What is alectinib?
Alectinib is a type of cancer medication used to treat non-small cell lung cancer (NSCLC) in people who have an error in their anaplastic lymphoma kinase (ALK) gene. This error is found in about 5 percent of people with NSCLC.
The defect in the ALK gene causes it to fuse with other genes, which causes cells to grow out of control and leads to ALK-positive cancer.
Alectinib works by blocking the ALK receptor, which helps to stop or slow the spread of cancer. Alectinib is a ALK tyrosine kinase inhibitor.
Alectinib was approved by the US Food and Drug Administration (FDA) in 2015.
What is alectinib used for?
Alectinib is a prescription medicine used to treat people with NSCLC:
- that is caused by an abnormal ALK gene, and
- that has spread to other parts of your body
It is not known if alectinib is safe and effective in children.
Alectinib may cause serious side effects, including:
- Liver problems (hepatotoxicity). Alectinib may cause liver injury. Your healthcare provider 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 alectinib. Tell your healthcare provider right away if you get any of the following signs and symptoms:
- 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. Alectinib 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 healthcare provider right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.
- Kidney problems. Alectinib may cause severe or life-threatening kidney problems. Tell your healthcare provider 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). Alectinib may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate and blood pressure during treatment with alectinib. Tell your healthcare provider right away if you feel dizzy, lightheaded, or if you faint during treatment with alectinib. Tell your healthcare provider if you take any heart or blood pressure medicines.
- Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with alectinib and can be severe. Your healthcare provider will do blood tests at least every 2 weeks for the first month and as needed during treatment with alectinib. Tell your healthcare provider right away if you get 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 alectinib. If this happens, you may not have enough healthy red blood cells. Your healthcare provider may temporarily stop alectinib and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your healthcare provider may either restart you on alectinib at a lower dose when the hemolytic anemia goes away, or may stop your treatment with alectinib. Tell your healthcare provider right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.
See "What are the side effects of alectinib?" below for more information about side effects.
What should I tell my doctor before taking alectinib?
Before you take alectinib, 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
How should I take alectinib?
- Take alectinib exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking alectinib unless your healthcare provider tells you to.
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with alectinib if you have side effects.
- Take alectinib 2 times a day.
- Take alectinib with food.
- Swallow alectinib capsules whole. Do not open or dissolve the capsule contents.
- If you vomit after taking a dose of alectinib, do not take an extra dose. Take your next dose at your regular time.
What happens if I miss a dose?
If you miss a dose of alectinib, do not take the missed dose. Take your next dose at your regular time.
What should I avoid while taking alectinib?
- Avoid spending time in the sunlight during treatment with alectinib and for 7 days after the final dose of alectinib. You may burn more easily and get severe sunburns. Use sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.
- The recommended dose of alectinib is 600 mg orally twice daily. Administer alectinib with food.
- See full prescribing information for further information about dosing.
What are the side effects of alectinib?
Alectinib may cause serious side effects, including:
- See "Important information"
The most common side effects of alectinib include:
- swelling in your hands, feet, ankles, face and eyelids
- muscle pain, tenderness, and weakness (myalgia). See "Important information"
These are not all of the possible side effects of alectinib. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Alectinib can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with alectinib or think you may be pregnant.
Females who are able to become pregnant should use effective birth control during treatment with alectinib and for 1 week after the final dose of alectinib.
Males who have female partners that are able to become pregnant should use effective birth control during treatment with alectinib and for 3 months after the final dose of alectinib.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if alectinib passes into your breast milk. Do not breastfeed during treatment with alectinib and for 1 week after the final dose of alectinib. Talk to your healthcare provider about the best way to feed your baby during this time.
- Do not store alectinib at temperatures above 86°F (30°C).
- Store alectinib capsules in the original container.
- Keep alectinib capsules dry and away from light.
Keep alectinib and all medicines out of the reach of children.
What are the ingredients in alectinib?
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.
Alectinib is distributed under the brandname Alecensa by Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.
Alecensa (alectinib) is a tyrosine kinase inhibitor (TKI) that works specifically on a protein called anaplastic lymphoma kinase (ALK protein). Tyrosine kinases (TK) help to determine processes such as growth, differentiation, metabolism, and cell death, and are involved in signaling pathways – these are pathways that control and regulate the flow of information between cells and their outside environment. Research has linked abnormal TK activity or mutations to various cancers – one of these is non-small cell lung cancer. Anaplastic lymphoma kinase (ALK) mutations are present in approximately 5% of NSCLC cases, and by inhibiting this protein, Alecensa reduces the growth of ALK-positive metastatic NSCLC. Alecensa is only used in metastatic NSCLC that has been tested and confirmed to be ALK-positive. Continue reading
More about alectinib
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- Side effects
- Dosage information
- During pregnancy
- Drug class: multikinase inhibitors
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