Imcivree prescribing information covers setmelanotide, a daily medicine for a few specific causes of obesity. These include damage to the hypothalamus, the brain area that helps control hunger, and certain genetic conditions. Its label excludes general obesity.
Which Imcivree prescribing information is current?
As of October 29, 2026, the day this article was written, DailyMed's record prints “Revised: 4/2026,” while the FDA label PDF prints “Revised: 03/2026.” The FDA's March 19, 2026 decision added acquired hypothalamic obesity from age 4. Both documents include that use.
Section 1: who the label covers
An indication is a use listed on the label. Imcivree's indications concern excess weight and long-term weight maintenance in these groups:
| Condition | Labeled minimum age |
|---|---|
| Acquired hypothalamic obesity, following injury or dysfunction in that brain area | 4 years |
| Bardet-Biedl syndrome, an inherited condition affecting several body systems | 2 years |
| POMC, PCSK1 or LEPR deficiency, genetic problems affecting hunger signaling | 2 years |
Section 2.1 describes a clinical diagnosis for Bardet-Biedl syndrome, with genetic confirmation considered below age 6. The deficiency indications require genetic testing. Results may be disease-causing, probably disease-causing, or of uncertain significance, meaning their effect is unclear. The clinician interprets them alongside the person's condition.
Benign or likely benign variants, considered unlikely to cause disease, are excluded. Section 1.1 also excludes “general (polygenic) obesity,” the common form involving many genes and other influences.
General obesity has different treatment labels, including Zepbound's tirzepatide label. Tirzepatide prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy as a compounded medication, which is different from an FDA-approved product such as Zepbound: the formulation offered here is not FDA-approved.
Section 2: doses depend on diagnosis and age
The label describes injection under the skin once daily. Its starting amounts for the first two weeks differ:
| Label group | Starting daily amount |
|---|---|
| Acquired hypothalamic obesity, age 4 and older | 0.5 mg |
| Genetic indications above, age 12 and older | 2 mg |
| Genetic indications above, age 6 to under 12 | 1 mg |
| Genetic indications above, age 2 to under 6 | 0.5 mg |
Later increases depend on side effects. The maintenance amount is 3 mg daily from age 6, with adjustments when needed; younger children's amounts depend on weight. The prescriber sets the actual dose.
Section 2.4 does not recommend Imcivree with kidney failure, or with severely reduced kidney function in acquired hypothalamic obesity. The genetic indications have separate reduced doses. Use is not recommended below age 6 and under 20 kg with severely reduced kidney function.
Sections 4–5: allergy, mood, erections and skin changes
A contraindication is a reason a medicine must not be used. Section 4 lists a previous serious allergy to setmelanotide or another ingredient.
Section 5 describes six warnings:
- Sexual arousal: spontaneous or more frequent erections can occur in males, and the label notes sexual side effects in females too. An erection lasting “longer than 4 hours” requires emergency medical attention under the label.
- Depression and suicidal thoughts: new or worsening symptoms need monitoring; the label describes circumstances for stopping treatment.
- Serious allergy: anaphylaxis, a potentially life-threatening allergic reaction, has been reported. The label calls for prompt medical attention and stopping treatment when a reaction occurs.
- Skin darkening: hyperpigmentation means increased skin color. New moles or darker existing moles can appear. The label calls for a “full body skin examination” before treatment and periodically during it.
- Acute adrenal insufficiency: in the acquired hypothalamic obesity trial, serious reactions linked to a sudden shortage of adrenal hormones occurred in 5% of people on Imcivree and none on placebo; the label calls for monitoring patients who already have secondary adrenal insufficiency, a shortfall that starts in the pituitary.
- Sodium imbalance: in patients with acquired hypothalamic obesity and central diabetes insipidus, a hormone problem affecting water balance, blood sodium fell in 6% on Imcivree versus 2% on placebo and rose in 5% versus 4%. The label calls for checking sodium when fluid intake or hydration changes.
Kanti and colleagues, Skin Pharmacology and Physiology, 2021, documented darker skin and moles during treatment in a small genetic-obesity study. Those findings support the attention to skin examinations.
Section 12.1: the link with PT-141
An MC4 (melanocortin 4) receptor agonist activates a cell switch involved in hunger, fullness and energy use. Setmelanotide has “20-fold less activity” at MC3 and MC1, related switches; MC1 influences pigment production.
Bremelanotide, also called PT-141, acts within this receptor family too. Its branded product, Vyleesi, has its own nausea and flushing rates, plus pigmentation and blood-pressure warnings. The Vyleesi label walkthrough explains those limits. The PT-141 mechanism guide and discovery history cover the wider background.
PT-141 prescribed through Promise is dispensed by a licensed U.S. compounding pharmacy as a compounded medication, which is different from an FDA-approved product such as Vyleesi: the formulation offered here is not FDA-approved.
Section 6: the side-effect table
The highlights list reactions occurring in at least 20% in at least one indication: skin darkening; injection-site reactions; nausea; headache; diarrhea; belly pain; vomiting; depression; and spontaneous erections. That does not mean each occurred that often in every group.
Table 5 concerns acquired hypothalamic obesity: 94 people received Imcivree and 48 received placebo, an inactive comparison treatment. Selected rows are:
| Reaction | Imcivree | Placebo |
|---|---|---|
| Skin darkening and related pigment changes | 58% | 10% |
| Nausea | 55% | 25% |
| Vomiting | 38% | 19% |
| Headache, including migraine | 37% | 31% |
| New or changed moles | 15% | 6% |
About 6 in 10 people on Imcivree had pigment changes, compared with 1 in 10 on placebo. These figures describe that trial's population, rather than another medicine or one person's likely experience.
Section 8: pregnancy, breastfeeding and age
The label calls for stopping when pregnancy is recognized unless benefits outweigh potential risks to the fetus. Human pregnancy data are unavailable. Breastfeeding during treatment is not recommended.
Safety and effectiveness are not established below age 4 for acquired hypothalamic obesity, or below age 2 for the genetic indications. Trials did not include patients aged 65 and older. Kidney function also affects prescribing decisions.
Section 14: the studies behind the label
Clément and colleagues' genetic-obesity trials, Lancet Diabetes & Endocrinology, 2020, studied specific POMC and LEPR deficiencies. Their results do not establish treatment for general obesity.
As of October 29, 2026, the day this article was written, the acquired hypothalamic obesity trial, TRANSCEND, has been published in The New England Journal of Medicine (July 9, 2026). The paper analyzes 120 people: BMI, weight measured relative to height, fell 16.5% on average with setmelanotide and rose 3.3% with placebo after 52 weeks. The label analyzes 142 people and reports a 15.84% fall with Imcivree against a 2.55% rise with placebo, a difference of 18.40 percentage points after 52 weeks at the therapeutic dose. The groups differ, which matters when comparing results.
As of October 29, 2026, the day this article was written, a September 10, 2026 announcement from Rhythm described additional follow-up from 30 children in France. Only five had 18-month measurements reported. That was observational follow-up, without a randomized comparison group, and did not broaden the U.S. indication.
Section 16: the branded vial and storage
Imcivree comes as a 1 mL multiple-dose vial containing 10 mg/mL. Unopened refrigerated vials are stored at 36°F–46°F until expiration. The label permits up to 30 days at 36°F–77°F, with brief excursions to 86°F. Opened vials have a 30-day limit, or expiration if sooner. Temperatures above 86°F require disposal. The original carton protects against light.
Where general weight-management care fits
Section 1.1 leaves general obesity outside Imcivree's indication. Tirzepatide belongs to a different treatment discussion; Imcivree's doses and trial results do not transfer to it. The tirzepatide product page identifies Promise's current offering.
What this label does not say
Imcivree's label covers setmelanotide only. It does not establish doses, storage or outcomes for compounded PT-141 or tirzepatide. FDA explains the separate review status of compounded medicines. A licensed provider may still prescribe — that decision is between you and your doctor.
At Promise, a licensed provider reviews every request, and not everyone qualifies.
