Find out the answers to commonly asked questions below.
Find out the answers to commonly asked questions below.
ALECENSA is an oral treatment known as an ALK inhibitor. It is used to treat ALK+ non-small cell lung cancer (NSCLC) that has been removed by surgery (adjuvant), or that has spread to other parts of the body (metastatic). ALK+ NSCLC is a type of NSCLC that is caused by alterations of the ALK gene. Learn more about ALECENSA.
ALECENSA is not a traditional chemotherapy. It works differently than chemotherapy. ALECENSA is an oral treatment called an ALK inhibitor. ALK inhibitors like ALECENSA work by targeting and blocking the abnormal ALK proteins responsible for the growth and spread of ALK+ mNSCLC. Learn why this is important.
The goal of treatment for ALK+ NSCLC that has spread to parts of the body outside of the lungs, or ALK+ mNSCLC, is usually to help people live longer without the disease getting worse (the tumors growing or spreading). This could mean shrinking tumors, stopping tumors from growing, or preventing new metastases. See clinical trial results.
ALECENSA was studied in 303 people with ALK+ mNSCLC. See clinical trial results.
In the clinical trial, ALECENSA helped some people live longer without their disease getting worse (the tumors growing or spreading). See clinical trial results for ALECENSA.
The size of tumors that have spread to the brain was measured in people taking ALECENSA. See results in the brain.
Possible serious side effects include liver problems (hepatotoxicity), lung problems, kidney problems, slow heartbeat (bradycardia), severe muscle pain, tenderness, and weakness (myalgia), and breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Find more information about these side effects and their symptoms here.
The most common side effects of ALECENSA include:
Here are some tips for managing common 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. 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.
Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medications you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
It’s important to take ALECENSA exactly as your doctor tells you to take it. Do not change your dose or stop taking ALECENSA unless your doctor tells you to. Here are some instructions for taking ALECENSA:
Your doctor prescribed ALECENSA to you as treatment for metastatic disease. They will determine how long you are on the medicine. Because ALECENSA was prescribed to you in this setting, you should take 600 mg orally twice daily until your disease spreads or you experience side effects that are not tolerable. In addition to stopping your treatment, your doctor may also choose to change your dose or temporarily stop treatment with ALECENSA to manage side effects.
ALECENSA should be stored in the original container at or below 86° F (30° C), in a dry place away from light. If you think your medicine was exposed to very hot or very cold temperatures, please contact your pharmacy.
Yes. No matter what type of health insurance you have, and even if you have none at all, there may be some potential options available to help you afford your medicine. Find our financial assistance options here.
If you have questions or concerns about ALECENSA, your diagnosis, or your treatment, you should discuss them with your healthcare team. For additional resources:
Genentech is unable to provide treatment advice. If you have questions about your medical condition, contact your doctor.
You are not alone. Along with your healthcare team and caregivers, we are here to support you on your path forward with ALECENSA.
Criteria | ALECENSA dose modification |
---|---|
ALT or AST elevation of >5X ULN with total bilirubin ≤2X ULN | Temporarily withhold until recovery to baseline or to ≤3X ULN, then resume at reduced dose. See dose reduction schedule. |
ALT or AST elevation >3X ULN with total bilirubin elevation >2X ULN in the absence of cholestasis or hemolysis | Permanently discontinue ALECENSA. |
Total bilirubin elevation >3X ULN | Temporarily withhold until recovery to baseline or to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Any grade treatment-related ILD/pneumonitis | Permanently discontinue ALECENSA. |
Grade 3 renal impairment | Temporarily withhold until serum creatinine recovers to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Grade 4 renal impairment | Permanently discontinue ALECENSA. |
Symptomatic bradycardia | Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. See dose reduction schedule. |
Bradycardiaa (life-threatening consequences, urgent intervention indicated) | Permanently discontinue ALECENSA if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. See dose reduction schedule. |
CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at same dose. |
CPK elevation >10X ULN or second occurrence of CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Hemolytic anemia | Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue. See dose reduction schedule. |
aHeart rate <60 bpm.
ALT=alanine transaminase; AST=aspartate transaminase; bpm=beats per minute; CPK=creatine phosphokinase; ILD=interstitial lung disease; ULN=upper limit of normal.
The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.