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About ALECENSA® (alectinib)

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What is ALECENSA and how is it thought to work?
Why did my doctor prescribe ALECENSA?

What is ALECENSA and how is it thought to work?

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. This is important to know because ALK+ mNSCLC may be treated by medications that target ALK.

Why did my doctor prescribe ALECENSA?

ALECENSA is prescribed for 2 different groups of people:

Human body with cancer spread beyond lungs

ALK+ mNSCLC

For people diagnosed with ALK+ metastatic non-small cell lung cancer (mNSCLC), or cancer that has spread beyond the lungs.

Human body with cancer within lung

ALK+ eNSCLC

It’s also used for people with ALK+ early-stage non-small cell lung cancer (eNSCLC) as an adjuvant treatment after surgery.

The goal of treatment for 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.

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The goal of treatment can be different for each person—be sure to talk to your doctor about your own treatment goals.

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How do I take ALECENSA?

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How was ALECENSA studied?

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  • ALK inhibitor: An ALK inhibitor is a type of medicine that is designed to bind to and block the activity of the ALK protein.

  • ALK+ mNSCLC: ALK (anaplastic lymphoma kinase)-positive metastatic non-small cell lung cancer is a type of lung cancer that has spread to other places in the body. It involves the mutation of the ALK gene.

  • Adjuvant treatment: Treatment given after surgery to help lower the risk that cancer will come back.

  • Metastatic non-small cell lung cancer (mNSCLC): This means that the cancer has started to spread. It’s also called advanced lung cancer, or stage 4.

  • Recurrence: This is when cancer comes back after surgery or treatment.

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.