Short answer: Imcivree is injected under the skin once daily at the start of the day. For acquired HO it starts at 0.5 mg and rises every 2 weeks to 3 mg. For BBS or POMC, PCSK1 or LEPR deficiency it starts at 2 mg at ages 12 and up, or 1 mg at ages 6 to 11, with a 3 mg maintenance dose. Under age 6, the dose depends on body weight.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Imcivree is approved for: Imcivree is approved to reduce excess body weight and keep it off long term in people 4 and older with acquired hypothalamic obesity (HO), and in people 2 and older with obesity due to Bardet-Biedl syndrome (BBS) or POMC, PCSK1 or LEPR deficiency confirmed by genetic testing (section 1). The label says it is not expected to work for general obesity or other types of obesity (section 1.1).
Source
IMCIVREE (setmelanotide) injection, for subcutaneous use, prescribing information and Patient Information. Rhythm Pharmaceuticals. DailyMed, version published April 2, 2026. DailyMed setid 70c3ccf7-4df0-4c75-ba07-fede9970c8d9
Imcivree is injected under the skin once daily at the beginning of the day, without regard to meals, in the abdomen, thigh or arm, using a different site each day. It is not injected into a vein or muscle (section 2.5).
It comes as a 10 mg/mL solution in a 1 mL multiple-dose vial and is drawn up with a 1 mL syringe and a 28- or 29-gauge needle. The vial is taken out of the refrigerator about 15 minutes before use, or rolled gently between the palms for 60 seconds (sections 2.5, 3).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Week | Daily dose | Volume to be injected |
|---|---|---|
| Weeks 1-2 | 0.5 mg once daily | 0.05 ml once daily |
| Weeks 3-4 | 1 mg once daily | 0.1 ml once daily |
| Weeks 5-6 | 2 mg once daily | 0.2 ml once daily |
| Weeks 7 and onward | 3 mg once daily | 0.3 ml once daily |
If the starting dose is not tolerated, Imcivree is stopped; if it is tolerated for 2 weeks, the dose goes up as shown.
| Age | Starting dose (2 weeks) | If the start is not tolerated | If tolerated for 2 weeks | Maintenance |
|---|---|---|---|---|
| 12 years and older | 2 mg (0.2 mL) once daily | Reduce to 1 mg; if 1 mg is tolerated for at least 1 week, go to 2 mg | Increase to 3 mg (0.3 mL); if 3 mg is not tolerated, go back to 2 mg | 3 mg (0.3 mL) once daily |
| 6 to less than 12 years | 1 mg (0.1 mL) once daily | Reduce to 0.5 mg; if 0.5 mg is tolerated for at least 1 week, go to 1 mg | Increase to 2 mg (0.2 mL); if 2 mg is tolerated, go to 3 mg; if not, go back to 1 mg | 3 mg (0.3 mL) once daily |
| Patient weight / treatment week | Daily Dose | Volume to be Injected |
|---|---|---|
| 15 kg to less than 20 kg: Week 1 and onward | 0.5 mg once daily | 0.05 mL once daily |
| 20 kg to less than 30 kg: Weeks 1-2 | 0.5 mg once daily | 0.05 mL once daily |
| 20 kg to less than 30 kg: Weeks 3 and onward | 1 mg once daily | 0.1 mL once daily |
| 30 kg to less than 40 kg: Weeks 1-2 | 0.5 mg once daily | 0.05 mL once daily |
| 30 kg to less than 40 kg: Weeks 3-4 | 1 mg once daily | 0.1 mL once daily |
| 30 kg to less than 40 kg: Weeks 5 and onward | 1.5 mg once daily | 0.15 mL once daily |
| Greater than or equal to 40 kg: Weeks 1-2 | 0.5 mg once daily | 0.05 mL once daily |
| Greater than or equal to 40 kg: Weeks 3-4 | 1 mg once daily | 0.1 mL once daily |
| Greater than or equal to 40 kg: Weeks 5-6 | 1.5 mg once daily | 0.15 mL once daily |
| Greater than or equal to 40 kg: Weeks 7 and onward | 2 mg once daily | 0.2 mL once daily |
Table 2 gives the same weight-based steps for children aged 4 to less than 6 with acquired HO. If the 0.5 mg starting dose is not tolerated, Imcivree is stopped.
Imcivree is used in people with acquired HO, a clinical diagnosis of BBS, or genetically determined or suspected POMC, PCSK1 or LEPR deficiency. The label notes there is no FDA-approved test for these gene variants.
Stomach and gut side effects are watched for while starting and raising the dose.
With severe kidney impairment (eGFR 15 to 29): not recommended for acquired HO; for BBS or POMC/PCSK1/LEPR deficiency at ages 12 and up, start at 0.5 mg and go up to a 1.5 mg maintenance dose; at ages 6 to 11, start at 0.5 mg with a 1 mg maintenance dose.
Imcivree is not recommended in end-stage kidney disease (eGFR under 15), or in children 2 to under 6 who weigh under 20 kg and have severe kidney impairment. Mild or moderate kidney impairment needs no change.
A full-body skin exam is done before starting and periodically during treatment.
If a dose is missed, the once-daily schedule resumes with the next scheduled dose. The Patient Information says to inject the next dose at the regular time the next day.
More on this: missed a dose of Imcivree.
In Dose Track you set up Imcivree as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.