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.

SKYCLARYS (NDA-216718)

(OMAVELOXOLONE)

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

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12/20/2024 (SUPPL-9)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during post approval use of SKYCLARYS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: hypersensitivity (urticaria, rash)

7 Drug Interactions

7.1 Effect of Other Drugs on SKYCLARYS

Additions and revisions underlined:

Omaveloxolone is a CYP3A4 substrate. Concomitant use of SKYCLARYS with moderate or strong CYP3A4 inducers is expected to result in clinically significant decreased exposure of omaveloxolone [see Clinical Pharmacology (12.3)]

8 Use in Specific Populations

8.1 Pregnancy

Newly added information:

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SKYCLARYS during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-866-609-1785 or by sending an email to SkyclarysPregnancySurveillance@ppd.com.

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

Patient Counseling Information

Newly added information:

Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SKYCLARYS during pregnancy [see Use in Specific Populations (8.1)].

Patient Information

Newly added information:

Pregnancy exposure registry: There is a pregnancy registry for women who are pregnant and are taking SKYCLARYS. The purpose of this registry is to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself by calling 1- 866-609-1785 or by sending an email to SkyclarysPregnancySurveillance@ppd.com.

01/25/2024 (SUPPL-2)

Approved Drug Label (PDF)

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Administration

Advise patients to take SKYCLARYS on an empty stomach at least 1 hour before eating [see Dosage and Administration (2.2)].

Advise patients to swallow SKYCLARYS capsules whole or to open the capsules and sprinkle the entire contents of both halves onto 2 tablespoons (30 mL) of applesauce, then stir the mixture. If sprinkled, advise patients to swallow the drug/applesauce mixture immediately and not to store for future use. Do not crush or chew the capsules. Inform patients that the contents of the SKYCLARYS capsules should not be mixed with milk or orange juice. Advise patients to not administer SKYCLARYS by an enteral feeding tube [see Dosage and Administration (2.2)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

How should I take SKYCLARYS?

Take SKYCLARYS exactly as your healthcare provider tells you to take it.
Take SKYCLARYS capsules on an empty stomach at least 1 hour before eating.
Swallow SKYCLARYS capsules whole. Do not crush or chew.
If SKYCLARYS capsules cannot be swallowed whole, the capsules may be opened and the entire contents of both halves sprinkled onto 2 tablespoonfuls (30 mL) of applesauce.
- Stir the mixture.
- Swallow all the mixture of medicine and applesauce right away. Do not store the mixture of medicine and applesauce to use at a later time.
- The contents of the SKYCLARYS capsules should not be mixed with milk or orange juice.
- Do not administer SKYCLARYS by an enteral feeding tube.
  If you miss a dose, then you should skip the missed dose and take the next dose at the regular time the next day. Do not double your next dose or take more than the prescribed dose.
  …