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.

TNKASE (BLA-103909)

(TENECTEPLASE)

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

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02/28/2025 (SUPPL-5197)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Newly added section:

Bleeding

Inform patients that bleeding can occur 1 or more days after administration of TNKase [see Warnings and Precautions (5.1)]. Instruct patients to contact a healthcare provider if they experience signs or symptoms consistent with bleeding (e.g., unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds) or symptoms of a stroke.

03/31/2023 (SUPPL-5194)

Approved Drug Label (PDF)

Other

(Prior Approval supplemental biologics application provides for revisions to labeling pursuant to the Physician Labeling Rule and the Pregnancy and Lactation Labeling Rule. Extensive changes to table; please refer to label for complete information)

02/28/2018 (SUPPL-5187)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Newly added subsection:

Hypersensitivity

Hypersensitivity, including urticarial/anaphylactic reactions, have been reported after

administration of TNKase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and

urticaria). Monitor patients treated with TNKase during and for several hours after

infusion. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.

Pregnancy

Additions and/or revisions underlined:

… In rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths … Thus, in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of TNKase on maternal or developmental toxicity was (5 mg/kg) was approximately 7 times human) exposure (based on AUC) at the dose for AMI. There are no adequate …

WARNINGS

Bleeding

Additions and/or revisions underlined:

… Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin

or antiplatelet agents should be discontinued immediately and treated appropriately.

Newly added information:

Thromboembolism

The use of thrombolytics can increase the risk of thrombo-embolic events in patients with

high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial

fibrillation.

6 Adverse Reactions

Newly added information:

The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label:

Hypersensitivity