Indications for IMCIVREE:
Chronic weight management in patients aged ≥6yrs 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).
Limitations of Use:
Not for use in obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign. Not for use in other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.
Adults and Children:
<6yrs: not established. Confirm diagnosis. Give by SC inj at the beginning of the day into abdomen, thigh or arm; rotate inj sites. 6–<12yrs: initially 1mg once daily for 2 weeks, if tolerated, may increase to 2mg daily; if starting dose is not tolerated, may reduce to 0.5mg daily. If the 2mg is tolerated and additional weight loss is desired, may increase to 3mg daily. ≥12yrs: initially 2mg once daily for 2 weeks, if tolerated, may increase to 3mg daily if additional weight loss is desired; if starting dose is not tolerated, may reduce to 1mg daily. Titrate up or down based on tolerability and weight loss goals.
Disturbance in sexual arousal. Monitor for new onset or worsening of depression. Suicidal ideation (consider discontinuing if occurs). Monitor for skin pigmentary lesions. Perform full body skin exam prior to and during therapy. Assess weight loss after 12–16 weeks of therapy. Discontinue if the patient fails to lose ≥5% of baseline body weight or 5% of baseline BMI (in those with growth potential). Evaluate periodically the weight loss impact on growth and maturation in children. Moderate/severe renal impairment and ESRD: not recommended. Neonates/infants: risk of serious adverse reactions due to benzyl alcohol. Pregnancy: discontinue if occurs. Nursing mothers: not recommended.
Melanocortin receptor agonist.
Inj site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper RTI, spontaneous penile erection.
Generic Drug Availability:
Multiple-dose vial (1mL)—1