Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

LEQEMBI IQLIK (BLA-761375)

(LECANEMAB-IRMB)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/13/2026 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Clinical Trials with Subcutaneous Administration

The safety of LEQEMBI for subcutaneous administration once every week was evaluated in open-label studies in 424 patients. This included 72 lecanemab-naïve patients [see Clinical Pharmacology (12.2)], and 49 patients who received subcutaneous LEQEMBI 360 mg, and 273 patients who received subcutaneous LEQEMBI 500 mg for treatment continuation. The overall safety profile in these patients was similar to that observed in patients who received LEQEMBI by intravenous infusion in Study 1 and Study 2. Injection-related reactions were observed in patients who received LEQEMBI subcutaneously, most of which were localized reactions; systemic reactions were less frequently observed. The majority of injection-related reactions occurred at the time of the first dose when initiating therapy. Recurrent localized injection-related reactions and/or delayed reactions occurring up to several days after an injection, were also observed. Localized injection-related reactions included erythema, induration, swelling, heat, pain, pruritus, rash, ecchymosis, nodule, and hematoma. Systemic injection-related reactions presented with symptoms of headache, chills, fever, and fatigue. Severe localized injection-related reactions and localized injection-related reactions leading to discontinuation or interruption of subcutaneous LEQEMBI did occur.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

. . .

How will I receive LEQEMBI?

. . .

When given under the skin (subcutaneously)

Read the detailed Instructions for Use that comes with your LEQEMBI IQLIK for information about the right way to prepare and give your LEQEMBI IQLIK injections at home.

After at least 2 consecutive doses of LEQEMBI IQLIK are given under the direct guidance of your healthcare provider, they will decide if it is appropriate for you or a caregiver to give (administer) LEQEMBI IQLIK.

Your healthcare provider will show you how to use LEQEMBI IQLIK and tell you how often you should use it. Use LEQEMBI IQLIK exactly as your healthcare provider tells you to.
LEQEMBI IQLIK is given as an injection under your skin (subcutaneous injection), into the front of your thighs or stomach-area (abdomen) by you or a caregiver. A healthcare provider or a caregiver may also give you an injection of LEQEMBI IQLIK in the back of your upper arm.
Do not inject into moles, scars, bruises, tattoos, or into areas where the skin is red, hard, tender, or injured.
Use a different injection site at least 1 inch away from the last site each time you use LEQEMBI IQLIK.
Do not inject into the 2-inch area around the belly button.

If you miss a dose of LEQEMBI IQLIK, inject the missed dose as soon as possible up to 6 days after the missed dose. Continue (resume) your next injection on your regularly scheduled day.

What are the possible side effects of LEQEMBI? LEQEMBI can cause serious side effects, including:

see “What is the most important information I should know about LEQEMBI?”
serious allergic reactions. Swelling of the face, lips, mouth, or tongue, hives, or difficulty breathing have happened during treatment with LEQEMBI. Tell your healthcare provider and get medical help right away if you have any symptoms of a serious allergic reaction during or after treatment with LEQEMBI.

. . .

injection-related reactions. Injection-related reactions may occur with LEQEMBI injection under the skin (subcutaneous injection with LEQEMBI IQLIK). Redness, swelling, heat, pain, itching, rash, bump, bruising and blood collection under the skin at the injection site may be observed. Headache, chills, fatigue, or fever may also be observed after an injection. Tell your healthcare provider if you experience these symptoms during or after an injection.

The most common side effects of LEQEMBI include:

infusion-related reactions with LEQEMBI injected into a vein
swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
headache

. . .

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Injection-Related Reactions

For patients receiving LEQEMBI IQLIK subcutaneous injection, advise them of the potential risks of injection reactions, which may present as erythema, induration, swelling, heat, rash, pain, itching, ecchymosis and hematoma at the injection site, but may also present with symptoms such as headache, fever, chills and fatigue. Instruct patients to contact their healthcare provider if injection-related reactions occur [see Adverse Reactions (6.1)].

Administration Instructions

For patients receiving LEQEMBI via subcutaneous injection, advise patients and caregivers that initiation of therapy will be performed under the supervision of a healthcare provider. Educate patients and/or caregivers on recognizing symptoms and management of anaphylaxis. If determined by a healthcare provider that administration of LEQEMBI by the patient or caregiver is appropriate, instruct them on the proper dosing regimen and the proper method of subcutaneous administration with LEQEMBI IQLIK. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use LEQEMBI IQLIK on their own [see Dosage and Administration (2.6)].