Obesity Pharmacotherapy
4. Setmelanotide( Imcivree)( change in BMI: > 5 % in 89 %)
a. Patient Selection: i. FDA-approval:
1. ≥2 years old with genetic variants interpreted as pathogenic, likely pathogenic, or variant of uncertain significance( VUS) in the following genes: a. POMC( proopiomelanocortin) b. PCSK-1( proprotein convertase subtilisin / kexin type 1 c. LEPR( leptin receptor) 2. ≥2 years old with Bardet-Biedl syndrome( BBS) ii.
CONTRAINDICATIONS 1. None iii. USE CAUTION 1. Renal disease b. To Start Setmelanotide: i. ii.
Ensure patient has an eligible genetic mutations or syndromes Complete“ Imcivree Start” form available on-line. Copy of patient’ s genetic test results will need to be submitted with form, except for BBS. iii. Contact specialty pharmacy to ensure supply of medication is available iv. Check basic metabolic panel to ensure adequate kidney function. v. Perform a complete skin exam, paying attention to nevi. vi. Review contraindications and side effects with patient and family: vii. Most common side effects: Injection site reactions, darkening of skin( ≈ 60- 70 %), nausea, vomiting, diarrhea, abdominal pain, headache, back pain, depression(~ 25 %), erections that happen without any sexual activity in males( ≈ 25 %) c. Start Setmelanotide: i. Refer to UpToDate for dosing scheme. ii.
Dosing Logistics: Vial and syringe administration. To minimize injection site reactions, provide instruction to remove excess medication such as droplets from outside syringe
d. |
Follow-up: |
i. |
If dose escalation is not tolerated, decrease by 1 mg daily and re-assess after 1 week |
ii. |
Check patient monthly x 3, at least, to start |
e. |
Review side effects |
i. |
Target dose is 2-3 mg daily depending on age. |
ii. |
If BMI is not stabilized or does not decrease by ≥5 % in 3-4 months, consider adding a second |
medication such as phentermine, topiramate or a GLP1RA |
iii. Check BMP annually to assess kidney function iv. Periodic complete skin examinations to follow up on existing nevi and evaluate for new skin lesions
f. |
Discontinue: If BMI continues to increase after 3-4 months of treatment at maximal tolerated dose. |
g. |
If unable to tolerate |
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