Well-established safety and tolerability profile1-3
Adverse reactions occurring in 2 or more IMCIVREE-treated patients (n=43)1*
|Injection site reactions‡||51|
|Spontaneous penile erection§||25|
*43 patients were treated with at least 1 dose of IMCIVREE; 1 patient initially randomized to placebo withdrew from the study prior to receiving IMCIVREE and is not included.
†Includes skin hyperpigmentation, hair color changes, melanoderma, melanocytic nevus.
‡Includes injection site erythema, pruritus, induration, pain, bruising, edema, reaction, hemorrhage, irritation, and mass.
§n=20 male patients.
Adverse events (AEs) were generally mild and transient2
- Reported incidences of nausea and vomiting primarily occurred within the first month of treatment, then sharply declined after 4 weeks2
- Nearly all nausea or vomiting events were mild and none were serious2
- Reported incidences of nausea and vomiting typically resolved within a few days in patients with a rare genetic disease of obesity in IMCIVREE clinical trials3
- Nausea and vomiting should be managed by dose titration and standard care1
- No serious AEs related to IMCIVREE were reported in the BBS trial2
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 3. Argente J et al. The Pediatric Endocrine Society Annual Meeting. Poster 155. April 28-May 1, 2022.