Koselugo

Adult Dosing .

Dosage forms:  CAP: 10 mg, 25 mg: GRANULE: 5 mg, 7.5 mg

Special Note

[strength clarification]

Info: 10 mg cap contains 32 mg vitamin E; 25 mg cap contains 36 mg vitamin E

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments

neurofibromatosis, type 1

[cap form, BSA 1.1-1.29 m^2]

Dose: 30 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, BSA 1.3-1.49 m^2]

Dose: 35 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, BSA 1.5-1.69 m^2]

Dose: 40 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, BSA 1.7-1.89 m^2]

Dose: 45 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, BSA >1.9 m^2]

Dose: 50 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[granule form, BSA 1.1-1.29 m^2]

Dose: 30 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, BSA 1.3-1.49 m^2]

Dose: 35 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, BSA 1.5-1.69 m^2]

Dose: 40 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, BSA 1.7-1.89 m^2]

Dose: 45 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, BSA >1.9 m^2]

Dose: 50 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[BSA 1.1-1.29 m^2]

Child-Pugh Class B: 25 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[BSA 1.3-1.49 m^2]

Child-Pugh Class B: 30 mg PO qam, 25 mg PO qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[BSA 1.5-1.69 m^2]

Child-Pugh Class B: 35 mg PO qam, 30 mg PO qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[BSA 1.7-1.89 m^2]

Child-Pugh Class B: 35 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[BSA >1.9 m^2]

Child-Pugh Class B: 40 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

Peds Dosing .

Dosage forms:  CAP: 10 mg, 25 mg: GRANULE: 5 mg, 7.5 mg

Special Note

[strength clarification]

Info: 10 mg cap contains 32 mg vitamin E; 25 mg cap contains 36 mg vitamin E

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments

neurofibromatosis, type 1

[cap form, 1 yo and older, BSA 0.55-0.69 m^2]

Dose: 20 mg PO qam, 10 mg PO qpm (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 0.7-0.89 m^2]

Dose: 20 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 0.9-1.09 m^2]

Dose: 25 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 1.1-1.29 m^2]

Dose: 30 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 1.3-1.49 m^2]

Dose: 35 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 1.5-1.69 m^2]

Dose: 40 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA 1.7-1.89 m^2]

Dose: 45 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[cap form, 1 yo and older, BSA >1.9 m^2]

Dose: 50 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; do not open cap

[granule form, 1 yo and older, BSA 0.4-0.59 m^2]

Dose: 12.5 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 0.6-0.69 m^2]

Dose: 15 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 0.7-0.89 m^2]

Dose: 20 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 0.9-1.09 m^2]

Dose: 25 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 1.1-1.29 m^2]

Dose: 30 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 1.3-1.49 m^2]

Dose: 35 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 1.5-1.69 m^2]

Dose: 40 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA 1.7-1.89 m^2]

Dose: 45 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

[granule form, 1 yo and older, BSA >1.9 m^2]

Dose: 50 mg PO bid (25 mg/m^2/dose PO bid); Info: for patients with symptomatic, inoperable plexiform neurofibromas; must open cap, but do not crush/chew granules

renal dosing

[no adjustment]

renal impairment: no adjustment

HD/PD: no adjustment; no supplement

hepatic dosing

[cap form, BSA 0.55-0.69 m^2]

Child-Pugh Class B: 10 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 0.7-0.89 m^2]

Child-Pugh Class B: 20 mg qam, 10 mg qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 0.9-1.09 m^2]

Child-Pugh Class B: 20 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 1.1-1.29 m^2]

Child-Pugh Class B: 25 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 1.3-1.49 m^2]

Child-Pugh Class B: 30 mg qam, 25 mg qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 1.5-1.69 m^2]

Child-Pugh Class B: 35 mg qam, 30 mg qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA 1.7-1.89 m^2]

Child-Pugh Class B: 35 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[cap form, BSA >1.9 m^2]

Child-Pugh Class B: 40 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 0.4-0.59 m^2]

Child-Pugh Class B: 10 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 0.6-0.69 m^2]

Child-Pugh Class B: 12.5 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 0.7-0.89 m^2]

Child-Pugh Class B: 15 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 0.9-1.09 m^2]

Child-Pugh Class B: 20 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 1.1-1.29 m^2]

Child-Pugh Class B: 25 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 1.3-1.49 m^2]

Child-Pugh Class B: 30 mg PO qam, 25 mg PO qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 1.5-1.69 m^2]

Child-Pugh Class B: 35 mg PO qam, 30 mg PO qpm (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA 1.7-1.89 m^2]

Child-Pugh Class B: 35 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined

[granule form, BSA >1.9 m^2]

Child-Pugh Class B: 40 mg bid (20 mg/m^2/dose bid); Child-Pugh Class C: not defined