IMMUCYST® BCG and ONCOTICE® (Bacillus Calmette and Guerin) - medicine shortages

29 April 2015

Health professionals are advised that:

  • Sanofi-Aventis Australia Pty Ltd has submitted a Medicine shortage notification  for IMMUCYST® BCG 6.6-19.2 x 100000000 CFU powder for injection vial (AUST R 168005) and
  • Merck Sharp & Dohme Australia Pty Ltd has submitted a Medicine shortage notification  for ONCOTICE® 5 hundred million CFU powder for injection vial (AUST R 59912)

The shortages are due to supply disruptions and there are no safety concerns with existing supplies of either product.

Alternative products available

Alternatives are available under the Special Access Scheme. To access alternatives please contact your hospital pharmacy.

For information on the Medicine Shortages (medicine.shortages@tga.gov.au) or the Special Access Scheme (sas@tga.gov.au) please contact the TGA via email or call 1800 020 653.

Background

The TGA published details of the shortages on the TGA Medicines Shortages website on 3 February 2015 and 14 April 2015 for IMMUCYST® and ONCOTICE® respectively. Since this time the TGA has been working with sponsors and professional bodies to ensure health professionals are informed about the shortages. We have also been working to identify alternative products.

Bacillus Calmette and Guerin is used for the treatment of primary or recurrent carcinoma in situ (CIS) of the urinary bladder.

Information for patients

The shortages are due to supply disruptions and there are no safety concerns with existing supplies of either product.

Enquiries should be directed to the treating doctor or hospital pharmacy.

Information for urologists/oncologists

Enquiries regarding supply of IMMUCYST®, ONCOTICE® and alternatives should be directed to the product sponsor and/or your hospital pharmacy.

ONCOTICE® should remain available for patients who have commenced treatment with the ONCOTICE® brand.

Alternatives are available under the Special Access Scheme. To access alternatives please contact your hospital pharmacy.

Reporting problems

Health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.