Active Ingredient: Donanemab
Donanemab is indicated for the treatment of Alzheimer’s disease. Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 700 milligrams donanemab, once every 4 weeks, 3 doses in total. Afterwards, intravenous, 1,400 milligrams donanemab, once every 4 weeks.
Confirm the presence of amyloid beta pathology prior to initiating treatment.
The recommended dosage of donanemab is 700 mg every four weeks for three doses, then 1400 mg every four weeks (see Table 1). Donanemab is administered every four weeks as an intravenous infusion over approximately 30 minutes. Donanemab must be diluted prior to administration (see Table 4).
Table 1. Dosing Schedule:
| Intravenous infusion (every 4 weeks) | Donanemab dosage (administered over approximately 30 minutes) |
|---|---|
| Infusions 1, 2, and 3 | 700 mg |
| Infusion 4 and beyond | 1400 mg |
Consider stopping dosing with donanemab based on reduction of amyloid plaques to minimal levels on amyloid PET imaging. In Study 1, dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET imaging.
If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.
Donanemab can cause amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H).
Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with donanemab. Obtain an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.
ARIA-E:
The recommendations for dosing interruptions for patients with ARIA-E are provided in Table 2.
Table 2. Dosing Recommendations for Patients With ARIA-E:
| Clinical symptom Severitya | ARIA-E severity on MRI | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Asymptomatic | May continue dosing at current dose and schedule | Suspend dosingb | Suspend dosingb |
| Mild | May continue dosing based on clinical judgment | Suspend dosingb | |
| Moderate or Severe | Suspend dosingb | ||
a Mild: discomfort noticed, but no disruption of normal daily activity.
Moderate: discomfort sufficient to reduce or affect normal daily activity.
Severe: incapacitating, with inability to work or to perform normal daily activity.
b Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification. Resumption of dosing should be guided by clinical judgment.
ARIA-H:
The recommendations for dosing interruptions for patients with ARIA-H are provided in Table 3.
Table 3. Dosing recommendations for patients With ARIA-H:
| Clinical symptom severity | ARIA-H severity on MRI | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Asymptomatic | May continue dosing at current dose and schedule | Suspend dosinga | Suspend dosingb |
| Symptomatic | Suspend dosinga | Suspend dosinga | |
a Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
b Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Use clinical judgment when considering whether to continue treatment or permanently discontinue donanemab.
In patients who develop intracerebral hemorrhage greater than 1 cm in diameter during treatment with donanemab, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Resumption of dosing should be guided by clinical judgment.
Administer donanemab intravenously over approximately 30 minutes.
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