05 November 2019
Dear Prescriber / Hospital Pharmacist
RE: LUCASSIN® brand of Terlipressin to be delisted from ARTG
Ikaria Australia Pty Ltd, which is now part of Mallinckrodt Pharmaceuticals, wishes to advise that the supply of the LUCASSIN® brand of Terlipressin to the Australian market will cease as of the end of November 2019.
An application to cancel the registration of the product on the Australian Register of Therapeutic Goods (ARTG) will be submitted to the TGA in December 2019. The registration will not be transferred to another Sponsor / Distributor.
Mallinckrodt Pharmaceuticals (Ikaria Australia Pty Ltd) is taking this step for commercial reasons only; there is no issue related to the clinical efficacy or safety of the product that has led to this decision.
An alternate brand of Terlipressin is approved for use in Australia – GLYPRESSIN, distributed by Ferring Pharmaceuticals Pty Ltd. Both products contain 0.85mg Terlipressin (equivalent to 1mg Terlipressin acetate)
The TGA approved indications are the same for both products, as are the dosage recommendations.
- Treatment of bleeding Oesophageal varices
- Treatment of patients with Hepatorenal syndrome (HRS) Type 1 who are actively being considered for liver transplant.
However, the pharmaceutical dosage form and excipients are different, as indicated below:
- LUCASSIN® is supplied as a sterile, lyophilized powder for injection in single-use clear glass vials for intravenous administration. Each vial must be reconstituted with 5mL of 0.9% sodium chloride injection prior to use. LUCASSIN contains the excipients – mannitol as a caking agent for the lyophilized powder and glacial acetic acid and/or sodium hydroxide for pH adjustment.
- GLYPRESSIN is supplied as a sterile solution for injection 8.5 mL clear, colourless solution in a clear glass ampoule. There is no reconstitution of this product prior to use. GLYPRESSIN contains the excipients: sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
Mallinckrodt Pharmaceuticals recognises that the supply of Terlipressin in your hospital is largely governed by State Tenders, so your centre may currently be using the GLYPRESSIN product. However, it is important that prescribers are fully informed of the discontinuation of LUCASSIN® so that transfer of any patient to GLYPRESSIN is done in a timely manner.
LUCASSIN will not be dispatched by our distributor, Symbion P/L, after November 30th, 2019.
Mallinckrodt Pharmaceuticals advises that at the end of December 2019, any remaining unopened stock of LUCASSIN® packs may be returned for credit.
In order to maintain uninterrupted supply of Terlipressin to Australian patients, Mallinckrodt Pharmaceuticals has notified the decision to discontinue LUCASSIN® to;
- TGA Medicines Shortages Division
- Ferring Pharmaceuticals Pty Ltd so that any increase in demand for GLYPRESSIN can be anticipated
Mallinckrodt Pharmaceuticals (Ikaria Australia Pty Ltd) sincerely wishes to thank you for your support of the product LUCASSI® since its first approval in Australia.
Should you have any questions regarding the proposed delisting of LUCASSIN® please contact our office on 03 9851 9100.
General Manager – Australia
Ground Floor, 17 Cotham Road Kew VIC 3101 Australia