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ALECENSA- alectinib hydrochloride capsule


  1. Patient Information
  2. Inform Patients Of The Following:
  3. Before You Take Alecensa, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Should I Take Alecensa?
  5. What Should I Avoid While Taking Alecensa?
  6. Alecensa May Cause Serious Side Effects, Including:
  7. What Are The Ingredients In Alecensa?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform Patients Of The Following: 

Hepatotoxicity

Inform patients of the signs and symptoms of bilirubin and hepatic transaminase elevations. Advise patients to contact their healthcare provider immediately for signs or symptoms of bilirubin and hepatic transaminase elevations[
ALECENSA is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC):

  • that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene,and
  • that has spread to other parts of your body
It is not known if ALECENSA is safe and effective in children.

Before You Take Alecensa, Tell Your Healthcare Provider 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 healthcare provider right away if you become pregnant during treatment with ALECENSA or think you may be pregnant.
    • Femaleswho are able to become pregnant should use effective birth control during treatment with ALECENSA and for 1 week after the final dose of ALECENSA.
    • Maleswho 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 healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take,including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

How Should I Take Alecensa? 

  • Take ALECENSA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ALECENSA unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALECENSA if you have side effects.
  • Take ALECENSA 2 times a day.
  • Take ALECENSA with food.
  • Swallow ALECENSA capsules whole. Do not open or dissolve the capsule contents.
  • If you miss a dose of ALECENSA, do not take the missed dose. Take your next dose at your regular time.
  • If you vomit after taking a dose of ALECENSA, do not take an extra dose. Take your next dose at your regular time.

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?

Alecensa May Cause Serious Side Effects, Including: 

    • Do not store ALECENSA at temperatures above 86 F (30 C).
    • Store ALECENSA capsules in the original container.
    • Keep ALECENSA capsules dry and away from light.
    Keep ALECENSA and all medicines out of the reach of children.General information about the safe and effective use of ALECENSA.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ALECENSA for a condition for which it was not prescribed. Do not give ALECENSA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ALECENSA that is written for health professionals.

What Are The Ingredients In Alecensa? 


Active ingredient: alectinib
Inactive ingredients: lactose monohydrate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate and carboxymethylcellulose calcium. Capsule shell contains: hypromellose, carrageenan, potassium chloride, titanium dioxide, corn starch, and carnauba wax. Printing ink contains: red iron oxide (E172), yellow iron oxide (E172), FD&C Blue No. 2 aluminum lake (E132), carnauba wax, white shellac, and glyceryl monooleate.
Distributed by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990
ALECENSA is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
2017 Genentech, Inc.
For more information, go to www.ALECENSA.com or call 1-800-253-2367.

Representative sample of labeling (see theHOW SUPPLIEDsection for complete listing):



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