Imcivree

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Select patients for treatment who have a clinical diagnosis of acquired HO or BBS or who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR.
• ( 2.1 ) Recommended starting dosage injected subcutaneously for:
• Adults and pediatric patients aged 4 years and older with acquired HO is 0.5 mg (0.05 mL) once daily for 2 weeks.
• ( 2.2 )
• Adults and pediatric patients aged 12 years and older with BBS or POMC, PCSK1, or LEPR deficiency is 2 mg (0.2 mL) once daily for 2 weeks.
• ( 2.3 ) Pediatric patients aged 6 to less than 12 years with BBS or POMC, PCSK1, or LEPR deficiency is 1 mg (0.1 mL) once daily for 2 weeks.
• ( 2.3 ) Pediatric patients aged 2 to less than 6 years with BBS or POMC, PCSK1, or LEPR deficiency is 0.5 mg (0.05 mL) once daily for 2 weeks.
• ( 2.4 ) Recommended maintenance dosage for
• adults and pediatric patients aged 6 years and older for all indications is 3 mg (0.3 mL) injected subcutaneously once daily.
• ( 2.2 , 2.3 ) Recommended maintenance dose for pediatric patients with acquired HO aged 4 years to less than 6 years and for pediatric patients with BBS or POMC, PCSK1, or LEPR deficiency aged 2 to less than 6 years is determined by body weight.
• ( 2.2 , 2.3 ) For recommended dosage in patients with renal impairment, see Full Prescribing Information.
• ( 2.4 ) For titration and administration recommendations, see Full Prescribing Information.
• ( 2.2 , 2.3 , 2.4 , 2.5 )
• 2.1 Patient Selection Acquired HO Select patients for treatment with IMCIVREE who have acquired HO [see Clinical Studies (14.1) ].
• BBS Select patients for treatment with IMCIVREE who have a clinical diagnosis of BBS [see Clinical Studies (14.2, 14.4)].
• Consider genetic confirmation in pediatric patients aged <6 years.
• POMC, PCSK1, or LEPR Deficiency Select patients for treatment with IMCIVREE who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR [see Clinical Studies (14.3, 14.4)].
• Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient [see Clinical Studies (14.3, 14.4)].
• An FDA-approved test for the detection of variants in the POMC, PCSK1, or LEPR genes is not available.
• 2.2 Recommended Dosage in Patients with Acquired HO Monitor patients for gastrointestinal (GI) adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the starting dosage is: Not tolerated, discontinue the product.
• Tolerated for 2 weeks, increase the dosage as presented in Table 1 or Table 2.
• Adults and Pediatric Patients Aged 6 Years and Older The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks.
• Pediatric Patients Aged 4 to Less Than 6 Years The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks. image description image description
• Recommended Dosage in Patients with BBS or POMC, PCSK1, or LEPR Deficiency
• Adults and Pediatric Patients Aged 12 Years and Older The recommended starting dosage is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks in
• adults and pediatric patients aged 12 years and older.
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the starting dosage is: Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily.
• If the 1 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 2 mg (0.2 mL) once daily.
• Tolerated for 2 weeks, increase the dosage to 3 mg (0.3 mL) once daily.
• If the 3 mg once daily dosage is not tolerated, decrease the dosage to 2 mg (0.2 mL) once daily.
• The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
• Pediatric Patients Aged 6 to Less Than 12 Years The recommended starting dosage is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years.
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the starting dosage is:
• Not tolerated, reduce the dosage to 0.5 mg (0.05 mL) once daily.
• If the 0.5 mg once daily dosage is tolerated for at least 1 week, increase the dosage to 1 mg (0.1 mL) once daily.
• Tolerated for 2 weeks, increase the dosage to 2 mg (0.2 mL) once daily.
• If the 2 mg daily dosage is:
• Not tolerated, reduce the dosage to 1 mg (0.1 mL) once daily.
• Tolerated, increase the dosage to 3 mg (0.3 mL) once daily.
• The recommended maintenance dosage is 3 mg (0.3 mL) injected subcutaneously once daily.
• Pediatric Patients Aged 2 to Less Than 6 Years The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years.
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the starting dosage is: Not tolerated, discontinue the product.
• Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 3. image description
• 2.4 Recommended Dosage in Patients with Renal Impairment Recommended Dosage in Patients with End Stage Renal Disease [estimated glomerular filtration (eGFR) less than 15 mL/min/1.73 m 2 ] IMCIVREE is not recommended for use in patients with end stage renal disease.
• Recommended Dosage in Patients with Severe Renal Impairment (eGFR of 15 to 29 mL/min/1.73 m 2 )
• Adults and Pediatric Patients Aged 4 Years and Older with Acquired HO IMCIVREE is not recommended for use in
• adults and pediatric patients aged 4 years and older with acquired HO and severe renal impairment.
• Adults and Pediatric Patients Aged 12 Years and Older with BBS or POMC, PCSK1, or LEPR Deficiency The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in
• adults and pediatric patients aged 12 years and older with severe renal impairment.
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)].
• If the recommended starting dosage is [see Use in Specific Populations (8.6)] :
• Not tolerated, discontinue IMCIVREE.
• Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) once daily.
• If the 1 mg daily dosage is tolerated for at least 1 week, increase the dosage to 1.5 mg (0.15 mL) once daily.
• The recommended maintenance dosage is 1.5 mg (0.15 mL) injected subcutaneously once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
• Pediatric Patients Ages 6 Years to Less Than 12 Years with BBS or POMC, PCSK1, or LEPR Deficiency The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 6 to less than 12 years with severe renal impairment.
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the recommended starting dosage is [see Use in Specific Populations (8.6)] :
• Not tolerated, discontinue IMCIVREE.
• Tolerated for 2 weeks, increase the dosage to 1 mg (0.1 mL) injected subcutaneously once daily.
• The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
• Pediatric Patients Aged 2 to Less Than 6 Years Weighing at Least 20 kg with BBS or POMC, PCSK1, or LEPR Deficiency The recommended starting dosage is 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks in pediatric patients aged 2 to less than 6 years with severe renal impairment and weight of at least 20 kg.
• 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 Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
• Monitor patients for GI adverse reactions during dosage initiation and titration [see Adverse Reactions (6.1)] .
• If the recommended starting dosage is [see Use in Specific Populations (8.6)] :
• Not tolerated, discontinue IMCIVREE.
• Tolerated for 2 weeks, increase the dosage based on baseline body weight, as presented in Table 4 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
• The recommended maintenance dosage is 1 mg (0.1 mL) injected subcutaneously once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .
• Monitor patients for adverse reactions [see Adverse Reactions (6.1)] .
• Recommended Dosage in Patients with Mild (eGFR of 60 to 89 mL/min/1.73 m 2 ) or Moderate (eGFR of 30 to 59 mL/min/1.73 m 2 ) Renal Impairment The recommended dosage in patients with acquired HO, BBS, or POMC, PCSK1, or LEPR Deficiency and mild or moderate renal impairment is the same as in those with normal kidney function [see Dosage and Administration (2.2, 2.3)]. image description
• 2.5 Administration Instructions Prior to initiation of IMCIVREE, train patients and their caregivers on proper injection technique.
• Instruct them to use a 1-mL syringe with a 28-gauge or 29-gauge needle appropriate for subcutaneous injection.
• Remove IMCIVREE from the refrigerator approximately 15 minutes prior to administration.
• Alternatively, warm IMCIVREE prior to administration by rolling the vial gently between the palms of the hands for 60 seconds.
• Inspect IMCIVREE visually before use.
• It should appear clear to slightly opalescent, colorless to slightly yellow.
• Do not use if particulate matter or discoloration is seen.
• Administer IMCIVREE once daily, at the beginning of the day, without regard to meals.
• Inject IMCIVREE subcutaneously in the abdomen, thigh, or arm, rotating to a different site each day.
• Do not administer IMCIVREE intravenously or intramuscularly.
• If a dose is missed, resume the once daily regimen as prescribed with the next scheduled dose.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 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 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 (14.2, 14.4)] 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 (14.3, 14.4)] Use of IMCIVREE for these indications is supported by evidence from one 66-week trial, 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 (Trial 2); from two 1-year, open-label trials that included 9 pediatric patients with POMC, PCSK1, or LEPR deficiency aged 6 to 17 years (Trial 3 and Trial 4); and one 1-year, open-label trial that included 12 pediatric patients with POMC or LEPR deficiency or BBS aged 2 to less than 6 years (Trial 5) [see Clinical Studies (14.2, 14.3, 14.4)] .
• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical trials of IMCIVREE did not include patients aged 65 and over. It is not known whether geriatric patients would respond differently than younger adult patients.
• 8.6 Renal Impairment 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 m 2 ).
• 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) ].
• 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 ).

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in the labeling:
• Disturbance in Sexual Arousal [see Warnings and Precautions (5.1)] Depression and Suicidal Ideation [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi [see Warnings and Precautions (5.4)] 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) ] Most common adverse reactions (incidence ≥20% in at least 1 indication) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 1-833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience 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 practice.
• 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.
• 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.
• Bardet-Biedl Syndrome (Adults and Pediatric Patients Aged 6 Years and Older) The safety of IMCIVREE was evaluated in a clinical trial, which included a 14‑week, randomized, double-blind, placebo-controlled period followed by a 52-week open-label treatment period, in 44 patients aged 6 years and older with obesity and a clinical diagnosis of BBS (Trial 2) [see Clinical Studies (14.2)] .
• The trial duration was 66 weeks.
• During the 14-week placebo-controlled period in Trial 2, the most common reported adverse reactions in IMCIVREE-treated patients when compared to placebo-treated patients were hyperpigmentation disorders (67% vs 0%, respectively) and vomiting (11% vs 0%, respectively).
• Adverse reactions were also evaluated during the 52-week active-treatment period, defined as the period from randomization to Week 52 in patients initially randomized to IMCIVREE, and from Week 14 to Week 66 in patients initially randomized to placebo.
• Table 6 summarizes the adverse reactions that occurred in 2 or more IMCIVREE-treated patients in Trial 2 during the 52-week active treatment period.
• POMC, PCSK1, and LEPR Deficiency (Adults and Pediatric Patients Aged 6 Years and Older) The safety of IMCIVREE was evaluated in two 52-week, open-label clinical trials of 27 patients aged 6 years and older with obesity due to POMC, PCSK1, or LEPR deficiency with POMC , PCSK1 , or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (Trial 3 and Trial 4) [see Clinical Studies (14.3)] .
• Table 7 summarizes the adverse reactions that occurred in the open-label trials during the first 52 weeks of treatment in 3 or more patients treated with IMCIVREE.
• POMC, PCSK1, and LEPR Deficiency and BBS (Pediatric Patients Aged 2 to less than 6 Years) The safety of IMCIVREE was evaluated in one 52-week, open-label clinical trial of 12 patients aged 2 to less than 6 years with obesity due to POMC, PCSK1, or LEPR deficiency with POMC , PCSK1 , or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance, or obesity due to BBS (Trial 5) [see Clinical Studies (14.4)] .
• No patients with PCSK1 were enrolled in the trial.
• Table 8 summarizes the adverse reactions that occurred in the open-label trial during 52 weeks of treatment in 3 or more patients treated with IMCIVREE.
• 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 image description image description image description image description
• 6.2 Postmarketing Experience 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

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient and caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Disturbance in Sexual Arousal Inform patients and caregivers 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 and caregivers that IMCIVREE may cause depression or suicidal ideation.
• Advise patients and 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)] .
• Hypersensitivity Reactions Inform patients and caregivers that serious hypersensitivity reactions have been reported with use of IMCIVREE.
• Advise patients and caregivers 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)] .
• Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi Inform patients and caregivers that skin darkening occurs in the majority of patients treated with IMCIVREE because of its mechanism of action.
• This change is reversible upon discontinuation of IMCIVREE.
• Inform patients and caregivers that the development of new melanocytic nevi may occur.
• Inform patients and caregivers that they should have a full body skin examination before starting and during treatment with IMCIVREE to monitor these changes [see Warnings and Precautions (5.4)] .
• 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)] .
• Pregnancy Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)] .
• Lactation Advise patients thattreatment with IMCIVREE is not recommended while breastfeeding [see Use in Specific Populations (8.2)] .
• Administration Instruct patients and caregivers how to prepare and administer the correct dose of IMCIVREE and assess their ability to inject subcutaneously to ensure the proper administration of IMCIVREE.
• Instruct patients to use a 1 mL syringe with a 28- or 29-gauge needle appropriate for subcutaneous injection [see Dosage and Administration (2.5)] .
• Manufactured for:
• Rhythm Pharmaceuticals, Inc. 222 Berkeley Street, Suite 1200 Boston, MA 02116 © 2026, Rhythm Pharmaceuticals, Inc.
• All rights reserved.
• IMCIVREE is a registered trademark of Rhythm Pharmaceuticals, Inc.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 10 mg/mL, clear to slightly opalescent, colorless to slightly yellow solution in a 1 mL multiple-dose vial. Injection:
• 10 mg/mL, clear to slightly opalescent, colorless to slightly yellow solution in a 1 mL multiple-dose vial.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• IMCIVREE injection is supplied as:
• 10 mg/mL, clear to slightly opalescent, colorless to slightly yellow solution in a 1-mL multiple-dose vial Package of 1 multiple-dose vial:
• NDC 72829-010-01 Store unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton.
• After removal from the refrigerator, vials may be kept at temperatures ranging from refrigerated to room temperature (2°C to 25°C [36°F to 77°F]) for up to 30 days with brief excursions up to 30°C (86°F).
• After the vial is punctured (opened), discard after 30 days.
• See Table 19 for a summary of storage conditions for IMCIVREE.
• Store vials in the original carton.
• Table 19 Recommended Storage for IMCIVREE Vials 1 If necessary, IMCIVREE may be stored at room temperature (≤30°C [≤86°F]) and then returned to refrigerated conditions Storage Condition Unopened Vial Opened Vial 2°C to 8°C (36°F to 46°F) Until the expiration date Up to 30 days, OR Until the expiration date (whichever is earlier) 2°C to 25°C (36°F to 77°F) with excursions permitted up to 30°C (86°F) 1 Up to 30 days, OR Until the expiration date (whichever is earlier) Up to 30 days, OR Until the expiration date (whichever is earlier) >30°C (>86°F) Discard and
• do not use Discard and
• do not use

Quoted from the official label, section “How Supplied”.

What is in it

• IMCIVREE contains setmelanotide acetate, a melanocortin 4 (MC4) receptor agonist.
• Setmelanotide is an 8 amino acid cyclic peptide analog of endogenous melanocortin peptide α‑MSH (alpha-melanocyte stimulating hormone).
• The chemical name for setmelanotide acetate is acetyl-L-arginyl-L-cysteinyl-D-alanyl-L-histidinyl-D-phenylalanyl-L-arginyl-L-tryptophanyl-L-cysteinamide cyclic (2→8)-disulfide acetate.
• Its molecular formula is C 49 H 68 N 18 O 9 S 2 (anhydrous, free-base), and molecular mass is
• 1117.3 Daltons (anhydrous, free-base).
• The chemical structure of setmelanotide acetate is:
• IMCIVREE (setmelanotide) injection is a sterile clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use.
• Each 1 mL vial of IMCIVREE contains 10 mg of setmelanotide provided as setmelanotide acetate, which is a salt with 2 to 4 molar equivalents of acetate, and the following inactive ingredients:
• 10 mg benzyl alcohol, 8 mg carboxymethylcellulose sodium (average MWt 90,500), 1 mg edetate disodium dihydrate, 100 mg N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl- glycero-3- phosphoethanolamine sodium salt, 11 mg mannitol, 5 mg phenol, hydrochloric acid, sodium hydroxide and Water for Injection.
• The pH of IMCIVREE is 5 to 6.
• CHEMICAL-STRUCTURES

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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