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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 BBS^1,3

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 age^3*
- 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.

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.

Skin Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmentary lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for additional Important Safety Information.

Important Safety Information

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

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Important Safety Information

Expand

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: