Safety profile
IMCIVREE has a well-established safety and tolerability profile1,2
- The safety of IMCIVREE has been evaluated across multiple indications in more than 700 patients over 10+ years, through clinical trials and real-world experience2
- AEs were generally mild and transient2,3
Adverse Reactions Occurring in 3 or More IMCIVREE-treated Patients Aged 2 to Less Than 6 Years With Obesity due to POMC or LEPR Deficiency or BBS in an Open-label Clinical Trial of 52-week Duration (N=12)1*
| Adverse reaction | N=12 |
|---|---|
| Skin hyperpigmentation† | 83% |
| Injection site reactions‡ | 67% |
| Vomiting | 58% |
| Nasopharyngitis | 42% |
| Melanocytic nevus§ | 33% |
| Fall | 33% |
| Fever | 33% |
| Upper respiratory tract infection | 33% |
| Cough | 25% |
| Diarrhea | 25% |
In the clinical trial for patients 2 to <6 years of age2,4:
- Reported incidences of nausea and vomiting often occurred within the first month of treatment
- Vomiting was observed at a higher incidence in the study for patients 2 to <6 years of age compared with other IMCIVREE studies in patients 6 years of age and older
- Nearly all vomiting events were mild, none were serious, and all resolved
*Safety analysis was conducted at the end of treatment in 12 patients (7 with POMC or LEPR deficiency and 5 with BBS). No patients with PCSK1 were enrolled in the trial.
†Includes skin hyperpigmentation, ephelides, nail pigmentation, lip pigmentation, skin discoloration, gingival hyperpigmentation.
‡Includes injection site bruising, pruritus, discoloration, erythema, induration, oedema, pain, urticaria.
§Includes new melanocytic nevus formation, increased melanocytic nevus size, and darkening of pre-existing melanocytic nevus.
Adverse Reactions Occurring in 2 or More IMCIVREE-treated Patients Aged 6 Years and Older With Obesity and a Clinical Diagnosis of BBS During the 52-week Active-treatment Period From the Start of IMCIVREE Treatment (N=43)1¶
| Adverse reaction | N=43 |
|---|---|
| Skin hyperpigmentation# | 63% |
| Injection site reactionsa | 51% |
| Nausea | 26% |
| Spontaneous penile erection** | 25% |
| Vomiting | 19% |
| Diarrhea | 14% |
| Melanocytic nevus†† | 14% |
| Headache | 7% |
| Skin striae | 7% |
| Aggression | 5% |
| Fatigue | 5% |
In the clinical trial for patients 6 years of age and older2,5:
- 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, none were serious, and they typically resolved within a few days
- Nausea and vomiting should be managed by dose titration and standard care
¶Forty-three 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.
aIncludes injection site erythema, pruritus, induration, pain, bruising, edema, reaction, hemorrhage, irritation, mass.
**n=20 male patients.
††Includes new melanocytic nevus formation, increased melanocytic nevus size, and darkening of pre-existing melanocytic nevus.
Hyperpigmentation with IMCIVREE is common and variable
Mechanism: IMCIVREE is an MC4 agonist that has some residual activity at the MC1 receptor. Activation of the MC1 receptor can lead to the accumulation of melanin, resulting in hyperpigmentation. Because hyperpigmentation is a result of residual MC1 receptor activity, it is reversible after treatment discontinuation.1,3,5,6
Onset and duration: Hyperpigmentation is common and expected. In clinical trials, measures of hyperpigmentation increased throughout the dose escalation period and generally plateaued in the initial months of treatment.2,5
Variability: The degree and presentation of hyperpigmentation is variable across patients. Hyperpigmentation may be influenced by a patient's individual baseline melanin levels.7
If hyperpigmentation is a concern, assess patient response to treatment to optimize tolerability and efficacy as you would with other adverse events. It is important to remember that continued treatment with IMCIVREE is necessary to sustain clinical benefits, including reduced weight and hunger.
Examples of hyperpigmentation
Individual experiences may vary.
Managing adverse events with IMCIVREE
Hear physicians, patients, and caregivers share their experiences with IMCIVREE.
Questions about the safety profile of IMCIVREE? Talk to a Rhythm representative.
Find information on prescribing and administering IMCIVREE.