For US Healthcare Professionals

Prescribing Information

Terms to know

    A
    ALK (anaplastic lymphoma kinase) gene

    The ALK gene makes an ALK protein, which may be involved in cell growth. Mutations of the ALK gene and protein have been found in certain types of cancer, including non-small cell lung cancer.

    ALK inhibitors

    ALK inhibitors are medicines that bind to and stop the ALK fusion protein. This may help prevent the growth and spread of tumor cells.

    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, involving the ALK gene. 

    C
    Central nervous system

    The central nervous system includes the brain and the spinal cord.

    Complete response

    The disappearance of all signs of cancer, such as tumors, in response to treatment. This does not mean the cancer has been cured. 

    D
    Duration of response

    The amount of time from when tumors first start to shrink in response to a given treatment to the time when tumors begin to grow again.

    E
    Exploratory analysis

    An assessment of study results that was not specifically designed to find differences between two treatments in a study.

    F
    FDA

    The Food and Drug Administration, or FDA, is a US federal agency whose mission is to protect public health. 

    M
    Median

    The median is the middle value, or number, in a set of measurements when arranged from least to greatest.

    Metastatic

    The spread of cancer from the place where it started to other places in the body.

    O
    Overall survival

    The length of time from the date of diagnosis or the start of treatment for a disease that people diagnosed with the disease are still alive.

    P
    PFS (progression-free survival)

    The length of time during and after cancer treatment when a patient lives with the disease without it getting worse. 

    Partial response

    The decrease in the size and spread of tumors in response to a given treatment.

    Protein

    A molecule that is needed for your body to function properly. Proteins are the basis of cells in your body, including ALK.

    S
    Study

    A type of research study, or clinical trial, that tests how well a new medicine works in people. Studies can test new methods of screening, prevention, diagnosis, or treatment of a disease

Important Safety Information & Indication

Who is ALECENSA® (alectinib) for?

ALECENSA is a prescription medicine used to treat people with non-small cell lung cancer that has spread to other parts of the body (mNSCLC) and is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. Your healthcare provider 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). ALECENSA may cause liver injury. 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. 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
  • Fever

Kidney problems. ALECENSA may cause severe or life-threatening kidney problems. 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.

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. Tell your doctor right away if you become pregnant during treatment with ALECENSA or think you may be pregnant
    • Women who are able to become pregnant should use effective birth control during treatment with ALECENSA and for 1 week after the final dose of ALECENSA
    • Men who have female partners that are able to become pregnant should use effective birth control during treatment with ALECENSA and for 3 months after the final 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 final 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 final dose of ALECENSA. You may burn more easily and get severe sunburns. Use sunscreen and lip balm with 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:

  • Tiredness
  • Constipation
  • Swelling in your hands, feet, ankles, face, and eyelids
  • Muscle pain, tenderness, and weakness (myalgia)
  • Low red blood cell count

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.