Zepbound 12.5 mg/0.5 mL injection

Zepbound 12.5 mg/0.5 mL injection

 Zepbound® (setmelanotide) is a prescription medication used for the chronic treatment of severe obesity associated with genetic disorders that affect the melanocortin-4 receptor (MC4R) pathway, such as Bardet-Biedl syndrome and Alström syndrome. These conditions result in dysfunctional appetite regulation and energy balance, leading to severe obesity. Zepbound helps manage obesity by targeting and activating the MC4R to improve the body’s ability to regulate hunger and energy expenditure.

The 12.5 mg/0.5 mL injection is a concentrated form of setmelanotide used in patients who require higher dosing to achieve optimal therapeutic effects, following initial treatment or as per a healthcare provider’s recommendation.

How It Works:
Setmelanotide, the active ingredient in Zepbound, is a melanocortin 4 receptor (MC4R) agonist that targets a key pathway involved in the regulation of appetite and energy homeostasis. By activating the MC4R, setmelanotide helps restore the body’s natural mechanisms of hunger control and energy expenditure, addressing the underlying cause of obesity in patients with certain genetic disorders. This mechanism helps patients lose weight and improve their overall metabolic health.

Dosage and Administration:
Each pre-filled injection contains 12.5 mg of setmelanotide in 0.5 mL of solution. The recommended dosage for most patients is a single subcutaneous injection of 12.5 mg once daily. The injection should be administered into the subcutaneous tissue of the abdomen, thigh, or upper arm. For optimal results and to minimize skin irritation, patients should rotate injection sites regularly.

Storage Instructions:
Zepbound should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) before first use. Once in use, the medication may be kept at room temperature (up to 77°F or 25°C) for up to 30 days. Do not freeze and avoid exposing the medication to heat or direct sunlight.

Important Safety Information:
Zepbound should not be used in patients who are hypersensitive to setmelanotide or any of its components. Common side effects include nausea, fatigue, headache, and injection site reactions. As with all MC4R agonists, there may be a risk of skin pigmentation changes. Serious but rare side effects include behavioral changes and the possibility of excessive weight loss if not properly monitored.

Clinical Use:
Zepbound is used exclusively for patients with genetic obesity due to defects in the MC4R pathway, including rare conditions like Bardet-Biedl syndrome and Alström syndrome. It is not indicated for general obesity or weight management in individuals without these specific genetic conditions. Zepbound should be used as part of a comprehensive treatment plan, including lifestyle modifications like diet and physical activity.