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Interested in starting a patient on IMCIVREE? It's only available through our specialty pharmacy.
Download and complete the Start Form

 

Indication

IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to BBS or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity
IMCIVREE delivered early, significant, and sustained reductions in measures of weight and hunger in BBS1,3

Weight reduction1

  • ~8% mean reduction in BMI in patients ≥6 years of age after 1 year1
    • Patients were not required to change their diet or exercise routine3
  • Clinically significant -0.8 mean change in BMI Z-score in patients <18 years of age3*
    • 100% of patients <12 years of age with BBS achieved a clinically significant ≥0.2 reduction in BMI Z-score (n=3)3,4
  • Clinically significant ~10% mean weight reduction in patients ≥18 years of age3

Hunger reduction

  • Statistically significant reduction in maximal hunger score1

Safety profile

  • The most common adverse reactions in IMCIVREE-treated patients were hyperpigmentation disorders, injection site reactions, and nausea1
    • 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 serious2
  • Depression and suicidal ideation, as well as disturbances in sexual arousal, may also occur during treatment with IMCIVREE1
  • Treatment with IMCIVREE is not recommended during breastfeeding. Patients should not take IMCIVREE while pregnant unless the benefits of therapy outweigh the potential risks1
  • Adverse events (AEs) were generally mild and transient3
  • No serious AEs related to IMCIVREE were reported in the BBS trial3

Study design: The efficacy and safety of IMCIVREE for the reduction of weight and hunger in patients with BBS were studied in a 66-week phase 3 clinical trial, which included a 14-week randomized, double-blind, placebo-controlled period and a 52-week open-label period. The study enrolled patients aged 6 years and older with obesity and a clinical diagnosis of BBS.1,3

*A clinically significant reduction is generally considered a ≥0.2 reduction in BMI Z-score. A 0.2 reduction is comparable to weight loss of approximately 5%.4

Patients ≥12 years of age who were able to self-report their hunger (n=14) recorded their daily maximal hunger in a diary, which was then assessed by the Daily Hunger Questionnaire Item 2. Hunger was scored on an 11-point scale from 0 (“not hungry at all”) to 10 (“hungriest possible”).1


References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. Eneli I et al. Appl Clin Genet. 2019;12:87-93. 3. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 4. Grossman DC et al; US Preventive Services Task Force. JAMA. 2017;317(23):2417-2426.

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Important Safety Information
WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Indication

IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to: