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.

SKLICE (NDA-202736)

(IVERMECTIN)

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

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06/16/2017 (SUPPL-3)

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

There are no studies with the use of SKLICE Lotion in pregnant women. Epidemiologic studies with the use of oral ivermectin during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester. However, systemic exposure from topical use of ivermectin is much lower than that from oral use. In animal reproduction studies, ivermectin induced adverse developmental outcomes when orally administered to pregnant mice, rats and rabbits during the period of organogenesis only at or near doses that were maternally toxic to the pregnant females.

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

Data

Human Data

Four published epidemiology studies, all performed in rural Africa to treat soil-transmitted helminths, evaluated pregnancy outcomes in a total of 744 women exposed to oral ivermectin in various stages of pregnancy. In the largest of these studies, 397 women in their second trimester of pregnancy were treated open-label with single doses of oral ivermectin, or ivermectin plus albendazole, for soil-transmitted helminths and compared with a pregnant, non-treated population. No differences in pregnancy outcomes were observed between treated and untreated populations. These studies cannot definitively establish or exclude the absence of any drug-associated risk during pregnancy, because either the timing of administration during gestation was not accurately ascertained or the administration occurred only during the second trimester.

8.2 Lactation

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

Risk Summary

There is information available on the presence of ivermectin in human milk in 4 lactating women after a single 150 mcg/kg oral dose of ivermectin. However, there is insufficient information from this study to determine the effects of ivermectin on the breastfed infant or the effects of ivermectin on milk production.

Topical ivermectin systemic exposure is much lower than that for oral ivermectin. Furthermore, the amount of ivermectin present in human milk after topical application of SKLICE to lactating women has not been studied.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKLICE Lotion and any potential adverse effects on the breastfed infant from SKLICE Lotion or from the underlying maternal condition.

Clinical Considerations

Advise a lactating woman to avoid accidental transfer of SKLICE Lotion to breast area where the infant might directly ingest the drug.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Inform the patient and caregiver of the following instructions:

Use SKLICE Lotion in the context of an overall lice management program.
Leave SKLICE Lotion on the hair and scalp for 10 minutes, and then rinse off with water.
It is recommended to wait 24 hours before applying shampoo to hair and scalp.
Advise a lactating woman to avoid accidental transfer of SKLICE Lotion directly to breast area where the infant might directly ingest the drug.

Patient Information

(Additions and/or revisions are underlined)

What is SKLICE Lotion?

…

Before you use SKLICE Lotion, tell your healthcare provider about all of your medical conditions, including if you or your child:

are breastfeeding or plan to breastfeed. Ivermectin has been found in breast milk when taken by mouth and may pass into breast milk after using SKLICE Lotion. If you use SKLICE Lotion and breastfeed your baby:

avoid accidental transfer of SKLICE Lotion to your breast to help prevent ingestion by your baby.
talk to your healthcare provider about the best way to feed your baby during treatment with SKLICE Lotion.

How should I use SKLICE Lotion?

It is important to use enough SKLICE Lotion to completely coat all of your hair and scalp. Leave SKLICE Lotion on your hair and scalp for a full 10 minutes, and then rinse off with water.
It is recommended to wait 24 hours before applying shampoo to hair and scalp.