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.

QUVIVIQ (NDA-214985)

(DARIDOREXANT HYDROCHLORIDE)

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

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09/30/2024 (SUPPL-10)

Approved Drug Label (PDF)

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about QUVIVIQ? QUVIVIQ may cause serious side effects, including:

Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Sleepiness may increase your risk for falls.

…

Who should not take QUVIVIQ?

Do not take QUVIVIQ:

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How should I take QUVIVIQ?

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If you take too much QUVIVIQ, call your healthcare provider, or contact your Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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What are the possible side effects of QUVIVIQ? QUVIVIQ may cause serious side effects, including:

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Temporary weakness in your legs that can happen during the day or at night.

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The most common side effects of QUVIVIQ include headache and sleepiness or tiredness.

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09/30/2024 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Patients with Compromised Respiratory Function

Additions and/or revisions underlined:

QUVIVIQ has been studied in mild to severe OSA not using CPAP, and in patients with moderate COPD. The effects of QUVIVIQ on respiratory function should be considered if prescribed to patients with compromised respiratory function. QUVIVIQ has not been studied in patients with mild or severe COPD [see Use in Specific Populations (8.7)].

8 Use in Specific Populations

USE IN SPECIFIC POPULATIONS
8.7 Patients with Compromised Respiratory Function

Additions and/or revisions underlined:

Obstructive sleep apnea

The respiratory depressant effect of QUVIVIQ was evaluated after one night and after five consecutive nights of treatment with QUVIVIQ 50 mg in a randomized, placebo-controlled, two-period crossover study in 25 patients with mild to moderate OSA (apnea-hypopnea index [AHI] 5 to 30 events per hour of sleep) not using CPAP. Following once-daily dosing of 50 mg in the evening, the mean treatment difference (daridorexant – placebo) on Day 5 for AHI was 0.74 (90% CI, -1.43 to 2.92).

QUVIVIQ was also evaluated after 5 consecutive nights of treatment with QUVIVIQ 50 mg in a randomized, placebo-controlled, double-blind, two-period crossover study in 16 patients with severe OSA (apnea-hypopnea index greater than or equal to 30 events per hour of sleep; studied range 30.8–82.2 events per hour) not using CPAP. Following once daily dosing of 50 mg in the evening, the mean treatment difference (daridorexant – placebo) on Day 5 for AHI was -3.74 (90% CI, -11.71 to 4.23).

Due to study limitations, including the short duration of the studies, clinically meaningful respiratory effects of QUVIVIQ in OSA cannot be excluded, including for long-term treatment [see Warnings and Precautions (5.5)].

Chronic obstructive pulmonary disease

The respiratory depressant effect of QUVIVIQ was evaluated after one night and after five consecutive nights of treatment with QUVIVIQ 50 mg in a randomized, placebo-controlled, two-period crossover study in 25 patients with moderate COPD (FEV1/FVC ratio less than or equal to 70% and 40% less than or equal to FEV1 less than 80% of predicted). Following once-daily dosing of 50 mg in the evening, the mean SpO2 treatment difference (daridorexant – placebo) on Day 5 was 0.18% (90% CI, -0.21 to 0.57).

QUVIVIQ has not been studied in patients with mild (FEV1 greater than or equal to 80% predicted) or severe COPD (FEV1 less than 40% of predicted).

Clinically meaningful respiratory effects of QUVIVIQ in patients with compromised respiratory function cannot be excluded [see Warnings and Precautions (5.5)].

09/30/2024 (SUPPL-12)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

Daridorexant is present in human breast milk in low amounts. In a clinical lactation study, daridorexant was detected in human milk at a mean daily infant dose of 0.0016 mg/kg, with a relative infant dose of <1% the maternal weight-adjusted dose (see Data). There are no data on the effects of daridorexant on the breastfed infant or its effects on milk production.

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Data

A lactation study in 10 healthy adult lactating women evaluated the concentrations of daridorexant in plasma and breast milk following a single dose of 50 mg daridorexant. The calculated mean daily infant dose is 0.0016 mg/kg based on an assumed infant body weight of 6 kg, and the relative infant dose is 0.22% of the maternal weight-adjusted dose. Approximately 87% of the total amount of daridorexant present in milk was detected by 24 hours after administration. The amount of daridorexant present in breast milk at steady state is expected to be similar to that after a single dose.

10/30/2023 (SUPPL-7)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effects of Other Drugs on QUVIVIQ

Section title revised

Additions and/or revisions underlined:

Table 2 describes clinically significant drug interactions where the concomitant use of other drugs affects QUVIVIQ.

7.2 Effects of QUVIVIQ on Other Drugs

Newly added section and table 3; please refer to label for complete information

10/30/2023 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:
QUVIVIQ is contraindicated:

in patients with narcolepsy.
in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ. Angioedema with pharyngeal involvement has been reported [see Adverse Reactions (6.2)].

6 Adverse Reactions

6.2 Post-Marketing Experience

Newly added section

The following adverse reactions have been identified during post-approval use of QUVIVIQ. 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.

Psychiatric disorders: Nightmares or abnormal dreams

Immune system disorders: Hypersensitivity (including angioedema, rash, urticaria)

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

MEDICATION GUIDE

Additions and/or revisions underlined:

Who should not take QUVIVIQ?

If you fall asleep often at unexpected times (narcolepsy).
If you are allergic to daridorexant, or any ingredients in QUVIVIQ. See the end of this Medication Guide for a complete list of ingredients in QUVIVIQ.