donanemab: clinical use

Prescribing considerations

• Initiation should be by a physician experienced in diagnosing and treating Alzheimer’s disease and through the required controlled-access registration system.
• Confirm amyloid pathology and establish ApoE4 status after appropriate counselling and consent.
• Assess cerebral-haemorrhage risk, ability to undergo reliable MRI monitoring, bleeding disorders and antithrombotic treatment.
• Safety and efficacy are not established in adults with Down’s syndrome or severe renal or hepatic impairment.

Contraindications and cautions

• Serious hypersensitivity to donanemab or an excipient.
• Ongoing anticoagulant therapy at treatment initiation.
• MRI evidence associated with high ARIA or intracerebral-haemorrhage risk.
• Relevant previous cerebral or subarachnoid haemorrhage, or inability to obtain satisfactory MRI safety assessments.

Monitoring

• Obtain a recent baseline brain MRI and perform required MRI monitoring.
• Urgently assess new neurological symptoms for ARIA, which may mimic ischaemic stroke.
• Record the product name and batch number.
• Observe after infusion and ensure facilities can manage severe infusion reactions or anaphylaxis.
• Permanently discontinue following an intracerebral haemorrhage larger than 1 cm, as specified by the product information.

Clinical pharmacology

Donanemab is an IgG1 antibody against plaque-associated N3pG amyloid beta. Binding promotes microglial removal of amyloid plaques. It is expected to be broken down into peptides and amino acids rather than metabolised through cytochrome P450.

Formulation and product differences

• Sterile concentrate requiring dilution before intravenous infusion.
• Each vial is single use; do not use solution that is cloudy, discoloured or visibly particulate.
• Contains sodium and is supplied in a light-protective carton for refrigerated storage; it must not be frozen or shaken.

Solution for infusion

Route: Intravenous

Strengths: 350 mg