Вінкристин-Тева

Letter to healthcare professionals (oncologists, hematologists, chemotherapists) regarding the potential shortage of the drug VINCRYSTIN-TEVA

September 20, 2021

This safety information is designed for healthcare professionals who prescribe vincristine. This information is provided in accordance with the requirements of the Pharmacovigilance Procedure approved by Order of the Ministry of Health of Ukraine dated December 27, 2006 No. 898 (as amended) and has been previously duly agreed with the State Enterprise "State Expert Center of the Ministry of Health of Ukraine". 

To assist the practicing physician. Not an advertisement.

Dear healthcare professionals,

Teva Ukraine LLC, in agreement with the State Enterprise "State Expert Center of the Ministry of Health of Ukraine", informs you about a potential shortage of the drug VINCRYSTIN-TEVA solution for injection, 1 mg/ml in 1 ml, or 2 ml, or 5 ml in a vial in a number of countries, including Ukraine, from September 2021 until at least the second quarter of 2022 due to disruptions in the supply of the active pharmaceutical ingredient (API) vincristine.

The API manufacturer has not provided Teva with sufficient quantities of vincristine API required for the production of VINCRISTIN-TEVA. The API manufacturer has also recently announced that it will no longer manufacture and supply vincristine API in the future.

Ensuring patient access to this important medicine is of utmost importance to us. We are making every effort and mobilizing all possible resources to prevent potential shortages. We are currently exploring various options to restore supply of this medicine to patients who need it. This includes exploring the possibilities of alternative manufacturers of the API vincristine.

We are open to working with the regulatory authority in Ukraine and are trying to find other urgent solutions to minimize the potential shortage as much as possible.

At the same time, to ensure a more stable supply in the future, we are working with the relevant regulatory authorities to qualify another API manufacturer. However, this process will take some time.

If, despite our best efforts, a shortage cannot be avoided, we encourage you to consider using Vincristine from other companies or alternative treatments for your patients. Please consider the potential shortage before starting treatment for your patients.

We are doing everything we can to ensure the uninterrupted supply of this important medicine for patients. We will continue to inform the relevant regulatory authorities in Ukraine of developments.

If you have any questions, please call 0-800-502-284 or email medinfo@teva.ua .

REPORTING OF SIDE EFFECTS

If you have information about the occurrence of an adverse reaction or lack of effectiveness when using a Teva drug, please contact the company's Pharmacovigilance Department by phone at +38050-462-17-67 or by email at Safety.Ukraine@teva.ua .

Adverse reactions should also be reported to the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" at the link https://aisf.dec.gov.ua/ or by phone +38044-202-17-00.