Class: Biological Therapy

Generic Name: alectinib

Trade Name: Alecensa®

For which conditions is this drug approved? Alecensa is approved to treat patients with non-small cell lung cancer (NSCLC) that has a mutation in the anaplastic lymphoma kinase (ALK) gene and has spread to other parts of the body. Alecensa is also approved for patients who have taken the medicine Xalkori® (crizotinib), but their NSCLC has gotten worse or they cannot tolerate Xalkori.

What is the mechanism of action? Alecensa is thought to work by blocking the activity of the ALK protein. Blocking the ALK protein may prevent NSCLC cells from growing and spreading.

How is Alecensa typically given (administered)? You will take Alecensa orally (by mouth) two times a day. Take Alecensa with food and swallow the capsules whole. Do not open or dissolve the capsules.

How are patients typically monitored? During treatment with Alecensa, your doctor will monitor you for the following:

• Liver problems (hepatotoxicity). Your doctor will do blood tests to check your liver function at least every two weeks for the first two months of treatment and as needed during treatment.
• Lung problems—specifically, severe or life-threatening swelling (inflammation) of the lungs.
• Slow heartbeat (bradycardia). Your healthcare provider will check your heart rate and blood pressure during treatment with Alecensa.
• Muscle pain, tenderness, and weakness (myalgia). Your healthcare provider will do blood tests at least every two weeks for the first month and as needed during treatment with Alecensa.

What are the common (occur in 30% or more of patients) side effects of treatment with Alecensa?

• Fatigue
• Constipation
• Edema (excess of watery fluid collecting in the cavities or tissues of the body)
• Myalgia (muscle pain)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Alecensa?

• Cough
• Rash
• Nausea
• Headache
• Diarrhea
• Dyspnea (difficult or labored breathing)
• Back pain
• Vomiting
• Weight gain
• Vision disorder

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• If you miss a dose of Alecensa, do not take the missed dose. Wait until your regular time to take your next dose.
• If you vomit after taking a dose of Alecensa, do not take an extra dose. Wait until your regular time to take your next dose.
• Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

• Before you take Alecensa, tell your healthcare provider about all of your medical conditions. Be especially sure to tell your doctor if you have:
  • Liver problems
  • Lung or breathing problems
  • A slow heartbeat
• Tell your doctor if you are pregnant or plan to become pregnant. Alecensa can harm your unborn baby. If you become pregnant or think you may be pregnant during treatment with Alecensa, tell your doctor right away.
• Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose.
• Men who have female partners who are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa.
• Tell your doctor if you 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 one week after the final dose. If you have a new baby, talk to your healthcare provider about the best way to feed your baby during treatment.
• Avoid sun exposure during treatment with Alecensa and for seven days after the final dose. Alecensa may cause you to burn more easily and get severe sunburns. Use sunscreen and lip balm with a SPF 50 or greater.

When should patients notify their physician?

Tell your healthcare provider right away if you get signs and symptoms of the following:

• A Liver problem
  • 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
• A lung problem
  • Trouble breathing
  • Shortness of breath
  • Cough
  • Fever
• A heart problem
  • Feeling dizzy
  • Feeling lightheaded
  • Feeling faint
  • If you take any heart or blood pressure medicines
• A muscle problem
  • Unexplained muscle pain or muscle pain that does not go away
  • Tenderness
  • Weakness

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect. Last updated 08/16.

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