The complete official prescribing information should always be consulted for authoritative prescribing instructions. The following is a structured educational summary of the current U.S. RETEVMO labeling revised in July 2026. It is not a substitute for the official label.
Indications
Current U.S. labeling includes:
- RET fusion-positive locally advanced or metastatic NSCLC in adults.
- RET-mutant advanced or metastatic medullary thyroid cancer in adults and pediatric patients aged 2 years and older who require systemic therapy.
- RET fusion-positive advanced or metastatic thyroid cancer in adults and pediatric patients aged 2 years and older requiring systemic therapy and meeting the radioactive-iodine criteria.
- RET fusion-positive locally advanced or metastatic solid tumors in adults and pediatric patients aged 2 years and older after progression on or following prior systemic treatment or when no satisfactory alternative treatment exists.
Dosage
For adults and adolescents aged 12 years and older, the current U.S. dose is weight-based: 120 mg twice daily for patients under 50 kg and 160 mg twice daily for patients weighing 50 kg or more.
Children aged 2 to less than 12 years receive dosing based on body-surface area.
Contraindications
The current U.S. label lists no contraindications. This does not mean selpercatinib is appropriate for every patient; substantial warnings and monitoring requirements remain.
Major warnings
The label addresses:
- Hepatotoxicity
- Interstitial lung disease/pneumonitis
- Hypertension
- QT interval prolongation
- Hemorrhagic events
- Hypersensitivity
- Tumor lysis syndrome
- Other clinically important adverse reactions and laboratory abnormalities.
Drug interactions
Important interaction categories include acid-reducing agents, CYP3A inhibitors and inducers, CYP2C8/CYP3A substrates, certain P-gp and BCRP substrates, and QT-prolonging medicines.
Special populations
The label addresses pregnancy, lactation, reproductive potential, pediatric use and hepatic impairment. Pediatric patients require particular attention to open growth plates.
Complete label
The official current prescribing information should be consulted before prescribing, dispensing or administering selpercatinib.