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.

SYLATRON (BLA-103949)

(PEGINTERFERON ALFA-2B)

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

Download Data

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12/21/2018 (SUPPL-5312)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

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

Risk Summary

Based on findings from animal studies, SYLATRON can cause embryo-fetal harm when administered to a pregnant woman. Available human data with SYLATRON use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than the recommended dose of 6 mcg/kg/week.

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

Data

Animal Data

In an embryo-fetal development study, rhesus monkeys received non-pegylated interferon alfa-2b daily by intramuscular injection during the period of organogenesis and beyond (Gestation Day 20-80). Nonpegylated interferon alfa-2b was abortifacient at 15 and 30 million international units (IU)/kg (estimated human equivalent of 5 and 10 million IU/kg, based on body surface area). The estimated Intron A human equivalent dose of 5 to 10 million IU/kg daily is approximately equal to a human equivalent dose of 79 to 158 mcg/kg/week of SYLATRON.

8.2 Lactation

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

Risk Summary

There are no data on the presence of peginterferon alfa-2b in human or animal milk, or on its effects on the breastfed infant, or milk production. Nonpegylated interferon alfa 2-b is present in human milk at low levels. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SYLATRON and any potential adverse effects on the breastfed infant from SYLATRON or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

(Newly Added Subsection)

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating SYLATRON.

Contraception

Females

SYLATRON may cause embryo-fetal harm when administered to a pregnant woman. Advise female patients of reproductive potential to use effective contraception during treatment with SYLATRON and for at least 10 days after the final dose.

Infertility

Females

Based on animal studies, SYLATRON may transiently impair fertility.

8.4 Pediatric Use

(Additions and/or revisions are underlined)

Safety and effectiveness in patients below the age of 18 years have not been established.

8.6 Hepatic Impairment

(Newly Added Subsection)

SYLATRON has not been studied in patients with melanoma who have hepatic impairment. In patients treated for viral hepatitis, peginterferon alfa-2b treatment is contraindicated in those with moderate or severe hepatic impairment (Child-Pugh scores >6). Discontinue SYLATRON if hepatic decompensation (Child-Pugh scores >6) occurs during treatment.

8.7 Renal Impairment

(Newly Added Subsection)

Reduce the dose of SYLATRON by 25% in patients with moderate renal impairment (CLcr 30 to 50 mL/min/1.73m2) and 50% in patients with severe renal impairment (CLcr < 30 mL/min/1.73m2) or ESRD requiring dialysis . A study in subjects with varying degrees of renal impairment showed that the mean exposure (AUC) to peginterferon alfa-2b increased in subjects with moderate and severe renal impairment or ESRD requiring dialysis, as compared to subjects with normal renal function (CLcr > 80 mL/min/1.73m2) following a single 4.5 mcg/kg dose of peginterferon alfa-2b.

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

17 PATIENT COUNSELING INFORMATION

(Extensive changes; please refer to labeling)

05/04/2018 (SUPPL-5310)

Approved Drug Label (PDF)

6 Adverse Reactions

6.3 Postmarketing Experience

Addition of the following to Gastrointestinal Disorders:

tongue pigmentation