Dosage of Koselugo

1.Recommended Dosage 

The recommended dosage of Koselugo is 25 mg/m2 orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity. 

Koselugo can be taken with or without food. The recommended dose of Koselugo based on body surface area (BSA) is shown in Table 1.

2.Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 2.

Dosage modifications for adverse reactions are in Table 3.

3.Dosage Modifications for Hepatic Impairment

Reduce the recommended dosage of Koselugo to 20 mg/m2 orally twice daily in patients with moderate hepatic impairment (Child-Pugh B). The recommended dosage of Koselugo for use in patients with severe hepatic impairment (Child-Pugh C) has not been established.

4.Dosage Modifications for Drug Interactions

Strong or Moderate CYP3A4 Inhibitors or Fluconazole Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with Koselugo. If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce the Koselugo dosage as recommended in Table 5. After discontinuation of the strong or moderate CYP3A4 inhibitor or fluconazole for 3 elimination half-lives, resume the Koselugo dose that was taken prior to initiating the inhibitor or fluconazole.

from FDA，2024.01