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Selumetinib Dosage

Medically reviewed by Drugs.com. Last updated on Apr 27, 2023.

Applies to the following strengths: 10 mg; 25 mg

Usual Pediatric Dose for Fibromatosis

Recommended dosage in pediatric patients ages 2 to 18 years old: 25 mg/m2 orally twice a day (approximately every 12 hours) until disease progression or unacceptable toxicity.

Recommended dosage to achieve 25 mg/m2 twice a day based on body surface area (BSA):


Comments:

Use: For the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

MILD HEPATIC DYSFUNCTION (Child-Pugh A): No dose adjustment recommended.

MODERATE HEPATIC DYSFUNCTION (Child-Pugh B): Reduce starting dosage to 20 mg/m2 twice a day.
Recommended dosage to achieve 20 mg/m2 twice a day based on body surface area (BSA):


SEVERE HEPATIC DYSFUNCTION (Child-Pugh C): Recommended dosage is unknown or not established.

Dose Adjustments

RECOMMENDED DOSE REDUCTIONS FOR ADVERSE REACTIONS:
General: If patient is unable to tolerate therapy after 2 dose reductions, therapy should be permanently discontinued.
Dose reduction recommendations based on body surface area (BSA):
BSA 0.55 to 0.69 m2:


BSA 0.7 to 0.89 m2:

BSA 0.9 to 1.09 m2:

BSA 1.1 to 1.29 m2:

BSA 1.3 to 1.49 m2:

BSA 1.5 to 1.69 m2:

BSA 1.7 to 1.89 m2:

BSA 1.9 m2 or greater:

RECOMMENDED DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
Cardiomyopathy:

Ocular Toxicity:

Gastrointestinal Toxicity:

Skin Toxicity:

Increased Creatine Phosphokinase (CPK):

Other Adverse Reactions:

RECOMMENDED DOSE REDUCTIONS FOR COADMINISTRATION WITH STRONG OR MODERATE CYP450 3A4 INHIBITORS OR FLUCONAZOLE:
General Recommendations:

Dose Reduction Recommendations for Coadministration with CYP450 3A4 inhibitors or fluconazole:

Body surface area dosing recommendations to achieve 20 mg/m2 twice a day:

Body surface area dosing recommendations to achieve 15 mg/m2 twice daily:

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is not dialyzable because it is highly protein bound and extensively metabolized.

Other Comments

Administration advice:


Storage requirements:

Monitoring:

Patient advice:

Further information

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