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.

LYBALVI (NDA-213378)

(OLANZAPINE; SAMIDORPHAN L-MALATE)

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

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01/30/2026 (SUPPL-11)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during post-approval use of olanzapine. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

. . .

syndrome of inappropriate antidiuretic hormone secretion (SIADH)

. . .

02/28/2025 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Olanzapine and samidorphan are present in human milk. A clinical lactation study in 12 healthy lactating women demonstrated that olanzapine and samidorphan are present in low levels in human milk (see Data). However, there are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see Clinical Considerations). There are no data on the effects of samidorphan or the combination of olanzapine and samidorphan on the breastfed infant, or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LYBALVI and any potential adverse effects on the breastfed infant from LYBALVI or from the underlying maternal condition.

Clinical Considerations

Infants exposed to LYBALVI should be monitored for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements).

Data

A single dose milk-only lactation study was conducted in 12 healthy adult lactating women. Following a 5 mg/10 mg oral dose of olanzapine and samidorphan, the mean quantities in human milk were detected to be 0.002 mg and 0.006 mg, respectively. The calculated weight-adjusted infant daily oral dose for olanzapine (~ 0.0005 mg/kg) and samidorphan (0.001 mg/kg) was less than 1% of the weight-adjusted maternal dose for olanzapine (0.07 mg/kg) and samidorphan (0.15 mg/kg), respectively.

01/22/2025 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.17 Hyperprolactinemia

Additions and/or revisions underlined:

. . .

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is considered in a patient with previously-detected breast cancer. As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in the olanzapine carcinogenicity studies conducted in mice and rats [see Nonclinical Toxicology (13.1)]. Published epidemiologic studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

. . .

fecal incontinence

. . .

somnambulism

. . .

01/30/2024 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.19 Interference with Laboratory Tests for Opioid Detection

LYBALVI may cause false positive results with urinary immunoassay methods used for detecting opioids. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results [see Contraindications (4) and Drug Interactions (7.4)].

7 Drug Interactions

7.4 Interference with Laboratory Tests

Newly added subsection:

Interference with Laboratory Tests for Opioid Detection

Because LYBALVI contains samidorphan, an opioid antagonist, LYBALVI may be cross- reactive with urinary immunoassay methods used for detecting opioids, resulting in false positive results. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results [see Contraindications (4) and Warnings and Precautions (5.19)].

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

Medication Guide

Newly added information:

Tell your healthcare provider if you take a urine drug screening test because LYBALVI may affect your test results. Tell those giving the drug screening test that you are taking LYBALVI.

09/25/2023 (SUPPL-5)

Approved Drug Label (PDF)

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

How should I store LYBALVI?

Store LYBALVI at room temperature between 68?F to 77?F (20?C to 25?C).

Keep tightly closed, in a dry place, and away from moisture.

…