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Koselugo Dosage

Generic name: SELUMETINIB 10mg
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on May 12, 2020.

Recommended Dosage

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

Take KOSELUGO on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose [see Clinical Pharmacology (12.3)]. The recommended dose of KOSELUGO based on body surface area (BSA) is shown in Table 1.

Table 1 Recommended Dosage Based on Body Surface Area
*
The recommended dosage for patients with a BSA less than 0.55m2 has not been established.

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.

Table 2 Recommended Dose Reductions for KOSELUGO for Adverse Reactions
*
Permanently discontinue KOSELUGO in patients unable to tolerate KOSELUGO after two dose reductions.

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 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.

Table 3 Recommended Dosage Modifications for KOSELUGO for Adverse Reactions
Severity of Adverse Reaction Recommended Dosage Modifications for KOSELUGO

Cardiomyopathy [see Warnings and Precautions (5.1)]

Asymptomatic decrease in left ventricular ejection (LVEF) of 10% or greater from baseline and less than lower level of normal

Withhold until resolution. Resume at reduced dose.

Symptomatic decreased LVEF
Grade 3 or 4 decreased LVEF

Permanently discontinue.

Ocular Toxicity [see Warnings and Precautions (5.2)]

Retinal Pigment Epithelial Detachment (RPED)

Withhold until resolution. Resume at reduced dose.

Retinal vein occlusion (RVO)

Permanently discontinue.

Gastrointestinal Toxicity[see Warnings and Precautions (5.3)]

Grade 3 Diarrhea

Withhold until improved to Grade 0 or 1. Resume at same dose. Permanently discontinue if no improvement within 3 days.

Grade 4 Diarrhea

Permanently discontinue.

Grade 3 or 4 Colitis

Permanently discontinue.

Skin Toxicity [see Warnings and Precautions (5.4)]

Grade 3 or 4

Withhold until improvement. Resume at reduced dose.

Increased Creatine Phosphokinase (CPK) [see Warnings and Precautions (5.5)]

Grade 4 Increased CPK
Any Increased CPK and myalgia

Withhold until improved to Grade 0 or 1. Resume at reduced dose. Permanently discontinue if no improvement within 3 weeks.

Rhabdomyolysis

Permanently discontinue.

Other Adverse Reactions [see Adverse Reactions (6.1)]

Intolerable Grade 2
Grade 3

Withhold KOSELUGO until improve to Grade 0 or 1. Resume at reduced dose.

Grade 4

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 [see Use in Specific Populations (8.7)].

Table 4 Recommended Dosage of KOSELUGO for Moderate Hepatic Impairment
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 [see Drug Interactions (7.1)].

Table 5 Recommended Dosage of KOSELUGO for Coadministration with Strong or Moderate CYP3A4 Inhibitors 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 a day

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.