Imcivree
- Generic Name: setmelanotide injection, for subcutaneous use
- Brand Name: Imcivree
- Drug Class: How Do Melanocortin Agonists Work?
Imcivree (Setmelanotide Injection, for Subcutaneous Use ) side effects drug center
- Related Drugs
- injection site reactions,
- skin hyperpigmentation,
- nausea,
- headache,
- diarrhea,
- abdominal pain,
- back pain,
- fatigue,
- vomiting,
- depression,
- upper respiratory tract infection, and
- spontaneous penile erection
- Spontaneous Penile Erection [see WARNINGS AND PRECAUTIONS]
- Depression and Suicidal Ideation [see WARNINGS AND PRECAUTIONS]
- Skin Pigmentation and Darkening of Pre-Existing Nevi [see WARNINGS AND PRECAUTIONS]
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:
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.
Imcivree Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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.
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 [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 Patients Treated with IMCIVREE in Open Label Clinical Studies of 52-week Duration
| IMCIVREE-treated Patients N = 27 % | |
| Injection site reaction a | 96 |
| Skin hyperpigmentation b | 78 |
| Nausea | 56 |
| Headache | 41 |
| Diarrhea | 37 |
| Abdominal pain c | 33 |
| Back pain | 33 |
| Fatigue | 30 |
| Vomiting | 30 |
| Depression d | 26 |
| Upper respiratory tract infection | 26 |
| Spontaneous penile erection e | 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 |
| a Includes injection site erythema, pruritus, edema, pain, induration, bruising, hypersensitivity, hematoma, nodule, and discoloration b Includes skin hyperpigmentation, pigmentation disorders, skin discoloration c Includes abdominal pain and upper abdominal pain d Includes depressed mood e n = 13 male patients | |
In a 12-week, placebo-controlled clinical study in an unapproved population, 4 female patients (7%) treated with IMCIVREE experienced sexual adverse reactions compared to 0 patients in the placebo group; 3 experienced a disturbance in sexual arousal and one experienced hypersensitivity of the labia.
Immunogenicity
As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
Approximately 61% of adult and pediatric patients with POMC-or LEPR-deficiency who received IMCIVREE (N=28) screened positive for antibodies to IMCIVREE, and 39% screened negative. The 61% of patients who screened positive for antibodies to IMCIVREE were inconclusive for antibodies to IMCIVREE in the confirmatory assay. There was no observation of a rapid decline in IMCIVREE concentrations to suggest the presence of anti-drug antibodies.
Approximately 13% of adult and pediatric patients with LEPR-deficiency (3 patients) confirmed positive for antibodies to alpha-MSH that were classified as low-titer and non-persistent. Of these 3 patients (13%), 2 tested positive post-IMCIVREE treatment and 1 was positive pretreatment. None of the patients with POMC-deficiency were confirmed to have antibodies to alpha-MSH.
Read the entire FDA prescribing information for Imcivree (Setmelanotide Injection, for Subcutaneous Use )