【Drug Name】

Name: Mobocertinib Capsules

Product Name:MOBDX

【Specification】

40mg

【Indications】

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

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

• has a certain abnormal epidermal growth factor receptor (EGFR) gene, and

• whose disease has worsened while on or after chemotherapy that contains platinum

Your healthcare provider will perform a test to make sure that MOBDX is right for you.

It is not known if MOBDX is safe and effective in children.

【Recommended Dosage】

• Take MOBDX exactly as your healthcare provider tells you to take it.

• Take your prescribed dose of MOBDX 1 time each day.

• Take MOBDX with or without food.

• Swallow MOBDX capsules whole. Do not open, chew, or dissolve the contents of the capsules.

• Do not change your dose or stop taking MOBDX unless your healthcare provider tells you to.

• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with MOBDX if you develop certain side effects.

• If you miss a dose of MOBDX, and it has been more than 6 hours, skip the dose and take your next dose at your regularly scheduled time the next day.

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

【Side Effects】

• Lung problems. MOBDX may cause severe lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, cough, chest pain, or fever.

• Heart problems, including heart failure. MOBDX may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start and during treatment with MOBDX. Tell your healthcare provider right away if you have any signs or symptoms of a heart problem, including feeling like your heart is pounding or racing, shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint.

• Diarrhea. Diarrhea is common during treatment with MOBDX, and may sometimes be severe. Diarrhea can cause you to lose too much body fluid (dehydration) and kidney problems. Your healthcare provider may tell you to start drinking more fluids and electrolytes to replace body salts or start taking your antidiarrheal medicines. Tell your healthcare provider right away if you have any loose stools or have stools more often than is normal for you.

The most common side effects of MOBDX include:

• diarrhea

• rash

• nausea

• mouth sores

• vomiting

• decrease appetite

• infection of skin around nails

• tiredness

• dry skin

• muscle or bone pain

MOBDX may affect fertility in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of MOBDX.

Call your doctor for medical advice about side effects.

【Storage】

• Store MOBDX at or below 86°F (30°C).

Keep MOBDX and all medicines out of reach of children.