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.

ONTAK (BLA-103767)

(DENILEUKIN DIFTITOX)

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

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02/03/2020 (SUPPL-5144)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infusion Reactions

(Additions and/or revisions underlined)

... Resuscitative equipment should be available during Ontak administration. Immediately stop and permanently discontinue Ontak for Grade 3 or higher infusion reactions.

6 Adverse Reactions

The term ‘clinically significant is added prior to adverse reactions in the first sentence of the section.

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

Based on its mechanism of action, denileukin diftitox may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. There are no available data on Ontak use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population are unknown.

8.2 Lactation

(PLLR conversion)

Risk Summary

There are no data on the presence of denileukin diftitox in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with denileukin diftitox and for 7 days after the final dose.

8.3 Females and Males of Reproductive Potential

(PLLR conversion)

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential prior to initiating Ontak.

Contraception

Females

Ontak may cause embryo-fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during treatment with Ontak and for at least 7 days after the final dose.

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

PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Discuss the following with patients prior to and during treatment with Ontak.

Infusion Reactions

Inform patients of the signs and symptoms of infusion reactions. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion reactions.

Capillary Leak Syndrome

Inform patients of the signs and symptoms of capillary leak syndrome. Advise patients to contact their healthcare provider immediately for signs and symptoms of capillary leak syndrome.

Visual Loss

Advise patients to inform their healthcare provider if they experience visual changes.

Pregnancy

Inform pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.

Females and Males of Reproductive Potential

Advise female patients of reproductive potential to use effective contraception during treatment with Ontak and for 7 days after the final dose.

Lactation

Advise women not to breastfeed during treatment with Ontak and for 7 days after the final dose.