Selpercatinib dosage is determined by the treatment indication, patient age, body weight, body-surface area, organ function, concomitant medicines and adverse reactions. The following information summarizes current U.S. RETEVMO labeling and is not an individualized prescription.
Current U.S. recommended dosage
| Patient group | Current U.S. labeled dosage |
|---|---|
| Adults and adolescents ≥12 years, <50 kg | 120 mg twice daily |
| Adults and adolescents ≥12 years, ≥50 kg | 160 mg twice daily |
| Children 2 to <12 years, BSA 0.33–0.65 m² | 40 mg three times daily |
| Children 2 to <12 years, BSA 0.66–1.08 m² | 80 mg twice daily |
| Children 2 to <12 years, BSA 1.09–1.52 m² | 120 mg twice daily |
| Children 2 to <12 years, BSA ≥1.53 m² | 160 mg twice daily |
These recommendations apply to current U.S. RETEVMO labeling and should not automatically be transferred to another selpercatinib product or jurisdiction.
40 mg strength
The 40 mg strength is used as part of the labeled dosage forms and pediatric dosing scheme. It is not automatically the standard adult daily dose.
Severe hepatic impairment
The U.S. label requires a dose reduction for patients with severe hepatic impairment. The exact reduced dose depends on the patient’s labeled starting regimen.
Adverse-reaction dose reductions
Dose reductions may be required for serious or clinically significant adverse reactions. Current labeling provides stepwise reductions from 160 mg twice daily, 120 mg twice daily, 80 mg twice daily and 40 mg twice daily, as applicable to the starting regimen.
Acid-reducing medicines
PPIs, H2 blockers and locally acting antacids can affect selpercatinib exposure. Current labeling provides specific administration modifications if these medicines cannot be avoided.
Important limitation
The dose of Selcaxen 40 mg should not be inferred from the strength alone. The Selcaxen product’s own regulatory documentation should be consulted if it differs from RETEVMO.