Koselugo Dosage
Generic name: SELUMETINIB 10mg
Dosage form: capsule
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Jan 24, 2024.
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.
|
|
Body Surface Area* |
Recommended Dosage |
0.55 – 0.69 m2 |
20 mg in the morning and 10 mg in the evening |
0.70 – 0.89 m2 |
20 mg twice daily |
0.90 – 1.09 m2 |
25 mg twice daily |
1.10 – 1.29 m2 |
30 mg twice daily |
1.30 – 1.49 m2 |
35 mg twice daily |
1.50 – 1.69 m2 |
40 mg twice daily |
1.70 – 1.89 m2 |
45 mg twice daily |
≥ 1.90 m2 |
50 mg twice daily |
Swallow KOSELUGO capsules whole with water. Do not chew, dissolve or open capsule.
Do not administer to patients who are unable to swallow a whole capsule.
Do not take a missed dose of KOSELUGO unless it is more than 6 hours until the next scheduled dose.
If vomiting occurs after KOSELUGO administration, do not take an additional dose, but continue with the next scheduled dose.
Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 2.
|
||||
Body Surface Area |
First Dose Reduction (mg/dose) |
Second Dose Reduction* (mg/dose) |
||
Morning |
Evening |
Morning |
Evening |
|
0.55 – 0.69 m2 |
10 |
10 |
10 mg once daily |
|
0.70 – 0.89 m2 |
20 |
10 |
10 |
10 |
0.90 – 1.09 m2 |
25 |
10 |
10 |
10 |
1.10 – 1.29 m2 |
25 |
20 |
20 |
10 |
1.30 – 1.49 m2 |
25 |
25 |
25 |
10 |
1.50 – 1.69 m2 |
30 |
30 |
25 |
20 |
1.70 – 1.89 m2 |
35 |
30 |
25 |
20 |
≥ 1.90 m2 |
35 |
35 |
25 |
25 |
Dosage modifications for adverse reactions are in Table 3.
Severity of Adverse Reaction | Recommended Dosage Modifications for KOSELUGO |
---|---|
Cardiomyopathy |
|
|
Withhold until resolution. Resume at reduced dose. |
|
Permanently discontinue. |
Ocular Toxicity |
|
|
Withhold until resolution. Resume at reduced dose. |
|
Permanently discontinue. |
Gastrointestinal Toxicity |
|
|
Withhold until improved to Grade 0 or 1. Resume at same dose. Permanently discontinue if no improvement within 3 days. |
|
Permanently discontinue. |
|
Permanently discontinue. |
Skin Toxicity |
|
|
Withhold until improvement. Resume at reduced dose. |
Increased Creatine Phosphokinase (CPK) |
|
|
Withhold until improved to Grade 0 or 1. Resume at reduced dose. Permanently discontinue if no improvement within 3 weeks. |
|
Permanently discontinue. |
Other Adverse Reactions |
|
|
Withhold KOSELUGO until improved to Grade 0 or 1. Resume at reduced dose. |
|
Withhold KOSELUGO until improved to Grade 0 or 1. Resume at reduced dose. Consider discontinuation. |
* Per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
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.
Body Surface Area | Moderate Hepatic Impairment (Child-Pugh B) (mg/dose) |
|
---|---|---|
Morning | Evening | |
0.55 – 0.69 m2 |
10 |
10 |
0.70 – 0.89 m2 |
20 |
10 |
0.90 – 1.09 m2 |
20 |
20 |
1.10 – 1.29 m2 |
25 |
25 |
1.30 – 1.49 m2 |
30 |
25 |
1.50 – 1.69 m2 |
35 |
30 |
1.70 – 1.89 m2 |
35 |
35 |
≥ 1.90 m2 |
40 |
40 |
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.
Body Surface Area | If the current dosage is 25 mg/m2 twice daily, reduce to 20 mg/m2 twice daily (mg/dose) |
If the current dosage is 20 mg/m2 twice daily, reduce to 15 mg/m2 twice daily (mg/dose) |
||
---|---|---|---|---|
Morning | Evening | Morning | Evening | |
0.55 – 0.69 m2 |
10 |
10 |
10 mg once daily |
|
0.70 – 0.89 m2 |
20 |
10 |
10 |
10 |
0.90 – 1.09 m2 |
20 |
20 |
20 |
10 |
1.10 – 1.29 m2 |
25 |
25 |
25 |
10 |
1.30 – 1.49 m2 |
30 |
25 |
25 |
20 |
1.50 – 1.69 m2 |
35 |
30 |
25 |
25 |
1.70 – 1.89 m2 |
35 |
35 |
30 |
25 |
≥ 1.90 m2 |
40 |
40 |
30 |
30 |
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