Approved regimen
Approved labeled regimen
Product-, indication-, and jurisdiction-specific — see the monograph
- The entries summarize the cited US FDA Imcivree label for the named rare-disease indications and age groups.
- Acquired hypothalamic obesity (age 4+): 0.5 mg SC once daily is the labeled starting dose for 2 weeks. The subsequent titration and, for ages 4 to under 6, maintenance regimen follow the label's age/weight tables.
- BBS or POMC/PCSK1/LEPR deficiency, age 12+: 2 mg SC once daily for 2 weeks is the labeled starting dose.
- BBS or POMC/PCSK1/LEPR deficiency, age 6 to under 12: 1 mg SC once daily for 2 weeks is the labeled starting dose.
- BBS or POMC/PCSK1/LEPR deficiency, age 2 to under 6: 0.5 mg SC once daily for 2 weeks, followed by the label's weight-based table.
- Maintenance: 3 mg SC once daily for patients age 6+ across approved indications; younger-patient maintenance is weight-based. Severe renal impairment has separate lower tables and is not a “no adjustment” population; the product is not recommended in end-stage renal disease or in acquired hypothalamic obesity with severe renal impairment.
- This is a label summary, not a substitute for the current indication-, age-, weight-, tolerability-, and renal-function tables.