Type 1 Neurofibromatosis

Indicated for neurofibromatosis type 1 (NF1) in patients aged ≥2 years who have symptomatic, inoperable plexiform neurofibromas (PN)

<2 years or body surface area (BSA) <0.55 m²: Safety and efficacy not established

≥2 years

• BSA ≥0.55 m²: 25 mg/m² PO BID (~q12hr)

• Recommended dosage based on BSA

• 0.55-0.69 m²: 20 mg PO qAM and 10 mg PO qPM
• 0.7-0.89 m²: 20 mg PO BID
• 0.9-1.09 m²: 25 mg PO BID
• 1.1-1.29 m²: 30 mg PO BID
• 1.3-1.49 m²: 35 mg PO BID
• 1.5-1.69 m²: 40 mg PO BID
• 1.7-1.89 m²: 45 mg PO BID
• ≥1.9 m²: 50 mg PO BID

Dosage Modifications

Dose reductions for adverse reactions based on BSA

• First dose reduction

• 0.55-0.69 m²: 10 mg BID
• 0.7-0.89 m²: 20 mg qAM and 10 mg qPM
• 0.9-1.09 m²: 25 mg qAM and 10 mg qPM
• 1.1-1.29 m²: 25 mg qAM and 20 mg qPM
• 1.3-1.49 m²: 25 mg BID
• 1.5-1.69 m²: 30 mg BID
• 1.7-1.89 m²: 35 mg qAM and 30 mg qPM
• ≥1.9 m²: 35 mg BID

• Second dose reduction

• 0.55-0.69 m²: 10 mg qDay
• 0.7-1.09 m²: 10 mg BID
• 1.1-1.29 m²: 20 mg qAM and 10 mg qPM
• 1.3-1.49 m²: 25 mg qAM and 10 mg qPM
• 1.5-1.89 m²: 25 mg qAM and 20 mg qPM
• ≥1.9 m²: 25 mg BID

• Subsequent dose reductions

• Permanently discontinue in patients unable to tolerate selumetinib after 2 dose reductions