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.

ORGOVYX (NDA-214621)

(RELUGOLIX)

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

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10/08/2025 (SUPPL-12)

Approved Drug Label (PDF)

7 Drug Interactions

Additions and/or revisions underlined:

…

Combined P-gp and Strong CYP3A Inducers

Relugolix is a P-gp and CYP3A substrate.

…

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined

…

Risk Summary

The safety and efficacy of ORGOVYX have not been established in females.

Relugolix was detected in human breast milk (see Data). There are no data on the effects of relugolix or its metabolites on the breastfed child, or the effects on milk production.

Data

In a milk-only lactation study in 8 healthy adult lactating women, the mean total amount of relugolix recovered in human breast milk over the first 24 hours was 0.003 mg and over 120 hours (5 days) was 0.004 mg following a single, oral, maternal dose of 40 mg. The mean calculated daily infant dose was 0.0006 mg/kg/day using 0.003 mg (the amount recovered in human breast milk over the first 24 hours). The relative infant dose was 0.1% of the maternal weight-adjusted dose of 40 mg.

10/18/2024 (SUPPL-6)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effect of Other Drugs on ORGOVYX

Additions and revisions underlined:

P-gp Inhibitors

Relugolix is a P-gp substrate. Coadministration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions associated with ORGOVYX.

Avoid coadministration of ORGOVYX with oral P-gp inhibitors.

If coadministration with an oral P-gP inhibitor cannot be avoided, take ORGOVYX first and wait at least 6 hours before taking the P-gp inhibitor. Closely monitor patients for increased adverse reactions [see Dosage and Administration (2.2)].

If an oral P-gp inhibitor will only be administered for up to 2 weeks, ORGOVYX may be interrupted while the P-gp inhibitor is being administered. Resume ORGOVYX after the P-gp is discontinued. If ORGOVYX is interrupted for more than 7 days, resume ORGOVYX at 360 mg on the first day, followed by 120 mg once daily.

Combined P-gp and Strong CYP3A Inducers

Coadministration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of ORGOVYX [see Clinical Pharmacology (12.3)].

Avoid coadministration of ORGOVYX with combined P-gp and strong CYP3A inducers.

If coadministration cannot be avoided, increase the ORGOVYX dose. After discontinuation of the combined P-gp and strong CYP3A inducer, resume ORGOVYX once daily at the same dose [see Dosage and Administration (2.3)].

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

PATIENT COUNSELING INFORMATION

Newly added information:

Drug Disposal

Advise patients to dispose of unused medication via a take-back option if available. Otherwise, advise to follow FDA instructions for disposing medication in the household trash, www.fda.gov/drugdisposal and NOT to flush down the toilet.

03/30/2023 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components.

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

(Newly added subsection)

ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or any of the product components [see Contraindications (4)]. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported in postmarketing in patients treated with ORGOVYX.

In the HERO study, patients treated with relugolix reported angioedema (0.2%) [see Clinical Trials Experience (6.1)].

Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care.

Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated.

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

…Clinically relevant adverse reactions in < 10% of patients who received ORGOVYX included increased weight, insomnia, gynecomastia, hyperhidrosis, depression, decreased libido, and angioedema.

6.2 Postmarketing Experience

(Newly added subsection)

The following adverse reactions have been identified during post-approval use of ORGOVYX. 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, including angioedema and urticaria.

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Hypersensitivity

Inform patients that if they have experienced severe hypersensitivity with relugolix or to any of the product components, ORGOVYX is contraindicated [see Contraindications (4)].

Inform patients that ORGOVYX can cause severe hypersensitivity reactions that include angioedema [see Warnings and Precautions (5.2)].
Advise patients who experience hypersensitivity symptoms to discontinue ORGOVYX and promptly contact their healthcare provider.