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Guide
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.
IMCIVREE (NDA-213793)
(SETMELANOTIDE ACETATE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
03/19/2026 (SUPPL-9)
5 Warnings and Precautions
5.1 Disturbance in Sexual Arousal
Additions and/or revisions underlined:
Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections and increased frequency of penile erections in males occurred in clinical trials with IMCIVREE [see Adverse Reactions (6.1)].
…
5.5 Acute Adrenal Insufficiency in Patients with Acquired HO
Newly added subsection:
In a clinical trial of adults and pediatric patients aged 4 years and older with acquired HO and secondary adrenal insufficiency, serious adverse reactions related to acute adrenal insufficiency were reported by 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.
5.6 Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus
Newly added subsection:
In a clinical trial of adults and pediatric patients aged 4 years and older with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency, hyponatremia was reported in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients, and hypernatremia was reported in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients.
In patients with acquired HO and concomitant DI/AVP deficiency, monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.
6 Adverse Reactions
Addition of the following to the bulleted line listing:
Acute Adrenal Insufficiency in Patients with Acquired HO [see Warnings and Precautions (5.5)]
Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus [see Warnings and Precautions (5.6)]
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
…
Acquired HO (Adults and Pediatric Patients Aged 4 Years and Older)
The safety of IMCIVREE was evaluated in a randomized, double-blind, placebo-controlled clinical trial which included a dose titration period of 4 to 8 weeks and a 52-week treatment period, in 142 patients aged 4 years and older with acquired HO (Trial 1) [see Clinical Studies (14.1)]. The trial duration was 56 to 60 weeks.
Table 5 summarizes the adverse reactions that occurred in 5% or more of the IMCIVREE-treated patients and more frequently than placebo-treated patients in Trial 1.
Please refer to label to view Table 5
Other Adverse Reactions in Patients Aged 4 Years and Older with Acquired HO
Disturbance in Sexual Arousal
Spontaneous penile erections and increased frequency of penile erections were reported in 7% of IMCIVREE-treated patients and 4% of placebo-treated patients.
Acute Adrenal Insufficiency
Serious adverse reactions related to acute adrenal insufficiency were reported by 5% of IMCIVREE-treated patients and no placebo-treated patients.
Sodium Imbalance
Among patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency, hyponatremia was reported in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients, and hypernatremia was reported in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients.
…
Other Adverse Reactions in Patients Aged 2 to less than 6 Years with Obesity due to POMC or LEPR Deficiency or BBS
Disturbance in Sexual Arousal
Spontaneous penile erections were reported in 8% of IMCIVREE-treated patients.
Depression
Depressed mood was reported in 8% of IMCIVREE-treated patients.
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
Acquired HO
The safety and effectiveness of IMCIVREE have been established to reduce excess body weight and maintain weight reduction long term in pediatric patients aged 4 years and older with acquired HO. Use of IMCIVREE for this indication is supported by evidence from a 56- to 60-week randomized, double-blind, placebo-controlled trial that included 76 pediatric patients with acquired HO aged 4 to 17 years [see Clinical Studies (14.1)].
Adverse reactions with IMCIVREE treatment in pediatric patients aged 4 to 17 years with acquired HO were generally similar to those reported in adults [see Adverse Reactions (6.1)]. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmented lesions [see Warnings and Precautions (5.4)].
The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 4 years of age with acquired HO.
BBS or POMC, PCSK1, or LEPR Deficiency
…
Adverse reactions with IMCIVREE treatment in pediatric patients aged 2 to less than 6 years with BBS, POMC, PCSK1, or LEPR deficiency were generally similar to those reported in adults and in pediatric patients aged 6 years and older. Pediatric patients with BBS, POMC, PCSK1, or LEPR deficiency treated with IMCIVREE had greater incidences of vomiting, skin hyperpigmentation, and new or darkening nevi compared to adults with BBS, POMC, PCSK1, or LEPR deficiency treated with IMCIVREE [see Adverse Reactions (6.1)]. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmented lesions [see Warnings and Precautions (5.4)].
The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 2 years of age with BBS, POMC, PCSK1, or LEPR deficiency.
8.6 Renal Impairment
Additions and/or revisions underlined:
…
Patients with severe renal impairment have a higher exposure of setmelanotide relative to patients with normal kidney function. IMCIVREE is not recommended for use in adults and pediatric patients aged 4 years and older with acquired HO and severe renal impairment.
For patients with BBS or POMC, PCSK1, or LEPR deficiency, reduce the recommended starting and maintenance dosage of IMCIVREE in adults and pediatric patients 2 years of age and older with severe renal impairment (eGFR 15-29 mL/min/1.73 m2). The use of IMCIVREE in pediatric patients aged 2 to less than 6 years with weight less than 20 kg and severe renal impairment is not recommended [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
…
Acute Adrenal Insufficiency in Patients with Acquired HO
Inform patients with adrenal insufficiency and their caregivers to contact their healthcare provider for any significant changes in fatigue or lethargy, mental status, dizziness, fever, or signs of infection which may require an increase in steroid dosing occur during treatment with IMCIVREE [see Warnings and Precautions (5.5)].
Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus
Inform patients with diabetes insipidus and their caregivers to contact their healthcare provider if changes in fluid intake or urine output or other signs of dehydration, mental status changes (e.g., confusion, lethargy), or significant nausea and vomiting occur which may require adjustments in concomitant therapies during treatment with IMCIVREE [see Warnings and Precautions (5.6)].
…
PATIENT INFORMATION
Additions and/or revisions underlined
What is IMCIVREE?
IMCIVREE is a prescription medicine used in adults and children:
4 years of age and older with acquired hypothalamic obesity (HO) to help them lose weight and keep the weight off.
2 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) to help them lose weight and keep the weight off.
2 years of age and older with obesity due to the genetic conditions proopiomelanocortin (POMC), proprotein convertase subtilisin kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.
Your healthcare provider should order a genetic test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.
IMCIVREE is not for use in people with the following conditions because it may not work:
Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results.
Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.
It is not known if IMCIVREE is safe and effective in children under 2 years of age.
…
Before using IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:
…
have adrenal insufficiency.
have diabetes insipidus.
…
What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:
…
Adrenal insufficiency. If you have acquired HO and adrenal insufficiency, your healthcare provider should evaluate your adrenal function before starting IMCIVREE. You or your caregiver should call your healthcare provider if you have changes in feeling tired or exhausted (fatigue), lack of energy (lethargy), mental status, or dizziness, or fever, or signs of infection during treatment with IMCIVREE. Your healthcare provider should monitor and adjust any medicines that may be affected during treatment.
Low sodium levels in the blood. If you have acquired HO and diabetes insipidus, you or your caregiver should watch for signs of dehydration. You or your caregiver should contact your healthcare provider if you have changes in fluid intake or urine output, confusion, lethargy, or nausea and vomiting during treatment with IMCIVREE. Your healthcare provider should closely monitor sodium levels in your blood and adjust your other medicines if needed.
…
12/20/2024 (SUPPL-7)
5 Warnings and Precautions
5.1 Disturbance in Sexual ArousalAdditions and revisions underlined:
Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males (24% in patients aged 6 years and older; 8% in patients aged 2 to less than years) and sexual adverse reactions in females (7% in IMCIVREE-treated patients aged 6 years and older and 0% in placebo-treated patients from an unapproved population) occurred in clinical studies with IMCIVREE [see Adverse Reactions (6.1)].
Additions and revisions underlined:
Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Depression (26% in patients aged 6 years and older), suicidal ideation (11% in patients aged 6 years and older), and depressed mood (8% in patients aged 2 to less than 6 years) occurred in adults and pediatric patients in IMCIVREE clinical studies [see Adverse Reactions (6.1)]. Patients with a history of depression or suicidal ideation may be at increased risk for recurrent episodes while taking IMCIVREE.
Subsection Title Revised
Additions and revisions underlined:
Generalized or focal increases in skin pigmentation occurred in the majority of patients (67% in patients aged 6 years and older; 83% in patients 2 to less than 6 years) treated with IMCIVREE in clinical trials [see Adverse Reactions (6.1) and Clinical Pharmacology (12.1)]. This effect is reversible upon discontinuation of the drug.
IMCIVREE may also cause the development of new melanocytic nevi or darkening of pre- existing nevi due to its pharmacologic effect. Development of new melanocytic nevi and darkening or increase in size of existing melanocytic nevi occurred in 16% of patients aged 6 years and older and 33% of patients aged 2 to less than 6 years.
6 Adverse Reactions
Additions and revisions underlined:
Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi [see Warnings and Precautions (5.4)]
Extensive changes; please refer to label
8 Use in Specific Populations
8.4 Pediatric UseAdditions and revisions underlined:
The safety and effectiveness of IMCIVREE have been established to reduce excess body weight and maintain weight reduction long term in pediatric patients aged 2 years and older with obesity due to:
· BBS [see Clinical Studies (14.1)]
· POMC, PCSK1, or LEPR deficiency with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) [see Clinical Studies (14.2)]
Use of IMCIVREE for these indications is supported by evidence from one 66-week study, which included a 14-week, randomized, double-blind, placebo-controlled period followed by a 52-week open-label period, and included 22 pediatric patients with BBS aged 6 to 17 years (Study 1); from two 1-year, open-label studies that included 9 pediatric patients with POMC, PCSK1, or LEPR deficiency aged 6 to 17 years (Study 2 and Study 3); and one 1-year, open- label study that included 12 pediatric patients with POMC or LEPR deficiency or BBS aged 2 to less than 6 years (Study 4) [see Clinical Studies (14.1, 14.2, 14.3)].
Adverse reactions with IMCIVREE treatment in pediatric patients aged 2 to less than 6 years were generally similar to those reported in adults and in pediatric patients aged 6 years and older. Pediatric patients treated with IMCIVREE had greater incidences of vomiting, skin hyperpigmentation, and new or darkening nevi compared to adults treated with IMCIVREE [see Adverse Reactions (6.1)]. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmented lesions. [see Warnings and Precautions (5.4)]
The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 2 years of age.
Additions and revisions underlined:
Patients with severe renal impairment have a higher exposure of setmelanotide relative to patients with normal kidney function. Reduce the recommended starting and maintenance dosage of IMCIVREE in adults and pediatric patients 2 years of age and older with severe renal impairment (eGFR 15-29 mL/min/1.73 m2).
Patient Counseling Information
Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi
Inform patients or caregivers that skin darkening occurs in the majority of patients treated with IMCIVREE because of its mechanism of action. This change is reversable upon discontinuation of IMCIVREE. Inform patients and caregivers that the development of new melanocytic nevi may occur.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient InformationAdditions and revisions underlined:
What is IMCIVREE?
IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to:
Bardet-Biedl syndrome (BBS) to help them lose weight and keep the weight off.
The genetic conditions proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.
Your healthcare provider should order a genetic test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.
IMCIVREE is not for use in people with the following conditions because it may not work:
Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results.
Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.
It is not known if IMCIVREE is safe and effective in children under 2 years of age.
The most common side effects of IMCIVREE include:
. . .
depression
11/15/2023 (SUPPL-5)
4 Contraindications
Additions and/or revisions underlined:
IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
5 Warnings and Precautions
5.3 Hypersensitivity ReactionsNew subsection added:
Serious hypersensitivity reactions, including anaphylaxis, have been reported with IMCIVREE. These reactions generally occurred within minutes to hours after injecting IMCIVREE [see Adverse Reactions (6.2)]. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of IMCIVREE. IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE.
6 Adverse Reactions
Addition of the following to the bulleted line listing:
Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
6.2 Postmarketing Experience
New subsection added:
The following adverse reactions have been identified during post-approval use of IMCIVREE. 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.
Hypersensitivity, including anaphylaxis
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
…
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported with use of IMCIVREE. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking IMCIVREE and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.3)].
…
PATIENT INFORMATION
Additions and/or revisions underlined:
…
Do not use IMCIVREE if you have had a serious allergic reaction to setmelanotide or any of the ingredients in IMCIVREE. Serious allergic reactions, including a severe allergic reaction called anaphylaxis, can happen when you use IMCIVREE. See the end of this Patient Information leaflet for a complete list of ingredients in IMCIVREE.
Before using IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:
have or have had areas of darkened skin, including skin discoloration (hyperpigmentation).
have or have had depression, or suicidal thoughts or behavior.
have had a prior allergic reaction to setmelanotide or any of the ingredients in IMCIVREE.
…
What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:
…
Serious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including:
swelling of your face, lips, tongue or throat
problems breathing or swallowing
severe rash or itching
fainting or feeling dizzy
rapid heartbeat
…
06/16/2022 (SUPPL-1)
5 Warnings and Precautions
5.1 Disturbance in Sexual ArousalAdditions and/or revisions underlined:
Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males (24%) and sexual adverse reactions in females (7% in IMCIVREE-treated patients and 0% in placebo-treated patients from an unapproved population) occurred in clinical studies with IMCIVREE [see Adverse Reactions (6.1)].
Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Additions and/or revisions underlined:
Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Depression (26%) and suicidal ideation (11%) occurred in adults and pediatric patients in IMCIVREE clinical studies [see Adverse Reactions (6.1)]. Patients with a history of depression or suicidal ideation may be at increased risk for recurrent episodes while taking IMCIVREE.
Monitor patients for new onset or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors or if clinically significant or persistent depression symptoms occur.
Additions and/or revisions underlined:
Generalized increased skin pigmentation occurred in the majority of patients (69%) treated with IMCIVREE in clinical trials [see Adverse Reactions (6.1) and Clinical Pharmacology (12.1)]. IMCIVREE may also cause darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug.
Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.
Additions and/or revisions underlined:
IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs, including IMCIVREE. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (IMCIVREE contains 10 mg of benzyl alcohol per mL) [see Use in Specific Populations (8.4)].
6 Adverse Reactions
Additions and/or revisions underlined:
The following clinically significant adverse reactions are described elsewhere in the labeling:
Extensive changes; please refer to label
8 Use in Specific Populations
8.4 Pediatric UseAdditions and/or revisions underlined:
The safety and effectiveness of IMCIVREE have been established for chronic weight management in pediatric patients aged 6 years and older with obesity due to:
POMC, PCSK1, or LEPR deficiency with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) [see Clinical Studies (14.1)]
BBS [see Clinical Studies (14.2)]
Use of IMCIVREE for these indications is supported by evidence from 2 one-year, open-label studies that included 9 pediatric patients with POMC, PCSK1, or LEPR deficiency, and from one 66-week study, which included a 14-week, randomized, double-blind, placebo-controlled period followed by a 52-week open-label period, and included 22 pediatric patients with BBS [see Clinical Studies (14.1, 14.2)].
The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 6 years old.
IMCIVREE is not approved for use in neonates or infants. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (IMCIVREE contains 10 mg of benzyl alcohol) [see Warnings and Precautions (5.4)].
Additions and/or revisions underlined:
Clinical studies of IMCIVREE did not include patients aged 65 and over. It is not known whether geriatric patients would respond differently than younger adult patients.
Additions and/or revisions underlined:
Patients with severe renal impairment have a higher exposure of setmelanotide relative to patients with normal kidney function. Reduce the recommended starting and target dosage of IMCIVREE in adults and pediatric patients 12 years of age and older with severe renal impairment (eGFR 15-29 mL/min/1.73 m2). The use of IMCIVREE in pediatric patients 6 to less than 12 years of age with severe renal impairment is not recommended [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].
The recommended dosage in patients with mild (eGFR of 60-89 mL/min/1.73 m^2) or moderate renal impairment (eGFR of 30-59 mL/min/1.73 m^2) is the same as those with normal kidney function [see Clinical Pharmacology (12.3)].
IMCIVREE is not recommended for use in patients with end stage renal disease (eGFR less than 15 mL/min/1.73 m^2).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or revisions underlined:
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Disturbance in Sexual Arousal
Inform patients that sexual adverse reactions, including spontaneous erection, may occur in patients treated with IMCIVREE. Advise patients to seek emergency medical treatment if an erection lasts longer than 4 hours [see Warnings and Precautions (5.1)].
Depression and Suicidal Ideation
Inform patients or caregivers that IMCIVREE may cause depression or suicidal ideation. Advise patients or caregivers to report any new or worsening symptoms of depression, suicidal thoughts or behaviors, or unusual changes in mood or behavior [see Warnings and Precautions (5.2)].
…
Newly added information