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Important Safety Information & Indication

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What it Treats

Who is ALECENSA 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.

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 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.

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
  • Are breastfeeding or plan to breastfeed

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

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.