Alectinib

WHY is this medicine prescribed?

Alectinib is used to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Alectinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Alectinib comes as a capsule to take by mouth. It is usually taken with food twice daily. Take alectinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alectinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open or dissolve them.

If you vomit after you take alectinib, do not immediately take another dose. Continue your regular dosing schedule.

Your doctor may temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects of alectinib. Tell your doctor how you are feeling during your treatment. Continue to take alectinib even if you feel well. Do not stop taking alectinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking alectinib,

• tell your doctor and pharmacist if you are allergic to alectinib, any other medications, or any of the ingredients in alectinib capsules. Ask your pharmacist for a list of the ingredients.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking alectinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had liver disease, lung or breathing problems, or a slow or irregular heartbeat.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You should not become pregnant while you are taking alectinib. If you are a female, you should use a reliable method of birth control while taking alectinib and for at least 1 week after your final dose. If you are a male, you and your female partner should use effective birth control while you are taking alectinib and for 3 months after your final dose. If you or your partner becomes pregnant while taking alectinib call your doctor immediately. Alectinib may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breast-feed while taking alectinib and for 1 week after your last dose.

• plan to avoid unnecessary or prolonged exposure to sunlight (including sunlamps and tanning beds) and to wear protective clothing, sunglasses, and a sunscreen that has a sun protection factor (SPF) of at least 50 while taking alectinib and for at least 7 days after your last dose. Alectinib may make your skin sensitive to sunlight.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Alectinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• swelling in your hands, face, or eyelids
• headache
• weight gain
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• new or worsening shortness of breath, difficulty breathing, or cough
• fever
• sudden chest pain
• dizziness, lightheadedness, or fainting
• vision changes
• sudden muscle pain, tenderness, or weakness
• back pain
• tiredness
• rash
• itchy skin
• loss of appetite
• nausea
• vomiting
• yellowing of skin or the whites of your eyes
• pain on the right side of your stomach area
• change in the amount or color of your urine
• new or worsening swelling in your legs or feet
• bleeding or bruising more easily than normal

Alectinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your heart rate and blood pressure regularly and order certain lab tests to check your body's response to alectinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.