Important Safety Information and Indication

VIZIMPRO may cause serious side effects, including:

• Lung or breathing problems. VIZIMPRO may cause severe inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing or shortness of breath, cough, or fever.
• Diarrhea. Diarrhea is common during treatment with VIZIMPRO, and can be severe and lead to death. Diarrhea can cause you to lose too much body fluid (dehydration). Your healthcare provider may tell you to start drinking more fluids or start taking your anti-diarrheal medicines. Tell your healthcare provider right away, if you have any loose stools or have stools more often than is normal for you.
• Skin reactions. Skin reactions are common with VIZIMPRO and can be severe. These skin reactions may include: dry skin, redness, rash, acne, itching, and peeling or blistering of your skin. Use moisturizers every day when taking VIZIMPRO. Use sunscreen and wear protective clothing that covers your skin, while exposed to sunlight, while you are taking VIZIMPRO. Your healthcare provider may prescribe other medicines to help skin reactions. Tell your healthcare provider right away about any worsening skin reactions.

Before taking VIZIMPRO, tell your healthcare provider about all your medical conditions, including if you:

• have frequent diarrhea.
• have a history of lung or breathing problems other than lung cancer.
• are pregnant, or plan to become pregnant. VIZIMPRO can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with VIZIMPRO.
• You should use effective birth control (contraception) during treatment and for at least 17 days after your last dose of VIZIMPRO. Talk to your healthcare provider about birth control methods that may be right for you during this time.
• Tell your healthcare provider right away if you become pregnant during your treatment with VIZIMPRO.

• are breastfeeding or plan to breastfeed. It is not known if VIZIMPRO passes into your breast milk. Do not breastfeed during treatment and for at least 17 days after your last dose of VIZIMPRO. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIZIMPRO and other medicines or supplements may affect each other causing side effects.

What should I avoid during treatment with VIZIMPRO?

Minimize exposure to sunlight. VIZIMPRO can cause skin reactions.

The most common side effects of VIZIMPRO include:

• rash
• diarrhea
• mouth pain and sores
• nail inflammation
• common cold
• dry skin
• decreased appetite
• decreased weight
• dry, red, itchy eyes
• hair loss
• itching

These are not all of the possible side effects of VIZIMPRO. You can ask your pharmacist or healthcare provider for more information about VIZIMPRO that is written for health professionals.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Indication: VIZIMPRO is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic).

• VIZIMPRO is used as a first treatment if tumors have certain types of abnormal epidermal growth factor receptor (EGFR) gene(s).

Your healthcare provider will perform a test to make sure that VIZIMPRO is right for you. It is not known if VIZIMPRO is safe and effective in children.

Please see Full Prescribing Information and Patient Information.