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.

CAPASTAT SULFATE (NDA-050095)

(CAPREOMYCIN SULFATE)

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

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01/17/2023 (SUPPL-78)

Approved Drug Label (PDF)

Boxed Warning

Additions and revisions underlined:

The use of Capastat® Sulfate may be associated with worse clinical outcomes, i.e., decreased

effectiveness and increased mortality, compared with other parenteral therapy for pulmonary

multidrug-resistant tuberculosis (MDR-TB) (see WARNINGS and ADVERSE REACTIONS). In

patients who require parenteral treatment for pulmonary MDR-TB, reserve Capastat Sulfate for those

with resistance to injectable aminoglycosides and limited treatment options.

. . .

5 Warnings and Precautions

WARNINGS

Newly added section

The use of Capastat Sulfate may be associated with worse clinical outcomes, i.e., decreased effectiveness and increased mortality, compared with other parenteral therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB) (see ADVERSE REACTIONS). In patients who require parenteral treatment for pulmonary MDR- TB, reserve Capastat Sulfate for those with resistance to injectable aminoglycosides and limited treatment options.

6 Adverse Reactions

Newly added information:

Increased Mortality and Decreased Effectiveness: The results of a meta-analysis of patient-level data from 12030 patients from 25 countries that included but was not limited to an evaluation of capreomycin (N=2401) for the treatment of pulmonary MDR-TB suggested that capreomycin may be associated with worse clinical outcomes, i.e., decreased effectiveness and increased mortality, compared with other parenteral therapy for pulmonary MDR-TB3 (see WARNINGS AND REFERENCES).