Setmelanotide Injection
Setmelanotide Injection is a once-daily injection under the skin that helps reduce excess body weight and keep it off in people with acquired hypothalamic obesity, Bardet-Biedl syndrome, or obesity from POMC, PCSK1, or LEPR deficiency.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Patient information guide — a plain-language walkthrough of Setmelanotide Injection, written from its FDA label.
What Setmelanotide Injection is used for
▾
Setmelanotide Injection is used to reduce excess body weight and keep it off long term in certain rare forms of obesity. The brand Imcivree is approved for:
- Acquired hypothalamic obesity in adults and children aged 4 years and older.
- Bardet-Biedl syndrome in adults and children aged 2 years and older.
- Obesity due to POMC, PCSK1, or LEPR deficiency, confirmed by genetic testing, in adults and children aged 2 years and older.
It is not indicated for general obesity, obesity from other genetic syndromes, or POMC, PCSK1, or LEPR variants classified as benign or likely benign.
How Setmelanotide Injection works
▾
Setmelanotide activates MC4 receptors in the brain. These receptors help regulate hunger, feeling full, and energy use. In people with obesity tied to this pathway not being activated enough, it may restore the signal. That leads to eating less and burning more energy.
It also activates MC1 receptors to a lesser degree, which is why skin darkening can happen.
Setmelanotide Injection dosage
▾
Imcivree is injected under the skin once a day. You start with a lower dose for 2 weeks, and your prescriber adjusts it from there.
- The dose depends on your age and diagnosis.
- In younger children, the maintenance dose depends on body weight.
- Kidney problems can change the dose.
Follow your prescriber and the product label for exact amounts.
Dosing details from the FDA-approved label
From the Setmelanotide Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and pediatric patients aged 4 years and older with acquired HO (starting dosage)
- 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks
- Adults and pediatric patients aged 12 years and older with BBS or POMC, PCSK1, or LEPR deficiency (starting dosage)
- 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks
- Pediatric patients aged 6 to less than 12 years with BBS or POMC, PCSK1, or LEPR deficiency (starting dosage)
- 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks
- Pediatric patients aged 2 to less than 6 years with BBS or POMC, PCSK1, or LEPR deficiency (starting dosage)
- 0.5 mg (0.05 mL) injected subcutaneously once daily for 2 weeks
- Adults and pediatric patients aged 6 years and older, all indications (maintenance dosage)
- 3 mg (0.3 mL) injected subcutaneously once daily
- Pediatric patients with acquired HO aged 4 years to less than 6 years, and pediatric patients with BBS or POMC, PCSK1, or LEPR deficiency aged 2 to less than 6 years (maintenance dosage)
- Determined by body weight
- Weight-based maintenance dose
- Patients with renal impairment
- See Full Prescribing Information
- Dosage adjustment for renal impairment is in the Full Prescribing Information
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Setmelanotide Injection side effects
▾
Common side effects
- Skin darkening (hyperpigmentation)
- Injection site reactions
- Nausea
- Headache
- Diarrhea
- Abdominal pain
- Vomiting
- Depression
When to get medical help
- Seek emergency care right away for an erection lasting longer than 4 hours.
- Call your doctor right away if you have new or worsening depression, unusual mood or behavior changes, or thoughts of suicide.
- Get medical help right away for signs of a serious allergic reaction, such as anaphylaxis. Stop the medicine. These reactions usually happen within minutes to hours after an injection.
- Tell your doctor about new or changing dark spots or moles on your skin.
- If you have acquired hypothalamic obesity and adrenal insufficiency, report signs of acute adrenal insufficiency.
- If you have acquired hypothalamic obesity and central diabetes insipidus, your sodium levels need monitoring for low or high sodium.
The most common side effects are:
- Skin darkening
- Injection site reactions
- Nausea
- Headache
- Diarrhea
- Abdominal pain
- Vomiting
- Depression
- Spontaneous penile erections
Get help right away for a serious allergic reaction, an erection lasting longer than 4 hours, or thoughts of suicide.
Setmelanotide Injection warnings and precautions
▾
- Depression and suicidal thoughts have occurred. Report mood changes right away.
- Serious allergic reactions, including anaphylaxis, can happen within minutes to hours of an injection.
- Sexual side effects include spontaneous erections in males and sexual side effects in females.
- Skin changes: darker skin, darker moles, and new moles. Get skin exams before and during treatment.
- Acquired hypothalamic obesity: watch for acute adrenal insufficiency, and for sodium imbalance if you also have diabetes insipidus.
Setmelanotide Injection interactions
▾
The label highlights one situation to be careful with.
- Diabetes insipidus (AVP deficiency) medicines: if you have acquired hypothalamic obesity and this condition, your doctor may need to adjust those medicines and check sodium levels.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Setmelanotide Injection
▾
- Do not use if you have had a serious allergic reaction to setmelanotide or its ingredients.
- Tell your doctor about any history of depression or suicidal thoughts.
- Pregnancy: stop when pregnancy is recognized unless benefits outweigh risks to the baby.
- Breastfeeding is not recommended.
- Not established in children younger than 4 with acquired hypothalamic obesity, or younger than 2 with Bardet-Biedl syndrome or POMC, PCSK1, or LEPR deficiency.
- People 65 and older were not studied.
- Severe kidney impairment needs a lower dose or is not recommended, depending on the condition. End stage renal disease is not recommended.
Setmelanotide Injection overdose
▾
If you take too much Imcivree, call Poison Help at 1-800-222-1222 or contact a medical toxicologist. Treatment is supportive and based on your symptoms.
What Setmelanotide Injection does in the body
▾
At 2.3 times the maximum recommended dose, Imcivree did not prolong the QT interval (a heart rhythm measure) to any clinically relevant extent. In 12 otherwise healthy people with obesity, short-term use increased resting energy expenditure and shifted the body toward burning fat. It is not approved for those patients.
How your body processes Setmelanotide Injection
▾
After an injection under the skin, blood levels peak at about 8 hours. Steady levels are reached within about 2 days of daily dosing. The half-life is about 11 hours. The body is expected to break it down into small peptides, and about 39% leaves unchanged in urine. Severe kidney impairment raises drug exposure.
How to store Setmelanotide Injection
▾
Store unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. refrigerator, vials may be kept at temperatures ranging from refrigerated to room temperature (2°C to 25°C ) for up to 30 days with brief excursions up to 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Setmelanotide Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Setmelanotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Imcivree for?
▾
How do I take it?
▾
What side effects should I expect?
▾
When should I call my doctor or get emergency help?
▾
Can I use it during pregnancy or while breastfeeding?
▾
Why do I need skin checks?
▾
Is Setmelanotide Injection available over the counter?
▾
When was Setmelanotide Injection first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Setmelanotide Injection on HelloPharmacist
Setmelanotide Injection forms and strengths (how it comes)
Setmelanotide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Imcivree is used to reduce excess body weight and maintain weight reduction in acquired hypothalamic obesity (age 4 and older).
- Imcivree is used for obesity due to Bardet-Biedl syndrome (age 2 and older).
- Imcivree is used for obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing (age 2 and older).
- Imcivree is injected under the skin once daily.
- Imcivree dosing depends on age, diagnosis, and in some young children, body weight.
- Imcivree dosing is reduced or not recommended with severe kidney impairment.
Setmelanotide Injection on the U.S. market: products, makers and brands
How Setmelanotide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Setmelanotide Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2020. Brand names on the directory include Imcivree; the rest are generics.
How widely Setmelanotide Injection is used (Medicaid data)
A general measure of how commonly Setmelanotide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Setmelanotide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Setmelanotide Injection prescribed? Of the 1,600 medications we measure, Setmelanotide Injection ranks #1,172 by Medicaid prescriptions — more than 27% of them.
Utilization by Setmelanotide Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
setmelanotide 10 MG/ML Injectable Solution
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2469346
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Setmelanotide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Setmelanotide Injection NDCs with Medicaid activity.
Compare Setmelanotide Injection products
A representative set of FDA-listed product records for Setmelanotide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/mL | Subcutaneous | Rhythm Pharmaceuticals, Inc × 3 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Setmelanotide Injection NDCs →
Setmelanotide Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Setmelanotide Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Setmelanotide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Setmelanotide Injection FDA approval history
How Setmelanotide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Setmelanotide Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2469247 1 dose form · 1 strength
-
Dose form (SCDF) Injectable Solution RxCUI 2469345In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 2469346
Look up RxCUI 2469247 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Setmelanotide Injection supply and shortage status
Whether Setmelanotide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Setmelanotide Injection brand names
Setmelanotide Injection is sold under one brand name in the FDA directory — Imcivree. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Setmelanotide Injection: manufacturers and labelers
One company lists Setmelanotide Injection products with the FDA. By number of product records, the largest are Rhythm Pharmaceuticals, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Setmelanotide Injection drug class (RxNorm)
Setmelanotide Injection belongs to the Melanocortin 4 Receptor Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Setmelanotide Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Rhythm Pharmaceuticals, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →