Manufactor:Bigbear Pharmaceutical Laos
Introduction：On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved selpercatinib, which is the first drug approved specifically for the treatment of metastatic non-small cell lung cancer (NSCLC) with transfection rearrangement gene (RET) fusion-positive ), and adults and pediatric patients 12 years and older with advanced or metastatic medullary thyroid cancer harboring a RET mutation who require systemic therapy, and RET refractory to systemic therapy and radioactive iodin...
Name: Selpercatinib Capsules
Product Name: SEPADX
SEPADX is a kinase inhibitor indicated for the treatment of:
• Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
• Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
• Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
• Select patients for treatment with SEPADX based on the presence of a RET gene fusion (NSCLC or thyroid) or specific RET gene mutation(MTC) •Recommended dosage in adults and pediatric patients 12 years of age or older is based on weight :
oLess than 50 kg: 120 mg orally twice daily
o50 kg or greater: 160 mg orally twice daily
•Reduce SEPADX dose in patients with severe hepatic impairment.
The most common side effects of SEPADX in adults are:
• increased levels of liver enzymes • increased blood sugar levels
• decrease in white blood cell count • decreased protein levels (albumin) in the blood
• decreased levels of calcium in the blood • dry mouth
• diarrhea • increased creatinine (kidney function test)
• high blood pressure • tiredness
• swelling of your arms, legs, hands, and feet (peripheral edema)
• decrease in platelet count
• increased cholesterol levels • rash
• decreased levels of salt (sodium) in the blood •constipation
• Store SEPADX at room temperature between 59°F to 86°F (15°C to 30°C).
Keep SEPADX and all medicines out of the reach of children.