Zepbound 10 mg/0.5 mL injection

Zepbound 10 mg/0.5 mL injection

 Zepbound® (setmelanotide) is a prescription medication used for the treatment of genetic disorders of obesity caused by mutations in the melanocortin 4 receptor (MC4R) pathway. It is indicated for the chronic treatment of severe obesity in patients aged 6 years and older with certain rare genetic disorders, such as Bardet-Biedl syndrome, Alström syndrome, and other related conditions that affect the MC4R pathway, leading to impaired energy balance regulation. Zepbound is designed to address the root causes of obesity by acting on the melanocortin-4 receptor to regulate appetite and energy balance.

The 10 mg/0.5 mL injection is the dosing concentration for subcutaneous injection, formulated for easy and effective delivery, typically given once daily.

How It Works:
Setmelanotide, the active ingredient in Zepbound, is a melanocortin 4 receptor (MC4R) agonist. MC4R is involved in the regulation of appetite and energy homeostasis. In individuals with MC4R pathway defects, such as those seen in Bardet-Biedl syndrome and Alström syndrome, the body cannot effectively regulate hunger and energy expenditure. Setmelanotide works by binding to and activating the MC4R, helping to restore appetite regulation and improve energy balance, leading to weight reduction in patients with these rare genetic disorders.

Dosage and Administration:
Each pre-filled injection contains 10 mg of setmelanotide in 0.5 mL of solution. The typical recommended dosage is one subcutaneous injection of 10 mg once a day. Injections should be administered into the subcutaneous tissue of the abdomen, thigh, or upper arm. For optimal results, patients should be instructed to rotate injection sites to avoid irritation.

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. Avoid freezing and do not expose the medication to direct sunlight or heat.

Important Safety Information:
Zepbound should not be used in patients who are hypersensitive to setmelanotide or any other component of the formulation. Common side effects include nausea, headache, injection site reactions, and fatigue. Serious adverse events are rare but may include skin pigmentation changes and behavioral changes due to MC4R activation. Regular monitoring of patients is recommended to assess for any potential adverse reactions.

Clinical Use:
Zepbound is used in patients with rare genetic conditions leading to obesity due to defects in the melanocortin-4 receptor pathway. It is not intended for use in general obesity management and should only be prescribed after confirming an underlying genetic mutation that affects the MC4R pathway. Long-term treatment may be required, and the medication should be used as part of a comprehensive care plan, which includes lifestyle interventions such as diet and exercise.