regimens as soon as possible.


Indication

ZERIT® (stavudine) is indicated for the treatment of HIV-infected patients in appropriate antiretroviral regimens, including use in combination with other nucleoside analogues, non-nucleoside reverse-transcriptase inhibitors, and HIV protease inhibitors. For your patients currently using ZERIT® (stavudine) Capsules and Powder for Oral Solution, it will be important to transition them to other antiretroviral agents such as those recommended by HIV treatment guidelines.

Videx® (didanosine) is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients. For your patients currently using Videx® (didanosine) it will be important to transition them to other antiretroviral agents such as those recommended by HIV treatment guidelines.


For more information

If you have questions or require additional information regarding this discontinuation, please contact the Bristol-Myers Squibb Medical Information Department on 0800 167 567.


Download the notifications

Discontinuation of Sale and Distribution of VIDEX (didanosine) - Dec 2016 - Australia

Discontinuation of Sale and Distribution of ZERIT (stavudine) - Dec 2016 - Australia

Discontinuation of Sale and Distribution of VIDEX (didanosine) - Dec 2016 - New Zealand

Discontinuation of Sale and Distribution of ZERIT (stavudine) - Dec 2016 - New Zealand

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