Imcivree

Adult Dosing .

Dosage forms:  INJ: 10 mg per mL

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 pts w/ 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 pts w/ 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 pts w/ 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

[see below]

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

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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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 pts w/ 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

[2-5 yo, <20 kg]

eGFR <30: avoid use

HD/PD: not defined

[2-5 yo, 20-29 kg]

eGFR 15-29: 0.5 mg qd; eGFR <15: avoid use

HD/PD: not defined

[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

[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

[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]