【Drug Name】

Name: Selpercatinib Capsules

Product Name: SEPADX

【Specification】

40mg

【Indications】

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)                                                                                                                      

【Recommended Dosage】

  • 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.  

【Side Effects】

       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

【Storage】

       • 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.