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.

DAURISMO (NDA-210656)

(GLASDEGIB MALEATE)

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

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03/27/2023 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Musculoskeletal Adverse Reactions

(Newly added subsection)

Musculoskeletal adverse reactions, which may be accompanied by CPK elevations, have occurred with DAURISMO and other drugs which inhibit the hedgehog (Hh) pathway. In BRIGHT AML 1003, musculoskeletal adverse reactions occurred in 45% of patients treated, with 2% (7/79) reported as Grade 3 or higher. The most frequent manifestations of musculoskeletal adverse reactions reported were musculoskeletal pain (30%) and muscle spasms (15%). Increased CPK laboratory values occurred in 16% of patients [see Adverse Reactions (6.1)].

Obtain baseline CPK levels prior to initiating DAURISMO and as clinically indicated (e.g., if muscle symptoms are reported). Obtain CPK and serum creatinine levels at least weekly in patients with musculoskeletal adverse reactions with concurrent CPK elevation greater than 2.5 times ULN until resolution of clinical signs and symptoms. Depending on the severity of symptoms, temporary dose interruption, dose reduction, or discontinuation of DAURISMO may be required for musculoskeletal adverse reactions or serum CPK elevation [see Dosage and Administration (2.2)].

6 Adverse Reactions

(Additions and/or revisions underlined)

The following clinically significant adverse reactions are described elsewhere in the labeling:

QTc Interval Prolongation [see Warnings and Precautions (5.2)]
Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.3)]

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

QTc Interval Prolongation

Inform patients of signs and symptoms that may be indicative of significant QTc interval prolongation. Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopal symptoms, and cardiac palpitations [see Warnings and Precautions (5.2)].

Musculoskeletal Adverse Reactions

Advise patients starting therapy with DAURISMO of the risk of muscle-related adverse reactions.
Advise patients to report promptly any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing DAURISMO[see Warnings and Precautions (5.3)].

03/19/2020 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

…

Adverse reactions reported in the first 90 days of therapy on the BRIGHT AML 1003 study are shown in Table 3.

Table 3. Adverse Reactions Occurring in greater than or equal to 10% of Patients Within the First 90 Days of Therapy in BRIGHT AML 1003

…

Changes in selected post-baseline laboratory values that were observed in patients with newly-diagnosed AML and other conditions for which DAURISMO is not indicated in the clinical trial are shown in Table 4.

Table 4. Selected Laboratory Abnormalities (greater than or equal to 15%) Within the First 90 Days of Therapy in BRIGHT AML 1003

…

7 Drug Interactions

(Extensive revisions; please refer to label)

8 Use in Specific Populations

8.6 Renal Impairment

(Newly added subsection)

No dosage modification is recommended for patients with mild to severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 89 mL/min). Monitor patients with severe renal impairment (eGFR 15 to 29 mL/min) for increased risk of adverse reactions, including QTc interval prolongation, due to increased glasdegib concentrations.

03/19/2020 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

…

Adverse reactions reported in the first 90 days of therapy on the BRIGHT AML 1003 study are shown in Table 3.

Table 3. Adverse Reactions Occurring in greater than or equal to 10% of Patients Within the First 90 Days of Therapy in BRIGHT AML 1003

…

Table 4. Selected Laboratory Abnormalities (greater than or equal to 15%) Within the First 90 Days of Therapy in BRIGHT AML 1003

…

7 Drug Interactions

(Extensive revisions; please refer to label)

8 Use in Specific Populations

8.6 Renal Impairment

(Newly added subsection)