A Kisunla monitoring checklist covers four things: a baseline MRI before the first infusion, three more MRIs on a fixed schedule, infusion-visit supervision, and symptom watch for ARIA between scans. Kisunla (donanemab-azbt) is Eli Lilly's IV infusion therapy for early symptomatic Alzheimer's disease, and its FDA prescribing information carries a boxed warning because treatment can cause ARIA, or amyloid-related imaging abnormalities — usually silent on a scan, but sometimes a serious brain bleed, and rarely fatal. Every item below exists to catch ARIA or an infusion reaction before it becomes dangerous, not to delay treatment. Caregivers who know the schedule and the warning signs are the ones who can act in time.
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 MRI schedule, start to finish
- Should genetic testing happen before starting?
- What to expect at the infusion itself
- Symptoms to watch for between scheduled scans
- How ARIA findings change the dosing plan
The MRI schedule, start to finish
Before the first infusion, the prescriber needs a recent brain MRI to confirm there's no existing bleeding or swelling that would make treatment unsafe. The FDA label does not set an exact "recency" window for how old that baseline scan can be, but in the pivotal TRAILBLAZER-ALZ 2 trial, baseline scans were obtained within 49 days of the first infusion — a useful reference point when scheduling. After that, the U.S.
label requires additional MRIs before the 2nd, 3rd, 4th, and 7th infusions to screen for ARIA, since that's when the condition is most likely to appear. Any new neurological symptom — not just a scheduled visit — also triggers an MRI on its own. A practical way to track this: mark infusions 1, 2, 3, 4, and 7 on a calendar as "MRI required before this visit," and treat every other infusion as "no scan needed unless something changes." Missing one of these scans means the clinic will not proceed with that infusion until it's done.
Should genetic testing happen before starting?
Lilly's safety materials recommend testing for the APOE ε4 gene before starting Kisunla, because carrying two copies (homozygous) changes the risk profile. There is currently no FDA-authorized APOE ε4 test, only lab-developed tests whose accuracy varies, and treatment can start without the result — it simply means the care team can't estimate genotype-specific risk ahead of time.
The reason this matters: APOE ε4 homozygotes, who make up roughly 15% of Alzheimer's patients, have higher rates of symptomatic, serious, and severe ARIA on imaging than heterozygotes or people with no ε4 copies. The monitoring schedule itself — the same MRI timing described above — doesn't change based on genotype. What changes is how closely the care team and caregiver should watch for symptoms in a known high-risk carrier.
- Ask the prescriber whether genetic testing was done or offered
- If the patient is a known ε4 homozygote, treat every symptom-watch window (see Section 4) as higher-stakes
- If testing wasn't done, treatment can still proceed — this is a risk-awareness step, not a gatekeeping one
What to expect at the infusion itself
Reactions tend to cluster early. In the TRAILBLAZER-ALZ 2 trial, infusion-related reactions occurred in about 8.7% of donanemab patients versus 0.5% on placebo, and 70% of those reactions happened within the first four infusions. About 4% of treated patients stopped therapy because of them.
Separately, immediate hypersensitivity reactions on the day of infusion occurred in 10.4% of patients versus 0.9% on placebo, and three participants (0.4%) had anaphylaxis, described as mild to moderate. Kisunla is not given to anyone with a known serious hypersensitivity to donanemab-azbt or its ingredients. Because of this pattern, Kisunla must be given by a clinician equipped to recognize and manage both infusion reactions and ARIA. For the first four infusions especially, caregivers should plan for the visit to include on-site medical supervision and emergency support, not just a quick in-and-out appointment.
Symptoms to watch for between scheduled scans
ARIA risk is highest in the first 24 weeks of treatment, which is why Lilly's safety materials call for heightened vigilance for ARIA symptoms during this window: headache, confusion, visual disturbance, nausea, or seizure. These can appear between scheduled MRIs, so a caregiver's job is to notice and report them immediately rather than wait for the next scan date. Any of these warrants a call to the care team the same day, not a wait-and-see approach until the next scheduled visit.
- Sudden or unusual headache, especially one that doesn't resolve
- New confusion or disorientation beyond the patient's usual baseline
- Vision changes — blurring, double vision, loss of part of the visual field
- Nausea with no other explanation
- Any seizure activity
How ARIA findings change the dosing plan
If an MRI shows ARIA — classified as ARIA-E (swelling) or ARIA-H (small bleeds) — the care team grades it by severity and symptoms. Dosing is interrupted and withheld until a follow-up MRI shows the finding has resolved or stabilized before the care team considers restarting infusions. This is why keeping every scheduled MRI — not just the baseline — is part of the checklist rather than a formality: a missed scan delays the dosing decision itself, not just the paperwork.
