Lecanemab

Lecanemab is a prescription medicine used for the treatment of Alzheimer’s disease. 

• Lecanemab is available under the following different brand names: Leqembi, lecanemab-irmb

Common side effects of Lecanemab include:

• fever,
• flu-like symptoms,
• chills,
• generalize aches,
• shakiness,
• joint pain,
• nausea,
• vomiting,
• low or high blood pressure, and
• low oxygen levels

Serious side effects of Lecanemab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat
• headache,
• confusion,
• visual changes,
• dizziness,
• nausea, and
• difficulty walking

Rare side effects of Lecanemab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable, IV solution

• 200 mg/2 mL single-dose vial
• 500 mg/5 mL single-dose vial
• Must dilute before administration

Alzheimer Disease

Adult dosage

• 10 mg/kg IV every 2 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lecanemab has no noted severe interactions with any other drugs.
• Lecanemab has no noted serious interactions with any other drugs.
• Lecanemab has no noted moderate interactions with any other drugs.
• Lecanemab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lecanemab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lecanemab?”

Cautions

• Infusion-related reactions
  • Infusion-related reactions were observed; a majority of these reactions occurred with the first infusion
  • Symptoms may include fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation
  • Monitor for any signs or symptoms of an infusion-related reaction; infusion rate may be reduced or may be discontinued, and appropriate therapy administered as clinically indicated
  • Consider premedication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids
• Amyloid-related imaging abnormalities (ARIA)
  • Monoclonal antibodies directed against aggregated forms of beta-amyloid can cause ARIA, characterized as ARIA with edema (ARIA-E), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis
  • ARIA-H can occur spontaneously in patients with Alzheimer's disease
  • ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta-amyloid generally occurs in association with an occurrence of ARIA-E
  • ARIA-H of any cause and ARIA-E can occur together
  • ARIA is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur
  • Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty; focal neurologic deficits may also occur; symptoms associated with ARIA usually resolve over time
  • See Dosing & Uses for monitoring and dosing interruption recommendations if ARIA-E or ARIA-H occurs
• Information for patients and caregivers
  • Inform patients that although ARIA can occur in any patient treated with this medication, there is an increased risk in patients who are ApoE ε4 homozygotes and that there is a test available to determine ApoE ε4 genotype
  • 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 this medication; encourage patients to participate in the ALZ-NET registry

Pregnancy and Lactation

• There are no adequate data regarding use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• No animal studies have been conducted to assess potential reproductive or developmental toxicity
• Lactation
  • There are no data regarding the presence in human milk, its effects on breastfed infants, or its effects on milk production
  • Published data from other monoclonal antibodies generally indicate the low passage of monoclonal antibodies into human milk and limited systemic exposure in breastfed infants
  • The effects of this limited exposure are unknown