Alectinib is a type of cancer medication used to treat non-small cell lung cancer (NSCLC) in people who have an error in their anaplastic lymphoma kinase (ALK) gene. This error is found in about 5 percent of people with NSCLC.

The defect in the ALK gene causes it to fuse with other genes, which causes cells to grow out of control and leads to ALK-positive cancer.

Alectinib works by blocking the ALK receptor, which helps to stop or slow the spread of cancer. Alectinib is a ALK tyrosine kinase inhibitor.

Alectinib was approved by the US Food and Drug Administration (FDA) in 2015.

What is alectinib used for?

Alectinib is a prescription medicine used to treat people with NSCLC:

• that is caused by an abnormal ALK gene, and
• that has spread to other parts of your body

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

Alectinib may cause serious side effects, including:

• Liver problems (hepatotoxicity). Alectinib may cause liver injury. Your healthcare provider will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with alectinib. Tell your healthcare provider right away if you get any of the following signs and symptoms:
  • feeling tired
  • feeling less hungry than usual
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • itchy skin
  • nausea or vomiting
  • pain on the right side of your stomach area
  • bleeding or bruising more easily than normal
• Lung problems. Alectinib may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.
• Kidney problems. Alectinib may cause severe or life-threatening kidney problems. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.
• Slow heartbeat (bradycardia). Alectinib may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate and blood pressure during treatment with alectinib. Tell your healthcare provider right away if you feel dizzy, lightheaded, or if you faint during treatment with alectinib. Tell your healthcare provider if you take any heart or blood pressure medicines.
• Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with alectinib and can be severe. Your healthcare provider will do blood tests at least every 2 weeks for the first month and as needed during treatment with alectinib. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
• Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take alectinib. If this happens, you may not have enough healthy red blood cells. Your healthcare provider may temporarily stop alectinib and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your healthcare provider may either restart you on alectinib at a lower dose when the hemolytic anemia goes away, or may stop your treatment with alectinib. Tell your healthcare provider right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

See "What are the side effects of alectinib?" below for more information about side effects.

• Take alectinib exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking alectinib unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with alectinib if you have side effects.
• Take alectinib 2 times a day.
• Take alectinib with food.
• Swallow alectinib capsules whole. Do not open or dissolve the capsule contents.
• If you vomit after taking a dose of alectinib, do not take an extra dose. Take your next dose at your regular time.

• The recommended dose of alectinib is 600 mg orally twice daily. Administer alectinib with food.
• See full prescribing information for further information about dosing.

Before you take alectinib, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have lung or breathing problems
• have a slow heartbeat

If you miss a dose of alectinib, do not take the missed dose. Take your next dose at your regular time.

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

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

• Avoid spending time in the sunlight during treatment with alectinib and for 7 days after the final dose of alectinib. You may burn more easily and get severe sunburns. Use sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.

Alectinib may cause serious side effects, including:

• See "Important information"

The most common side effects of alectinib include:

• tiredness
• constipation
• swelling in your hands, feet, ankles, face and eyelids
• muscle pain, tenderness, and weakness (myalgia). See "Important information"
• anemia

These are not all of the possible side effects of alectinib. For more information, ask your healthcare provider or pharmacist.

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

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

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.