Setmelanotide — Membership Pricing

Other medications in Weight Management

• Cellulose/Citric Acid Hydrogel
• Naltrexone/Bupropion ER
• Phentermine/Topiramate ER

About Setmelanotide

Setmelanotide (brand name Imcivree) represents a significant advancement for individuals living with specific genetic forms of obesity. This highly specialized medication targets underlying causes of severe hunger. Understanding this innovative treatment and its potential costs is crucial. At TheDrugClub, we are dedicated to helping our members navigate complex prescription pricing and discover potential savings.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Setmelanotide is approved for (FDA label)

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and older with syndromic or monogenic obesity due to: o Bardet-Biedl syndrome (BBS) o Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Source: Read the full FDA label on DailyMed. Label effective date: April 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Setmelanotide (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. SPL document ID: 4e69249c-b81d-8559-e063-6294a90adbc2. Label effective date: April 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Setmelanotide (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. SPL document ID: 4e69249c-b81d-8559-e063-6294a90adbc2. Label effective date: April 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Setmelanotide (FDA label)

IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. SPL document ID: 4e69249c-b81d-8559-e063-6294a90adbc2. Label effective date: April 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Setmelanotide (FDA label)

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females 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. ( 5.1 ) 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. ( 5.2 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE. ( 5.3 ). Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi: Generalized increased skin pigmentation, darkening of pre-existing nevi, and development of new nevi have occurred.

Source: FDA prescribing information (DailyMed). Set ID: 70c3ccf7-4df0-4c75-ba07-fede9970c8d9. SPL document ID: 4e69249c-b81d-8559-e063-6294a90adbc2. Label effective date: April 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.