Alecensa
Alecensa (alectinib) is an anaplastic lymphoma kinase (ALK) inhibitor. It's a targeted therapy that treats non-small cell lung cancer (NSCLC) that has a change in the ALK gene. Alecensa (alectinib) is a first-choice medication for NSCLC that has spread to other parts of the body (metastatic). It can also be used to treat early-stage NSCLC after surgery. This medication is taken by mouth twice daily. Some common side effects include constipation, tiredness, and muscle pain.
What is Alecensa (alectinib)?
What is Alecensa (alectinib) used for?
Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in adults
Early stage ALK-positive NSCLC in adults after surgery
How Alecensa (alectinib) works
Alecensa (alectinib) is a targeted therapy anticancer medication. Specifically, it's an anaplastic lymphoma kinase (ALK) inhibitor that blocks a protein called ALK.
The ALK protein is made by the ALK gene. This gene is something that everyone is born with. It plays an important role in helping babies develop in the womb. In people with ALK-positive NSCLC, this gene doesn’t work like it should. It ends up making abnormal proteins and causing cancer.
By blocking the abnormal ALK protein, Alecensa (alectinib) can help slow or stop the spread of NSCLC cells that are ALK-positive.
Drug Facts
What are the side effects of Alecensa (alectinib)?
Common Side Effects
- High creatine phosphokinase (up to 77%)
- Higher liver enzymes (up to 75%)
- Lower red blood cell count (up to 69%)
- Tiredness (26-41%)
- Higher creatinine levels (up to 41%)
- Constipation (up to 42%)
- Muscle aches and pain (up to 34%)
- Swelling in the body (up to 30%)
- Higher uric acid levels (up to 30%)
- Low blood calcium levels (29%)
- Higher blood sugar levels (22%)
- Cough (up to 20%)
- Lower sodium levels (18%)
- Changes in potassium levels (up to 17%)
- Rash (up to 23%)
- Nausea (up to 18%)
- Headache (17%)
- Diarrhea (up to 16%)
Other Side Effects
- Vomiting
- Vision problems
- Change in taste
- Back pain
- Kidney problems
- Slow heart rate
- Weight gain
- Having trouble catching your breath
Serious Side Effects
- Serious lungs problems: trouble breathing, cough, or fever
- Dangerously slow heartbeat: Tiredness, weakness, feeling dizzy or confused, feeling faint, trouble breathing, chest pain, getting tired easily during physical activity
- Serious liver problems: feeling very tired, nausea, vomiting, itchy skin, yellowing of the whites of the eyes or skin, stomach pain and swelling, swelling in the legs or ankles, dark-colored urine, pale-colored stool
- Kidney problems: feeling confused, tiredness, nausea, vomiting, change in urine color, change in amount of urine produced, or swelling in the legs and feet
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dry cough, shortness of breath or trouble breathing
- Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Fatigue
- Swelling of the ankles, hands, or feet
Pros and cons of Alecensa (alectinib)
Pros
A first-choice option for people with ALK-positive NSCLC
Taken by mouth
Shrink size of brain metastases in about 80% of people with metastatic ALK-positive NSCLC in clinical trials
Pharmacist tips for Alecensa (alectinib)
Alecensa (alectinib) is available as 150 mg capsules, so you’ll need 4 capsules to make up the typical dose. Take your dose with food and swallow the capsules whole. Don't open or dissolve the capsules.
If you miss or throw up your Alecensa (alectinib) dose, take the next dose at the scheduled time. If you vomit a dose, don't take an extra dose to make up for the vomited dose.
Let your oncologist know if you’re having troublesome side effects with Alecensa (alectinib). They might change your dose or have you take a break from the medication if you experience serious side effects.
Alecensa (alectinib) can make your skin more sensitive to the sun and ultraviolet (UV) rays. Make sure to protect your skin from the sun and avoid tanning beds while you're taking this medication and for a week after your last dose. If you need to go outside, protect your skin by wearing sunscreen with at least SPF of 50, wearing a wide-brimmed hat, or staying in shaded areas.
Protect Alecensa (alectinib) from heat. Store it at room temperature in the original container, away from light and moisture. Make sure to store it out of reach of children and pets.
It's not known if Alecensa (alectinib) can pass into your breastmilk or affect your milk production, but to avoid the risk of causing harm to your baby, don't breastfeed during your treatment and for 1 week after the last dose.
Frequently asked questions about Alecensa (alectinib)
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What are the risks and warnings for Alecensa (alectinib)?
Alecensa (alectinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver problems
Alecensa (alectinib) can raise your risk for liver problems, such as liver irritation or swelling. Your oncologist will order lab work to check your liver health during treatment. You’ll need to get your liver checked at least every 2 weeks during the first 3 months, then once a month for the remainder of your treatment. Sometimes, your oncologist might lower your dose of Alecensa (alectinib) or stop your treatment. Let your care team know if you experience symptoms of liver problems, such as tiredness, feeling less hungry than normal, yellowing of the skin or whites of your eyes, dark urine, itchy skin, or nausea.
Muscle pain
Alecensa (alectinib) can cause muscle pain. Let your oncologist know if you experience any unexplained muscle pain, tenderness, or weakness. To monitor your muscle health, your oncologist can check your creatine phosphokinase (CPK) labs. This should be checked every 2 weeks during the first month of treatment with Alecensa (alectinib), and as needed throughout your treatment. If the CPK level is high, it could be a sign of muscle damage.
Slow heart rate
Alecensa (alectinib) can cause some people to have a slow heart rate, which can lead to symptoms like dizziness, lightheadedness, and feeling faint. Your oncologist will ask you to check your heart rate and blood pressure regularly during your treatment. Let them know if you're taking any blood pressure medications that can also affect your heart rate. If your heart rate drops too low, they'll have you stop taking Alecensa (alectinib) for a short period of time until your heart rate recovers. But if this keeps happening, they might need to change you to a different medication.
Kidney problems
Some people experienced kidney problems while taking Alecensa (alectinib). This can happen as early as 2 weeks after starting this medication. But some people didn't experience kidney problems until they had been taking Alecensa (alectinib) for more than a year. If you develop problems with your kidney, your oncologist might need to lower your dose of Alecensa (alectinib) or stop your treatment completely. Let your care team know right away if you experience nausea, muscle cramps, a change in the amount or color of your urine, or swelling in your legs or feet.
Lung problems
Although rare, some people treated with Alecensa (alectinib) developed interstitial lung disease (ILD) or pneumonitis, usually within the first 2 to 4 months after starting treatment. If this happens, you'll need to stop Alecensa (alectinib) treatment. Let your oncologist know right away if you experience trouble breathing, cough, or fever.
Red blood cell problem
Alecensa (alectinib) might raise the risk of a red blood cell problem called hemolytic anemia, where your red blood cells get destroyed faster than they're made. Your oncologist might stop your treatment or lower your dose of Alecensa (alectinib) if you experience this problem. Let your care team know if you experience tiredness, weakness, dizziness, or trouble breathing.
Harm to unborn baby
Alecensa (alectinib) hasn't been studied in human pregnancy, but based on animal studies, it can cause harm to unborn babies. Females who are able to get pregnant should use an effective form of birth control during the treatment with Alecensa (alectinib) and for 1 week after the last dose.
If you're a male taking Alecensa (alectinib) and have female partner(s) who are able to get pregnant, you should use an effective form of birth control during treatment and for 3 months after the last dose.
Alecensa (alectinib) dosage forms
Typical dosing for Alecensa (alectinib)
Adults: The typical dose of Alecensa (alectinib) is 600 mg by mouth twice daily with food.
Your dose of Alecensa (alectinib) might be lower if you have liver problems.
What are alternatives to Alecensa (alectinib)?
Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in adults
Early stage ALK-positive NSCLC in adults after surgery
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer that has spread to other parts of the body
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer that has spread to other parts of the body
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References
Best studies we foundALK Positive. (n.d.). What is ALK-positive lung cancer?
American Cancer Society. (2024). Surgery for non-small cell lung cancer.
American Lung Association. (n.d.). Interstitial lung disease (ILD).
American Lung Association. (2024). Brain metastasis from lung cancer.
American Lung Association. (2024). Chemotherapy for lung cancer.
American Lung Association. (2024). ALK and lung cancer.
Aujla, R. S., et al. (2024). Creatine phosphokinase. StatPearls.
Genentech, Inc. (2024). Alecensa- alectinib hydrochloride capsule [package insert]. DailyMed.
MedlinePlus. (2022). Uric acid test.
MedlinePlus. (2023). Creatine kinase.
Mok, T., et al. (2020). Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Annals of Oncology.
National Cancer Institute. (n.d.). Anaplastic lymphoma kinase.
National Cancer Institute. (n.d.). Pneumonitis.
National Cancer Institute. (2017). FDA approves alectinib for initial treatment of ALK-positive lung cancer.
National Comprehensive Cancer Network. (2024). Early and locally advanced non-small cell lung cancer.
National Comprehensive Cancer Network. (2024). Metastatic non-small cell lung cancer.
National Heart, Lung, and Blood Institute. (2022). Hemolytic anemia.
Sikkema, B. J., et al. (2023). 1367P Predictive clinical characteristics for body weight gain in patients treated with alectinib: Analyses of J-ALEX, ALUR, and ML29453. Annals of Oncology.
Sikkema, B. J., et al. (2024). Body weight gain associated with alectinib in patients with ALK+ non-small cell lung cancer: Pooled analysis of individual patient data from four prospective clinical trials. Journal of Clinical Oncology.
Wu, Y. L., et al. (2024). Alectinib in resected ALK-positive non-small-cell lung cancer. The New England Journal of Medicine.
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