Notification of Somatuline LA 30mg discontinuation

IPSEN has notified the Therapeutic Goods Administration (TGA) that as of 15th December, 2020, Somatuline® LA 30mg (lanreotide acetate) will no longer be supplied in Australia (due to the low volume of requests and the presence of a suitable replacement, Somatuline® Autogel®). A notice of the discontinuation of the product will be published on both the IPSEN Australia website and the TGA website. Somatuline® LA 30mg is currently approved for the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory. 1 To ensure ongoing supply of lanreotide to Australian patients, IPSEN have an alternate presentation of lanreotide: Somatuline® Autogel® (lanreotide as acetate) in 60mg/90mg/120mg solution for injection in a ready-to-use prefilled syringe2 . The indications 2 for Somatuline® Autogel® are:

• the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory

• the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours

• the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

While the formulations are different, the active ingredient of Somatuline® LA 30mg and Somatuline® Autogel® 60mg/90mg/120mg solution for injection prefilled syringe, is identical (lanreotide acetate) 1,2 . Somatuline® LA is formulated as a prolonged-release depot suspension for intramuscular injection1 . Somatuline® Autogel® is formulated as a prolonged-release solution for deep subcutaneous injection2 . In patients previously treated with Somatuline® LA once every 14 days for acromegaly, the initial dose of Somatuline® Autogel® should be 60mg every 28 days. Please refer to the Somatuline® Autogel® Product Information for more information on transitioning patients2 . Somatuline® Autogel® is available on the Pharmaceutical Benefits Scheme. Additional detail is provided below, however we recommend that you consult the PBS (www.pbs.gov.au) for further information regarding the availability of Somatuline® Autogel®.

Should you require further information regarding the discontinuation of Somatuline® LA 30mg, please contact the IPSEN Medical Information Department on 1800 317 033.

Date of Preparation: March 2022 ALL-AU-000086

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DATE OF PREPARATION: MARCH 2022. ALL-AU-000088
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