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 4 receptor (MC4R) agonist presented as a 1 mg/mL injection solution (prefilled pen) for subcutaneous use. It treats obesity linked to specific genetic deficiencies, including POMC, LEPR, PCSK1, Bardet‑Biedl and Alström syndromes, in patients with confirmed diagnoses.

GNH India supplies Imcivree as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Rhythm Pharmaceuticals Netherlands B.V.

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Indications & Clinical Uses

Imcivree (setmelanotide) is indicated for rare genetic forms of obesity that involve the melanocortin‑4 receptor pathway.

  • Obesity due to proopiomelanocortin (POMC) deficiency: reduces appetite and supports weight management in patients with confirmed POMC deficiency.
  • Obesity due to leptin receptor (LEPR) deficiency: improves weight outcomes in individuals with genetically confirmed LEPR deficiency.
  • Obesity due to proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency: aids weight control in patients with PCSK1 deficiency.
  • Obesity associated with Bardet‑Biedl syndrome: helps achieve weight reduction in patients with this ciliopathy‑related obesity.
  • Obesity associated with Alström syndrome: contributes to weight management in patients with Alström syndrome.

How It Works

  • Setmelanotide selectively activates the melanocortin‑4 receptor (MC4R) located in the hypothalamus. Activation mimics the action of endogenous α‑melanocyte‑stimulating hormone, suppressing hunger signals and enhancing energy expenditure, thereby correcting the signaling deficit that underlies certain monogenic forms of obesity.

Side Effects

Common Side Effects

  • Injection‑site pain or erythema.
  • Nausea or vomiting.
  • Diarrhea or abdominal discomfort.
  • Headache.
  • Fatigue.
  • Hyperpigmentation of the skin.

Serious or Rare Side Effects

  • Severe hypersensitivity reactions, including anaphylaxis.
  • Persistent severe hyperpigmentation.
  • Significant cardiovascular events such as hypertension.
  • Acute pancreatitis.
  • Severe injection‑site infection requiring medical attention.

Precautions & Warnings

Imcivree requires careful monitoring due to its targeted mechanism and injectable form.

  • Pregnancy: safety unknown; avoid unless potential benefit justifies the risk.
  • Breastfeeding: unknown; consider discontinuation if infant exposure is a concern.
  • Renal impairment: monitor renal function and adjust therapy as needed.
  • Hypersensitivity: discontinue immediately if signs of an allergic reaction appear.
  • Monitoring: regularly assess weight, metabolic parameters, and skin pigmentation changes.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Setmelanotide may interact with other agents that influence appetite or the melanocortin pathway.

Major Interactions (Avoid)

  • Concomitant use of other MC4R agonists: risk of additive pharmacologic effects.
  • Live vaccines: potential alteration of immune response.

Moderate Interactions (Monitor Closely)

  • Hormonal therapies affecting appetite (e.g., glucocorticoids): monitor weight changes.
  • Strong CYP450 inhibitors or inducers: observe for any unexpected pharmacodynamic changes, although metabolism is minimal.
  • Immunosuppressants: watch for altered infection risk.

Frequently Asked Questions

Imcivree is prescribed for patients with obesity caused by specific genetic defects such as POMC, LEPR, PCSK1 deficiencies, as well as Bardet‑Biedl and Alström syndromes. It targets the underlying pathway that drives excessive appetite in these rare conditions.

Setmelanotide is a selective agonist of the melanocortin‑4 receptor (MC4R) in the brain. By activating MC4R, it mimics natural hormone signals that reduce hunger and increase energy expenditure, addressing the signaling gap present in certain monogenic obesity disorders.

The specific dose and titration schedule are determined by the prescribing clinician based on the patient’s genetic diagnosis, weight, and response. Imcivree is supplied as a 1 mg/mL prefilled pen for subcutaneous injection.

Safety data for setmelanotide in pregnancy and lactation are limited. The product is classified as having an unknown pregnancy category, so it should only be used if the potential benefit justifies any possible risk to the fetus or infant.

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

Imcivree is distinct because it directly targets the MC4R pathway, whereas most other anti‑obesity agents act on appetite centers indirectly or through metabolic enzymes. Its use is limited to rare genetic forms of obesity, while broader‑acting drugs address common obesity but lack the pathway specificity of setmelanotide.

Imcivree must be stored refrigerated at 2‑8 °C. Keep the prefilled pen in its original packaging, protect it from light, and never freeze or shake the product to maintain stability.

Imcivree is given as a subcutaneous injection using the prefilled pen. The injection site is typically the abdomen or thigh, and the pen is designed for single‑use dosing as instructed by the healthcare professional.

Serious risks include severe hypersensitivity reactions (including anaphylaxis), persistent hyperpigmentation, significant cardiovascular events such as hypertension, and rare cases of pancreatitis. Patients should be monitored closely for any of these events and seek immediate medical attention if they occur.

Imcivree is contraindicated in individuals with known hypersensitivity to setmelanotide or any excipients in the formulation. It should also be avoided in patients where the genetic cause of obesity is not confirmed, as the drug’s efficacy relies on specific MC4R pathway defects.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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