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.

LYUMJEV (BLA-761109)

(INSULIN LISPRO-AABC)

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

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10/14/2022 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes to add trials in pediatric population; please refer to label

8 Use in Specific Populations

8.4 Pediatric Use

Additions and revisions underlined:

The safety and effectiveness of LYUMJEV to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of LYUMJEV for this indication is supported by evidence from an adequate and well-controlled study in 716 pediatric patients with type 1 diabetes mellitus aged 1 year and older, and from studies in adult and pediatric patients with diabetes mellitus [see Clinical Pharmacology (12.3) and Clinical Studies (14.5)].

LYUMJEV-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to LYUMJEV-treated adults [see Adverse Reactions (6.1)]. It is expected that LYUMJEV-treated pediatric patients who receive continuous subcutaneous insulin infusion (CSII) are more likely to have infusion site-related adverse reactions than those who receive subcutaneous injections [see Adverse Reactions (6.1)]. Monitor injection and infusion sites closely when initiating therapy with LYUMJEV in pediatric patients. If persistent injection or infusion site reactions occur, discontinue LYUMJEV and initiate therapy with an alternative insulin.

8.5 Geriatric Use

Additions and revisions underlined:

Of the total number of LYUMJEV-treated patients in clinical studies for type 1 or type 2 diabetes (PRONTO-T1D and PRONTO-T2D, respectively), 17% (187/1,116) were 65 years of age and older, while 2% (18/1,116) were 75 years of age and older [see Clinical Studies (14.2, 14.3)].

No overall differences in safety or effectiveness of LYUMJEV have been observed between patients 65 years of age and older and younger adult patients.

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

Patient Information

Additions and revisions underlined:

What is LYUMJEV?

LYUMJEV is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

08/13/2021 (SUPPL-3)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

LYUMJEV is contraindicated:

during episodes of hypoglycemia.
in patients with hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV.

5 Warnings and Precautions

5.8 Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction

(Newly added subsection)

Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection of LYUMJEV may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure [see Dosage and Administration (2.2), How Supplied/Storage and Handling (16.2), and Patient Counseling Information (17)].

6 Adverse Reactions

(Additions and/or revisions underlined)

The following adverse reactions are also discussed elsewhere:

Hypoglycemia [see Warnings and Precautions (5.3)].
Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)]
Hypokalemia [see Warnings and Precautions (5.5)].
Hypersensitivity Reactions [see Warnings and Precautions (5.6)].

6.1 Clinical Trial Experience

(Extensive additions/revisions; please refer to label)

7 Drug Interactions

(Additions and/or revisions underlined)

Table 5 includes clinically significant drug interactions with LYUMJEV.

Table 5. Clinically Significant Drug Interactions with LYUMJEV

…

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

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

…

Instructions for Patients Using Continuous Subcutaneous Infusion (Insulin Pump)

Do not use LYUMJEV U-200 in an insulin pump.
Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
Instruct patients to follow healthcare provider recommendations when setting pump basal rates and bolus settings.
Refer to the continuous subcutaneous infusion pump user manual to see if LYUMJEV can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual.
Instruct patients to replace insulin in the reservoir at least every 9 days, or according to the pump user manual whichever is shorter. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
Instruct patients to discard insulin exposed to temperatures higher than 98.6°F (37°C).
Instruct patients to inform healthcare provider and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their healthcare provider [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)].

PATIENT INFORMATION

(Extensive additions/revisions; please refer to label)