Alectinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat non-small cell lung cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe liver, lung, muscle, or heart problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: alectinib, oral; Alecensa

What is this medicine used for?

This medicine is taken by mouth to treat non-small cell lung cancer when:

• You have a certain type of abnormal gene, and
• Your cancer has spread to other parts of your body, and
• Your lung cancer either got worse while taking another medicine, or you couldn’t take crizotinib.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Any other lung disease or breathing problem
• Heart disease or a slow heartbeat
• Liver disease

Males: Use an effective birth control method while you are taking this medicine and for 3 months after stopping it. Talk with your healthcare provider about effective birth control.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 1 week after you finish treatment. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine and for at least 1 week after you finish treatment.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine 2 times per day, with food. Do not break, crush, or chew the capsules. Swallow them whole. Do not touch or handle crushed or broken capsules.

What if I miss a dose?

If you miss a dose or vomit after taking a dose, skip that dose and take the next regular dose. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine and for 7 days after you finish treatment, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may cause severe liver problems. Contact your healthcare provider right away if you develop severe tiredness, severe stomach pain, severe nausea or vomiting, loss of appetite, dark urine, itchy skin, yellowing of the eyes and skin, or unusual bruising or bleeding. These are signs of possible liver damage.

This medicine may cause a very slow heartbeat that can be severe. Your healthcare provider will check your heart rate and blood pressure regularly while you are taking this medicine. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint while you are taking this medicine. Also tell your provider if you start or stop taking heart or blood pressure medicines.

Muscle problems are common with this medicine and can sometimes be severe. Tell your healthcare provider right away if you have tenderness, weakness, unexplained muscle pain, or muscle pain that does not go away.

This medicine may cause life-threatening lung inflammation. Contact your healthcare provider right away if you have any new or worsening trouble breathing, shortness of breath, cough, or fever.

You need to have blood tests and checkups regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worse shortness of breath or cough, trouble breathing, sore throat, or fever; slow or irregular heartbeat; severe dizziness or fainting; unusual tiredness or weakness; unexplained muscle pain or muscle pain that doesn’t go away; vision problems; severe stomach pain, diarrhea, nausea, or vomiting; loss of appetite; yellowing of the eyes and skin; dark urine; light-colored bowel movements; unusual bruising or bleeding; numbness or tingling; unexplained swelling of your eyelids, hands, or feet.

Other: Mild rash, mild diarrhea, constipation, mild nausea or vomiting, headache, mild tiredness, back pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Clonidine (Catapres, Kapvay)
• Digoxin (Lanoxin)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), ivabradine (Corlanor), methyldopa, propafenone (Rythmol), and verapamil (Calan, Covera, Verelan)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the original container. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.