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
Side effects of Alecensa (alectinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
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%)
Less Common Side Effects
- Vomiting
- Vision problems
- Change in taste
- Back pain
- Kidney problems
- Slow heart rate
- Weight gain
- Having trouble catching your breath
Alecensa (alectinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- 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
The following Alecensa (alectinib) 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 these 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
Cons
- Need to take 4 pills twice daily
- Must take with food
- Commonly causes weight gain
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.
Common questions about Alecensa (alectinib)
No, Alecensa (alectinib) isn’t chemotherapy. It’s a targeted therapy that works against a specific protein called ALK in certain lung cancers. This is different from chemotherapy, which works against all fast-growing cells in the body, including cancer cells. Talk with your oncologist if you have questions about treatment options for NSCLC.
Alecensa (alectinib) isn’t immunotherapy. In general, immunotherapy works by activating your body’s own immune system to detect and attack cancer cells. Some examples of immunotherapies for lung cancer are Opdivo (nivolumab) and Keytruda (pembrolizumab). Alecensa (alectinib), on the other hand, is a targeted therapy that treats NSCLC with the ALK mutation. Immunotherapies for lung cancer aren’t typically used together with Alecensa (alectinib).
How well Alecensa (alectinib) works depends on the condition being treated. For people with metastatic ALK-positive non-small cell lung cancer (NSCLC), a study found that about 63% of those taking Alecensa (alectinib) were still alive after 5 years, compared to about 46% of people who received a different NSCLC treatment. In a different study of people with early stage NSCLC, results showed that about 94% of those taking Alecensa (alectinib) after surgery didn't have signs or symptoms of the cancer returning at the 2-year check up, compared to 63% of those who received chemotherapy.
In general, you'll continue taking Alecensa (alectinib) as long as it’s helping to treat your cancer. But if you're taking Alecensa (alectinib) following surgery for early-stage NSCLC, your oncologist will likely ask you take this medication for a total of 2 years. However, they might tell you to pause treatment or consider other anticancer options if you experience side effects that you can’t tolerate. Speak with your oncologist if you have questions about your treatment plan.
Alecensa (alectinib) can make you more sensitive to the sun and raise your risk of sunburn. Avoid tanning beds or spending time in the sun for a long period of time while you're taking Alecensa (alectinib) and for at least a week after your last dose. When going outside, use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm with at least SPF of 50 to protect your skin from getting sunburn. You can also protect yourself from the sun by wearing a wide-brimmed hat, loose-fitting long sleeves and long pants, or staying in the shade.
Yes, you can gain weight after starting Alecensa (alectinib). Studies showed that almost 50% of people taking Alecensa (alectinib) experienced weight gain, typically during the first year of treatment. If you’re concerned about weight gain while taking Alecensa (alectinib), talk with your oncologist. They can provide tips on healthy eating during cancer treatment.
No, hair loss isn’t one of the side effects reported by people who took Alecensa (alectinib) in clinical trials. If you notice hair loss after starting this medication, talk with your oncology team. They can look into what might be causing this side effect.
No, you shouldn't take Alecensa (alectinib) if you're pregnant or breastfeeding. This medication hasn't been studied in human pregnancy nor in nursing mothers. But based on animal studies, it can cause harm to unborn and breastfed babies. If you're able to become pregnant, make sure to use birth control during Alecensa (alectinib) treatment and for a week after your last dose. If you're nursing, don't breastfeed while you're taking Alecensa (alectinib) and for a week after your treatment ends. Talk with your oncologist if you have any questions about Alecensa (alectinib) and pregnancy or nursing.
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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
Typical dosage 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.
