IMCIVREE has a well-established safety and tolerability profile1,2
Adverse reactions occurring in 2 or more IMCIVREE-treated patients (n=43)1*
(%) | |
Hyperpigmentation disorders† | 63 |
Injection site reactions‡ | 51 |
Nausea | 26 |
Spontaneous penile erection§ | 25 |
Vomiting | 19 |
Diarrhea | 14 |
Headache | 7 |
Skin striae | 7 |
Aggression | 5 |
Fatigue | 5 |
*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.1
†Includes skin hyperpigmentation, hair color changes, melanoderma, and melanocytic nevus.1
‡Includes injection site erythema, pruritus, induration, pain, bruising, edema, reaction, hemorrhage, irritation, and mass.1
§n=20 male patients.1
AEs were generally mild and transient1-5
- Reported incidences of nausea and vomiting primarily occurred within the first month of treatment, then sharply declined after 4 weeks
- Nearly all nausea or vomiting events were mild and none were serious
- Reported incidences of nausea and vomiting typically resolved within a few days in patients with a rare genetic disease of obesity in IMCIVREE clinical trials
- Nausea and vomiting should be managed by dose titration and standard care
- No serious AEs related to IMCIVREE were reported in the BBS trial
- The safety of IMCIVREE has been evaluated in >700 patients over ~10 years of clinical trials
Hyperpigmentation was common but rarely led to discontinuation1,3
- Changes in skin pigmentation or hair color typically presented 2-3 weeks after initiation of IMCIVREE, with most events occurring within the first month of treatment2
- Skin darkening plateaued within the initial months of treatment and was not dose-dependent2
- Hyperpigmentation is variable5
- This effect is reversible upon discontinuation of treatment1
- Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions1
- Hyperpigmentation is not unexpected given that IMCIVREE also activates the melanocortin-1 receptor, which results in melanin production1
Managing adverse events with IMCIVREE
Hear physicians, patients, and caregivers share their experiences with IMCIVREE
AE=adverse event.
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. Argente J et al. The Pediatric Endocrine Society Annual Meeting. Poster 155. April 28-May 1, 2022. 3. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext. 4. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 5. U.S. National Library of Medicine. Identifier: NCT02431442. ClinicalTrials.gov. Accessed August 9, 2023. 6. Clément K et al. Lancet Diabetes Endocrinol. [Supplementary appendix] 2020;8(12):960-970.