Kisunla

Mild cognitive impairment due to Alzheimer's disease & mild Alzheimer's dementia (early symptomatic Alzheimer's disease) that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

350 mg for 1st dose, 700 mg for 2nd dose, 1,050 mg for 3rd dose, followed by 1,400 mg every 4 wk. Administer as IV infusion over approx 30 min. Maintain treatment until amyloid plaques are cleared, up to max of 18 mth.

Hypersensitivity. Baseline MRI findings of prior intracerebral haemorrhage >1 cm, >2 microhaemorrhages, superficial siderosis or vasogenic oedema (ARIA-E), which are suggestive of cerebral amyloid angiopathy (CAA). Severe white matter disease. Any finding that could prevent a satisfactory MRI evaluation for safety monitoring.

Reassess individual benefit-risk of treatment at regular intervals & if patient progresses to moderate Alzheimer's disease. Risk of amyloid-related imaging abnormalities (ARIA), characterised as ARIA w/ oedema (ARIA-E) & ARIA w/ hemosiderin deposition (ARIA-H). Safety has not been examined in patients w/ pre-treatment MRI showing ARIA-E, >4 microhaemorrhages, >1 area of superficial siderosis, severe white matter disease or intracerebral haemorrhage >1 cm. Not indicated in ApoE ε4 homozygous patients. Testing for ApoE ε4 status is required prior to initiation of treatment to inform the risk of developing ARIA. Presence of ApoE ε4 allele is associated w/ CAA. Perform MRI at baseline (w/in 6 mth of initiating treatment), prior to 2nd dose, prior to 3rd dose, prior to 4th dose & prior to 7th dose. Consider suspending dose in case of asymptomatic mild ARIA. Suspend dose in case of asymptomatic moderate or severe ARIA & symptomatic ARIA. Permanently discontinue treatment in case of serious ARIA-E, serious ARIA-H or intracerebral haemorrhage >1 cm. Exercise additional caution when considering the administration of antithrombotics or a thrombolytic agent to a patient already being treated w/ donanemab. Higher anti-drug Ab titre was associated w/ increased incidence of infusion-related reactions/immediate hypersensitivity events. Immediately discontinue administration if serious infusion-related reactions occur. Contains 46 mg Na per 1,400 mg dose, equiv to 2% of WHO-recommended max daily intake of 2 g Na for an adult. Not recommended during pregnancy. May be transmitted from mother to breastfed infant. No relevant use in the paed population for the treatment of Alzheimer's disease.

ARIA-E, ARIA-H, headache.

Neurodegenerative Disease Drugs

N06DX05 - donanemab ; Belongs to the class of other anti-dementia drugs.

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