【Drug Name】

Name: Sotorasib Tablets

Product Name: SOTOLDX

【Specification】

120mg

【Indications】

SOTOLDX is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC): 

• that has spread to other parts of the body or cannot be removed by surgery, and 

• whose tumor has an abnormal KRAS G12C gene, and 

• who have received at least one prior treatment for their cancer. Your healthcare provider will perform a test to make sure that SOTOLDX is right for you. It is not known if SOTOLDX is safe and effective in children.

【Recommended Dosage】

• Take SOTOLDX exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking SOTOLDX unless your healthcare provider tells you to. 

• Take SOTOLDX 1 time each day, at about the same time each day. 

• Take SOTOLDX with or without food. 

• Swallow SOTOLDX tablets whole. Do not chew, crush, or split tablets. 

• If you cannot swallow SOTOLDX tablets whole: 

o Place your daily dose of SOTOLDX in a glass of 4 ounces (120 mL) of non-carbonated, room temperature water without crushing the tablets. Do not use any other liquids. 

o Stir until the tablets are in small pieces (the tablets will not completely dissolve). The color of the mixture may be pale yellow to bright yellow. 

o Drink the SOTOLDX and water mixture right away or within 2 hours of preparing. Do not chew pieces of the tablet. 

o Rinse the glass with an additional 4 ounces (120 mL) of water and drink to make sure that you have taken the full dose of SOTOLDX. 

o If you do not drink the mixture right away, stir the mixture again before drinking. 

• If you take an antacid medicine, take SOTOLDX either 4 hours before or 10 hours after the antacid. 

• If you miss a dose of SOTOLDX, take the dose as soon as you remember. If it has been more than 6 hours, do not take the dose. Take your next dose at your regularly scheduled time the next day. Do not take 2 doses at the same time to make up for a missed dose. 

• If you vomit after taking a dose of SOTOLDX, do not take an extra dose. Take your next dose at your regularly scheduled time the next day.

【Side Effects】

SOTOLDX may cause serious side effects, including: 

• Liver problems. SOTOLDX may cause abnormal liver blood test results. Your healthcare provider should do blood tests before starting and during treatment with SOTOLDX to check your liver function. Tell your healthcare provider right way if you get any signs or symptoms of liver problems, including: 

o your skin or the white part of your eyes turns yellow (jaundice)

o nausea or vomiting

o bleeding or bruising

o dark or “tea-colored” urine 

o loss of appetite

o light-colored stools (bowel movements) 

o pain, aching, or tenderness on the right side of your stomach-area (abdomen)

o tiredness or weakness

• Lung or breathing problems. SOTOLDX may cause inflammation of the lungs that can lead to death. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough or fever. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with SOTOLDX if you develop side effects. The most common side effects of SOTOLDX include: 

• diarrhea 

• liver problems 

• muscle or bone pain 

• cough

• nausea 

• changes in liver function tests 

• tiredness 

• changes in certain other blood tests 

These are not all the possible side effects of SOTOLDX.

【Storage】

• Store SOTOLDX at room temperature between 68°F to 77°F (20°C to 25°C). 

• The bottle has a child-resistant closure. 

Keep SOTOLDX and all medicines out of the reach of children.