How ALECENSA® (alectinib) May Help

ALECENSA may work when prior crizotinib treatment stops working or can no longer be tolerated

Results from 2 studies have shown ALECENSA effectively shrank tumors in people with ALK+ NSCLC that had spread to other parts of the body and who have taken the medicine crizotinib, but their NSCLC worsened.

Tumors shrank in up to 44% of people treated with ALECENSA (38% in Study 1 and 44% in Study 2).

In Study 1, people whose ALK+ NSCLC tumors responded to ALECENSA continued to respond for a mediana of 7.5 months.

In Study 2, people whose ALK+ NSCLC tumors responded to ALECENSA continued to respond for a median of 11.2 months.

If you experience side effects, your doctor may:

  • Change your dose of ALECENSA
  • Temporarily stop treatment with ALECENSA
  • Permanently stop treatment with ALECENSA

To get the most of any treatment, it is important for you to take your medicine exactly as your doctor tells you.

If you and your doctor decide that ALECENSA is right for you, treatment goals may be set to see how your ALK+ NSCLC tumors respond to treatment with ALECENSA.

Select Important Safety Information

ALECENSA may cause serious side effects, including:

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 

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

ALECENSA may work in the brain

ALECENSA is an ALK inhibitor approved by the FDA and has shown that it may shrink tumors that spread to the brain.

In studies, ALECENSA showed the ability to shrink ALK+ NSCLC tumors that spread to the brain and other parts of the body in people who had taken the medicine crizotinib, but their NSCLC worsened.

Approximately 3 out of 5 people with ALK+ NSCLC had brain tumors shrink with ALECENSA.

Tumor Response with Alecensa Image

In people with brain tumors that responded to ALECENSA treatment, tumor response in the central nervous system continued for a median of 9.1 months.

a The median is the middle value, or number, in a set of measurements when arranged from least to greatest.
b It is important to know that a complete response is not the same as cure.

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Who Is ALECENSA For?

ALECENSA is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and:

  • whose type of NSCLC is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and
  • who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib

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

The effectiveness of ALECENSA in these patients is based on studies that measured 2 types of response to treatment (response rate and duration of response). There is an ongoing study to find out how ALECENSA works over a longer period of time.

Important Safety Information

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 once a 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 

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 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.

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 a 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, and eyelids

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.