Use and Important Safety Information
WHAT IS LEQEMBI?
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about LEQEMBI?
LEQEMBI can cause serious side effects, including:
ARIA (Amyloid-Related Imaging Abnormalities). ARIA is a side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal.
- ARIA commonly shows up as temporary swelling in areas of the brain that usually goes away over time
- Small spots of bleeding in or on the surface of the brain can occur
- Less often, larger areas of bleeding in the brain can occur
- Most people with ARIA don’t have any symptoms. However, some people may notice:
- Some people have a gene called ApoE4 that may increase the risk of ARIA. Talk to your healthcare provider about testing to see if you have this gene
- You may be at a higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving LEQEMBI. Talk to your healthcare provider to see if any of the medicines you’re taking increase this risk
- Your healthcare provider will check for ARIA with MRI (magnetic resonance imaging) scans before you start LEQEMBI and during treatment
- You should carry information that says you are receiving LEQEMBI, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms
– headache
– confusion that gets worse
– dizziness
– vision changes
– nausea
– difficulty walking
– seizures
WHAT IS LEQEMBI?
LEQEMBI is a prescription medicine used to treat people with early Alzheimer’s disease, which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
Serious allergic reactions:
Do not receive LEQEMBI if you have serious allergic reactions to LEQEMBI or any of the ingredients in LEQEMBI.
– swelling of the face, lips, mouth, or tongue
– itchy bumps on the skin, also known as hives
– difficulty breathing
Infusion-related reactions:
- Tell your healthcare provider right away if you notice any of these symptoms during a LEQEMBI infusion:
- If you have an infusion-related reaction, your healthcare provider may give you medicines before your next infusion to lower the chance of having a reaction
- All your medical conditions, including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. It is not known if LEQEMBI could harm your unborn or breastfeeding baby
-
All the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin)
– fever
– flu-like symptoms (chills, body aches, feeling shaky, joint pain)
– nausea and/or vomiting
– dizziness or lightheadedness
– fast or slow heart rate, or feeling like your chest is pounding
– difficulty breathing or shortness of breath
The most common side effects of LEQEMBI include infusion-related reactions, ARIA, and headaches.
These are not all the possible side effects of LEQEMBI. Call your doctor for more information and medical advice about side effects. You may report side effects to the FDA at www.fda.gov/medwatch
or call
1-800-FDA-1088.
Before receiving LEQEMBI, tell your healthcare provider about:
Please read the Prescribing Information and Medication Guide for LEQEMBI.
For the best experience
LEQEMBI Companion™ should be viewed on a mobile device such as a mobile phone or tablet. Bring your device with you to your LEQEMBI appointments so you can use LEQEMBI Companion there.
Please see Use and Important Safety Information including Boxed WARNING for LEQEMBI. Please see the Full Prescribing Information for LEQEMBI.
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