Alecensa (alectinib)

What is Alecensa?

Alecensa is a brand-name prescription drug. It’s approved to treat a certain type of lung cancer that’s anaplastic lymphoma kinase-positive (ALK+). This means the cancer has a mutation (abnormal change) in the ALK gene.

Specifically, Alecensa is prescribed for adults with metastatic ALK+ non-small cell lung cancer (NSCLC). (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

Alecensa contains the active drug alectinib, which is an ALK inhibitor. This type of drug is commonly used to treat specific types of cancer. Alecensa belongs to a larger class of drugs called tyrosine kinase inhibitors. (A class of drugs is a group of medications that work in a similar way.)

Alecensa comes as capsules that are taken by mouth twice each day with food. Alecensa is available in only one strength: 150 mg.

Effectiveness

In a clinical study, Alecensa was given to people with metastatic ALK+ NSCLC who hadn’t received any treatment in the past. Alecensa was compared to another ALK inhibitor called crizotinib (Xalkori). In this study, there weren’t any people who took a placebo (no active drug).

People in the study took either Alecensa 600 mg twice a day or crizotinib 250 mg twice a day. The researchers looked to see which drug gave people a longer progression-free survival (PFS) time. PFS shows how long a person with cancer lives without their cancer getting worse.

In the study, half of the people who took Alecensa had a PFS of nearly 26 months. In comparison, half of the people who took crizotinib had a PFS of at least 10 months.

For more information about the effectiveness of Alecensa, see the section “Alecensa uses” below.

Alecensa generic

Alecensa contains the active drug alectinib.

Alecensa is available only as a brand-name medication. It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication.

Alecensa side effects

Alecensa can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Alecensa. These lists do not include all possible side effects.

For more information on the possible side effects of Alecensa, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Alecensa, you can do so through MedWatch.

Mild side effects

The mild side effects of Alecensa that are more common* can include:

• constipation
• edema (swelling in your feet, hands, or legs)
• fatigue (lack of energy)
• muscle pain
• anemia (low red blood cell level)
• hyperglycemia (high blood sugar level)
• reduced blood levels of calcium, sodium, phosphate, and potassium

The mild side effects of Alecensa that are less common† can include:

• headache
• back pain
• changes in taste, including being unable to taste certain foods
• lymphopenia (low level of lymphocytes, which are a type of white blood cell)
• neutropenia (low level of neutrophils, which are a type of white blood cell)
• cough
• diarrhea
• nausea
• vomiting
• increased skin sensitivity to sunlight, which may lead to sunburn
• rash
• shortness of breath
• weight gain

* These side effects occurred in at least 20% of people in clinical studies.
† These side effects occurred in less than 20% of people in clinical studies.

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Alecensa aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Vision problems. Symptoms can include:
  • blurry vision
  • reduced ability to see
  • seeing floaters
• Problems with your muscles. Symptoms can include:
  • myalgia (muscle pain)
  • muscle tenderness
  • muscle weakness
• Hemolytic anemia (rapid breakdown of red blood cells). Symptoms can include:
  • jaundice (yellowing of your skin or the whites of your eyes)
  • shortness of breath
  • dizziness
  • weakness

Other serious side effects, which are explained in more detail below in “Side effect details,” include:

• allergic reaction
• inflammation or swelling in your lungs
• kidney damage
• liver damage
• bradycardia (slow heart rate)

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Alecensa. But it’s not known how many people have had an allergic reaction to Alecensa in clinical trials.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Alecensa. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Constipation

Constipation is a common side effect of Alecensa. In fact, a clinical study showed that 34% of people who took the drug had constipation.

Fortunately, there are ways to help prevent or relieve constipation while you’re taking Alecensa. Try to drink at least 8 glasses of water every day and include fiber in your diet. Foods that contain high amounts of fiber include whole grains, fruits, and vegetables.

There are also medications that you can use to help relieve constipation. Your doctor may recommend medications for you that are safe to take during Alecensa treatment.

Talk with your doctor if you have constipation while you’re taking Alecensa. This is especially important to do if you don’t have a bowel movement for 2 or more days.

Fatigue

It’s fairly common to have fatigue (lack of energy) while you’re taking Alecensa. In clinical studies, 26% to 41% of people who took the drug had fatigue.

In some cases, fatigue can be a sign of other side effects from Alecensa, including:

• anemia (low red blood cell level), including hemolytic anemia
• bradycardia (slow heart rate)

If you feel fatigued while you’re taking Alecensa, talk with your doctor. They can discuss ways to help improve your energy levels.

Inflammation or swelling in your lungs

Although rare, Alecensa can cause inflammation, swelling, or infection in your lungs. In a clinical study, these side effects occurred in 0.7% of people who took the drug.

Inflammation in your lungs is also called pneumonitis. With this condition, you may have a cough or trouble breathing. Inflammation can scar and damage your lungs, which can lead to interstitial lung disease. With interstitial lung disease, it’s difficult for you to breathe, and the damage in your lungs is usually permanent.

During Alecensa treatment, your doctor will monitor you for any symptoms of lung inflammation. Symptoms of this condition can include:

• cough
• fever
• shortness of breath
• trouble breathing

If you have any symptoms of lung inflammation while you’re taking Alecensa, tell your doctor right away. They’ll check to see what’s causing your symptoms and can recommend whether you need medical treatment.

Kidney damage

It’s possible that Alecensa may affect your kidneys. In clinical studies, 8% of people who took Alecensa had their kidney function worsen during treatment.

If the drug has only a mild effect on your kidney function, your doctor may adjust your dosage of Alecensa. This allows you to keep taking the medication. In fact, during clinical studies, 3.2% of people had to have their dosage of Alecensa lowered because their kidney function worsened during treatment.

However, if your kidney function is severely affected by the drug, your doctor may recommend that you stop taking Alecensa.

Symptoms of kidney issues can vary, but may include:

• changes in the color of your urine
• having to urinate more often or less often than usual
• confusion
• edema (swelling in your feet, hands, or legs)
• fatigue (lack of energy)
• irregular heartbeat
• shortness of breath

Symptoms of kidney damage may overlap with symptoms of some other side effects of Alecensa. Because of this, it’s important to call your doctor if you have any symptoms of kidney problems. Your doctor can check to see if your kidney function has been affected by the drug.

Liver damage

Alecensa may cause damage to your liver.

Certain blood tests that measure liver enzymes (types of proteins) are used to check for liver damage and see how well your liver is working. In clinical studies, 34% to 51% of people taking Alecensa had higher than normal results on these blood tests. However, for most patients, the elevated levels weren’t serious. And the levels returned to normal on their own. In fact, less than 1% of people had to permanently stop taking Alecensa because of liver damage.

Your doctor will monitor your liver function while you’re taking Alecensa. During your first 3 months of treatment, you’ll likely have blood tests to check your liver function at least every 2 weeks. After the first 3 months of treatment, you’ll only need to have blood tests once a month (unless your doctor advises otherwise).

Based on the results of your lab tests, your doctor may recommend that you take a lower dosage of Alecensa. In some cases, your doctor may have you either temporarily or permanently stop taking the drug.

Symptoms of liver problems can vary, but may include:

• bleeding or bruising more easily than usual
• dark urine
• itchy skin
• pain on the right side of your belly
• jaundice (yellowing of your skin or the whites of your eyes)

If you have symptoms of liver problems, call your doctor. They’ll check to see what’s causing your symptoms and can recommend whether you need medical treatment.

Muscle pain

It’s not unusual to have muscle pain while you’re taking Alecensa. In clinical studies, 23% to 29% of people who took Alecensa had pain in their muscles.

For some people, Alecensa may increase the blood level of an enzyme (a type of protein) called creatine phosphokinase (CPK). This enzyme is typically released in your body when your muscles are damaged or injured. It’s not known for sure why Alecensa increases CPK, but the increased level may be a sign that muscle damage has happened.

While you’re taking Alecensa, your doctor will monitor your CPK levels by ordering blood tests. Depending on your blood levels of CPK, your doctor may recommend that you take a lower dosage of Alecensa. In some cases, your doctor may have you either temporarily or permanently stop taking the drug.

If you have any unexplained muscle pain, tenderness, or weakness, talk with your doctor. They can check to see what’s causing your discomfort. And they’ll recommend ways to improve your symptoms.

Slow heart rate

It’s possible to have bradycardia (slow heart rate) while you’re taking Alecensa. During clinical studies, bradycardia occurred in 8.6% of people who took the drug.

Symptoms of bradycardia can include:

• chest pain
• dizziness or feeling lightheaded
• fainting or nearly fainting
• fatigue (lack of energy)
• easily getting tired during physical activity
• shortness of breath

Your doctor will monitor your heart rate while you’re taking Alecensa. If your heart rate slows down a bit, but you aren’t having any symptoms, your doctor probably won’t change your dosage of Alecensa. And they probably won’t have you stop using the drug.

But if you start to have symptoms of bradycardia, your doctor may have you temporarily stop taking Alecensa until your symptoms go away.

If your doctor thinks that your bradycardia is life threatening, they may have you permanently stop taking the drug. And they may possibly recommend a cancer treatment other than Alecensa.

Alecensa dosage

The Alecensa dosage your doctor prescribes will depend on several factors. These include:

• other medical conditions you may have
• other medications you may be taking
• changes on certain lab test results while you’re taking Alecensa
• how you’re feeling while taking Alecensa

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Alecensa comes as capsules that are taken by mouth with food. It’s available in one strength: 150 milligrams (mg).

Dosage for ALK+ non-small cell lung cancer

The typical dosage of Alecensa for ALK+ NSCLC is 600 mg taken twice each day with food.

If you have side effects from Alecensa, your doctor may lower your dosage to either 450 mg twice daily or 300 mg twice daily. If you’re still having side effects while taking 300 mg twice each day, your doctor may recommend that you stop taking Alecensa and try another cancer treatment.

What if I miss a dose?

If you miss a dose of Alecensa, or if you vomit after taking your dose, don’t take an extra dose. Just wait and take your next dose of Alecensa at the usual time.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Alecensa is meant to be used as long as it’s keeping your cancer from getting worse. If you and your doctor determine that Alecensa is safe and effective for you, you’ll likely take it long term. If you have bothersome or severe side effects from Alecensa, or if your cancer becomes worse during treatment, your doctor will recommend you stop using Alecensa.

Alecensa uses

The Food and Drug Administration (FDA) approves prescription drugs such as Alecensa to treat certain conditions.

Alecensa for non-small cell lung cancer

Alecensa is used to treat a type of cancer called anaplastic lymphoma kinase-positive non-small cell lung cancer (ALK+ NSCLC). It’s prescribed for adults with metastatic ALK+ NSCLC. (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

ALK+ NSCLC is a type of lung cancer that can occur in people who’ve never smoked. The cancer is called ALK+ because it has the ALK mutation. (A mutation is an abnormal change in a gene.)

This mutation causes the cells in your lungs to multiply much more quickly than they should. (Cells that multiply are making more cells.) These abnormally multiplying cells are cancerous, and they can spread from your lungs to other parts of your body.

Before you start Alecensa treatment, your doctor will do certain tests to ensure that your cancer is ALK+.

Effectiveness for non-small cell lung cancer

In a clinical study, Alecensa was given to people with metastatic ALK+ NSCLC who hadn’t received any treatment in the past. Alecensa was compared to another ALK-inhibitor called crizotinib (Xalkori). In this study, there weren’t any people who took a placebo (no active drug).

People in the study took either Alecensa 600 mg twice a day or crizotinib 250 mg twice a day. The researchers looked to see which drug gave people a longer progression-free survival (PFS) time. A PFS shows how long a person with cancer lives without their cancer getting worse.

In the study, half of the people who took Alecensa had a PFS of nearly 26 months. In comparison, half of the people who took crizotinib had a PFS of at least 10 months.

In two other clinical studies, Alecensa was given to people with metastatic ALK+ NSCLC who had been treated in the past with crizotinib. In these studies, everyone took Alecensa. There weren’t any people who took either another cancer drug or a placebo (no active drug).

The researchers looked to see how many people had their cancer shrink in size with treatment. In these studies, about 38% to 48% of people had their cancer shrink in size.

Alecensa cost

As with all medications, the cost of Alecensa can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Alecensa at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Your insurance plan may require you to get prior authorization before approving coverage for Alecensa. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Alecensa.

If you’re not sure if you’ll need to get prior authorization for Alecensa, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Alecensa, or if you need help understanding your insurance coverage, help is available.

Several options may be available for cost assistance with Alecensa. For more information and to find out if you’re eligible for support, visit the drug manufacturer’s website or call 877-436-3683.

How long Alecensa works

Alecensa is approved to treat a certain type of lung cancer that’s anaplastic lymphoma kinase-positive (ALK+). This means the cancer has a mutation (abnormal change) in the ALK gene.

Specifically, Alecensa is prescribed for adults with metastatic ALK+ non-small cell lung cancer (NSCLC). (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

Alecensa is meant to be taken as long as it’s keeping your cancer from getting worse.

Current treatment guidelines from the National Comprehensive Cancer Network recommend Alecensa as a preferred drug for treating metastatic ALK+ NSCLC. This is because Alecensa is better at extending people’s life and stopping their cancer from growing than are other available treatments.

In one clinical study, Alecensa treatment was compared to treatment with crizotinib (Xalkori). Researchers looked to see which drug helped people live longer without their cancer getting worse. In the study, people either took Alecensa (600 mg twice a day) or crizotinib (250 mg twice a day). No one in the study took a placebo (no active drug).

In this study, half of the people who took Alecensa lived nearly 26 months or more without their cancer getting worse. In comparison, half of the people who took crizotinib lived at least 10 months without their cancer getting worse.

How Alecensa works

Alecensa is used to treat a type of cancer called anaplastic lymphoma kinase-positive non-small cell lung cancer (ALK+ NSCLC). It’s prescribed for adults with metastatic ALK+ NSCLC. (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

What is ALK+ NSCLC?

With ALK+ NSCLC, the cancer cells have the ALK mutation. (A mutation is an abnormal change in a gene.) This mutation causes the cells in your lungs to multiply much more quickly than they should. These abnormally multiplying cells are cancerous, and they can spread from your lungs to other parts of your body.

What does Alecensa do?

Alecensa contains the active drug alectinib, which is an ALK inhibitor. This type of drug is commonly used to treat specific types of cancer. Alecensa belongs to a larger class of drugs called tyrosine kinase inhibitors. (A class of drugs is a group of medications that work in a similar way.)

When mutated, the ALK protein tells cancer cells in your body to make more cells and spread out beyond your lungs. Alecensa works by attaching to the ALK protein and blocking its action. By inhibiting (blocking) the action of the ALK protein, Alecensa stops the protein from telling cancer cells to multiply. This helps prevent the lung cancer from growing and spreading in your body.

How long does it take to work?

Each person’s cancer responds differently to treatment with Alecensa. In clinical studies, people taking Alecensa were followed for several months to over 1 year. In the studies, 79% of people taking Alecensa had the size and spread of their cancer reduced with treatment. And 82% of people taking Alecensa had a response that lasted for at least 6 months.

While you’re taking Alecensa, your doctor will order tests to monitor your cancer and see if Alecensa is working to stop it from growing. Talk with your doctor about how often you’ll need to have these tests during treatment.

Alecensa and alcohol

It’s not known for sure if it’s safe to drink alcohol during Alecensa treatment. Alcohol can damage your liver and affect how well it works. If you take Alecensa and have a damaged liver, certain side effects of Alecensa may be worse or more dangerous for you. And if your liver function is affected too much, you may have to stop taking Alecensa.

If you drink alcohol, talk with your doctor about whether it’s safe for you to drink during Alecensa treatment.

Alecensa interactions

Alecensa can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Alecensa and other medications

Below is a list of medications that can interact with Alecensa. This list does not contain all the drugs that may interact with Alecensa.

Before taking Alecensa, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alecensa and drugs that interact with certain proteins

Alecensa may interact with certain proteins inside your body that bind (attach) to certain other drugs. These proteins are called P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).

This interaction may affect how well the other drugs work inside your body.

Examples of medications that bind to P-gp and may be affected by Alecensa include:

• certain heart medications, such as:
  • amlodipine (Norvasc)
  • digoxin
• certain antibiotics, such as:
  • clarithromycin (Biaxin)
  • fluconazole (Diflucan)
• certain HIV medications, such as:
  • atazanavir (Reyataz)
  • ritonavir (Norvir)
• other medications, such as:
  • cyclosporine (Gengraf, Neoral, Sandimmune)
  • tacrolimus (Prograf)

Examples of medications that bind to BCRP and may be affected by Alecensa include:

• certain chemotherapies, such as:
  • mitoxantrone
  • methotrexate
• certain targeted cancer drugs, such as:
  • imatinib (Gleevec)
  • nilotinib (Tasigna)

Alecensa and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Alecensa. However, you should still check with your doctor or pharmacist before using any of these products while taking Alecensa.

Alecensa and foods

There aren’t any foods that have been specifically reported to interact with Alecensa. If you have questions about eating certain foods while taking Alecensa, talk with your doctor.

Alternatives to Alecensa

Other drugs are available that can treat anaplastic lymphoma kinase-positive non-small cell lung cancer (ALK+ NSCLC). Some may be a better fit for you than others. If you’re interested in finding an alternative to Alecensa, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that may be used to treat ALK+ NSCLC include:

• brigatinib (Alunbrig)
• ceritinib (Zykadia)
• crizotinib (Xalkori)
• lorlatinib (Lorbrena)

Alecensa vs. Alunbrig

You may wonder how Alecensa compares with other medications that are prescribed for similar uses. Here we look at how Alecensa and Alunbrig are alike and different.

Ingredients

Alecensa contains the drug alectinib, while Alunbrig contains the drug brigatinib. Both alectinib and brigatinib belong to the same class of drugs called tyrosine kinase inhibitors (TKIs). (A class of drugs is a group of medications that work in a similar way.)

Uses

Both Alecensa and Alunbrig are approved to treat anaplastic lymphoma kinase-positive non-small cell lung cancer (ALK+ NSCLC). They’re prescribed for adults with metastatic ALK+ NSCLC. (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

Both Alecensa and Alunbrig may be used in people who have or have not been treated in the past with other drugs.

Drug forms and administration

Alecensa comes as capsules that are taken by mouth. It should be taken twice each day with food.

Alunbrig comes as tablets that are taken by mouth once each day. It can be taken with or without food.

Side effects and risks

Alecensa and Alunbrig both belong to the same class of medications. Therefore, these drugs can cause very similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Alecensa, with Alunbrig, or with both drugs (when taken individually).

• Can occur with Alecensa:
  • weight gain
• Can occur with Alunbrig:
  • fever
  • insomnia (trouble sleeping)reduced appetite
  • belly pain
  • tingling in your hands or feet
• Can occur with both Alecensa and Alunbrig:
  • back pain
  • constipation
  • cough
  • diarrhea
  • fatigue (lack of energy)
  • headache
  • muscle pain or spasms
  • nausea or vomiting
  • rash
  • shortness of breath
  • changes in taste, including being unable to taste certain foods
  • edema (swelling in your feet, hands, or legs)
  • increased skin sensitivity to sunlight, which may lead to sunburn
  • neutropenia (low level of neutrophils, which are a type of white blood cell)
  • anemia (low red blood cell level)
  • lymphopenia (low level of lymphocytes, which are a type of white blood cell)

Serious side effects

These lists contain examples of serious side effects that can occur with Alecensa, with Alunbrig, or with both drugs (when taken individually).

• Can occur with Alecensa:
  • kidney damage, which may lead to kidney failure
  • hemolytic anemia
• Can occur with Alunbrig:
  • high blood pressure
  • pancreatitis (inflammation of your pancreas)
• Can occur with both Alecensa and Alunbrig:
  • bradycardia (slow heart rate)
  • inflammation or swelling in your lungs
  • vision problems, including blurry vision, reduced ability to see, or seeing floaters
  • muscle pain (myalgia), tenderness, or weakness
  • liver damage
  • hyperglycemia (high blood sugar level)

Effectiveness

The only condition both Alecensa and Alunbrig are used to treat is metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).

The use of Alecensa and Alunbrig in treating metastatic ALK+ NSCLC hasn’t been directly compared in a clinical study. But both drugs have been studied separately for this condition. Clinical trials have shown that Alecensa and Alunbrig are effective when it’s used as the first drug to treat someone with metastatic ALK+ NSCLC.

Studies have also shown that both Alecensa and Alunbrig are effective at treating metastatic ALK+ NSCLC in people who have taken crizotinib in the past. But for these people, either their cancer worsened with crizotinib treatment, or they had intolerable side effects from the drug.

Costs

Alecensa and Alunbrig are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Alecensa and Alunbrig prices will vary depending on your prescribed dose. The actual cost also depends on your insurance plan, your location, and the pharmacy you use.

Alecensa vs. Zykadia

You may wonder how Alecensa compares with other medications that are prescribed for similar uses. Here we look at how Alecensa and Zykadia are alike and different.

Ingredients

Alecensa contains the drug alectinib, while Zykadia contains the drug ceritinib. Both medications belong to the same class of drugs called tyrosine kinase inhibitors (TKIs). (A class of drugs is a group of medications that work in a similar way.)

Uses

Both Alecensa and Zykadia are approved to treat anaplastic lymphoma kinase-positive non-small cell lung cancer (ALK+ NSCLC). They’re prescribed for adults with metastatic ALK+ NSCLC. (With metastatic lung cancer, the cancer has spread from your lungs to other parts of your body.)

Alecensa and Zykadia are each approved to use in people with metastatic ALK+ NSCLC who haven’t been treated in the past for this condition. But these drugs can also be used by people who’ve tried other treatments in the past.

Drug forms and administration

Alecensa comes as capsules that are taken by mouth. It should be taken twice each day with food.

Zykadia comes as tablets taken by mouth. It should be taken once daily with food.

Side effects and risks

Alecensa and Zykadia both belong to the same class of drugs. Therefore, these medications can cause very similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Alecensa, with Zykadia, or with both drugs (when taken individually).

• Can occur with Alecensa:
  • changes in taste, including being unable to taste certain foods
  • edema (swelling in your feet, hands, or legs)
  • weight gain
  • lymphopenia (low level of lymphocytes, which are a type of white blood cell)
• Can occur with Zykadia:
  • chest pain
  • fever
  • itching
  • pain in your arms or legs
  • pain or discomfort in your esophagus (the tube that connects your throat and stomach)
  • reduced appetite
  • belly pain
  • weight loss
  • thrombocytopenia (low level of platelets, which are a type of blood cell that helps form clots)
• Can occur with both Alecensa and Zykadia:
  • back pain
  • constipation
  • cough
  • diarrhea
  • fatigue (lack of energy)
  • headache
  • muscle pain
  • nausea or vomiting
  • rash
  • shortness of breath
  • increased skin sensitivity to sunlight, which may lead to sunburn
  • anemia (low red blood cell level)
  • neutropenia (low level of neutrophils, which are a type of white blood cell)

Serious side effects

These lists contain examples of serious side effects that can occur with Alecensa, with Zykadia, or with both drugs (when taken individually).

• Can occur with Alecensa:
  • digestive problems, such as diarrhea, vomiting, and pain in your belly
  • hemolytic anemia
• Can occur with Zykadia:
  • severe digestive problems, such as diarrhea, vomiting, and pain in your belly
  • long QT interval (a type of abnormal heart rhythm)
  • pancreatitis (inflammation of your pancreas)
• Can occur with both Alecensa and Zykadia:
  • bradycardia (slow heart rate)
  • inflammation or swelling in your lungs
  • liver damage
  • vision problems, including blurry vision, reduced ability to see, or seeing floaters
  • hyperglycemia (high blood sugar level)
  • kidney damage, which may lead to kidney failure

Effectiveness

The only condition both Alecensa and Zykadia are used to treat is metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).

These drugs haven’t been directly compared in clinical studies. But one study did use information from other clinical trials and health databases to compare how the two medications affected overall survival in people with metastatic ALK+ NSCLC. (Overall survival is used to describe the length of time that people live after their condition is diagnosed or treatment is started.)

This study compared 183 people who took Alecensa (this information was from clinical trials) with 67 people who took Zykadia (this information was from a health database). The researchers found that of people who took Alecensa, half were still living after about 24 months of treatment. In comparison, of the people taking Zykadia, half were still living after about 15 months of treatment.

Costs

Alecensa and Zykadia are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Alecensa costs significantly more than Zykadia. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

How to take Alecensa

You should take Alecensa according to your doctor’s or healthcare professional’s instructions.

When to take

Alecensa should be taken two times each day with food. The drug’s manufacturer doesn’t recommend a certain time of day to take Alecensa. But most people find it convenient to take the drug once in the morning and once in the evening.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Alecensa with food

Alecensa should be taken with food.

Can Alecensa be crushed, split, or chewed?

No, Alecensa capsules should be swallowed whole. You shouldn’t open or break the capsules.

If you have trouble swallowing capsules, talk with your doctor or pharmacist about other treatment options that are easier for you to take.

Alecensa and pregnancy

Alecensa shouldn’t be used during pregnancy.

Animal studies have shown that Alecensa can cause harm to a developing fetus when given to pregnant female. But keep in mind that animal studies don’t always predict what will happen in humans. And there isn’t any information available about Alecensa use in pregnant humans.

However, because of animal study results, and the way the drug works, it’s thought that Alecensa could cause harm in human fetuses. Because of this, it’s recommended that the drug be avoided during pregnancy.

If you’re pregnant, or thinking about becoming pregnant, talk with your doctor before starting Alecensa.

Alecensa and birth control

Alecensa shouldn’t be used by people who are pregnant. Alecensa should also be avoided if you or your partner may become pregnant. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Alecensa.

Note: Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.

For females taking Alecensa

If you’re able to become pregnant and you’re taking Alecensa, you should use an effective form of birth control during treatment. You should continue to use birth control until at least 1 week after your last dose of Alecensa.

For males taking Alecensa

If you’re a male taking Alecensa and you have a sexual partner who can possibly get pregnant, you and your partner should use an effective method of birth control. You should continue using birth control for at least 3 months after you stop taking Alecensa.

Alecensa and breastfeeding

Alecensa shouldn’t be used while breastfeeding. It’s not known if Alecensa passes into human breast milk. But if Alecensa does pass into human breast milk, it can cause severe side effects in a child who’s breastfed.

If you take Alecensa, you shouldn’t breastfeed until at least 1 week after your last dose of the drug.

If you have questions about breastfeeding while using Alecensa, talk with your doctor. They can recommend safe and healthy ways to feed your child.

Common questions about Alecensa

Here are answers to some frequently asked questions about Alecensa.

Is Alecensa chemotherapy?

No, Alecensa, which contains the drug alectinib, isn’t considered a chemotherapy drug. (Chemotherapy generally refers to traditional drugs used to treat cancer.)

Chemotherapy drugs target all cells in your body that are multiplying quickly. (Cells that are multiplying are making more cells.) Because cancer cells are quickly multiplying, chemotherapy affects them. But chemotherapy can also affect healthy cells in your body that are quickly multiplying. This causes some of the familiar side effects of chemotherapy, including hair loss and infections.

Unlike chemotherapy, Alecensa is a type of targeted therapy. Targeted therapies work only on specific cells in your body. Alecensa only targets specific ALK+ cancer cells, rather than all the quickly multiplying cells in your body. Because targeted therapies affect specific cells, they usually cause fewer side effects compared with chemotherapy.

What is the typical life expectancy for someone taking Alecensa?

The life expectancy for someone taking Alecensa can vary. The drug works to prevent lung cancer from growing and spreading. So Alecensa treatment can help extend someone’s progression-free survival (PFS) time. A PFS shows how long a person with cancer lives without their cancer getting worse.

In clinical studies, people took either Alecensa or crizotinib twice a day and the researchers looked at which drug gave people a longer PFS time. In the study, half of the people who took Alecensa had a PFS of nearly 26 months. In comparison, half of the people who took crizotinib had a PFS of at least 10 months.

Your doctor can tell you more about Alecensa’s effects on PFS and life expectancy.

Why do I need to avoid the sun while I’m taking Alecensa?

You should try to avoid sunlight because Alecensa may make your skin more sensitive to sunlight. (This condition is also called photosensitivity.) In fact, during clinical studies, 9.9% of people taking Alecensa reported skin sensitivity to the sun.

It’s not known for sure why this side effect occurs with Alecensa. But almost all of the people affected by it had only grade 1 photosensitivity. This means their sunburn was painless and it caused only mild redness on their skin.

While you’re taking Alecensa, you may sunburn more easily or get severe sunburns. Because of this, you should use sunscreen and lip balm with at least an SPF of 50 during treatment. Doing this will help to protect you from sunburn while you’re using Alecensa.

Can Alecensa cure non-small cell lung cancer?

No, unfortunately, Alecensa isn’t a cure for non-small cell lung cancer (NSCLC).

However, in clinical studies, half of the people with NSCLC who took Alecensa lived for nearly 26 months or more without their cancer worsening. And these people didn’t have any growth or spread of their cancer to other parts of their body over this period of time.

How will my doctor monitor muscle pain I may have while I’m taking Alecensa?

If you have muscle pain, your doctor may check your creatine phosphokinase (CPK) level.

Alecensa may increase your blood levels of the CPK enzyme (a type of protein). This enzyme is typically released when your muscles are damaged or injured. An increased CPK level may be a sign that muscle damage has occurred.

Your doctor will likely check your CPK level every 2 weeks during your first month of Alecensa treatment. After that, your doctor will order the test if they think it’s needed. They may also order it if you’re having muscle pain.

Depending on your blood levels of CPK, your doctor may recommend that you either temporarily or permanently stop taking Alecensa. They may also lower your dosage of the drug.

If you have muscle pain during Alecensa treatment, let your doctor know. They can recommend whether you need to have your CPK level checked.

Alecensa precautions

This drug comes with several precautions. Before taking Alecensa, talk with your doctor about your health history. Alecensa may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Severe kidney or liver problems. It’s not known if Alecensa is safe for use in people with severe kidney or liver problems. Talk with your doctor about any history of kidney or liver problems before you start taking Alecensa.
• Lung problems. If youhave lung disease or any breathing problems, Alecensa could worsen your condition. Talk with your doctor about any history of lung or breathing problems before you start taking Alecensa.
• Slow heart rate. If you have bradycardia (slow heart rate), Alecensa could worsen your condition. When you start taking Alecensa, your doctor will monitor your heart rate. They may recommend that you stop using Alecensa if your heart rate gets too slow during treatment. Before you start taking Alecensa, talk with your doctor if you have a history of slow heart rate.
• Pregnancy. Alecensa shouldn’t be used during pregnancy. For more information, please see the “Alecensa and pregnancy” section above.
• Breastfeeding. Alecensa shouldn’t be used while breastfeeding. For more information, please see the “Alecensa and breastfeeding” section above.

Note: For more information about the potential negative effects of Alecensa, see the “Alecensa side effects” section above.

Alecensa overdose

Do not use more Alecensa than your doctor recommends. Doing so may cause you to overdose on the medication.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Alecensa expiration, storage, and disposal

When you get Alecensa from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Alecensa capsules should be stored at room temperature, but not above 86°F (30°C). They should be kept in their original container. This helps protect the drug from light and moisture. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Alecensa and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.