Obesity:

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); or Bardet-Biedl syndrome (BBS).

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 or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Adult Dosage:

Confirm diagnosis. Give by SC inj at the beginning of the day into abdomen, thigh or arm; rotate inj sites. ≥12yrs: initially 2mg once daily for 2 weeks. Target dose: 3mg once daily. If starting dose is not tolerated, reduce to 1mg once daily. If the 1mg once daily dosage is tolerated for at least 1 week, increase to 2mg once daily. If the starting dose is tolerated for 2 weeks, increase to 3mg once daily. If the 3mg once daily dosage is not tolerated, decrease to 2mg once daily. Severe renal impairment (eGFR 15–29mL/min/1.73m2): initially 0.5mg once daily for 2 weeks. Target dose: 1.5mg once daily. If the starting dose is tolerated for 2 weeks, increase to 1mg once daily. If the 1mg daily dosage is tolerated for at least 1 week, increase to 1.5mg once daily. If starting dose is not tolerated, discontinue treatment.

Children Dosage:

<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. Target dose: 3mg once daily. If the starting dose is not tolerated, reduce to 0.5mg once daily. If the 0.5mg once daily dosage is tolerated for at least 1 week, increase to 1mg once daily. If the starting dose is tolerated for 2 weeks, increase to 2mg once daily. If the 2mg daily dosage is not tolerated, reduce to 1mg once daily; if the 2mg is tolerated, increase to 3mg once daily.

IMCIVREE Warnings/Precautions:

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 (for POMC, PCSK1, or LEPR deficiency) and after 1 year (for BBS) 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. Severe renal impairment (aged 6–<12yrs) and ESRD (aged ≥6yrs): not recommended. Neonates/infants: risk of serious adverse reactions due to benzyl alcohol. Pregnancy: discontinue if occurs. Nursing mothers: not recommended.

IMCIVREE Classification:

Melanocortin 4 (MC4) receptor agonist.

Adverse Reactions:

Inj site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper RTI, spontaneous penile erection.

Generic Drug Availability:

NO

How Supplied:

Multiple-dose vial (1mL)—1

Pricing for IMCIVREE

1ml of 10mg/ml vial (Qty: 1)
Appx. price $3261
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