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.

LEXISCAN (NDA-022161)

(REGADENOSON)

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

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05/31/2018 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myocardial Ischemia

Additions and/or revisions underlined:

… Cardiac resuscitation equipment and trained staff should be available before administering LEXISCAN. Adhere to the recommended duration of injection. As noted in an animal study, longer injection times may increase the duration and magnitude of increase in coronary blood flow.

6 Adverse Reactions

6.1 Clinical Trials Experience

Inadequate Exercise Stress

Additions and/or revisions underlined:

… The timing of the administration of LEXISCAN following inadequate exercise did not alter the common adverse reaction profile.

01/17/2017 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Bronchoconstriction

(Additions and/or revisions are underlined)

… Appropriate bronchodilator therapy and resuscitative measures should be available prior to and following LEXISCAN administration.

5.8 Seizure

(Additions and/or revisions are underlined)

LEXISCAN may lower the seizure threshold; obtain a seizure history…

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

Inadequate Exercise Stress

In an open-label, multi-center trial evaluating LEXISCAN administration following inadequate exercise stress, 1,147 patients were randomized into one of two groups. Each group underwent two LEXISCAN stress myocardial perfusion imaging (MPI) procedures. Group 1 received LEXISCAN 3 minutes following inadequate exercise in the first LEXISCAN stress (MPI 1). Group 2 rested 1 hour after inadequate exercise to allow hemodynamics to return to baseline prior to receiving LEXISCAN (MPI 1). Both groups returned for a second stress MPI 1-14 days later and received LEXISCAN without exercise (MPI 2).

The most common adverse reactions are similar in type and incidence to those in Table 1 above for both Groups. The timing of the administration of LEXISCAN did not alter the common adverse reaction profile.

Table 4 shows a comparison of cardiac events of interest for the two groups. The cardiac events were numerically higher in Group 1.

Table 4 Cardiac Events of Interest in Inadequate Exercise Stress Study (Table has been added; please refer to label)

6.2 Post-Marketing Experience

(Additions and/or revisions are underlined)

The following adverse reactions have been reported from worldwide marketing experience with regadenoson...

Cardiovascular

Myocardial infarction, cardiac arrest, ventricular arrhythmias, supraventricular tachyarrhythmias including atrial fibrillation with rapid ventricular response (new-onset or recurrent), atrial flutter, heart block (including third-degree block), asystole, marked hypertension, symptomatic hypotension in association with transient ischemic attack, acute coronary syndrome (ACS), seizures and syncope have been reported…

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There are no available data on LEXISCAN use in pregnant women to inform a drug-associated risk. In animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

…In rabbits, maternal toxicity occurred at regadenoson doses administered during organogenesis at 4 times the MRHD; however, there were no teratogenic effects in offspring at this dose…

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There is no information on the presence of regadenoson in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential risk of serious cardiac reactions in the breastfed infant, advise the nursing mother to pump and discard breast milk for 10 hours after administration of LEXISCAN.

8.6 Renal Impairment

(Additions and/or revisions are underlined)

No dose adjustment is needed in patients with renal impairment including patients with end stage renal disease and/or dependent on dialysis.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Hypersensitivity

Inform patients that allergic reactions have been reported with LEXISCAN. Advise patients how to recognize such a reaction and when to seek medical attention.

Respiratory

Advise patients with COPD or asthma about the need for administration of pre- and post-study bronchodilator therapy and to call their clinician if they experience any shortness of breath or difficulty breathing following an MPI study with LEXISCAN.

Seizures

Advise patients that they may be at increased risk of seizures. Question patients about a history of seizures.

Lactation

Advise a woman to pump and discard breast milk for 10 hours after LEXISCAN administration.