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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.

DOSING

IMCIVREE recommended dosing1

  • Periodically assess response to IMCIVREE therapy. In pediatric patients, evaluate the impact of weight loss on growth and maturation
  • Evaluate weight loss after 12 to 16 weeks of treatment
  • If a patient has not lost at least 5% of baseline body weight, or 5% of baseline BMI for patients with continued growth potential, discontinue IMCIVREE as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment

BMI=body mass index.
*If starting dose is not tolerated, decrease to 1 mg once daily.
If increased dose is not tolerated, revert to previous dose.
If 3-mg once-daily dose is not tolerated, maintain patient on 2 mg once daily.
§If starting dose is not tolerated, decrease to 0.5 mg once daily.

PREPARATION & ADMINISTRATION

MULTIPLE-DOSE VIAL FOR ONCE-DAILY SUBCUTANEOUS INJECTION1

  • IMCIVREE should be injected at the beginning of the day, without regard to meals
  • Patients who store their IMCIVREE in the refrigerator should remove it 15 minutes prior to administration, or warm the vial between their hands for 60 seconds before injecting
  • IMCIVREE should be injected subcutaneously in the abdomen, thigh, or arm, rotating to a different site each day
IMCIVREE treatment

See Instructions for Use for more information on administration

STORAGE

Storing IMCIVREE1,2

Storage
Protect from light. Do not freeze. Store in the original carton.

Unopened vial
Store unopened vials in refrigerator at 2°C to 8°C (36°F to 46°F).

Open (in-use) vial
Opened vials can be stored at temperatures ranging from refrigerated to room temperature [2°C to 25°C (36°F to 77°F)] with brief excursions permitted up to 30°C (86°F).

Discard unused portion 30 days after first opening or if stored above 30°C (86°F).

Supplied as a multiple-dose vial

*If necessary, IMCIVREE may be stored at room temperature (≤30°C [≤86°F]) and then returned to refrigerator.
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. IMCIVREE [patient information]. Boston, MA. Rhythm Pharmaceuticals, Inc.

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: