Is Setmelanotide approved by the FDA?
Setmelanotide received FDA approval on November 25, 2020. The approval was granted for the treatment of obesity caused by rare genetic disorders, including pro-opiomelanocortin (POMC) deficiency, proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency.
Setmelanotide, marketed under the brand name Imcivree, is a medication used to aid weight loss and control hunger in individuals with certain genetic conditions. It is specifically approved for use in patients aged 6 years and older.
Uses and Administration
Setmelanotide is indicated for weight management in individuals with genetic deficiencies that affect their body’s ability to regulate hunger and satiety. Before prescribing setmelanotide, doctors perform genetic tests to ensure the medication is appropriate for the patient.
The medication is administered as a subcutaneous injection once a day, typically in the morning. Patients can use setmelanotide with or without food. It is crucial to follow the prescription instructions and to prepare the injection only when ready to use.
Side Effects
Common Side Effects:
- Bruising, swelling, warmth, redness, oozing, or bleeding at the injection site
- Skin darkening
- Headache
- Erection without any sexual activity in males
- Nausea, vomiting, diarrhea, or stomach pain
Serious Side Effects:
- Allergic reactions: hives, difficulty breathing, swelling of the face, lips, tongue, or throat
- Suicidal thoughts or mood changes
- Prolonged erections in males
Patients should report any severe side effects to their doctor immediately. Routine skin exams are recommended before and during treatment with setmelanotide to monitor for any skin changes or discoloration.
Warnings and Precautions
- Allergic Reactions: Do not use setmelanotide if allergic to any of its components.
- Mental Health: Monitor for signs of depression or suicidal thoughts and report them to the doctor.
- Pregnancy and Breastfeeding: Weight loss during pregnancy can harm the unborn baby. Setmelanotide should not be used by pregnant women or those planning to become pregnant. Breastfeeding is also not recommended during treatment.
- Drug Interactions: Setmelanotide can interact with other medications, including over-the-counter drugs, vitamins, and herbal supplements. Patients should inform their healthcare provider of all medications they are taking.
Conclusion
It is a crucial treatment option for individuals struggling with genetic conditions that affect their body's ability to regulate hunger and satiety. Patients must follow their doctor’s instructions carefully and report any side effects or concerns during treatment.
How to obtain the latest development progress of all drugs?
In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!
