Non-small cell lung cancer, or NSCLC, is a common form of lung cancer. However, a small portion of people with NSCLC—about 5%—have a change in the anaplastic lymphoma kinase, or ALK, gene.
This change in the ALK gene results in an abnormal ALK fusion protein
The abnormal protein causes this type of lung cancer, also called ALK+ NSCLC, to grow and spread to other parts of the body ( ALK+ mNSCLC )
Doctors test people who have NSCLC to find out if they are ALK+. Knowing ALK status helps doctors choose which treatment to prescribe.
An important treatment goal for people who have just learned that they have ALK+ NSCLC that has spread to other parts of the body (mNSCLC) is to help prevent their tumor from further growing or spreading for as long as possible.
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.
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:
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:
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.
Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take ALECENSA. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop ALECENSA and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on ALECENSA at a lower dose when the hemolytic anemia goes away, or may stop your treatment with ALECENSA. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.
Before you take ALECENSA, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
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 SPF 50 or greater to help protect against sunburn.
The most common side effects of ALECENSA include:
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.
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