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Getting your patient started on IMCIVREE

Prescribing IMCIVREE for your patients

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1. Download the IMCIVREE Prescription Start Form (preferred method)

Use the Start Form to initiate the prescription and help connect your patient with Rhythm InTune.

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2. Complete all fields in the Start Form

Select the appropriate indication and choose the titration and maintenance dose by age and, for ages 2 to <6, by weight.

To enroll in Rhythm InTune, your patient should complete and sign pages 2 and 3.

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3. Sign and submit the Start Form

Fax the completed form to 1-877-805-0130 or email patientsupport@rhythmtx.com.

Download Start Form

To help avoid unnecessary delays during the insurance approval process:

  • Use the IMCIVREE Prescription Start Form
  • Complete all fields in the form
  • Ensure the appropriate indication and dosage are selected

If e-prescribing, please be sure to:

  • Select PANTHERx Rare Pharmacy in the US, or Special Care Pharmacy Services in Puerto Rico
  • Consider also submitting the Prescription Start Form, which includes the Rhythm InTune patient consent form and additional information fields often required for insurance approval, as these are not typically included when e-prescribing
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Personalized patient support

Helping patients stay on track along their IMCIVREE journey:

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Patient Access

Financial Assistance: The majority of patients, regardless of coverage type, have obtained approval for IMCIVREE. Financial assistance programs are available for eligible patients.
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Starting Treatment

Injection Training and Treatment Education: Patients and caregivers may choose to receive injection training through on-demand videos, live virtual training, or in-person instruction, as well as education on what to expect in the first 90 days.
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Ongoing Treatment

Adherence, Wellness, and Community: Rhythm InTune Patient Education Managers* help patients and their caregivers with ongoing wellness tips, disease education, and help connecting with others living with BBS.

Patients can enroll in Rhythm InTune by completing the consent section of the IMCIVREE Prescription Start Form or can learn more by visiting RhythmInTune.com.

*Patient Education Managers are employees of Rhythm Pharmaceuticals and do not provide medical care or advice. We encourage your patients to always speak to their healthcare providers regarding their medical care.

Learn more about Patient Education Managers

See how they can help your patient along their IMCIVREE journey.

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Questions?

For more information about Rhythm InTune, contact us at 1-855-206-0815 (M-F, 8am-6pm ET) or by emailing patientsupport@rhythmtx.com

Preparing your patients for IMCIVREE treatment1

Once-daily icon

Once-daily administration of IMCIVREE can help reduce BMI

Subcutaneous injection, administered:

  • At the beginning of the day
  • With or without food
  • In the abdomen, thigh, or arm, rotating injection sites daily

IMCIVREE can be self-administered or given by a caregiver. Refrigerated storage is recommended, with room temperature storage permitted for up to 30 days.

Glass vial and packaging for IMCIVREE

Reestablishing MC4R pathway function through continuous treatment with IMCIVREE is foundational for effective long-term treatment of obesity due to BBS.

Follow the titration schedule to reach a maintenance dose to optimize efficacy and tolerability1

Young Children (2 to <6 years of age)
Baseline body weightWeeks 1-2 (Starting Dose)Weeks 3-4Weeks 5-6Week 7 and onward
15 to <20 kg (33-44 lbs)0.5 mg once daily (recommended maintenance dose)
20 to <30 kg (44-66 lbs)0.5 mg once daily1.0 mg once daily (recommended maintenance dose)
30 to <40 kg (66-88 lbs)0.5 mg once daily1.0 mg once daily1.5 mg once daily (recommended maintenance dose)
≥40 kg (≥88 lbs)0.5 mg once daily1.0 mg once daily1.5 mg once daily2.0 mg once daily (recommended maintenance dose)

Uptitration:

Increase dose by 0.5 mg every 1-2 weeks until recommended maintenance dose by body weight.

If the starting dose is:

  • Not tolerated, discontinue
  • Tolerated for the initial 2 weeks, increase dosage based on baseline body weight, as shown above

When the child reaches age 6, the maintenance dose increases to 3.0 mg regardless of weight.

Children (6 to <12 years of age)
Starting Dose (Weeks 1-2)Uptitration dose (Typically weeks 3-4)Recommended maintenance dose
(Typically weeks 5 and onward)
1.0 mg once daily2.0 mg once daily3.0 mg once daily

If the starting
dose is:

  • Not tolerated, reduce to 0.5 mg once daily; if 0.5 mg is tolerated for at least one week, increase to 1 mg once daily
  • Tolerated for 2 weeks, increase to 2 mg once daily; if 2 mg dose is not tolerated, reduce to 1 mg once daily; if 2 mg once daily is tolerated, increase to 3 mg once daily
Adults and children (≥12 years of age)
Starting Dose (Weeks 1-2)Recommended maintenance dose
(Weeks 3 and onward)
2.0 mg once daily3.0 mg once daily

If the starting
dose is:

  • Not tolerated, reduce to 1 mg once daily; if 1 mg is tolerated for at least one week increase to 2 mg once daily
  • Tolerated for 2 weeks, increase to 3 mg once daily; if 3 mg is not tolerated, reduce to 2 mg once daily

  • No dose adjustments are needed for patients with mild to moderate renal impairment
  • Not recommended for use in patients with end-stage renal disease

Effective, long-term weight management starts with setting patient expectations

In clinical trials, it took some time for hunger and weight reductions to be noted, while patients experienced certain AEs soon after starting treatment. This chart highlights some of the most common AEs, but it does not include all reported AEs.

Timing of common effects seen in clinical trials1-6

Timeline of clinical effects including onset of weight loss, hunger reduction, and common side effects

Weight reduction

Meaningful weight reduction began within 6-8 weeks and continued over time.1-4

Hunger reduction

Hunger reduction began within weeks. Measures of hunger increased quickly upon dose reduction or discontinuation of IMCIVREE.1,2,3,5

Nausea and vomiting

Nausea and vomiting were primarily reported within the first 4 weeks of treatment and typically resolved within a few days; nearly all events were mild and none were serious.3,6

Hyperpigmentation

Hyperpigmentation typically occurred within 2-3 weeks and increased throughout the dose titration period; levels generally plateaued in the initial months of treatment and were sustained over long-term treatment with IMCIVREE.3,6

Achieving the benefits of treatment with IMCIVREE may take time. Talking to patients about when they can expect weight and hunger benefits and common adverse reactions may help them manage through the short-term treatment initiation to achieve their longer-term goals.

Learn more about patient resources for treatment initiation, including injection training.

Find Resources

kg=kilogram, lbs=pounds, LEPR=leptin receptor, MC4R=melanocortin-4 receptor, mg=milligram, PCSK1=proprotein convertase subtilisin/kexin type 1, POMC=proopiomelanocortin

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to BBS or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, and spontaneous penile erection

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.

References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc., 2026. 2. Argente J, Verge CF, Okorie U, et al. Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial. Lancet Diabetes Endocrinol. 2025;13(1):29-37. doi:10.1016/S2213-8587(24)00273-0 3. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7 4. Argente J, et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022. 5. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext 6. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.

Indication and Important Safety Information

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to BBS or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, and spontaneous penile erection

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.

References:1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc., 2026.2. Argente J, Verge CF, Okorie U, et al. Setmelanotide in patients aged 2-5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial. Lancet Diabetes Endocrinol. 2025;13(1):29-37. doi:10.1016/S2213-8587(24)00273-03. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-74. Argente J, et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022.5. Haqq AM, Chung WK, Dollfus H, et al. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext6. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.
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