Zykadia (ceritinib) is a brand-name prescription drug. It’s FDA-approved to treat a type of non-small cell lung cancer (NSCLC) in adults.

Specifically, Zykadia is approved to treat NSCLC that’s metastatic and anaplastic lymphoma kinase-positive (ALK+). Metastatic means that the cancer has spread from your lungs to another part of your body. And ALK+ means that your ALK gene is abnormal.

For more information about this type of NSCLC and how Zykadia is used, see the “Zykadia uses” section below.

Drug details

The active drug in Zykadia is ceritinib. Ceritinib belongs to a class of medications called kinase inhibitors. (A class of medications is a group of drugs that work in a similar way.) This drug works to stop the growth and spread of certain cancer cells.

Zykadia comes as tablets that are taken by mouth once a day. It’s available in one strength: 150 milligrams (mg).

FDA approval

Zykadia was approved by the Food and Drug Administration (FDA) in 2017, and received orphan drug status. This means the drug is approved to treat a condition that’s rare and may not have many treatment options available. Zykadia received orphan status because it treats ALK+ metastatic NSCLC, which is a rare condition.

Orphan drug status may also be called orphan designation or orphan status. Drugs that are approved under orphan drug status go through clinical trials to prove that the medication is safe and effective, in the same way as other FDA-approved drugs.

Effectiveness

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

Zykadia 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. Generics usually cost less than brand-name drugs.

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

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Zykadia, you can do so through MedWatch.

Mild side effects

Mild side effects* of Zykadia can include:

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.

Note: Other side effects (specifically decreased appetite and weight loss) were reported when people took 750 milligrams (mg) of Zykadia per day. This dosage is not approved in the United States, however. See the “Zykadia dosage” section for details about the drug’s approved dosages.

* This is a partial list of mild side effects from Zykadia. To learn about other mild side effects, talk with your doctor or pharmacist, or view Zykadia’s patient brochure.

Serious side effects

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

Serious side effects and their symptoms can include:

  • Heart rhythm problems, such as bradycardia (slowed heart rate) or long QT syndrome (lengthening of part of your heart rhythm). Symptoms can include:
    • abnormal heart rate
    • chest pain or discomfort
    • dizziness
    • fainting
    • lightheadedness
  • High blood sugar. Symptoms can include:
    • dry mouth
    • headache
    • increased thirst
    • urinating more often than usual
    • trouble concentrating
  • Pancreatitis (inflammation of the pancreas). Symptoms can include:
    • abdominal (belly) cramps
    • flatulence (gas)
    • severe upper abdominal pain that may get worse after eating, and may spread to your back
  • Allergic reaction.*
  • Liver damage.*
  • Lung problems.*

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Gastrointestinal problems

Gastrointestinal (GI) problems were among the most common side effects in clinical studies of Zykadia. GI problems may include symptoms such as:

Most people who took Zykadia reported mild GI problems. But rarely, these symptoms may become severe.

If you have mild GI problems while taking Zykadia, over-the-counter drugs for symptoms such as nausea and vomiting may help manage these problems. But, make sure to check with your doctor or pharmacist before taking any new medications with Zykadia.

If your symptoms become severe or bother you, call your doctor. They may have you temporarily stop taking Zykadia until your side effects go away. They may also recommend treatments to help relieve GI side effects.

Liver damage

Zykadia can cause liver damage. However, stopping Zykadia treatment due to liver damage was rare in clinical studies.

More commonly, Zykadia increased levels of certain liver enzymes when taken in studies. (An enzyme is a type of protein.) Increases in liver enzymes can be a sign of liver damage or a sign that your liver isn’t working the way it should.

Symptoms of liver damage may include:

  • bruising or bleeding more easily than usual
  • decreased appetite
  • feeling more tired than usual
  • itchy skin
  • nausea and vomiting
  • pain on the right side of your abdomen (belly)
  • urine that looks dark or brown

While taking Zykadia, you’ll have blood tests at least once a month to monitor your liver enzyme levels. If your liver enzyme levels increase, your doctor may have you stop taking the drug until your levels return to normal. Then, they’ll likely have you start taking Zykadia again, at a lower dosage than before. If you have a severe increase in your liver enzymes, your doctor will likely have you stop taking Zykadia completely.

If you notice symptoms of liver damage while taking Zykadia, call your doctor right away.

Lung problems

Rarely, Zykadia can cause lung inflammation (swelling and damage). This can be severe or life threatening.

In clinical studies, Zykadia specifically caused interstitial lung disease and pneumonitis (inflammation in the lungs) in rare cases.

Symptoms of lung problems caused by Zykadia can be similar to symptoms caused by lung cancer. So it can be hard to tell the difference between them. Lung problems caused by Zykadia can be severe, so you should talk with your doctor right away if you experience symptoms such as:

Your doctor will work to rule out other potential causes for your symptoms. If your doctor determines that you’re experiencing lung problems as a side effect of Zykadia, they’ll have you stop taking the medication.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Zykadia. However, this wasn’t reported in the drug’s clinical studies.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth or redness/deepening of skin color for a brief time)

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 an allergic reaction to Zykadia, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The following information describes Zykadia 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. They may lower your Zykadia dosage depending on whether the drug causes side effects for you and how severe the side effects are.

Drug forms and strengths

Zykadia comes as tablets that are taken by mouth. It’s available in one strength: 150 milligrams (mg).

Note: Zykadia used to be available as capsules that were taken by mouth, but this form of the drug is no longer produced by the manufacturer.

Dosage for non-small cell lung cancer

The recommended Zykadia dosage for treating non-small cell lung cancer* is 450 mg (three tablets) taken once daily with food.

* Specifically, Zykadia is approved to treat non-small cell lung cancer that’s metastatic and anaplastic lymphoma kinase-positive (ALK+). See “Zykadia uses” below for more information.

What if I miss a dose?

If you miss a Zykadia dose, check to see how much time remains before your next scheduled dose is due:

  • If there are at least 12 hours before your next scheduled dose is due, you can take the missed dose when you remember.
  • If there are less than 12 hours before your next scheduled dose is due, you should skip the missed dose.

If you have questions about whether to skip or take a missed dose, call your doctor or pharmacist.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

What if I vomit after taking my Zykadia dose?

If you vomit after taking a dose of Zykadia, you shouldn’t take another dose. Instead, simply take your next scheduled dose the next day. Taking an additional dose after vomiting may increase your risk for side effects from Zykadia. Doing this could also make vomiting worse.

Will I need to use this drug long term?

Zykadia is meant to be used as a long-term treatment. If you and your doctor determine that Zykadia is safe and effective for you, you’ll likely take it long term. You may continue treatment until either the drug is no longer effective for treating your cancer or you have side effects that become intolerable.

As with all medications, the cost of Zykadia can vary. To find current prices for Zykadia in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. 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 may have to get Zykadia 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.

Before approving coverage for Zykadia, your insurance company may require you to get prior authorization. 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 prior authorization request and decide if the drug will be covered.

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

Financial and insurance assistance

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

Novartis Pharmaceuticals Corporation, the manufacturer of Zykadia, offers help through the Novartis Oncology Patient Support Program. Through this program, you’ll be able to talk with staff members who can tell you about financial assistance for Zykadia. For more information and to find out if you’re eligible for support, call 800-282-7630 or visit the program website.

Generic version

Zykadia is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

The Food and Drug Administration (FDA) approves prescription drugs such as Zykadia to treat certain conditions. Zykadia may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Zykadia for non-small cell lung cancer

With lung cancer, abnormal cells in your lungs grow and spread quickly. There are two main types of lung cancer: non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). NSCLC, which Zykadia is approved to treat, is the most common type of lung cancer.

Zykadia is specifically approved to treat NSCLC that’s metastatic and anaplastic lymphoma kinase-positive (ALK+). Metastatic means that the cancer has spread from your lungs to another part of your body. And ALK+ means that your anaplastic lymphoma kinase (ALK) gene is abnormal. This abnormal gene causes cells in your lungs to become cancerous.

Symptoms of lung cancer

In its early stages, NSCLC doesn’t usually cause symptoms. As the cancer grows, it may begin to cause symptoms, including:

If it becomes metastatic, NSCLC can cause symptoms such as:

  • trouble breathing
  • pain in areas where the cancer has spread, such as in your bones, head, neck, or abdomen (belly)
  • trouble speaking
  • seizures (changes in the electrical activity in your brain)
  • worsened fatigue and weakness

Effectiveness for non-small cell lung cancer

A clinical study showed Zykadia to be safe and effective for treating non-small cell lung cancer. This study looked at how long people lived without their cancer spreading or getting worse. This length of time is referred to as progression-free survival (PFS).

In this study, people who took Zykadia had longer PFS than people who received chemotherapy.

Treatment guidelines from the National Comprehensive Cancer Network recommend ceritinib as a treatment option for people with ALK+ metastatic NSCLC. (Ceritinib is the active drug in Zykadia.)

Zykadia and children

Zykadia isn’t approved for use in children. The drug has only been studied in adults, so it isn’t known if it may be safe or effective for children.

There aren’t known interactions between drinking alcohol and taking Zykadia.

However, Zykadia can cause liver problems. And drinking large amounts of alcohol can damage your liver. So if you drink excessively while taking Zykadia, this might increase your risk for liver problems. This can also increase your risk for side effects from Zykadia.

If you drink alcohol, talk with your doctor before starting Zykadia about how much is safe for you to drink during treatment.

Zykadia can interact with several other medications. It can also interact with certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Zykadia and other medications

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

Before taking Zykadia, 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.

Types of drugs that can interact with Zykadia include:

  • Strong CYP3A4 inhibitors. CYP3A4 is an enzyme (a type of protein) that your body uses to break down drugs such as Zykadia. If this enzyme is inhibited (slowed down), your risk for side effects from Zykadia increases. Examples of strong CYP3A4 inhibitors include:
    • ritonavir
  • Strong CYP3A4 inducers. CYP3A4 inducers are drugs that increase the amount of the CYP3A4 enzyme in your body. This can increase how quickly your body breaks down drugs like Zykadia. And this could cause the drug to not work as well as usual. Examples of strong CYP3A4 inducers include:
    • rifampin
  • Certain drugs that affect your heart rate or rhythm. Zykadia can cause changes to your heart rhythm. If it’s taken with certain other medications that affect your heart rate or rhythm, your risk for heart-related side effects increases. These include abnormal heartbeats or a slowed heart rate. Examples of these drugs include:
  • Drugs metabolized (broken down) by CYP2C9 or CYP3A. Zykadia can affect the amount of CYP2C9 or CYP3A enzymes in your body. If you take drugs that are metabolized by either of these enzymes, taking Zykadia could increase your risk for side effects from the other drug. Examples of medications metabolized by these enzymes include:
    • warfarin (Coumadin) metabolized by CYP2C9
    • midazolam metabolized by CYP3A

Zykadia and herbs and supplements

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

Zykadia and foods

You shouldn’t eat grapefruit or drink grapefruit juice while taking Zykadia. This is because grapefruit may cause levels of Zykadia in your blood to increase, which could increase your risk for side effects.

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

You should take Zykadia according to your doctor’s or healthcare provider’s instructions.

When to take

Zykadia is taken by mouth once a day, with food. You can take it at any time of day, but you should take it at about the same time each day.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Note: If you miss a dose of Zykadia, you can take the missed dose as soon as you remember only if there are at least 12 hours before your next scheduled dose. Then, take your next dose as scheduled. If you vomit right after taking Zykadia, you shouldn’t take another dose. See the “Zykadia dosage” section above for details.

Taking Zykadia with food

You should take your Zykadia dose with food. This can decrease your risk for gastrointestinal side effects from Zykadia. These side effects can include nausea, vomiting, and diarrhea.

Can Zykadia be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Zykadia tablets. If you have trouble swallowing tablets, talk with your doctor about other treatment options for your condition.

Zykadia is used to treat non-small cell lung cancer that’s metastatic* and anaplastic lymphoma kinase-positive (ALK+).

With cancer, abnormal cells in your body grow and spread quickly. Cancer cells use specific enzymes (types of protein) to carry out the functions they need to grow. Some of the enzymes used are called kinases. The type of cancer that Zykadia treats has an abnormality in the gene that makes anaplastic lymphoma kinase (ALK). This kind of cancer is called ALK+.

The active drug in Zykadia, ceritinib, belongs to a group of drugs called kinase inhibitors. It works to block the action of kinases, including ALK. This stops cancer cells from growing and spreading.

* Metastatic means that the cancer has spread from your lungs to another part of your body.

How long does it take to work?

Zykadia begins working right after you take your first dose. But, you aren’t likely to “feel” the medication working. Your doctor will monitor your cancer to see if Zykadia is preventing it from growing.

If you have more questions about whether Zykadia is working for you, talk with your doctor. They can help evaluate how well Zykadia is working to treat your cancer.

Zykadia should not be taken during pregnancy. In animal studies, the drug caused birth defects in offspring when given to pregnant females. And at higher doses, the drug caused loss of pregnancy in some animals. Animal studies don’t always predict what will happen in humans, however.

If you’re pregnant or planning to become pregnant, talk with your doctor about cancer treatment options other than Zykadia.

Zykadia is not safe to take during pregnancy. 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 Zykadia.

For more information about taking Zykadia during pregnancy, see the “Zykadia and pregnancy” section above.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” below refers to sex assigned at birth.

For females using Zykadia

If you’re able to become pregnant and you’re prescribed Zykadia, you’ll need to use effective birth control during treatment. And you’ll need to continue birth control for at least 6 months after your last Zykadia dose. Talk with your doctor about your birth control options while taking Zykadia.

For males using Zykadia

If your sexual partner is able to become pregnant and you’re taking Zykadia, you should use a condom during your Zykadia treatment. And you should continue to use a condom during sex for at least 3 months after your last dose of Zykadia.

You should not breastfeed while taking Zykadia. And, you should avoid breastfeeding for at least 2 weeks after your last dose of the drug. This is because although it isn’t known whether Zykadia may pass into breast milk, the drug could cause serious side effects in a breastfed child if it does.

Talk with your doctor about cancer treatment options other than Zykadia if you’re breastfeeding or if you plan on breastfeeding.

Here are answers to some frequently asked questions about Zykadia.

Will Zykadia cure my lung cancer?

No, Zykadia isn’t a cure for lung cancer. Currently, there isn’t a cure for lung cancer.

However, in a clinical study, adults who took Zykadia lived longer without their cancer getting worse, compared with people who received chemotherapy.

If you have questions about how well Zykadia works, or other treatment options that may be available, talk with your doctor.

Is Zykadia a chemotherapy drug?

No, Zykadia isn’t a chemotherapy drug. Chemotherapy treatments work by attacking all cells in the body that are multiplying rapidly. This includes healthy cells as well as cancer cells. This is why chemotherapy can cause many side effects.

Examples of chemotherapy drugs include:

  • cisplatin
  • carboplatin
  • pemetrexed

Zykadia is what’s known as a targeted therapy. It works on specific enzymes (a type of protein) within cancer cells. These enzymes are called kinases. Zykadia is especially effective at targeting the anaplastic lymphoma kinase (ALK), which is why it’s used to treat ALK-positive (ALK+) metastatic* non-small cell lung cancer.*

If you have questions about how Zykadia works or how it differs from other cancer treatments, talk with your doctor or pharmacist.

* Metastatic means that the cancer has spread from your lungs to another part of your body. See the “How Zykadia works” section above for more information about the type of cancer Zykadia is used to treat.

Will I need to have lab tests while I’m taking Zykadia?

Yes, your doctor will order lab tests to monitor you while you’re taking Zykadia.

You’ll have several tests done before you start Zykadia treatment. These include tests that check for:

  • Anaplastic lymphoma kinase (ALK) mutation. Zykadia should only be used to treat metastatic non-small cell lung cancer that’s confirmed to have a mutation (abnormal change) in the ALK gene. This type of cancer is called ALK-positive.*
  • Blood sugar levels. Although not common, Zykadia can cause hyperglycemia (high blood sugar). Your doctor will check your fasting blood sugar levels before you start treatment with Zykadia. This test is to measure your baseline (typical) blood sugar levels before treatment.
  • Lipase and amylase levels. In rare cases, Zykadia can cause pancreatitis (inflammation in your pancreas). Lipase and amylase are two enzymes (a type of protein) made by your pancreas. Increases in your lipase and amylase levels can be a sign of pancreatitis. Your doctor will check these levels before you start taking Zykadia. This test is to measure your baseline enzyme levels before starting treatment.

During Zykadia treatment, your doctor will continue to monitor you with lab tests. These may include blood sugar tests periodically. This may also include lipase and amylase tests if your doctor thinks this is needed, such as if you have possible symptoms of pancreatitis.

You’ll also have liver enzyme tests at least once a month during Zykadia treatment. Although it is rare, Zykadia can cause liver damage. And increased liver enzyme levels can be a sign of liver damage.

Your doctor will also monitor your heart rate and blood pressure throughout treatment. If you have questions about what lab tests or monitoring you’ll need while taking Zykadia, talk with your doctor.

* Metastatic means that the cancer has spread from your lungs to another part of your body. See the “How Zykadia works” section above for more information about the type of cancer Zykadia is used to treat.

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

  • Liver problems. Although rare, Zykadia can cause liver damage. If you have existing liver problems, you may be at higher risk for this side effect. Be sure to tell your doctor about any liver problems you have before you start taking Zykadia. They can help determine if Zykadia is a safe option for you.
  • Diabetes or high blood sugar. Zykadia can cause increases in blood sugar. Usually, these increases are mild. But in rare cases, high blood sugar can become serious. If you have diabetes or high blood sugar already, you may be at higher risk for this side effect than usual. Your risk for developing serious increases in blood sugar may also be higher than usual. If you have diabetes or high blood sugar, make sure your doctor knows this before you start taking Zykadia. They can recommend whether Zykadia is a safe treatment option for you.
  • Heart problems, such as long QT syndrome. Although it isn’t common, Zykadia can cause changes to your heart rhythm. People with existing heart problems, including long QT syndrome, may be at higher risk for these side effects. If you have a history of heart problems, talk with your doctor before you take Zykadia. They can discuss the safety of Zykadia for treating your cancer.
  • Pancreatitis. Pancreatitis is a possible side effect of Zykadia. If you have pancreatitis, or a history of this condition, you may be at higher risk for this side effect. Be sure your doctor is aware of any conditions you have as well as your medical history before taking Zykadia. Your doctor may have you try a different medication to treat your condition.
  • Allergic reaction. If you’ve had an allergic reaction to Zykadia or any of its ingredients, you shouldn’t take Zykadia. Ask your doctor what other medications are better options for you.
  • Pregnancy. Zykadia should not be taken during pregnancy. For more information, see the “Zykadia and pregnancy” section above.
  • Breastfeeding. Zykadia should not be taken while breastfeeding. For more information, see the “Zykadia and breastfeeding” section above.

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

Do not use more Zykadia than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Zykadia

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 your local emergency number, or go to the nearest emergency room right away.

When you get Zykadia 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 with your pharmacist about whether you might still be able to use it.

Storage

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

Zykadia tablets should be stored at a room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container, away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Zykadia 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.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.