HPS Pharmacies wishes to give notice that Merck Sharp & Dohme are continuing to experience a supply interruption for OncoTICE® as follows:

OncoTICE Bladder Instillation
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
ARTG 59912

This is a long-term supply interruption that is expected to continue until at least the end of December 2024. The Therapeutic Goods Administration (TGA) has authorised the supply of an internationally registered alternative under Section 19A of the Therapeutic Goods Act 1989. The alternative product, VesiCulture BCG, is registered in Denmark. The package insert and product labelling is in English.

Some of the key differences between VesiCulture and OncoTICE® are summarised in the table below (adapted from Link Communication 2023).

  OncoTICE® VesiCulture
Strain Tice BCG BCG Danish strain 1331
Contents of one vial 500 million CFU
(2-8 × 108 CFU)		 30mg per vial
(Approx. 2.5 x 108 CFU)
Pack size One or three glass vials Four glass vials
Dosage Each instillation comprises 2-8 × 108 CFU (the contents of one reconstituted and diluted vial of OncoTICE suspended in 0.9% sodium chloride up to a total volume of 50 mL) Normal dose (120 mg) = 4 reconstituted vials. The required dose is resuspended in 50 ml sterile preservative-free 0.9% sodium chloride.
Standard dose 1 vial 4 vials
Storage of reconstituted product 2 hours at 2-8 °C. Protect from light Up to 4 hours at 2-8 °C. Protect from light

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Merck Sharp & Dohme on 1800 818 553, or your pharmacist at HPS Pharmacies. For further information on VesiCulture, please consult the Instructions for Use.

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References:

  1. OncoTice® (Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) Australian approved product information. Macquarie Park: Merck Sharp & Dohme. Approved May 2023.
  2. Sharma A. Communication to Healthcare Professionals; Link Healthcare: 2023.
  3. VesiCulture® (Mycobacterium bovis (BCG), Danish strain 1331) Instructions for Use. Copenhagen: AJVaccines. Approved April 2021.

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