Uses

Alectinib is used to treat a certain type of lung cancer. It works by slowing or stopping the growth of cancer cells. Alectinib belongs to a class of drugs known as tyrosine kinase inhibitors.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking alectinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily. Swallow the capsules whole. Do not open or dissolve the contents of the capsules. If you vomit after taking a dose, do not take an extra dose. Take your next dose at the regular time.

The dosage is based on your medical condition, side effects, lab test results, and response to treatment. Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Side Effects

Tiredness, constipation, nausea, vomiting, diarrhea, swelling ankles/feet/hands, back pain, headache, weight gain, or vision changes (such as blurred vision, decreased vision) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• slow heartbeat
• dizziness
• lightheadedness
• fainting
• unexplained muscle pain/tenderness/weakness
• signs of kidney problems (such as change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• new/worsening lung disease (such as trouble breathing, shortness of breath, cough, fever)
• chest pain
• sudden severe bleeding
• black/bloody stools
• vomit that contains blood or looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking alectinib, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• slow heartbeat
• kidney disease

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps during treatment and for at least 1 week after stopping this medication. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alectinib. Alectinib may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for at least 1 week after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as kidney and liver function tests, heart rate, blood pressure, a blood test for muscle problems called creatine phosphokinase-CPK level) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store this medication below 86 degrees F (30 degrees C) in the original container to protect from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.