Frequently Asked Questions (FAQs)
about ALECENSA® (alectinib)

Have questions about ALECENSA?

Find out the answers to commonly asked questions below.

General

ALECENSA is an oral treatment known as an ALK inhibitor. It is used to treat ALK+ non-small cell lung cancer (NSCLC) that has been removed by surgery (adjuvant), or that has spread to other parts of the body (metastatic). ALK+ NSCLC is a type of NSCLC that is caused by alterations of the ALK gene. Learn more about ALECENSA.

ALECENSA is not a traditional chemotherapy. It works differently than chemotherapy. ALECENSA is an oral treatment called an ALK inhibitor. ALK inhibitors like ALECENSA work by targeting and blocking the abnormal ALK proteins responsible for the growth and spread of ALK+ mNSCLC. Learn why this is important.

The goal of treatment for ALK+ NSCLC that has spread to parts of the body outside of the lungs, or ALK+ mNSCLC, is usually to help people live longer without the disease getting worse (the tumors growing or spreading). This could mean shrinking tumors, stopping tumors from growing, or preventing new metastases. See clinical trial results.

Clinical trial results and safety

Clinical trial results and safety

ALECENSA was studied in 303 people with ALK+ mNSCLC. See clinical trial results.

In the clinical trial, ALECENSA helped some people live longer without their disease getting worse (the tumors growing or spreading). See clinical trial results for ALECENSA.

The size of tumors that have spread to the brain was measured in people taking ALECENSA. See results in the brain.

Possible serious side effects include liver problems (hepatotoxicity), lung problems, kidney problems, slow heartbeat (bradycardia), severe muscle pain, tenderness, and weakness (myalgia), and breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Find more information about these side effects and their symptoms here.

The most common side effects of ALECENSA include:

  • constipation  
  • tiredness  
  • swelling in your hands, feet, ankles, face, and eyelids 
  • rash 
  • cough 

Here are some tips for managing common side effects.

These are not all of the possible side effects of ALECENSA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Taking ALECENSA

Taking ALECENSA    

Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:

  • have liver problems
  • have lung or breathing problems
  • have a slow heartbeat
  • are pregnant or plan to become pregnant. ALECENSA can harm your unborn baby.
  • Females who are able to become pregnant:
    • Your doctor will do a test to see if you are pregnant before starting treatment with ALECENSA
    • You should use effective birth control (contraception) during treatment with ALECENSA and for 5 weeks after the last dose of ALECENSA
    • Tell your doctor right away if you become pregnant during treatment with ALECENSA or think you may be pregnant
  • Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ALECENSA and for 3 months after the last dose of ALECENSA
  • are breastfeeding or plan to breastfeed. It is not known if ALECENSA passes into your breast milk. Do not breastfeed during treatment with ALECENSA and for 1 week after the last dose of ALECENSA. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medications you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

It’s important to take ALECENSA exactly as your doctor tells you to take it. Do not change your dose or stop taking ALECENSA unless your doctor tells you to. Here are some instructions for taking ALECENSA:

  • Take ALECENSA twice a day with food  
  • The standard dose of ALECENSA is four 150-mg capsules. The total dose is 600 mg
  • You will take 2 doses of ALECENSA each day, for a total of 1200 mg (eight capsules)
  • Take ALECENSA exactly as your doctor tells you to take it
  • If you have severe liver disease, your doctor may start you on a different dose
  • During clinical trials, participants were not instructed on which foods or how much food to eat when taking ALECENSA
  • For questions about how to take ALECENSA, talk to your doctor or care team

Your doctor prescribed ALECENSA to you as treatment for metastatic disease. They will determine how long you are on the medicine. Because ALECENSA was prescribed to you in this setting, you should take 600 mg orally twice daily until your disease spreads or you experience side effects that are not tolerable. In addition to stopping your treatment, your doctor may also choose to change your dose or temporarily stop treatment with ALECENSA to manage side effects.

ALECENSA should be stored in the original container at or below 86° F (30° C), in a dry place away from light. If you think your medicine was exposed to very hot or very cold temperatures, please contact your pharmacy.

Additional information

Additional information

Yes. No matter what type of health insurance you have, and even if you have none at all, there may be some potential options available to help you afford your medicine. Find our financial assistance options here.

If you have questions or concerns about ALECENSA, your diagnosis, or your treatment, you should discuss them with your healthcare team.  For additional resources: 
 

  • Chat with one of our live representatives:
    ALECENSA Patient Resource Center: (800) ALECENSA (253-2367); translation services are available Monday-Friday, 9 am-8 pm ET

  • Ask nurse-specific medical questions related to your Genentech medicine: 
    Genentech: (800) 821-8590 Monday-Friday, 8 am-8 pm ET


Genentech is unable to provide treatment advice. If you have questions about your medical condition, contact your doctor.

You are not alone. Along with your healthcare team and caregivers, we are here to support you on your path forward with ALECENSA.

Clipboard icon

How was ALECENSA studied?

Heart over hand icon

Where can I find more support?

Important Safety Information & Indications

Who is ALECENSA for?

ALECENSA is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

  • as treatment when your lung cancer has spread to other parts of your body (metastatic), or
  • to help prevent your lung cancer from coming back after your tumor has been removed by surgery (adjuvant)

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

What is the most important information I should know about ALECENSA?

Everyone reacts differently to treatment with ALECENSA. It’s important to know the most serious and most common side effects with ALECENSA.

Your doctor may lower the dose or stop treatment with ALECENSA if any side effects occur. Contact your doctor right away if you have any of the following side effects.

ALECENSA may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with ALECENSA and can be severe. Your doctor 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 ALECENSA to check your liver function. Tell your doctor 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. ALECENSA 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 doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. ALECENSA may cause severe kidney problems that can lead to death. Tell your doctor 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). ALECENSA may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with ALECENSA and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with ALECENSA. Tell your doctor right away if you have any 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 ALECENSA. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop ALECENSA and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on ALECENSA at a lower dose when the hemolytic anemia goes away, or may stop your treatment with ALECENSA. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

What should I tell my doctor before taking ALECENSA?

Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:

  • have liver problems
  • have lung or breathing problems
  • have a slow heartbeat
  • are pregnant or plan to become pregnant. ALECENSA can harm your unborn baby.
    Females who are able to become pregnant:
    • Your doctor will do a test to see if you are pregnant before starting treatment with ALECENSA
    • You should use effective birth control (contraception) during treatment with ALECENSA and for 5 weeks after the last dose of ALECENSA
    • Tell your doctor right away if you become pregnant during treatment with ALECENSA or think you may be pregnant
    Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ALECENSA and for 3 months after the last dose of ALECENSA
  • are breastfeeding or plan to breastfeed. It is not known if ALECENSA passes into your breast milk. Do not breastfeed during treatment with ALECENSA and for 1 week after the last dose of ALECENSA. Talk to your doctor about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ALECENSA?

Avoid spending time in the sunlight during treatment with ALECENSA and for 7 days after the last dose of ALECENSA. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.

What are the possible side effects of ALECENSA?

The most common side effects of ALECENSA include:

  • constipation
  • tiredness
  • swelling in your hands, feet, ankles, face, and eyelids
  • rash
  • cough

These are not all of the possible side effects of ALECENSA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.