Setmelanotide Safety and Usage Update: Key Considerations

Setmelanotide Safety and Usage Update: Key Considerations for Patients and Physicians

Clinical Practice Guidelines

For patients undergoing treatment with setmelanotide, it is recommended that the drug's impact be monitored at least every six months as part of standard clinical practice.

Sexual Arousal Disturbances

Male patients may experience spontaneous penile erections, while female patients could encounter sexual adverse reactions. Medical attention is advised for erections lasting more than four hours.

Mental Health Considerations

Instances of depression and suicidal ideation have been reported. Patients should be closely observed for any signs of depression or suicidal thoughts. Discontinuation of setmelanotide should be considered if these symptoms are significant or persistent.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been documented. Patients should seek immediate medical help if such reactions are suspected and discontinue the medication.

Pediatric Use

For children, physicians should evaluate the effects of weight loss on growth and maturation. In Europe, growth should be monitored using age- and sex-appropriate growth curves.

Risks in Neonates and Low Birth Weight Infants

Setmelanotide is not approved for neonates or infants due to risks of serious and fatal reactions, such as "gasping syndrome," from benzyl alcohol-preserved drugs.

Adverse Reactions

Common adverse reactions (≥20% incidence) include skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

Lactation Advisory

Breastfeeding is not recommended during treatment with setmelanotide.

Reporting Adverse Reactions

Suspected adverse reactions should be reported to Rhythm Pharmaceuticals or the FDA. In Europe, refer to section 4.8 of the Summary of Product Characteristics for reporting guidelines.

Forward-looking Statements

This release contains forward-looking statements regarding setmelanotide's potential benefits, regulatory progress, and clinical trials. These statements are subject to risks and uncertainties, including clinical trial outcomes, regulatory approval processes, and competitive market dynamics.

Contact Information

For further inquiries, Rhythm Pharmaceuticals can be contacted for investor relations and media communications.

Trial Update

One patient from the initial group of 12 did not complete follow-up appointments and discontinued early in the trial.