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.

AMYVID (NDA-202008)

(FLORBETAPIR F-18)

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

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06/23/2025 (SUPPL-46)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Risk of Image Misinterpretation and Other Errors

Additions and/or revisions underlined:

Errors may occur in the estimation of brain amyloid beta neuritic plaque density during AMYVID image interpretation [see Clinical Studies (14)].

The use of clinical information in the interpretation of AMYVID images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an AMYVID scan.

Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Dosage and Administration (2.4)].

5.2 Radiation Risk

Additions and/or revisions underlined:

AMYVID contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1, 2.2)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

The safety of AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials. Table 2 shows adverse reactions reported in greater than or equal to 0.4% of subjects from the clinical trials.

Please refer to label to view Table 2.

…

Adverse reactions that occurred in <0.4% of subjects included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Radiation Risk

Advise patients of the radiation risk of AMYVID. Instruct patients to drink water to ensure adequate hydration prior to administration of AMYVID and to continue drinking and voiding frequently following administration to reduce radiation exposure [see Warnings and Precautions (5.2)].

Pregnancy

Inform pregnant women of the potential risks of fetal exposure to radiation doses with AMYVID [see Use in Specific Populations (8.1)].

Lactation

Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) after AMYVID administration to minimize radiation exposure to the breastfed infant [see Use in Specific Populations (8.2)].

12/20/2019 (SUPPL-36)

Approved Drug Label (PDF)

Other

(Physician Labeling Rule (PLR)/Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer to label)