Product image of Imcivree (Setmelanotide) supplied by GNH India

Imcivree

Active Ingredient:
Setmelanotide
Origin:
EU

Imcivree (Setmelanotide)

Setmelanotide, the active ingredient in Imcivree, is a melanocortin receptor agonist presented as a 1 mg/mL subcutaneous injection solution for subcutaneous use. It treats obesity associated with rare genetic deficiencies, including POMC, PCSK1, LEPR, Bardet‑Biedl and Alström syndromes.

GNH India supplies Imcivree as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to global quality standards and provides cold‑chain logistics for biologic products, ensuring product integrity from manufacturing to end‑user. GNH India also offers regulatory support and documentation to facilitate import clearance across multiple regions.

Manufacturer / TM Owner

Rhythm Pharmaceuticals Netherlands B.V.

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Indications & Clinical Uses

  • Imcivree is indicated for obesity linked to specific genetic pathways that affect appetite regulation.
  • Obesity due to POMC deficiency: reduces appetite and supports weight loss in patients with confirmed POMC deficiency.
  • Obesity due to PCSK1 deficiency: improves energy balance and promotes weight reduction in individuals with PCSK1‑related obesity.
  • Obesity due to LEPR deficiency: lowers hunger signals and aids weight management in patients lacking functional leptin receptors.
  • Obesity associated with Bardet‑Biedl syndrome: helps achieve clinically meaningful weight loss in this rare genetic disorder.
  • Obesity associated with Alström syndrome: contributes to reduced body weight in patients with Alström‑related obesity.

How It Works

  • Setmelanotide selectively binds to and activates the melanocortin‑4 receptor (MC4R) in the hypothalamus, a key regulator of energy homeostasis. MC4R activation decreases appetite and increases energy expenditure, thereby addressing the underlying pathophysiology of obesity caused by genetic defects that impair this signaling pathway.

Side Effects

Common Side Effects

  • Injection site erythema or pain
  • Nausea or vomiting
  • Headache
  • Constipation or abdominal discomfort
  • Hyperpigmentation of skin or mucous membranes
  • Fatigue or dry mouth

Serious or Rare Side Effects

  • Severe hyperpigmentation extending beyond injection site
  • Hypersensitivity reactions, including anaphylaxis
  • Cardiovascular events such as elevated blood pressure or tachycardia
  • Psychiatric symptoms, including suicidal ideation or mood changes

Precautions & Warnings

  • Imcivree requires careful monitoring in several clinical situations.
  • Pregnancy: safety not established; use only if potential benefit justifies the risk.
  • Breastfeeding: unknown effects; consider discontinuation.
  • Renal impairment: monitor renal function as clearance may be reduced.
  • Cardiovascular disease: observe blood pressure and heart rate during therapy.
  • Hypersensitivity: discontinue immediately if severe allergic reaction occurs.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Setmelanotide has a limited interaction profile, but caution is advised with certain co‑medications.

Major Interactions (Avoid)

  • Concurrent use of other MC4R agonists: may produce additive pharmacodynamic effects.
  • Strong CYP450 inhibitors (theoretical): could increase systemic exposure, although metabolism is minimal.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: blood pressure changes may require dose adjustment.
  • Drugs affecting glucose metabolism: monitor glycemic control as weight loss can alter insulin sensitivity.
  • Other injectable biologics: may increase risk of injection‑site reactions.

Frequently Asked Questions

Imcivree is a prescription medication indicated for the treatment of obesity in patients who have a confirmed genetic deficiency such as POMC, PCSK1, LEPR, Bardet‑Biedl syndrome, or Alström syndrome. It targets the underlying pathway that regulates appetite and energy expenditure in these rare conditions.

Setmelanotide is a selective agonist of the melanocortin‑4 receptor (MC4R) located in the hypothalamus. By activating MC4R, it reduces hunger signals and increases energy expenditure, thereby correcting the disrupted signaling that leads to severe obesity in patients with specific genetic mutations.

The dosing regimen for Imcivree is individualized. A qualified prescriber determines the starting dose, titration steps, and maintenance dose based on the patient’s genetic diagnosis, body weight, and clinical response. No fixed schedule is provided in public materials.

Safety data for setmelanotide in pregnancy and lactation are limited. The product is classified as having an unknown pregnancy category, and breastfeeding is not recommended unless the potential benefit outweighs the possible risk. Decisions should be made by the treating physician.

To request Imcivree, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, cold‑chain shipping details and necessary import documentation.

Unlike non‑specific appetite suppressants, Imcivree targets the MC4R pathway and is approved only for rare genetic forms of obesity. Conventional anti‑obesity agents act broadly on central or peripheral mechanisms and are not indicated for these specific genetic deficiencies.

Imcivree must be stored refrigerated at 2‑8 °C. Keep the prefilled pen in its original packaging, protect it from light, and avoid freezing or shaking. Follow the label instructions for any temperature excursions and discard after the recommended in‑use period.

Imcivree is supplied as a prefilled pen containing a 1 mg/mL solution for subcutaneous injection. The patient or caregiver injects the prescribed volume into the abdomen, thigh or upper arm, rotating sites as instructed by the healthcare professional.

Serious adverse events include severe hyperpigmentation, hypersensitivity reactions such as anaphylaxis, cardiovascular effects like elevated blood pressure, and psychiatric symptoms including suicidal ideation. Patients should be monitored regularly for these conditions, and therapy should be stopped if they occur.

Imcivree is contraindicated in individuals with known hypersensitivity to setmelanotide or any excipients, and in patients without a confirmed genetic diagnosis of the indicated deficiencies. Caution is also advised for pregnant or breastfeeding women due to insufficient safety data.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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