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Imcivree
setmelanotide
Adult Dosing .
Dosage forms: INJ: 10 mg per mL
hypothalamic obesity, acquired
- [3 mg SC qd]
- Start: 0.5 mg SC qd x2wk, then 1 mg SC qd x2wk, then 2 mg SC qd x2wk
obesity, Bardet-Biedl syndrome-associated
- [1-3 mg SC qd]
- Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, POMC deficiency-associated
- [1-3 mg SC qd]
- Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, PCSK1 deficiency-associated
- [1-3 mg SC qd]
- Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, LEPR deficiency-associated
- [1-3 mg SC qd]
- Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
renal dosing
- [hypothalamic obesity]
- eGFR <30: avoid use
- HD/PD: not defined
- [all other indications]
- eGFR 15-29: start 0.5 mg qd x2wk, then 1 mg qd x1wk, then incr. to 1.5 mg qd as tolerated; eGFR <15: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ: 10 mg per mL
hypothalamic obesity, acquired
- [4-5 yo, 15-19 kg]
- Dose: 0.5 mg SC qd
- [4-5 yo, 20-29 kg]
- Dose: 1 mg SC qd; Start: 0.5 mg SC qd x2wk
- [4-5 yo, 30-39 kg]
- Dose: 1.5 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk
- [4-5 yo, >40 kg]
- Dose: 2 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk
- [6 yo and older]
- Dose: 3 mg SC qd; Start: 0.5 mg SC qd x2wk, then 1 mg SC qd x2wk, then 2 mg SC qd x2wk
obesity, Bardet-Biedl syndrome-associated
- [2-5 yo, 15-19 kg]
- Dose: 0.5 mg SC qd
- [2-5 yo, 20-29 kg]
- Dose: 1 mg SC qd; Start: 0.5 mg SC qd x2wk
- [2-5 yo, 30-39 kg]
- Dose: 1.5 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk
- [2-5 yo, >40 kg]
- Dose: 2 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk
- [6-11 yo]
- Dose: 0.5-3 mg SC qd; Start: 1 mg SC qd x2wk, then incr. by 1 mg/day to 3 mg SC qd as tolerated; Info: may decr. dose to 0.5 mg SC qd for at least 1wk if 1 mg SC qd not tolerated
- [12 yo and older]
- Dose: 1-3 mg SC qd; Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, POMC deficiency-associated
- [2-5 yo, 15-19 kg]
- Dose: 0.5 mg SC qd; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 20-29 kg]
- Dose: 1 mg SC qd; Start: 0.5 mg SC qd x2wk; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 30-39 kg]
- Dose: 1.5 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, >40 kg]
- Dose: 2 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [6-11 yo]
- Dose: 0.5-3 mg SC qd; Start: 1 mg SC qd x2wk, then incr. by 1 mg/day to 3 mg SC qd as tolerated; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 0.5 mg SC qd for at least 1wk if 1 mg SC qd not tolerated
- [12 yo and older]
- Dose: 1-3 mg SC qd; Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in POMC gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, PCSK1 deficiency-associated
- [2-5 yo, 15-19 kg]
- Dose: 0.5 mg SC qd; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 20-29 kg]
- Dose: 1 mg SC qd; Start: 0.5 mg SC qd x2wk; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 30-39 kg]
- Dose: 1.5 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, >40 kg]
- Dose: 2 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [6-11 yo]
- Dose: 0.5-3 mg SC qd; Start: 1 mg SC qd x2wk, then incr. by 1 mg/day to 3 mg SC qd as tolerated; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 0.5 mg SC qd for at least 1wk if 1 mg SC qd not tolerated
- [12 yo and older]
- Dose: 1-3 mg SC qd; Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in PCSK1 gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
obesity, LEPR deficiency-associated
- [2-5 yo, 15-19 kg]
- Dose: 0.5 mg SC qd; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 20-29 kg]
- Dose: 1 mg SC qd; Start: 0.5 mg SC qd x2wk; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, 30-39 kg]
- Dose: 1.5 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [2-5 yo, >40 kg]
- Dose: 2 mg SC qd; Start: 0.5 mg SC qd, then incr. by 0.5 mg/day q2wk; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance
- [6-11 yo]
- Dose: 0.5-3 mg SC qd; Start: 1 mg SC qd x2wk, then incr. by 1 mg/day to 3 mg SC qd as tolerated; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 0.5 mg SC qd for at least 1wk if 1 mg SC qd not tolerated
- [12 yo and older]
- Dose: 1-3 mg SC qd; Start: 2 mg SC qd x2wk, then incr. to 3 mg SC qd as tolerated; Info: for patients with variant in LEPR gene interpreted as pathogenic, likely pathogenic, or of uncertain significance; may decr. dose to 1 mg SC qd for at least 1wk if 2 mg SC qd not tolerated
renal dosing
- [hypothalamic obesity]
- eGFR <30: avoid use
- HD/PD: not defined
- [all other indications, 2-5 yo, <20 kg]
- eGFR <30: avoid use
- HD/PD: not defined
- [all other indications, 2-5 yo, 20-29 kg]
- eGFR 15-29: 0.5 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [all other indications, 2-5 yo, >30 kg]
- eGFR 15-29: start 0.5 mg qd x2wk, then incr. to 1 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [all other indications, 6-11 yo]
- eGFR 15-29: start 0.5 mg qd x2wk, then incr. to 1 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [all other indications, 12 yo and older]
- eGFR 15-29: start 0.5 mg qd x2wk, then 1 mg qd x1wk, then incr. to 1.5 mg qd as tolerated; eGFR <15: avoid use
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- breastfeeding
- eGFR <15
- eGFR 15-29 (hypothalamic obesity use)
- eGFR 15-29 (patients 2-5 yo with wt <20 kg)
- caution: eGFR 15-29 (patients 2 yo and older with wt >20 kg except in hypothalamic obesity use)
- caution: skin pigmentary lesion, pre-existing
- caution: depression history
- caution: suicidality history
- caution: adrenal insufficiency, secondary
- caution: diabetes insipidus, central
Drug Interactions .
Overview
setmelanotide
melanocortin agonist
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- depression
- suicidal ideation
- adrenal insufficiency, acute (hypothalamic obesity use)
Common Reactions
- injection site reaction
- skin hyperpigmentation, reversible
- vomiting
- nausea
- URI
- headache
- diarrhea
- abdominal pain
- back pain
- melanocytic nevus
- fever
- fatigue
- depression
- penile erection
- cough
- arthralgia
- asthenia
- dizziness
- xerostomia
- dry skin
- insomnia
- vertigo
- constipation
- alopecia
- rigors
- influenza-like symptoms
- muscle spasm
- extremity pain
- rash
- suicidal ideation
- oropharyngeal pain
- gastroenteritis
- striae
- sodium imbalance (hypothalamic obesity use)
- aggression
- adrenal insufficiency, acute (hypothalamic obesity use)
- ear infection
Safety/Monitoring .
Monitoring Parameters
dermatologic exams at baseline, then periodically; signs/symptoms of depression, behavior changes, suicidality; signs of acute adrenal insufficiency if secondary adrenal insufficiency; Na with fluid intake or hydration status changes if central diabetes insipidus
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; wt loss during pregnancy offers no benefit and may cause fetal harm; no human data available; no known risk of teratogenicity based on animal data at 11x MRHD
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for setmelanotide: catabolism; CYP450: none
Excretion: for setmelanotide: urine (39% unchanged); Half-life: 11h
Subclass: Inherited Metabolic Disorders ; Obesity/Weight Management: Melanocortin Receptor Agonists
Mechanism of Action
for setmelanotide: binds and activates melanocortin receptors, reestablishing impaired MC4 receptor pathway activity in brain to regulate appetite and weight control
Formulary .
No Formulary Selected
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