Lecanemab-irmb
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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AMYLOID RELATED IMAGING ABNORMALITIES
See full prescribing information for complete Boxed Warning.
Patients treated with LEQEMBI may experience amyloid related imaging abnormalities (ARIA) which is characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H).
ARIA usually occurs during the early treatment phase and is asymptomatic. However, serious and life-threatening events may occur rarely. Serious intracerebral hemorrhage has also been observed in these patients who have taken LEQEMBI. Patients who are Apolipoprotein E ε4 ( ApoE ε4) homozygotes, which constitute 15% of Alzheimer's disease have a higher incidence of developing ARIA including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and non-carriers. Therefore, it is recommended that all patients with Alzheimer's undergo Testing for ApoE ε4 status prior to initiation of treatment with LEQEMBI. Please note that prescribers can provide LEQEMBI, even if genotype testing is not available, however, the Apolipoprotein E ε4 status or the risk of ARIE cannot be determined. |
Overview
Lecanemab-irmb is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that is FDA approved for the treatment of Alzheimer’s disease. This drug is ideally initiated during the early phase of dementia or mild cognitive impairment (which was the population tested in the clinical trials of this drug).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Amyloid Related Imaging Abnormalities,Hypersensitivity Reactions, and Infusion-Related Reaction.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Lecanemab-irmb FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lecanemab-irmb FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Lecanemab-irmb Contraindications in the drug label.
Warnings
|
AMYLOID RELATED IMAGING ABNORMALITIES
See full prescribing information for complete Boxed Warning.
Patients treated with LEQEMBI may experience amyloid related imaging abnormalities (ARIA) which is characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H).
ARIA usually occurs during the early treatment phase and is asymptomatic. However, serious and life-threatening events may occur rarely. Serious intracerebral hemorrhage has also been observed in these patients who have taken LEQEMBI. Patients who are Apolipoprotein E ε4 ( ApoE ε4) homozygotes, which constitute 15% of Alzheimer's disease have a higher incidence of developing ARIA including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and non-carriers. Therefore, it is recommended that all patients with Alzheimer's undergo Testing for ApoE ε4 status prior to initiation of treatment with LEQEMBI. Please note that prescribers can provide LEQEMBI, even if genotype testing is not available, however, the Apolipoprotein E ε4 status or the risk of ARIE cannot be determined. |
There is limited information regarding Lecanemab-irmb Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lecanemab-irmb Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lecanemab-irmb Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lecanemab-irmb Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lecanemab-irmb in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lecanemab-irmb in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lecanemab-irmb during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lecanemab-irmb in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lecanemab-irmb in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lecanemab-irmb in geriatric settings.
Gender
There is no FDA guidance on the use of Lecanemab-irmb with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lecanemab-irmb with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lecanemab-irmb in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lecanemab-irmb in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lecanemab-irmb in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lecanemab-irmb in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lecanemab-irmb Administration in the drug label.
Monitoring
There is limited information regarding Lecanemab-irmb Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lecanemab-irmb and IV administrations.
Overdosage
There is limited information regarding Lecanemab-irmb overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lecanemab-irmb Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lecanemab-irmb Mechanism of Action in the drug label.
Structure
There is limited information regarding Lecanemab-irmb Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lecanemab-irmb Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lecanemab-irmb Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lecanemab-irmb Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lecanemab-irmb Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lecanemab-irmb How Supplied in the drug label.
Storage
There is limited information regarding Lecanemab-irmb Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lecanemab-irmb Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lecanemab-irmb interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lecanemab-irmb Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lecanemab-irmb Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.