Zydelig is a brand-name prescription medication. It’s approved to treat chronic lymphocytic leukemia (CLL) that’s relapsed (has come back or worsened after improving with past treatment).

Zydelig is given in combination with the drug rituximab (Rituxan). And it’s prescribed for adults whose other health conditions make them able to receive rituximab alone. Zydelig should not be used as a first-line treatment for CLL. (First-line treatment is the first therapy that’s given for a condition.)

Zydelig details

Zydelig contains the active drug idelalisib. It’s a targeted therapy for CLL. (Targeted therapies work on specific traits of cancer cells to stop the cancer from growing and spreading.) Specifically, Zydelig is a kinase inhibitor. It works by inhibiting (blocking) the action of a particular protein called a kinase.

Zydelig comes as tablets that are taken by mouth twice each day. It’s available in two strengths: 100 mg and 150 mg.

Effectiveness

Clinical trials have found Zydelig effective for CLL treatment. To learn about the Zydelig’s effectiveness, see the section “Zydelig uses” below.

Zydelig 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.)

Zydelig can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Zydelig. These lists don’t include all possible side effects.

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

Your side effects may vary from those listed below depending on whether you’re using Zydelig with other treatments, and other factors.

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

Mild side effects

Mild side effects of Zydelig 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.

* This is a partial list of mild side effects from Zydelig. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Zydelig’s medication guide.

Serious side effects

Serious side effects from Zydelig aren’t usually common, but they can occur. Call your doctor right away if you have serious side effects. But 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:

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

* Zydelig has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. Boxed warnings alert doctors and patients about drug effects that may be dangerous.

Side effect details

You may wonder how often certain side effects occur with this drug. Below are some details about some of the side effects this drug may cause. You can also see this article for detailed explanations of Zydelig’s side effects.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Zydelig. But it’s not known how often allergic reaction occurs in people taking this drug.

Symptoms of a mild allergic reaction can include:

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 Zydelig. But call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Liver problems

Zydelig can cause serious and sometimes fatal liver problems. In fact, Zydelig has a boxed warning for liver problems. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about a drug’s effects that may be dangerous.

During clinical trials, 16% of people who took Zydelig had serious or fatal liver problems. It’s not known how often these problems occurred in people who took treatments other than Zydelig.

Symptoms of liver problems can include:

  • jaundice (yellowing of your skin or the whites of your eyes)
  • pain in the upper right area of your abdomen (belly)
  • dark urine or pale stools
  • bruising or bleeding more easily than usual

Liver problems can be found using certain blood tests called liver function tests. These tests measure the levels of enzymes (certain proteins) that are made by your liver. If you have high levels of liver enzymes in your blood, it may be a sign of liver damage. Before starting Zydelig and while taking the drug, your doctor will order liver function tests to check the health of your liver.

If you have problems with your liver during treatment, you may need to temporarily stop taking Zydelig. If your liver function improves after stopping the drug, your doctor may recommend that you restart Zydelig. But they may have you take a lower dosage of the drug than you took before. However, if you have severe liver problems during treatment, your doctor will recommend that you permanently stop taking Zydelig.

If you have any symptoms of liver problems while taking Zydelig, call your doctor right away.

Colitis and severe diarrhea

Zydelig can cause severe diarrhea and colitis (inflammation in your bowel) that are serious and sometimes fatal. In fact, Zydelig has a boxed warning for these problems. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about a drug’s effects that may be dangerous.

In clinical trials, 20% of people who took Zydelig had colitis or diarrhea that was either serious or fatal. But it’s not known how often these problems occurred in people who took treatments other than Zydelig.

If you have diarrhea while you’re taking Zydelig, talk with your doctor and ask them how to manage this side effect. They may prescribe medication to help reduce your diarrhea. Or in some cases, they may recommend that you stop taking Zydelig. In any case, be sure to drink plenty of water to help avoid dehydration (low fluid levels).

If your diarrhea improves after stopping Zydelig, your doctor may have you restart the drug. But they’ll likely recommend you take a lower dosage of Zydelig than you took before. However, if your diarrhea is severe, your doctor may recommend that you permanently stop taking Zydelig.

Intestinal perforation

Sometimes, Zydelig can cause intestinal perforation (a tear in the wall of your intestine). This side effect can be life threatening. In fact, Zydelig has a boxed warning for intestinal perforation. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about a drug’s effects that may be dangerous.

It’s not known how often intestinal perforation occurred in clinical trials of Zydelig. Symptoms of the condition may include:

  • new or worsening pain in your abdomen (belly)
  • fever or chills
  • nausea
  • vomiting

Call your doctor right away if you have symptoms of an intestinal perforation. Your doctor can order certain tests to check if you have this condition. If you do have intestinal perforation, your doctor will recommend that you permanently stop taking Zydelig.

Pneumonitis

Zydelig can cause serious and sometimes fatal pneumonitis (inflammation in your lungs). In fact, Zydelig has a boxed warning for risk of pneumonitis. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about a drug’s effects that may be dangerous.

In clinical trials, 4% of people who took Zydelig had pneumonitis. In comparison, 1% of people who took treatment other than Zydelig had pneumonitis.

Symptoms of pneumonitis may include:

  • new or worsening cough
  • shortness of breath
  • wheezing

If you have symptoms of pneumonitis while you’re taking Zydelig, call your doctor right away. Your doctor may order certain tests, such as chest X-rays, to check the health of your lungs.

If you have pneumonitis, your doctor may recommend treatment with corticosteroids. (These drugs help to reduce inflammation.) And your doctor will likely recommend that you permanently stop taking Zydelig.

Neutropenia

Taking Zydelig can cause neutropenia (a low level of certain white blood cells called neutrophils). With this condition, your immune system’s ability to fight off infections may be weakened. And you may have an increased risk of infections, including serious infections, which are discussed in the section just below.

In clinical trials, 58% of people who took Zydelig had grade 3 or 4 neutropenia. But it’s not known how many people who took drugs other than Zydelig had this condition. (Grade 3 or 4 neutropenia is a more serious case of neutropenia that may require hospitalization.)

During Zydelig treatment, your doctor may order blood tests regularly to check your white blood cell level. If your white blood cell level falls too low, your doctor may recommend that you stop taking Zydelig until the level improves.

When your white blood cell level has improved, your doctor may have you restart Zydelig. But they’ll likely recommend that you take a lower dosage of the drug than you used before.

Infections related to neutropenia

Because having neutropenia may increase your risk of infections, it’s important to watch for symptoms of infection. These symptoms will vary, depending on the infection you have, but they may include:

  • fever or chills
  • sore throat
  • cough
  • trouble breathing
  • sores in your mouth
  • burning sensation when you urinate

If you have any symptoms of infection while you’re taking Zydelig, call your doctor right way. If you do have an infection, you may need to stop taking Zydelig until your infection has been treated. For more information about serious infections that may occur while you’re taking Zydelig, see the section “Serious infections” just below.

To help lower your risk of infection during Zydelig treatment, it’s important to pay extra attention to your hygiene. For example, you should wash your hands frequently with soap and water. And try to avoid contact with crowds and people who are sick.

Serious infections

Taking Zydelig can increase your risk of serious infections, which can sometimes be life threatening. These infections include:

In fact, Zydelig has a boxed warning for increased risk of serious infections. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about a drug’s effects that may be dangerous.

In clinical trials, 48% of people who took Zydelig had serious or fatal infections. But PJP and CMV infections occurred in less than 1% of people who took Zydelig. It’s not known how often serious infections occurred in people who took drugs other than Zydelig in these trials.

In some cases, your doctor may have you take medication to prevent PJP while you’re taking Zydelig. If you do get PJP while you’re taking Zydelig, your doctor will recommend that you permanently stop taking Zydelig.

If you have an infection before starting Zydelig treatment, the infection should be treated before you start taking Zydelig. During Zydelig treatment, if you have any symptoms of infection, see your doctor right away. (For a list of possible symptoms of infection, see the section just above.) Your doctor can check to see if you have an infection, and they’ll recommend treatment if needed.

The following information describes Zydelig 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

Zydelig comes as tablets that are taken by mouth. It’s available in two strengths: 100 milligrams (mg) and 150 mg.

Dosage for chronic lymphocytic leukemia

The typical starting dosage of Zydelig for relapsed* chronic lymphocytic leukemia (CLL) is 150 mg taken twice daily.

If you have certain side effects from Zydelig, your doctor may have you stop taking the drug until your side effects are reduced. When you restart Zydelig, your doctor may recommend that you take a lower dosage of Zydelig, such as 100 mg twice daily.

Don’t stop taking Zydelig or make any changes to your dosage unless your doctor instructs you to do so.

* Relapsed means the cancer has either come back or worsened after improving with past treatment.

What if I miss a dose?

What you’ll need to do for a missed dose of Zydelig depends on how late your dose is. For example:

  • If it’s within 6 hours of when you should have taken your dose, go ahead and take the missed dose. Then take your next scheduled dose as usual.
  • If it’s been more than 6 hours since you should have taken a dose, just skip the missed dose. Then take your next scheduled dose as usual. Don’t take two doses together to make up for a missed dose.

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.

Will I need to use this drug long term?

Zydelig is meant to be used as a long-term treatment. If you and your doctor determine that Zydelig is safe and effective for you, you’ll likely take it for as long as it continues to work for you.

Your doctor may recommend that you stop using Zydelig if your cancer worsens or you have bothersome or severe side effects.

The Food and Drug Administration (FDA) approves prescription drugs such as Zydelig to treat certain conditions. Zydelig may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Zydelig for relapsed chronic lymphocytic leukemia (CLL)

Zydelig is FDA-approved to treat chronic lymphocytic leukemia that has relapsed. CLL is a type of cancer that affects white blood cells called B cells. With CLL, cancer cells are mainly found in your blood and bone marrow. With relapse, the cancer has come back or gotten worse after improving with past treatment.

For this use, Zydelig is given with a drug called rituximab (Rituxan). Zydelig is approved for use in adults whose other health conditions make them able to receive treatment with rituximab alone.

It’s important to note that Zydelig shouldn’t be used as a first treatment for CLL. Instead, the drug is only approved for relapsed CLL.

Zydelig is a targeted therapy for CLL. (Targeted therapies work on specific traits of cancer cells.) It works by blocking the action of a specific protein that helps the cancerous B cells grow and multiply (make more cells).

Effectiveness for relapsed CLL

One clinical trial looked at people with relapsed CLL. In this study, some people took Zydelig with rituximab, while other people took a placebo (treatment with no active drug) with rituximab.

In the study, Zydelig was effective in increasing the length of time that some people lived without their disease progressing (getting worse). This length of time is called progression-free survival. For example:

  • At least 50% of people who took Zydelig with rituximab had a progression-free survival of 19.4 months.
  • In comparison, at least 50% people who took a placebo with rituximab had a progression-free survival of 6.5 months.

Of people who took Zydelig with rituximab, 83.6% had their CLL improve but not go away completely. And of people who took a placebo with rituximab, 15.5% had the same response.

Zydelig and children

Zydelig isn’t FDA-approved for use in children and it’s currently not known if the drug is safe or effective in for use in children. CLL rarely occurs in children.

If you have questions about using Zydelig for cancer treatment in a child, talk with your doctor. They can discuss available treatment options with you.

Zydelig is approved to treat chronic lymphocytic leukemia (CLL) in combination with a drug called rituximab (Rituxan).

Like Zydelig, rituximab is a targeted therapy. (Targeted therapies work on specific traits of cancer cells.) However, rituximab is a different type of targeted therapy than Zydelig is.

Rituximab is a monoclonal antibody. It’s made in a lab from immune system cells. This drug works by helping your body to recognize and attack certain cancer cells. Zydelig, on the other hand, is a kinase inhibitor. It works to treat CLL by inhibiting (blocking) the action of a particular protein called a kinase.

In addition, these two drugs come in different forms. Zydelig comes as tablets that are taken by mouth. However, rituximab is given by intravenous (IV) infusion. (With an IV infusion, the drug is injected into your vein over a period of time.)

If you have questions about whether you’ll need to use rituximab with Zydelig, talk with your doctor.

Zydelig can cause serious, and sometimes life threatening liver problems.* Drinking alcohol while you’re using Zydelig could further increase your risk of liver issues. Because of this, you should avoid drinking alcohol while you’re taking Zydelig.

In addition, certain other side effects of Zydelig, such as nausea and diarrhea, could also be worsened by drinking alcohol.

If you drink alcohol, talk with your doctor before drinking while you’re taking Zydelig.

* Zydelig has a boxed warning for risk of liver problems. A boxed warning is the most serious warning from the FDA. For more information, see the section “Zydelig side effects” above.

Zydelig can interact with several other medications. It can also interact with certain supplements.

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.

Zydelig and other medications

Below are lists of medications that can interact with Zydelig. These lists don’t contain all the drugs that may interact with Zydelig.

Before taking Zydelig, 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.

Zydelig and certain drugs used to treat infection

Certain drugs used to treat infection may interact with Zydelig. These interactions may cause increased side effects of Zydelig, or they may make Zydelig less effective for you.

Certain drugs used to treat infection that can increase Zydelig’s side effects

Taking Zydelig with certain drugs used to treat infection can cause Zydelig to build up in your body. This interaction can increase your risk of side effects from Zydelig. To learn more about the possible side effects of Zydelig, see the section “Zydelig side effects” above.

Examples of drugs used to treat infection that can increase your risk of side effects from Zydelig include:

  • certain antibiotics, such as:
  • certain antifungals, such as:
    • itraconazole (Sporanox)
    • posaconazole (Noxafil)
    • voriconazole (Vfend)
  • certain antivirals used for HIV, such as:
    • atazanavir (Reyataz)
    • cobicistat (Tybost)
    • ritonavir (Norvir)
    • indinavir sulfate (Crixivan)
    • nelfinavir mesylate (Viracept)
    • saquinavir mesylate (Invirase)

Typically, the drugs listed above should be avoided while you take Zydelig. But if you need to take one of them, your doctor will monitor you closely for possible side effects.

Certain drugs used to treat infection that can makes Zydelig less effective

Taking Zydelig with certain drugs used to treat infection can lower the amount of Zydelig in your body. This interaction could make Zydelig less effective in treating your condition.

Examples of drugs used to treat infection that can make Zydelig less effective include:

  • rifabutin (Mycobutin)
  • rifampin (Rifadin)
  • rifapentine (Priftin)

Typically, the drugs listed above should be avoided while you’re taking Zydelig. If you need to take one of these drugs, your doctor will likely recommend that you take a different drug for your infection.

Zydelig and certain seizure medications

Taking certain seizure medications with Zydelig can lower the amount of Zydelig in your body. This interaction could make Zydelig less effective in treating your condition.

Examples of seizure medications that can make Zydelig less effective include:

Typically, the drugs listed above should be avoided while you’re taking Zydelig. If you need to take one of these drugs, your doctor will likely recommend that you take a different drug for your seizures.

Zydelig and certain drugs whose levels may be increased

If taken together, Zydelig can slow your body’s breakdown of certain other drugs. This interaction can lead to increased levels of the other drugs in your body. And it can increase your risk of side effects from those drugs.

Examples of drugs whose levels might be increased if they’re taken with Zydelig include:

If you take one of these drugs, talk with your doctor about whether it’s right for you to continue taking it with Zydelig.

Zydelig and herbs and supplements

Certain herbs and supplements may interact with Zydelig.

Zydelig and St. John’s wort

Taking St. John’s wort (Hypericum perforatum) with Zydelig may lower the amount of Zydelig in your body. This interaction could make Zydelig less effective in treating your condition. Because of this, you shouldn’t take St. John’s wort while you’re using Zydelig.

Zydelig and foods

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

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

Your insurance plan may require you to get prior authorization before approving coverage for Zydelig. 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 Zydelig.

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

Financial and insurance assistance

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

A program called Zydelig AccessConnect is available, and it can help lower the cost of Zydelig. It also provides other resources related to Zydelig treatment. For more information and to find out if you’re eligible for support, call 844-6ACCESS (844-622-2377) or visit the program website.

Generic version

Zydelig isn’t 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.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Zydelig, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed below are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Alternatives for CLL

Examples of other drugs that may be used to treat chronic lymphocytic leukemia (CLL) include:

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

Ingredients

Zydelig contains the drug idelalisib, while Venclexta contains the drug venetoclax. These medications are both targeted treatments for cancer. (This means they work on certain traits found in some cancer cells.) However, each of these drugs works in a different way in your body to treat cancer.

Uses

Zydelig is approved to treat chronic lymphocytic leukemia (CLL) that has relapsed (come back or worsened after improving with past treatment). It’s prescribed with the drug rituximab (Rituxan) for adults whose other health conditions make them able to receive rituximab alone.

Venclexta is also approved to treat CLL. In addition, it’s approved to treat small lymphocytic lymphoma (SLL) and newly diagnosed acute myeloid leukemia (AML) in adults. For AML, Venclexta is used with certain other drugs. It can be given to adults ages 75 years and older, or to adults who can’t receive standard chemotherapy drugs. (Chemotherapy refers to traditional drugs used to treat cancer.)

Drug forms and administration

Zydelig and Venclexta both come as tablets that are taken by mouth. But Zydelig is taken twice a day, while Venclexta is taken only once a day.

Side effects and risks

Zydelig and Venclexta have some similar side effects and some that differ. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Zydelig and Venclexta (when taken individually).

  • Can occur with Zydelig:
    • chills
    • reduced appetite
  • Can occur with Venclexta:
    • swelling in your legs, feet, arms, or hands
    • pain in your muscles, joints, or bones
  • Can occur with both Zydelig and Venclexta:
    • diarrhea
    • nausea and vomiting
    • fatigue (lack of energy)
    • cough
    • abdominal (belly) pain
    • rash
    • fever

Serious side effects

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

  • Can occur with Zydelig:
    • severe skin reactions
    • allergic reaction
    • severe diarrhea and colitis (bowel inflammation)*
    • intestinal perforation (tear in the wall of your intestine)*
  • Can occur with Venclexta:
    • tumor lysis syndrome (TLS), which is a condition that’s caused by the death of cancer cells in your body
  • Can occur with both Zydelig and Venclexta:
    • severe congenital anomalies (commonly known as birth defects), if taken during pregnancy
    • neutropenia (low level of certain white blood cells)
    • serious infections, such as pneumonia or sepsis (infection in your bloodstream)*

* Zydelig has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. Boxed warnings alert doctors and patients about drug effects that may be dangerous. For more information, see the section “Zydelig side effects” above.

Effectiveness

Zydelig and Venclexta have different approved uses, but they’re both used to treat CLL in adults.

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Zydelig and Venclexta to be effective in treating CLL.

Costs

Zydelig and Venclexta are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics. But the actual price you’ll pay for either Zydelig or Venclexta depends on your prescribed dosage and your insurance coverage.

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

Ingredients

Zydelig contains the drug idelalisib, while Copiktra contains the drug duvelisib. These medications are both targeted treatments for cancer. They work in a very similar way in your body, targeting one specific trait of cancer cells.

Uses

Zydelig is approved to treat chronic lymphocytic leukemia (CLL) that has relapsed (come back or worsened after improving with past treatment). It’s prescribed with the drug rituximab (Rituxan) for adults whose other health conditions make them able to receive rituximab alone.

Copiktra is approved to treat CLL, small lymphocytic lymphoma (SLL), and follicular lymphoma. Specifically, it’s used for these conditions in adults who’ve used at least two other treatments in the past. And Copiktra is only approved for forms of these conditions that have either relapsed or didn’t respond to other treatment.

Drug forms and administration

Zydelig comes as tablets that are taken by mouth. Copiktra, on the other hand, comes as capsules that are taken by mouth. Both drugs are taken twice each day.

Side effects and risks

Zydelig and Copiktra can cause very similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, or with both Zydelig and Copiktra (when taken individually).

  • Can occur with Zydelig:
    • chills
  • Can occur with Copiktra:
    • pain in your muscles, joints, or bones
  • Can occur with both Zydelig and Copiktra:
    • rash
    • fever
    • diarrhea
    • nausea and vomiting
    • fatigue (lack of energy)
    • cough
    • reduced appetite
    • abdominal (belly) pain

Serious side effects

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

  • Can occur with Zydelig:
    • allergic reaction
    • intestinal perforation (tear in the wall of your intestine)*
  • Can occur with Copiktra:
  • Can occur with both Zydelig and Copiktra:
    • severe congenital anomalies (commonly known as birth defects), if taken during pregnancy
    • serious infections, such as pneumonia or sepsis (infection in your bloodstream)**
    • severe diarrhea and colitis (bowel inflammation)**
    • severe skin reactions***

* Zydelig has boxed warnings for these side effects.
** Zydelig and Copiktra have boxed warnings for these side effects.
*** Copiktra has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. Boxed warnings alert doctors and patients about drug effects that may be dangerous. For more information on the side effects of Zydelig that have a boxed warning, see the section “Zydelig side effects” above.

Effectiveness

Zydelig and Copiktra are both used to treat CLL. Copiktra is also used for SLL and follicular B-cell NHL in adults.

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Zydelig and Copiktra to be effective for treating these conditions.

Costs

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

Zydelig and Copiktra generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

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

When to take

Zydelig should be taken twice each day, about 12 hours apart. For example, you could take your doses at 8 a.m. and 8 p.m. 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.

Taking Zydelig with food

You can take Zydelig either with or without food.

Can Zydelig be crushed, split, or chewed?

No, you should swallow Zydelig tablets whole. Don’t crush, split, or chew the tablets. If you have trouble swallowing Zydelig tablets, talk with your doctor or pharmacist.

Zydelig is approved to treat chronic lymphocytic leukemia (CLL) that has relapsed (come back or worsened after improving with past treatment).

What happens with CLL

CLL affects B lymphocytes. These are a type of white blood cell that helps your body fight off infections.

CLL causes abnormal B lymphocytes to develop in your bone marrow. These abnormal cells are cancer cells, which don’t work like typical lymphocytes. The cancer cells also take up a lot of space in your bone marrow. This prevents your bone marrow from making enough healthy blood cells.

The cancer cells that form with CLL have several traits that help them survive longer and multiply faster than healthy blood cells. (Cells that multiply are making more cells.)

What Zydelig does

Zydelig is targeted therapy for the types of cancer it’s approved to treat. Specifically, it’s a type of drug called a kinase inhibitor. Zydelig works by inhibiting (blocking) the action of a particular protein called a kinase.

Kinase proteins help certain chemical reactions happen inside your cells. And kinases help certain cancer cells survive, grow, multiply, and spread.

Lots of different kinases are involved in controlling how cells grow and multiply. Kinases are found in healthy cells as well as cancer cells. But different types of cancer cells have higher levels of certain kinases than healthy cells have. This means the cancer cells can multiply faster and live longer than the healthy cells can.

Zydelig blocks the action of a particular kinase called PI3K delta. Cancerous B cells have more of this particular kinase than healthy B cells have. Blocking the action of PI3K delta stops the cancer cells from multiplying, and it also causes them to die. This can shrink your cancer or stop it getting worse for some period of time.

How long does it take to work?

Zydelig starts to work within a few hours after you take your first dose. But you probably won’t notice the drug working. Instead, your doctor will order blood tests during your Zydelig treatment to check if the drug is working for you.

Zydelig’s use during pregnancy hasn’t been studied in humans. However, Zydelig did cause congenital anomalies (commonly known as birth defects) when it was given to pregnant females in animal studies. Keep in mind that animal studies don’t always predict what will happen in humans. However, Zydelig may be harmful to a human fetus if it’s taken during pregnancy.

Because of this risk, it’s recommended that you use birth control to prevent pregnancy while you’re taking Zydelig. For more information about using birth control, see the section “Zydelig and birth control” below.

Before you start treatment with Zydelig, tell your doctor if you’re pregnant or planning to become pregnant. And while you’re taking Zydelig, be sure to see your doctor right away if you become pregnant or think you may be pregnant.

Zydelig could be harmful to a fetus if taken during pregnancy. For more information about the risks of Zydelig use in pregnancy, see the section “Zydelig and pregnancy” above.

Birth control recommendations for people using Zydelig are described below. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about birth control options while you’re using Zydelig.

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 using Zydelig

If you’re able to become pregnant, you should use birth control while taking Zydelig. And you should continue to use birth control for at least 1 month after stopping treatment.

For males using Zydelig

If you’re sexually active with a partner who’s able to become pregnant, you should use birth control while taking Zydelig. And you should continue to use birth control for at least 3 months after stopping treatment.

It’s not known if Zydelig passes into breast milk. However, it’s recommended that you don’t breastfeed while you’re taking the drug. And you should continue to avoid breastfeeding for 1 month after stopping treatment.

If you’re taking Zydelig, talk with your doctor about safe and healthy ways to feed your child while you’re using the drug.

Here are answers to some frequently asked questions about Zydelig.

Is Zydelig a chemotherapy drug?

No, Zydelig isn’t a chemotherapy drug. Instead, it’s called a targeted therapy. Targeted therapies work more precisely on cancer cells than chemotherapy does.

Targeted therapies affect certain proteins that are more active in cancer cells than in healthy cells. These proteins help the cancer cells live longer and multiply faster than healthy cells do. (Cells that multiply are making more cells.) By blocking the action of these proteins, targeted therapies can prevent the cancer cells from growing and multiplying.

Chemotherapy drugs, on the other hand, work by killing cancer cells. But these drugs can also kill healthy cells, especially those that multiply quickly, such as blood cells.

This is why chemotherapy often causes several side effects in your body. However, targeted therapies can also have significant side effects.

If you have questions about whether you need to use chemotherapy for your condition, talk with your doctor.

Will Zydelig cure my condition?

No, it won’t. Unfortunately, there’s no known cure for cancer, including relapsed chronic lymphocytic leukemia (CLL), which Zydelig is approved to treat. (With relapsed cancer, the cancer has either come back or gotten worse after improving with treatment in the past.) However, taking Zydelig could extend the length of time you live without your cancer getting worse.

If you have questions about how effective Zydelig may be for your condition, talk with your doctor.

Can older people use Zydelig?

Yes, in general, older people can use Zydelig. In fact, the drug has similar effectiveness in older people and younger people.

However, in clinical trials of Zydelig, people ages 65 years and older were more likely to get serious side effects from the drug. And older people were also more likely to stop taking Zydelig due to side effects. Unfortunately, older people were also more likely to die from serious side effects of the drug than younger people were.

If you have questions about the safety of using Zydelig given your age, talk with your doctor.

How can I help prevent infections while I’m using Zydelig?

Taking Zydelig can cause neutropenia (low level of certain white blood cells). This condition canweaken the activity of your immune system, which increases your risk of infections.

For example, Zydelig can increase your risk of the flu, colds, urinary tract infections (UTIs), and cold sores. Zydelig can also increase your risk of more serious infections, such as pneumonia and sepsis (infection in your bloodstream).

To help prevent infections, you can:

  • wash your hands frequently with soap and water
  • disinfect objections that you frequently touch
  • avoid crowds and people who are sick
  • eat healthy foods
  • get plenty of sleep
  • talk with your doctor about whether you need to have certain vaccines, such as the flu shot
  • keep appointments for any blood tests your doctor orders to check your blood cell levels

While taking Zydelig, be sure to see your doctor right away if you have any signs of infection, especially a fever. For more information about infections during Zydelig treatment, see the section “Zydelig side effects” above.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous. The boxed warnings for Zydelig are described below.

Liver problems

Zydelig can cause serious and sometimes fatal liver problems. Both before starting and while you’re taking Zydelig, your doctor will order blood tests called liver function tests. These tests allow your doctor to monitor the health of your liver.

Symptoms of liver problems may include yellowing of your skin or the whites of your eyes. You may also have pain in the upper right side of your belly and bruising or bleeding that happens more easily than usual.

If you have symptoms of liver problems, call your doctor right away. Your doctor may have you stop taking Zydelig if you have liver problems. Or they may lower your dosage of the drug. For more information about liver problems caused by Zydelig, see the “Zydelig side effects” section above.

Colitis and severe diarrhea

Zydelig can cause colitis (inflammation in your bowel) and severe diarrhea that’s serious and sometimes fatal. While you’re taking Zydelig, if the number of bowel movements you have each day increases by six or more movements, call your doctor right away.

Your doctor may recommend treatment for the diarrhea. And in some cases, your doctor may have you stop taking Zydelig. Or they may lower your dosage of the drug. For more information about colitis and severe diarrhea that’s caused by Zydelig, see the “Zydelig side effects” section above.

Intestinal perforation

Zydelig can cause serious and sometimes fatal intestinal perforation (tear in the wall of your intestine). Symptoms of this condition may include new or worsening abdominal (belly) pain, fever, and chills. You may also have nausea or vomiting. Call your doctor right away if you have any symptoms of intestinal perforation. If you have this condition, you’ll need to stop taking Zydelig.

Pneumonitis

Zydelig can cause serious and sometimes fatal pneumonitis (inflammation in your lungs). Symptoms of pneumonitis include new or worsening cough, shortness of breath, and wheezing.

If you have any of these symptoms while taking Zydelig, call your doctor right away. Your doctor may order certain tests, such as chest X-rays, to check the health of your lungs.

If you have pneumonitis, you may need treatment with corticosteroids, which help to reduce inflammation. And you’ll likely need to stop taking Zydelig. For more information about pneumonitis, see the “Zydelig side effects” section above.

Risk of serious infections

Zydelig canincrease your risk of serious, and sometimes fatal, infections. This includes infections such as pneumonia and sepsis (infection in your bloodstream). And it includes infections caused by cytomegalovirus (CMV).

If you already have an infection, it should be treated before you start taking Zydelig. While taking Zydelig, if you have any symptoms of infection, such as a fever, call your doctor right way. You may need to stop taking Zydelig until your infection has been treated.

However, if you get an infection called Pneumocystis jirovecii pneumonia (PJP), you’ll need to stop Zydelig permanently. In some cases, your doctor may recommend that you take medication to prevent PJP while you’re taking Zydelig. For more information about the risk of serious infections with Zydelig, see the “Zydelig side effects” section above.

Other precautions

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

  • Neutropenia. Zydelig may cause new or worsened neutropenia (low level of certain white blood cells). During treatment, you’ll have blood tests regularly to check your white blood cell levels. If your white blood cell level falls too low, you may need to stop taking Zydelig until your blood cell level recovers. When your blood cell levels have improved, your doctor may have you restart Zydelig. But you’ll likely take the drug on a lower dosage than you took previously.
  • History of serious allergic reactions. If you’ve had a serious allergic reaction to Zydelig in the past, your doctor won’t prescribe this drug. If you’re unsure about your medication allergies, talk with your doctor.
  • History of severe skin reactions. If you’ve had severe skin reactions to a drug before, your doctor won’t prescribe Zydelig. Examples include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Be sure to tell your doctor about any serious skin problems you’ve experienced. They can recommend a different drug for your condition.
  • Pregnancy. Zydelig can harm a fetus if taken during pregnancy. For more information, please see the “Zydelig and pregnancy” section above.
  • Breastfeeding. It’s not known if Zydelig passes into breast milk. You shouldn’t breastfeed if you’re taking Zydelig. For more information, please see the “Zydelig and breastfeeding” section above.

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

Taking more than the recommended dosage of Zydelig may lead to serious side effects. Do not take more Zydelig than your doctor recommends.

What to do if you think you’ve taken too much Zydelig

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. However, if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Zydelig 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 can depend on many factors, including how and where you store the medication.

Zydelig tablets should be stored at room temperature (68°F to 86°F/20°C to 30°C) in a tightly sealed container.

Keep Zydelig tablets in the bottle they were dispensed in. Don’t transfer them to another container. 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 Zydelig 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 on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Zydelig is approved to treat relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, in adultswhose other health conditions make them able to receive rituximab alone. Zydelig should not be used as a first-line treatment.

Administration

Zydelig is taken by mouth twice daily.

Mechanism of action

Zydelig contains idelalisib, which is an inhibitor of the kinase PI3K delta.

PI3K delta is involved in various cell signaling pathways that aid cell survival and proliferation. This kinase is overexpressed in malignant B cells. By blocking PI3K delta, Zydelig induces apoptosis and reduces proliferation of malignant B cells.

Pharmacokinetics and metabolism

Idelalisib is rapidly absorbed after oral administration of Zydelig tablets, and it reaches peak concentration (Cmax) in 1.5 hours. Bioavailability is not significantly affected by food.

Idelalisib is highly (84% or more) bound to plasma proteins. The drug is primarily metabolized by aldehyde oxidase and CYP3A. Its major metabolite is inactive against PI3K delta, but the metabolite is a strong inhibitor of CYP3A.

Idelalisib has a terminal half-life of 8.2 hours.

Contraindications

Zydelig is contraindicated in people with a history of serious allergic reaction, such as anaphylaxis or toxic epidermal necrolysis.

Storage

Store Zydelig in its original container at room temperature (68°F to 86°F/20°C to 30°C).

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 another 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.

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