A donanemab monitoring checklist tracks the brain scans, symptom checks, and blood work needed to catch serious side effects of this Alzheimer's drug early. Donanemab, sold as Kisunla (donanemab-azbt), is an infused medication that clears amyloid plaque from the brain but carries real risks that require scheduled surveillance. The biggest risk is ARIA, short for amyloid-related imaging abnormalities — brain swelling or small bleeds that show up on MRI before they cause symptoms. The checklist below follows the required MRI schedule, explains what triggers an unscheduled scan, and covers the genetic test, blood thinner question, and infusion reactions caregivers should ask about before the first dose.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- The required MRI schedule
- What to watch for between scheduled scans
- Should you ask about ApoE ε4 genetic testing first?
- Blood thinners, strokes, and the boxed warning
- Infusion reactions and what happens during treatment
- How long does treatment last?
- Frequently Asked Questions
The required MRI schedule
Every patient needs a recent brain MRI before starting Kisunla. After that, the label requires additional safety MRIs before the 2nd, 3rd, 4th, and 7th infusions specifically to screen for ARIA, according to Lilly's prescribing information summary.
Caregivers should put these scan dates on the calendar alongside infusion appointments, since missing one means the next dose has to wait. The schedule is front-loaded because ARIA risk is highest early in treatment, not evenly spread across the whole course.
- Baseline MRI: before infusion 1
- Safety MRI: before infusion 2
- Safety MRI: before infusion 3
- Safety MRI: before infusion 4
- Safety MRI: before infusion 7
What to watch for between scheduled scans
The first 24 weeks of treatment call for heightened attention to ARIA symptoms, since this is the period of highest risk. Watch for headache, confusion, visual disturbance, nausea, and gait difficulty, and treat a seizure as an emergency. An MRI is warranted whenever any of these symptoms appear, regardless of where the patient falls in the scheduled scan sequence, per Lilly's ARIA management summary. Caregivers are often the ones who notice a change in gait, new confusion, or a complaint of headache that doesn't fit the patient's pattern.
Reporting these promptly, rather than waiting for the next scheduled appointment, is what allows an unscheduled MRI to happen in time. If ARIA is found, what happens next depends on severity. A radiographically mild, asymptomatic case of ARIA-E (brain swelling) may allow dosing to continue. Moderate or severe ARIA-E requires pausing treatment until a follow-up MRI shows the swelling has resolved and any symptoms are gone, with that follow-up scan suggested 2 to 4 months after the abnormality is first found, according to the same Lilly summary.
Should you ask about ApoE ε4 genetic testing first?
ApoE ε4 is a gene variant linked to higher Alzheimer's risk, and testing for it is recommended before starting Kisunla. Patients who carry two copies (ε4 homozygotes, about 15% of Alzheimer's patients) have a materially higher rate of ARIA — including symptomatic and severe cases — than those with one copy or none, per Lilly's genotype guidance.
There's an important limit here: no FDA-authorized ApoE ε4 test currently exists, and the monitoring and management steps are the same no matter what the result shows. The test informs the conversation about risk and benefit before starting treatment, but it does not change the MRI schedule or how ARIA is handled if it occurs.
Blood thinners, strokes, and the boxed warning
Kisunla carries a boxed warning for ARIA because it can be serious or fatal. One trial patient died of an intracerebral hemorrhage after receiving clot-dissolving (thrombolytic) therapy for stroke-like symptoms that were actually caused by ARIA-E, according to Lilly's antithrombotic FAQ.
Clinicians are warned to consider ARIA-E as a possible cause of new neurological symptoms before giving thrombolytic treatment. Caregivers of a patient on blood thinners should make sure any emergency room team treating a sudden stroke-like symptom knows the patient is on donanemab. In trial data, ARIA-E occurred in 19.3% of donanemab patients on anticoagulants versus 24.6% of those with no antithrombotic use — Lilly notes the event count and limited non-aspirin exposure in the data mean firm conclusions aren't possible, so caution with anticoagulant or thrombolytic use is still advised.
- Carry a card or note listing the donanemab infusion schedule and most recent MRI date
- Tell any emergency provider about donanemab treatment before thrombolytic therapy is considered
- Keep anticoagulant use on the radar for every infusion visit, even without symptoms
Infusion reactions and what happens during treatment
Infusion-related reactions occurred in about 9% to 16% of donanemab-treated trial participants, mostly during the first four infusions and typically starting during the infusion or within 30 minutes afterward, per Lilly's infusion reaction FAQ. The infusion team slows or stops the infusion if a reaction occurs and treats it as needed; antihistamine, acetaminophen, or corticosteroid pre-treatment may be considered before later doses. Caregivers accompanying a patient to early infusions should expect to stay through a brief observation period afterward, since that 30-minute window after infusion is when a reaction is most likely to appear.
How long does treatment last?
Kisunla is designed as a finite course rather than an indefinite one. Dosing can stop once amyloid plaque falls to minimal levels on PET imaging — under 11 centiloids on a single scan, or 11 to 25 centiloids confirmed on two consecutive scans — according to Lilly's treatment-duration FAQ. Clinical judgment still guides the stop decision for each patient, so ask the treating physician when a repeat PET scan is planned and what result would end dosing.
Frequently Asked Questions
Does every patient need genetic testing before starting donanemab?
Testing for ApoE ε4 is recommended, but no FDA-authorized test exists yet, and the monitoring steps during treatment don't change based on the result.
Can dosing continue if an MRI finds ARIA?
It depends on severity — mild, asymptomatic ARIA-E may allow continued dosing, but moderate or severe cases require pausing until a follow-up MRI shows resolution.
Is donanemab given forever once started?
No. It's designed to stop once PET imaging shows amyloid plaque has fallen to a pre-specified minimal level, confirmed by the treating physician.
