SELPERCATINIB 40 & 80 MG TABLETS
"RETEVMO (selpercatinib) is a kinase inhibitor. RETEVMO (selpercatinib) is supplied as 40 mg or 80 mg hard gelatin capsules for oral use. Each capsule contains inactive ingredients of microcrystalline cellulose and colloidal silicon dioxide. The 40 mg capsule shell is composed of gelatin, titanium dioxide, ferric oxide black and black ink. The 80 mg capsule shell is composed of gelatin, titanium dioxide, FD&C blue #1 and black ink. The black ink is composed of shellac, potassium hydroxide and ferric oxide black.
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RETEVMO (selpercatinib) Capsules: 40 mg, 80 mg.
Recommended dosage in adults and pediatric patients 12 years of age or older is based on weight • Less than 50 kg: 120 mg orally twice daily • 50 kg or greater: 160 mg orally twice daily • Reduce RETEVMO dose in patients with severe hepatic impairment.
RETEVMO (selpercatinib) is a kinase inhibitor indicated for the treatment of: • Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
2.Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy1
3.Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate1
4.Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options1