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Patient counseling information

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).1

ARIA

  • Inform patients that LEQEMBI® may cause ARIA. ARIA most commonly presents as a temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain
  • Inform patients that most people with swelling in areas of the brain do not experience symptoms, however, some people may experience symptoms such as headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure. Instruct patients to notify their healthcare provider if these symptoms occur
  • Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking LEQEMBI, and that the use of antithrombotic or thrombolytic medications while taking LEQEMBI may increase the risk of bleeding in the brain
  • Notify patients that their healthcare provider will perform MRI scans to monitor for ARIA
  • Inform patients that although ARIA can occur in any patient treated with LEQEMBI, there is an increased risk in patients who are ApoE ε4 homozygotes, and that testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Inform patients that if testing is not performed, it cannot be determined if they are ApoE ε4 homozygotes and at a higher risk for ARIA

    Patient registry

    • Advise patients that the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) is a voluntary provider-enrolled patient registry that collects information on treatments for AD, including LEQEMBI. Encourage patients to participate in the ALZ-NET registry

      Hypersensitivity reactions

      • Inform patients that hypersensitivity reactions, including angioedema and anaphylaxis have occurred in patients who were treated with LEQEMBI. Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reactions

        Infusion-related reactions

        • Advise patients of the potential risk of infusion-related reactions, which can include flu-like symptoms, nausea, vomiting, and changes in blood pressure, the majority of which occur with the first infusion
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          ARIA is a consequence of amyloid presence in blood vessel walls that can occur spontaneously in patients with AD or as a result of treatment with a monoclonal antibody (including LEQEMBI) that removes amyloid.1-7 Learn more about ARIA

          Learn more about ARIA

          Detailed ARIA screening and management strategies are provided in the LEQEMBI PI1

          Monitor the safety of your patients from the start

          • Symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty1
          • Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI, if indicated
          • After initiation of treatment with LEQEMBI, obtain follow-up MRIs
          • If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment (see below for dosing interruptions)
          • In patients who suspend dosing due to ARIA, consider a follow-up MRI to assess for resolution or stabilization 2 to 4 months after initial identification. Resumption of dosing should be guided by clinical judgment

          Note: If infusions are being administered at a facility that is separate from that of the prescribing neurologist, the infusion center and prescriber will need to communicate to ensure that patients receive the additional MRIs before the 5th, 7th and 14th infusions are administered.

          MRI guidelines MRI guidelines

          Do NOT administer the 5th, 7th, or 14th infusion until the additional MRIs have been completed and confirmed1

          Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated1

          Recommendations for dosing interruptions for patients with ARIA-E1
          • Recommendations depend on clinical symptoms and radiographic severity

          ARIA-E severity on MRI

          Recommendations for dosing interruptions for patients with ARIA-E graph

          *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.1

          †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.1

          • Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E1
          • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic but radiographically severe ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E1

          If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment. Dosing was able to be continued in most patients with ARIA1,3,4

          Recommendations for dosing interruptions for patients with ARIA-H1
          • Recommendations depend on the type of ARIA-H and radiographic severity

          ARIA-H severity on MRI

          Recommendations for dosing interruptions for patients with ARIA-H graph

          ‡Mild/moderate: 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.1

          §Severe: Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; use clinical judgment in considering whether to continue treatment or permanently discontinue LEQEMBI.1

          • In patients who develop intracerebral hemorrhage >1 cm in diameter during treatment with LEQEMBI, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Use clinical judgment in considering whether to continue treatment after radiographic stabilization and resolution of symptoms or permanently discontinue LEQEMBI1
          ARIA MRI classification criteria
          • The radiographic severity of ARIA associated with LEQEMBI was classified by the criteria shown below1
          ARIA MRI classification criteria
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          From diagnosis to infusion: your road map for LEQEMBI

          Diagnosis to Infusion Brochure

          Brochure that provides an overview of the steps involved from diagnosis through treatment with LEQEMBI (for eligible patients)

          Download the brochure
          Learn about supply information and additional considerations for LEQEMBI