Lecanemab
What is Lecanemab?[edit | edit source]
- Lecanemab (Leqembi) is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line.
What are the uses of this medicine?[edit | edit source]
Lecanemab (Leqembi) is a prescription medicine used to treat people with Alzheimer’s disease.
Limitations of use:
- Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.
- There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
How does this medicine work?[edit | edit source]
- Lecanemab-irmb is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
- The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease.
- Leqembi reduces amyloid beta plaques.
Who Should Not Use this medicine ?[edit | edit source]
- This medicine have no usage limitations.
What drug interactions can this medicine cause?[edit | edit source]
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Is this medicine FDA approved?[edit | edit source]
- Lecanemab was approved for medical use in the United States in January 2023.
How should this medicine be used?[edit | edit source]
- Confirm the presence of amyloid beta pathology prior to initiating treatment.
- Obtain a recent (within one year) brain MRI prior to initiating treatment to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA).
Recommended dosage:
- The recommended dosage of Leqembi is 10 mg/kg that must be diluted then administered as an intravenous infusion over approximately one hour, once every two weeks.
- Obtain an MRI prior to the 5th, 7th, and 14th infusions.
- If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms.
Administration:
- Leqembi is given by a healthcare provider through a needle placed in your vein (intravenous (IV) infusion) in your arm.
- Leqembi is given every 2 weeks. Each infusion will last about 1 hour.
- If you miss an infusion of Leqembi, you should receive your next dose as soon as possible.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form: As Injection:
- 500 mg/5 mL (100 mg/mL) solution in a single-dose vial
- 200 mg/2 mL (100 mg/mL) solution in a single-dose vial
This medicine is available in fallowing brand namesː
- Leqembi
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- infusion-related reactions
- headache
- swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
Less common, but serious side effects may include:
- Amyloid Related Imaging Abnormalities or “ARIA”
- infusion-related reactions
What special precautions should I follow?[edit | edit source]
- Monoclonal antibodies directed against aggregated forms of beta amyloid, including Leqembi, can cause amyloid related imaging abnormalities (ARIA). Inform patients that Leqembi may cause Amyloid Related Imaging Abnormalities or “ARIA”.
- 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.
- 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 Alzheimer’s disease, including Leqembi. Encourage patients to participate in the ALZ-NET registry.
- It is not known if lecanemab-irmb passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving Leqembi.
What to do in case of emergency/overdose?[edit | edit source]
- In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.
- Overdose related information is also available online at poisonhelp.org/help.
- In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
- In the event of overdose, general supportive measures should be instituted as necessary.
- Monitor the patient for adverse reactions.
Can this medicine be used in pregnancy?[edit | edit source]
- It is not known if Leqembi will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Leqembi.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness of Leqembi in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- Active ingredient: lecanemab-irmb.
- Inactive ingredients: arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection.
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by:
- Eisai Inc.
- Nutley, NJ
What should I know about storage and disposal of this medication?[edit | edit source]
Unopened Vial:
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Store in the original carton to protect from light.
- Do not freeze or shake.
Diluted Solution:
- After dilution, immediate use is recommended.
- If not administered immediately, store Leqembi refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours, or at room temperature up to 30°C (86°F) for up to 4 hours.
- Do not freeze.
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