Professor Ashley Bush.

Mohana Basu THE TGA has registered an Alzheimer’ s disease treatment to slow progression in patients with confirmed amyloid plaque in the brain and specific genetic profiles.

Eli Lilly’ s donanemab( Kisunla) is indicated for patients with mild cognitive impairment who do not carry apolipoprotein E ε4( ApoE ε4), which is linked to a higher risk of brain swelling and bleeding.

Each infusion will cost around $ 4700 a month on a private script, but Eli Lilly has already applied for

PBS funding, which the PBAC will assess in July.

The company said about 450,000 Australians could be eligible for initial assessment.

Patients required testing to assess their ApoE ε4 status, and PET scans or CSF tests to confirm evidence of beta-amyloid brain plaque.

Psychiatrist and neuroscientist Professor Ashley Bush said treatment could take up to 18 months, which would take the cost beyond $ 80,000.

“ Donanemab slows Alzheimer’ s

disease by about a third of the rate of decline,” said Professor Bush, from the Florey Institute of Neuroscience and Mental Health in Victoria.

“ For some patients, it might slow the disease more, and for others, less.” A study of 1700 patients, published in JAMA in 2023, showed that the monoclonal antibody slowed cognitive and functional decline by up to 35 % compared with placebo at 18 months by helping immune cells clear amyloid plaque.

“ The main risk is amyloid-related

imaging abnormalities( ARIA), which can be serious and require regular brain scans for anyone on the drug, adding to the cost of treatment,” Professor Bush said.

ARIA, detectable via MRI, can present as temporary swelling in areas of the brain— which usually resolves over time— or as small spots of bleeding in or on the brain’ s surface.

Rarely, it can involve larger areas of brain bleeding and life-threatening events. JAMA 2023; 21 Nov.

Mohana Basu A SERIES of accidental liquid risperidone overdoses in children last year often involved babysitters or extended family members administering the antipsychotic, the TGA has warned.

Of the 22 paediatric oral risperidone overdoses reported in 2024, the watchdog says most involved children who received 10 times the prescribed dose, such as 5mL instead of 0.5mL.

They received 10 times the prescribed dose.

No patient died, but the TGA has mandated that suppliers update the drug information with clearer instructions, including visual aids.

Adverse events could include sedation, tachycardia, hypotension, QT prolongation and convulsions.

The overdoses frequently followed misunderstanding of the instructions; incorrect use of the supplied syringe; or administration by alternative carers, such as babysitters or relatives, the TGA said.

Government data suggested that doctors wrote around 25,000 PBS scripts for risperidone 1mg / mL oral liquid for young patients with autism last year.

The TGA said doctors and pharmacists could help by giving clear, comprehensive explanations of how to use the supplied syringe to measure the exact dose.

Correction

As a result of an editing oversight, we mistakenly duplicated a story in the 16 May print edition; we clearly thought it was so good we printed it twice! We apologise for the error.