Imcivree Side Effects Center

Last updated on RxList: 6/24/2022
Imcivree Side Effects Center

What Is Imcivree?

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

What Are Side Effects of Imcivree?

Side effects of Imcivree include:

  • injection site reactions,
  • skin hyperpigmentation,
  • nausea,
  • headache,
  • diarrhea,
  • abdominal pain,
  • back pain,
  • fatigue,
  • vomiting,
  • depression,
  • upper respiratory tract infection, and
  • spontaneous penile erection

Call your doctor at once if you have the following serious side effects:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
  • low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
  • severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.

Dosage for Imcivree

The starting dose of Imcivree in adult and pediatric patients 12 years of age or older is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks. The starting dose of Imcivree in pediatric patients 6 to less than 12 years of age is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks.

Imcivree In Children

The safety and effectiveness of Imcivree for obesity due to POMC, PCSK1, or LEPR deficiency have been established in pediatric patients aged 6 years and older.

The safety and effectiveness of Imcivree have not been established in pediatric patients younger than 6 years old.

What Drugs, Substances, or Supplements Interact with Imcivree?

Imcivree may interact with other medicines.

Tell your doctor all medications and supplements you use.

Imcivree During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Imcivree; it is unknown how it would affect a fetus. It is recommended to discontinue Imcivree when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. It is unknown if Imcivree passes into breast milk. Breastfeeding is not recommended while using Imcivree.

Additional Information

Our Imcivree (setmelanotide) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Surprising Causes of Weight Gain See Slideshow
Imcivree Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Disturbance in Sexual Arousal [see WARNINGS AND PRECAUTIONS]
  • Depression and Suicidal Ideation [see WARNINGS AND PRECAUTIONS]
  • Skin Pigmentation and Darkening of Pre-Existing Nevi [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

POMC, PCSK1, And LEPR Deficiency

The safety of IMCIVREE was evaluated in two 52-week, open-label clinical studies of 27 patients with obesity due to POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (Study 1 and Study 2) [see Clinical Studies].

Table 1 summarizes the adverse reactions that occurred in the open-label studies during the first 52 weeks of treatment in 3 or more patients treated with IMCIVREE.

Table 1: Adverse Reactions Occurring in 3 or More IMCIVREE-Treated Patients with Obesity due to POMC, PCSK1, or LEPR Deficiency in Open-Label Clinical Studies of 52-Week Duration (Study 1 and Study 2)

IMCIVREE-treated Patients
N = 27
%
Injection site reaction 1 96
Skin hyperpigmentation 2 78
Nausea 56
Headache 41
Diarrhea 37
Abdominal pain 3 33
Back pain 33
Fatigue 30
Vomiting 30
Depression 4 26
Upper respiratory tract infection 26
Spontaneous penile erection 5 23
Arthralgia 19
Asthenia 19
Dizziness 15
Dry mouth 15
Dry skin 15
Insomnia 15
Vertigo 15
Alopecia 11
Chills 11
Constipation 11
Influenza-like illness 11
Muscle spasm 11
Pain in extremity 11
Rash 11
Suicidal ideation 11
1 Includes injection site erythema, pruritus, edema, pain, induration, bruising, hypersensitivity, hematoma, nodule, and discoloration
2 Includes skin hyperpigmentation, pigmentation disorders, skin discoloration
3 Includes abdominal pain and upper abdominal pain
4 Includes depressed mood
5 n = 13 male patients

Bardet-Biedl Syndrome

The safety of IMCIVREE was evaluated in a clinical study, which included a 14-week, randomized, double-blind, placebo-controlled period followed by a 52-week open-label, treatment period, in 44 patients with obesity and a clinical diagnosis of BBS (Study 3) [see Clinical Studies]. The study duration was 66 weeks.

During the 14-week placebo-controlled period in Study 3, the most common reported adverse reactions in IMCIVREE-treated patients when compared to placebo-treated patients were hyperpigmentation disorders (67% vs 0%, respectively) and vomiting (11% vs 0%, respectively).

Adverse reactions were also evaluated during the 52-week active-treatment period, defined as the period from randomization to Week 52 in patients initially randomized to IMCIVREE, and from Week 14 to Week 66 in patients initially randomized to placebo. Table 2 summarizes the adverse reactions that occurred in 2 or more IMCIVREE-treated patients in Study 3 during the 52-week active treatment period.

Table 2: Adverse Reactions Occurring in 2 or More IMCIVREE-Treated Patients with Obesity and a Clinical Diagnosis of BBS During the 52-week Active-Treatment Period from the Start of IMCIVREE Treatment (Study 3)

Preferred Term IMCIVREE-treated Patients
N = 431
%
Hyperpigmentation Disorders 2 63
Injection Site Reactions3 51
Nausea 26
Spontaneous penile erection 4 25
Vomiting 19
Diarrhea 14
Headache 7
Skin striae 7
Aggression 5
Fatigue 5
1 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
2 Includes skin hyperpigmentation, hair color changes, melanoderma, melanocytic nevus
3 Includes injection site erythema, pruritis, induration, pain, bruising, edema, reaction, hemorrhage, irritation, mass
4n = 20 male patients

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Imcivree (Setmelanotide Injection, for Subcutaneous Use )

© Imcivree Patient Information is supplied by Cerner Multum, Inc. and Imcivree Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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