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.

REYVOW (NDA-211280)

(LASMIDITAN SUCCINATE)

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

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09/15/2022 (SUPPL-8)

Approved Drug Label (PDF)

7 Drug Interactions

7.4 P-glycoprotein (P-gp) Transporter Substrates

Newly added subsection:

Coadministration of REYVOW with P-gp substrates where a small change in substrate plasma concentration may lead to serious toxicities (e.g., digoxin) is not recommended [see Clinical Pharmacology (12.3)].

07/15/2022 (SUPPL-7)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724. To learn more please call or visit www.migrainepregnancyregistry.com.

…

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

MEDICATION GUIDE

Additions and/or revisions underlined:
…
Before you take REYVOW, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have high blood pressure
have a low heart rate
are allergic to lasmiditan
are pregnant or plan to become pregnant. It is not known if REYVOW will harm your unborn baby.
- Pregnancy Registry: There is a pregnancy registry for pregnant women who take REYVOW. The purpose of this registry is to collect information about the health of you and your baby if you take REYVOW during pregnancy. To learn more call 1-833-464-4724 or visit www.migrainepregnancyregistry.com. You may also talk to your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed. It is not known if REYVOW passes into your breastmilk.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:
…
Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)].
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy [see Use in Specific Populations (8.1)].

…

06/03/2021 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

Less Common Adverse Reactions

The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, feeling hot or feeling cold, palpitations, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and hallucinations.

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

Medication Guide

(Additions and/or revisions underlined)

• Swallow REYVOW tablets whole. Do not split, crush, or chew.

Do not take more than one dose in a 24-hour period.

PATIENT COUNSELING INFORMATION

(Newly added information)

Administration – Advise patients to swallow tablets whole (do not split, crush, or chew) [see Dosage and Administration (2)].

07/17/2020 (SUPPL-1)

Approved Drug Label (PDF)

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Abuse and Dependence – Advise patients that REYVOW is a federally controlled substance because it has the potential to be abused. Advise patients to keep their medication secure.