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.

NURTEC ODT (NDA-212728)

(RIMEGEPANT SULFATE)

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

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08/01/2025 (SUPPL-28)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions, including anaphylaxis, dyspnea, and rash, have occurred in patients treated with NURTEC ODT. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1, 6.2)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

. . .

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis) [see Contraindications (4) and Warnings and Precautions (5.1)]

. . .

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

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

What are the possible side effects of NURTEC ODT? NURTEC ODT may cause serious side effects including:

Allergic reactions. Allergic reactions, including trouble breathing and rash, can happen after you take NURTEC ODT. This can happen days after you take NURTEC ODT. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction:

. . .

Rash

. . .

03/21/2025 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsections:

5.2 Hypertension

Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including NURTEC ODT, in the postmarketing setting.

Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. NURTEC ODT was discontinued in many of the reported cases.

Monitor patients treated with NURTEC ODT for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of NURTEC ODT is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

5.3 Raynaud’s Phenomenon

Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including NURTEC ODT.

In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

NURTEC ODT should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Hypertension [see Warnings and Precautions (5.2)]
Raynaud’s Phenomenon [see Warnings and Precautions (5.3)]

Newly added subsection:

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of NURTEC ODT. 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.

Vascular Disorders: Hypertension [see Warnings and Precautions (5.2)], Raynaud’s phenomenon [see Warnings and Precautions (5.3)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Hypertension

Inform patients that hypertension can develop or pre-existing hypertension can worsen with NURTEC ODT, and that they should contact their healthcare provider if they experience elevation in their blood pressure [see Warnings and Precautions (5.2)].

Raynaud’s Phenomenon

Inform patients that Raynaud’s phenomenon can develop or worsen with NURTEC ODT. Advise patients to discontinue NURTEC ODT and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon [see Warnings and Precautions (5.3)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Before you take NURTEC ODT, tell your healthcare provider about all of your medical conditions, including if you:

have high blood pressure.
have circulation problems in your fingers and toes.

. . .

What are the possible side effects of NURTEC ODT?

NURTEC ODT may cause serious side effects including:

. . .

High blood pressure. High blood pressure or worsening of high blood pressure can happen after you take NURTEC ODT. Contact your healthcare provider if you have an increase in blood pressure.
Raynaud’s phenomenon. A type of circulation problem can worsen or happen after you take NURTEC ODT. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.

. . .

04/11/2022 (SUPPL-9)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Risk Summary

Additions and/or revisions underlined:

… In animal studies, oral administration of rimegepant during organogenesis resulted in adverse effects on development in rats (decreased fetal body weight and increased incidence of skeletal variations) at exposures greater than those used clinically and which were associated with maternal toxicity.

Data

Animal Data

Oral administration of rimegepant (0, 10, 60, or 300 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreased fetal body weight and an increased incidence of fetal skeletal variations at the highest dose tested (300 mg/kg/day) …

… The highest dose tested (50 mg/kg/day) was associated with plasma exposures (AUC) approximately 10 times that in humans at the MRHD.

Oral administration of rimegepant (0, 10, 25, or 60 mg/kg/day) to rats throughout gestation and lactation resulted in no effects on pre-or postnatal development. The highest dose tested (60 mg/kg/day) was associated with plasma exposures (AUC) approximately 24 times that in humans at the MRHD.

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

A lactation study was conducted, and the results have established a relative infant dose of less than 1% of the maternal weight-adjusted dose and the milk-to-plasma ratio of 0.20 (see Data). These data support that transfer of rimegepant into breastmilk is low. There are no data on the effects of rimegepant on a breastfed infant or on milk production.

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

Data

A study was conducted in twelve healthy adult lactating women who were between 2 weeks and 6 months postpartum and were administered a single oral dose of rimegepant 75 mg. The relative infant dose was <1%. The average milk to plasma ratio was 0.20.

12/08/2021 (SUPPL-12)

Approved Drug Label (PDF)

7 Drug Interactions

Additions and/or revisions underlined:

7.3 P-gp Inhibitors

Concomitant administration of NURTEC ODT with potent inhibitors of P-gp (e.g., amiodarone, cyclosporine, lapatinib, quinidine, ranolazine) may result in increased exposure of rimegepant. Avoid another dose of NURTEC ODT within 48 hours when it is concomitantly administered with potent inhibitors of P-gp [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 NURTEC ODT during pregnancy. For more information, healthcare providers or patients are encouraged to contact: 1-877-366-0324, email nurtecpregnancyregistry@ppd.com, or visit nurtecpregnancyregistry.com.

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

PATIENT COUNSELING INFORMATION

Newly added information:

Pregnancy Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NURTEC ODT during pregnancy. Encourage participation and advise patients about how they may enroll in the registry [see Use in Specific Populations (8.1)].

05/27/2021 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Acute Treatment of Migraine

The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in 682 patients with migraine who received one 75 mg dose of NURTEC ODT [see Clinical Studies (14)]. Approximately 85% were female, 74% were White, 21% were Black, and 17% were Hispanic or Latino. The mean age at study entry was 40 years (range 18-75 years of age).

Long-term safety was assessed in an open-label extension study using a different oral dosage form of rimegepant. That study evaluated 1,798 patients, dosing intermittently for up to one year, including 1,131 patients who were exposed to rimegepant 75 mg for at least 6 months, and 863 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.

The most common adverse reaction in Study 1 was nausea (2% in patients who received NURTEC ODT compared to 0.4% of patients who received placebo).

Hypersensitivity, including dyspnea and severe rash, occurred in less than 1% of patients treated with NURTEC ODT [see Contraindications (4) and Warnings and Precautions (5.1)].

Preventive Treatment of Episodic Migraine

The safety of NURTEC ODT for the preventive treatment of episodic migraine in adults has been established in a randomized, double-blind, placebo-controlled trial with an open-label extension (Study 2) using a different oral dosage form of rimegepant [see Clinical Studies (14)]. In the 12-week, double-blind treatment period, 370 patients with migraine received one 75 mg dose of rimegepant every other day. Approximately 81% were female, 80% were White, 17% were Black, and 28% were Hispanic or Latino. The mean age at study entry was 41 years (range 18-74 years of age). Long-term safety was assessed in an open-label extension study that included 603 patients who were treated for up to one year. Overall, 527 patients were exposed to rimegepant 75 mg for at least 6 months, and 311 were exposed for at least one year.

The most common adverse reactions (occurring in at least 2% of rimegepant-treated patients and at a frequency of at least 1% higher than placebo) in Study 2 were nausea (2.7% in patients who received rimegepant compared with 0.8% of patients who received placebo) and abdominal pain/dyspepsia (2.4% in patients who received rimegepant compared with 0.8% of patients who received placebo).

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

Medication Guide:

(Additions and/or revisions underlined)

What are the ingredients in NURTEC ODT?

Active ingredient in NURTEC ODT: rimegepant

Inactive ingredients in NURTEC ODT: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin