What is the most important information I should know about ALECENSA® (alectinib)?

It is important to know what to expect with your treatment. These are some of the potential side effects you should be aware of when taking ALECENSA.

Tell your doctor right away if you have any new or worsening symptoms described below.

ALECENSA may cause serious side effects

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. Symptoms to look out for include:

  • 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. Symptoms to look out for include:

  • Trouble breathing

  • Shortness of breath

  • Cough

  • Fever

Kidney problems

ALECENSA may cause severe or life-threatening kidney problems. Symptoms to look out for include:

  • A change in the amount or color of your urine

  • 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. Symptoms to look out for include:

  • Feeling dizzy

  • Lightheaded

  • If you faint during treatment

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. Symptoms of muscle problems to look out for include:

  • Unexplained muscle pain

  • Muscle pain that doesn’t go away

  • Tenderness

  • Weakness

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 (anemia) 

If you experience side effects, your doctor may change your dose of ALECENSA. Your doctor may also temporarily stop or permanently stop treatment with ALECENSA to help manage 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.

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