Zejula is a brand-name prescription drug. It’s FDA-approved for use in adults to treat certain cancers that affect the ovaries, fallopian tubes, or peritoneum. (The peritoneum is a thin layer of tissue that lines the inside of your belly.)

Specifically, Zejula is approved to treat the following forms of ovarian cancer:*

  • Advanced ovarian cancer. With advanced ovarian cancer, the cancer has spread out of the ovaries. For this use, Zejula is given as a first-choice maintenance treatment. As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy. Specifically, Zejula is used in people whose cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum. (Chemotherapy describes traditional drugs used to treat cancer.)
  • Recurrent ovarian cancer. With recurrent cancer, the cancer improved with past treatment, but it has come back. For this use, Zejula is given as a maintenance treatment. And it’s used in people whose ovarian cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum.
  • Advanced ovarian cancer that’s already been treated with three or more chemotherapy regimens. For this use, Zejula is given to people whose cancer is related to a genetic mutation (abnormal gene change) called homologous recombination deficiency (HRD).

* Certain cancers in the fallopian tubes and peritoneum can be so similar to ovarian cancer that they’re sometimes labeled as ovarian cancer. In this article, cancer of the ovaries, fallopian tubes, and peritoneum are all referred to as “ovarian cancer.”

Drug form, administration, and active ingredient

Zejula comes as capsules that are taken by mouth. It contains the active drug niraparib.

Niraparib belongs to a class of drugs called poly (ADP-ribose) polymerase (PARP) inhibitors. A drug class describes a group of medications that work in a similar way.

FDA approval

In 2017, the Food and Drug Administration (FDA) approved Zejula for maintenance treatment of recurrent ovarian cancer. Zejula was the first PARP drug approved for ovarian cancer that has responded to chemotherapy that’s made with platinum.

Then, in 2020, the FDA expanded Zejula’s approval to include treatment of advanced ovarian cancer that’s already been treated with three or more chemotherapy regimens.

Effectiveness

In clinical studies, Zejula was effective as a maintenance treatment for recurrent ovarian cancer.

In other clinical studies, Zejula was also effective in treating advanced ovarian cancer. The drug was effective as a maintenance therapy after one round of chemotherapy, and in treating advanced ovarian cancer that had already been treated with three or more chemotherapy regimens.

For more information on Zejula’s effectiveness, see the “Zejula uses” section below.

Zejula 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.)

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

For more information on the possible side effects of Zejula, 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 it has approved. If you would like to report to the FDA a side effect you’ve had with Zejula, you can do so through MedWatch.

Mild side effects

Mild side effects of Zejula 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 Zejula. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Zejula’s prescribing information.

Serious side effects

Serious side effects from Zejula 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:

* These serious side effects are explained in more detail below in “Side effect details.”

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Zejula. But it’s not known for sure how many people using Zejula have had an allergic reaction to the drug.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

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

Nausea

It’s likely that you’ll have nausea while you’re taking Zejula. In clinical trials, nausea occurred in 57% to 74% of people who took Zejula. (This percentage varied depending on the type of cancer being treated.) In comparison, nausea occurred in 28% to 35% of people who took a placebo (treatment with no active drug).

It’s helpful to point out that for most people in these studies, their nausea was mild. And depending on the condition being treated, only 1% to 10% of people taking Zejula had severe nausea. Also, up to 13% of people in studies either had their Zejula dosage lowered or stopped taking the drug due to nausea.

The manufacturer of Zejula states that taking doses of this drug at bedtime may help reduce nausea that’s caused by it. Talk with your doctor about whether doing this is a good option for you.

If you have nausea while you’re taking Zejula, talk with your doctor. They may recommend a medication to help reduce your nausea. They may also recommend treatments for nausea that don’t involve taking a medication. These treatments may include applying a heating pad to your stomach. Or in some cases, your doctor may recommend that you take a drug other than Zejula for your cancer.

Blood disorders

It’s possible that you’ll have certain blood disorders while you’re taking Zejula.

In clinical studies, the following blood disorders were most commonly seen:

  • Thrombocytopenia. With thrombocytopenia, you have a low level of platelets. (Platelets are cells that clump together to help stop bleeding.) If your platelet level is too low, your body can’t form clots like usual. So your body isn’t unable to stop bleeding in some cases. During studies, thrombocytopenia occurred in 52% to 66%* of people who took Zejula. In comparison, 5% of people who took a placebo† had thrombocytopenia. Thrombocytopenia was severe for about half of the people taking Zejula in these studies. For example, 28% to 39%* of people had severe thrombocytopenia.
  • Anemia. With anemia, you have a low level of red blood cells (RBCs). RBCs are important because they carry oxygen throughout your body. When your RBC level is low, your organs may not get enough oxygen to work properly. In studies, anemia occurred in 50% to 64%* of people who took Zejula. In comparison, 7% to 18%* of people who took a placebo had anemia. For half the people taking Zejula in these studies, anemia was severe. For instance, 25% to 31%* of people had severe anemia.
  • Neutropenia. With neutropenia, you have a low level of neutrophils, which are a type of white blood cell that helps your body fight off infections. If your body doesn’t have enough neutrophils, your risk for infection is increased. In studies, neutropenia occurred in 20% to 42%* of people who took Zejula. In comparison, 6% to 8%* of people who took a placebo had neutropenia. Neutropenia was severe for many of the people taking Zejula in these studies. Specifically, 13% to 21%* of people had severe neutropenia.

* These percentages varied depending on the condition being treated.
† A placebo is a treatment with no active drug.

Symptoms of blood disorders will vary depending on the specific disorder that affects you. But some general symptoms of blood disorders may include:

  • feeling tired or weak
  • having unexplained weight loss
  • bleeding or bruising more easily than usual
  • frequent infections

Bone marrow problems that cause blood disorders with Zejula

Rarely, symptoms of blood disorders may be a sign of serious problems in your bone marrow. These serious problems, which can occur with Zejula use, may include:

  • Acute myeloid leukemia (AML). AML is a type of blood cancer that affects your white blood cells. This type of cancer quickly worsens if it’s not promptly treated.
  • Myelodysplastic syndrome (MDS). With MDS, which is a rare condition, your bone marrow stops making normal, healthy blood cells. In some people, MDS can lead to AML.

In clinical trials, 0.8% of people who took Zejula developed MDS or AML. These conditions occurred in people who had been taking Zejula for as little as 2 weeks. But they also occurred in people who had been taking the drug for almost 5 years.

Monitoring for and managing blood disorders with Zejula

Before you start treatment with Zejula, your doctor will order tests to check your blood cell levels. During your first month of Zejula treatment, your doctor will order these tests every week. Then after this first month, but for the rest of your first year of treatment, your doctor will order the tests once every month. After that, you’ll only have these blood tests when your doctor feels they’re needed.

Also during treatment, let your doctor know if you have symptoms of a blood disorder. These symptoms (listed above) will vary depending on the disorder that you have.

Your doctor may order blood tests to check whether you have a blood disorder, including MDS or AML. If needed, your doctor will recommend an appropriate treatment.

If you develop MDS or AML while taking Zejula, your doctor will recommend that you stop taking Zejula.

Fatigue

In clinical trials of Zejula, fatigue (lack of energy) was a commonly reported side effect. Depending on the condition treated, 51% to 57% of people who took the drug had fatigue. In comparison, 41% of people who took a placebo had fatigue. (A placebo is a treatment with no active drug.)

Although a lot of people had fatigue during clinical studies of Zejula, only 3% to 8% of people reported that their fatigue was serious.

Keep in mind that fatigue can also be a symptom of blood disorders, which are a possible side effect of Zejula. Because of this, tell your doctor if you have fatigue while you’re taking Zejula. Your doctor may order certain tests to see what’s causing your fatigue. And your doctor will recommend a plan to help reduce your fatigue.

If your fatigue is severe, your doctor may have you stop taking Zejula. In this case, they may recommend that you take a different drug for your cancer.

High blood pressure

It’s possible to have high blood pressure while you’re taking Zejula. For example, in clinical trials of Zejula, high blood pressure was reported in:

  • 14% to 20% of people taking Zejula
  • 5% to 7% of people taking a placebo (treatment with no active drug)

In addition, severe high blood pressure was reported in:

  • 5% to 9% of people taking Zejula
  • 1% to 2% of people taking a placebo

But less than 1% of people taking Zejula stopped using the drug because of severe high blood pressure.

Most people with high blood pressure typically don’t have any symptoms of the condition. That’s why high blood pressure is sometimes called a silent disease. However, if you have severe high blood pressure, you may start to feel dizzy or have shortness of breath. You may also have changes in your vision or chest pain.

If you have any symptoms of high blood pressure while you’re taking Zejula, call your doctor right away. But if your symptoms feel life threatening, call 911 or your local emergency number.

Monitoring for high blood pressure during Zejula treatment

When you first start taking Zejula, your doctor will monitor your blood pressure and heart rate once a week for the first 2 months of treatment. Then they’ll continue to monitor these things monthly for your first year of treatment. After that, your doctor will recommend how often to check your blood pressure and heart rate during treatment.

If you already have high blood pressure, heart disease, or an abnormal heart rhythm, your doctor will monitor you much more closely if you take Zejula. If you develop high blood pressure during Zejula treatment, your doctor may prescribe a blood pressure medication for you. Or they may adjust your dosage of Zejula.

Hair loss (not a side effect)

In clinical studies, hair loss wasn’t reported as a side effect of Zejula. So the drug isn’t thought to cause hair loss.

However, Zejula is only approved for use in people whose cancer has improved in the past with chemotherapy. Hair loss is a common side effect of chemotherapy. But after having chemotherapy, hair typically grows back after 3 to 6 months.

It’s important to note that Zejula is often prescribed for people before their hair has time to grow back after chemotherapy. In fact, for people with recurrent ovarian cancer,* treatment with Zejula needs to start no later than 8 weeks after they had their most recent chemotherapy regimen. This timeline can make it seem like Zejula is causing hair loss. But it may just be that your body hasn’t yet recovered from the chemotherapy.

If you have questions about hair loss while you’re taking Zejula, talk with your doctor. They can suggest ways to help you cope with this effect.

* With recurrent ovarian cancer, the cancer improved with treatment in the past, but it has come back.

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

  • whether you have side effects from Zejula
  • other medical conditions you may have

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

Zejula comes as capsules that are taken by mouth. It’s available in one strength: 100 milligrams (mg).

Dosage for maintenance treatment of recurrent ovarian cancer

Zejula is approved as a maintenance treatment for recurrent ovarian cancer.* As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy. With recurrent cancer, the cancer improved with past treatment, but it has come back.

The typical Zejula dosage for this use is 300 mg taken once a day. (To get this full dose, you’ll take three 100-mg capsules.) You should try to take your dose at the same time each day.

For this use, it’s important to note that Zejula should be started within 8 weeks of your most recent cancer treatment with platinum-containing chemotherapy. (Chemotherapy describes traditional drugs used to treat cancer.)

If you have side effects from Zejula, your doctor may prescribe for you a dosage of Zejula that’s different than the typical dosage.

* This includes certain cancers in the fallopian tubes and peritoneum (lining inside your belly). Because they can be so similar to ovarian cancer, these forms of cancer are sometimes labeled as ovarian cancer.

Dosage for maintenance treatment of advanced ovarian cancer

Zejula is also approved as a first-line maintenance treatment for advanced* ovarian cancer.† As a first-line treatment, Zejula is used for maintenance before other medications are used. However, before starting Zejula, you’ll still receive chemotherapy that’s made from platinum. (Chemotherapy describes traditional drugs used to treat cancer.)

As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy.

The typical Zejula dose for this use depends on either your body weight or your platelet count.

  • For people who either weigh less than 170 pounds (77 kilograms) or people with a platelet count that’s less than 150,000 per microliter (μL), Zejula is given at a dose of 200 mg (two 100-mg capsules) taken once a day.
  • For people who either weigh more than or equal to 170 pounds (77 kilograms) or people with a platelet count that’s greater than or equal to 150,000/μL, Zejula is given at a dose of 300 mg (three 100-mg capsules) taken once a day.

It’s important to note that, for this use, Zejula should be started within 12 weeks of your most recent cancer treatment with a platinum-containing chemotherapy regimen.

If you have side effects from Zejula, your doctor may prescribe for you a dosage of Zejula that’s different than the typical dose.

* With advanced ovarian cancer, the cancer has spread out of the ovaries.
† This includes certain cancers in the fallopian tubes and peritoneum (lining inside your belly). Because they can be so similar to ovarian cancer, these forms of cancer are sometimes labeled as ovarian cancer.

Dosage for treatment of advanced ovarian cancer after three or more chemotherapies

Zejula is approved for treating advanced* ovarian cancer† that has been treated in the past with three or more chemotherapy regimens. (Chemotherapy describes traditional drugs used to treat cancer.)

The typical Zejula dosage for this use is 300 mg taken once a day. (To get this full dose, you’ll take three 100-mg capsules.) You should try to take your dose at the same time each day.

If you have side effects from Zejula, your doctor may prescribe for you a dosage of Zejula that’s different than the typical dosage.

* With advanced ovarian cancer, the cancer has spread out of the ovaries.
† This includes certain cancers in the fallopian tubes and peritoneum (lining inside your belly). Because they can be so similar to ovarian cancer, these forms of cancer are sometimes labeled as ovarian cancer.

What if I miss a dose?

If you miss a dose of Zejula, or you vomit right after taking your dose, just skip that dose. Then take your next dose at the usual time. Don’t “double up” your dose by taking an extra dose of Zejula. Doing so can increase your risks of side effects from the drug.

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?

Zejula is meant to be used as a long-term treatment. Usually, you’ll continue taking Zejula until you have bothersome or severe side effects from the drug, or until your cancer worsens.

If you and your doctor determine that Zejula is safe and effective for you, you’ll likely take it long term.

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 Zejula, 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 used to treat a different condition.

Alternatives for maintenance treatment of recurrent ovarian cancer

Examples of other drugs that may be used for maintenance treatment* of recurrent† ovarian cancer‡ include:

  • bevacizumab (Avastin)
  • nintedanib (Ofev)
  • olaparib (Lynparza)
  • paclitaxel
  • pazopanib (Votrient)
  • rucaparib (Rubraca)

* As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy.
† With recurrent cancer, the cancer improved with past treatment, but it has come back.
‡ This includes certain cancers in the fallopian tubes and peritoneum (lining inside your belly). Because they can be so similar to ovarian cancer, these forms of cancer are sometimes labeled as ovarian cancer.

Alternatives for treatment of advanced ovarian cancer

Examples of other drugs that may be used to treat advanced* ovarian cancer† include:

  • bevacizumab (Avastin)
  • carboplatin
  • cisplatin
  • docetaxel
  • paclitaxel
  • olaparib (Lynparza)
  • rucaparib (Rubraca)

* With advanced ovarian cancer, the cancer has spread out of the ovaries.
† This includes certain cancers in the fallopian tubes and peritoneum (lining inside your belly). Because they can be so similar to ovarian cancer, these forms of cancer are sometimes labeled as ovarian cancer.

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

Ingredients

Zejula contains the active drug niraparib, while Lynparza contains the active drug olaparib. Both Zejula and Lynparza belong to a class of drugs called poly (ADP-ribose) polymerase (PARP) inhibitors. (A drug class is a group of medications that work in a similar way).

Uses

Zejula and Lynparza are approved to treat certain cancers that affect the ovaries, fallopian tubes, or peritoneum. (The peritoneum is a thin layer of tissue that lines the inside of your belly.) Because certain cancers in the fallopian tubes and peritoneum can be so similar to ovarian cancer, they’re sometimes labeled as ovarian cancer.

Specifically, Zejula and Lynparza are approved as maintenance treatments for recurrent ovarian cancer. With recurrent cancer, the cancer improved with past treatment, but it has come back. As a maintenance treatment, Zejula or Lynparza is used after your cancer has first been treated with other therapy.

For this use, the drugs are given to people whose cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum. (Chemotherapy describes traditional drugs used to treat cancer.)

In addition, Zejula is approved to treat the following forms of ovarian cancer:

  • Advanced ovarian cancer. With advanced ovarian cancer, the cancer has spread out of the ovaries. For this use, Zejula is given as a first-choice maintenance treatment. As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy. Specifically, Zejula is used in people whose cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum.
  • Advanced ovarian cancer that’s been treated with three or more chemotherapy regimens. For this use, Zejula is given to people whose cancer is related to a genetic mutation (abnormal gene change) called homologous recombination deficiency (HRD).

And Lynparza is also approved to treat:

  • advanced ovarian cancer that has a certain mutation in theBRCA* gene; for this use, Lynparza is given as a maintenance treatment
  • advanced ovarian cancer with a certain mutation in the BRCA gene that’s been treated in the past with three or more chemotherapy regimens
  • metastatic† breast cancer with a certain mutation in the BRCA gene, but that is HER2-negative‡
  • metastatic pancreatic cancer with a certain mutation in the BRCA gene; for this use, Lynparza is given as a maintenance treatment
  • metastatic prostate cancer with a certain mutation in the homologous recombination repair (HRR) gene; for this use, Lynparza is given for cancer that’s been treated in the past with one of two specific chemotherapy regimens

* BRCA stands for “breast cancer” gene. The BRCA mutation is linked to the growth and spread of certain types of cancer.
† Metastatic cancer has spread from where it started to other areas in your body.
‡ HER-2 negative cancer cells don’t have certain proteins called human epidermal growth factor receptor 2 on their surface.

Drug forms and administration

Zejula comes as capsules, while Lynparza comes as tablets. Both medications are taken by mouth. Zejula is taken once daily, but Lynparza is taken twice daily.

Side effects and risks

Zejula and Lynparza contain drugs that belong to the same medication class. Therefore, these medications can cause very similar side effects, but some different ones as well. 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 Zejula, with Lynparza, or with both drugs (when taken individually).

  • Can occur with Zejula:
    • trouble sleeping
    • cough
  • Can occur with Lynparza:
    • altered sense of taste
    • weakness
    • respiratory tract infections, such as the flu or common cold
    • pain in your joints
  • Can occur with both Zejula and Lynparza:
    • nausea and vomiting
    • fatigue (lack of energy)
    • decreased appetite
    • constipation or diarrhea
    • pain in your belly or muscles
    • headache

Serious side effects

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

Effectiveness

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Zejula and Lynparza to be effective for maintenance treatment of recurrent ovarian cancer. These studies looked at adults whose cancer improved in the past with chemotherapy that’s made with platinum.

Costs

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

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

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

Ingredients

Zejula contains the active drug niraparib, while Rubraca contains the active drug rucaparib. Both Zejula and Rubraca belong to a class of drugs called poly (ADP-ribose) polymerase (PARP) inhibitors. (A drug class is a group of medications that work in a similar way.)

Uses

Zejula and Rubraca are approved to treat certain cancers that affect the ovaries, fallopian tubes, or peritoneum. (The peritoneum is a thin layer of tissue that lines the inside of your belly.) Because certain cancers in the fallopian tubes and peritoneum can be so similar to ovarian cancer, they’re sometimes labeled as ovarian cancer.

Specifically, Zejula and Rubraca are approved as maintenance treatments for recurrent ovarian cancer. With recurrent cancer, the cancer improved with past treatment, but it has come back. As a maintenance treatment, Zejula or Rubraca is used after your cancer has first been treated with other therapy.

For this use, the drugs are used in people whose cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum. (Chemotherapy describes traditional drugs used to treat cancer.)

In addition, Zejula is approved to treat the following forms of ovarian cancer:

  • Advanced ovarian cancer. With advanced ovarian cancer, the cancer has spread out of the ovaries. For this use, Zejula is given as a first-choice maintenance treatment. As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy. Specifically, Zejula is used in people whose cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum.
  • Advanced ovarian cancer that’s been treated with three or more chemotherapy regimens. For this use, Zejula is given to people whose cancer is related to a genetic mutation (abnormal gene change) called homologous recombination deficiency (HRD).

And Rubraca is also approved to treat:

  • ovarian cancer that’s linked to a mutation in the BRCA* gene
  • ovarian cancer that has been treated in the past with two or more chemotherapy regimens
  • prostate cancer that’s related to a mutation in the BRCA gene and has been treated in the past with two chemotherapy regimens

* BRCA stands for “breast cancer” gene. The BRCA mutation is linked to the growth and spread of certain types of cancer.

Drug forms and administration

Zejula comes as capsules, while Rubraca comes as tablets. Both medications are taken by mouth. Zejula is taken once a day, but Rubraca is taken twice a day.

Side effects and risks

Zejula and Rubraca contain drugs that belong to the same medication class. Therefore, these medications can cause very similar side effects, but some different ones as well. 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 Zejula, with Rubraca, or with both drugs (when taken individually).

  • Can occur with Zejula:
    • muscle pain
    • trouble sleeping
    • shortness of breath
    • cough
  • Can occur with Rubraca:
  • Can occur with both Zejula and Rubraca:
    • nausea and vomiting
    • fatigue (lack of energy)
    • belly pain
    • decreased or loss of appetite
    • diarrhea or constipation
    • headache

Serious side effects

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

Effectiveness

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Zejula and Rubraca to be effective for maintenance treatment of recurrent ovarian cancer. These studies looked at adults whose cancer improved in the past with chemotherapy that’s made with platinum.

Costs

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

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

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

Zejula is approved for use in adults to treat certain cancers that affect the ovaries, fallopian tubes, and peritoneum (lining inside your belly). Because certain cancers in the fallopian tubes and peritoneum can be so similar to ovarian cancer, they’re sometimes labeled as ovarian cancer. In this article, we refer to all three of these three cancers as “ovarian cancer.”

Specifically, Zejula is approved to treat epithelial ovarian cancer. Epithelial cancer occurs when certain cells, called epithelial cells, begin to grow abnormally and more quickly than usual. Epithelial cells are found throughout your body. In the ovaries, epithelial cells cover the outer surface of the ovary.

Below, we describe the approved uses of Zejula for treating epithelial ovarian cancer.

Zejula for maintenance treatment of recurrent ovarian cancer

Zejula is FDA-approved as a maintenance treatment for recurrent ovarian cancer in adults. As a maintenance treatment, Zejula is given after your cancer has already been treated with other drugs in the past. And with recurrent cancer, your cancer improved with past treatment, but it has now come back.

For this use, Zejula is used only after your cancer has disappeared, either partially or completely, with chemotherapy that’s made with platinum. (Chemotherapy describes traditional drugs used to treat cancer.)

Effectiveness for recurrent ovarian cancer

In a clinical study, Zejula was effective in treating recurrent ovarian cancer.

In the study, some people took Zejula while other people took a placebo (treatment with no active drug). The researchers looked to see which group of people lived longer without their ovarian cancer growing or getting worse.

People with recurrent ovarian cancer could participate in the study if their cancer had improved in the past with chemotherapy that’s made from platinum. Specifically, these people had received at least two regimens of chemotherapy made from platinum. And with their most recent chemotherapy regimen, their cancer had disappeared, either partially or completely.

People in the study took either Zejula or the placebo until their cancer worsened or they had serious side effects from treatment.

The researchers found that:

  • of people who took Zejula, 50% of them were still alive 21 months after they started taking the drug
  • of people who took the placebo, 50% of them were still alive 5.5 months after they began taking the placebo

Zejula for treatment of advanced ovarian cancer

Zejula is also FDA-approved for treating advanced ovarian cancer. With advanced ovarian cancer, the cancer has spread outside of the ovaries.

Specifically, Zejula can be used in the following ways to treat advanced ovarian cancer:

  • First-line maintenance treatment. As a maintenance treatment, Zejula is used after your cancer has first been treated with other therapy. And as first-line treatment, Zejula is used for maintenance before other medications are used. Specifically, Zejula is given to people whose advanced ovarian cancer disappeared, either partly or completely, after treatment with chemotherapy that’s made with platinum. (Chemotherapy describes traditional drugs used to treat cancer.)
  • Treatment after three or more chemotherapy regimens. For this use, Zejula is used for advanced ovarian cancer that’s positive for a certain mutation (abnormal gene change) called homologous recombination deficiency (HRD). This genetic mutation helps determine what treatments your cancer will respond to. People who have this mutation are more likely to respond to treatment with Zejula.

Effectiveness for advanced ovarian cancer

In a clinical study, Zejula was effective in treating advanced ovarian cancer.

In the study, researchers looked to see if Zejula helped shrink cancer tumors in people with advanced ovarian cancer. The researchers also looked to see how long the drug’s effect lasted in these people.

People with advanced ovarian cancer could participate in the study if they’d received at least three chemotherapy regimens in the past. But they couldn’t join the study if they’d used a drug in the same class of medications as Zejula. (Zejula belongs to a drug class called PARP inhibitors. A drug class describes a group of medications that work in the same way.)

In this study, no one took a placebo (treatment with no active drug). Instead, everyone in the study took Zejula.

The researchers found that:

  • 24% of people had a partial response to Zejula. With a partial response, their cancer didn’t disappear completely, but it did get smaller in size.
  • No one in the study had a complete response to treatment. With a complete response, their cancer would have disappeared completely.

Another study looked at using Zejula as the first maintenance treatment used after treatment with chemotherapy that’s made from platinum. The researchers found that:

  • Of people who took Zejula, 50% of them were still alive after nearly 14 months.
  • Of people who got a placebo, 50% of them were still alive after about 8 months.

Zejula for other conditions

In addition to the uses listed above, Zejula is being studied for other possible uses. Below is information on one possible use for Zejula that’s currently being studied.

Zejula for prostate cancer (under study)

Zejula isn’t approved to treat prostate cancer. But there’s currently a study underway that’s looking to see if Zejula is effective in treating this condition. Specifically, researchers want to see if Zejula can treat metastatic, castration-resistant prostate cancer.

With metastatic prostate cancer, the cancer has spread from your prostate to other parts of your body. And with castration-resistant cancer, drugs that lower certain hormone levels didn’t work to stop the cancer from growing.

This study is scheduled to be completed around February 2021. Final results from the study aren’t yet available. But the information collected so far does look promising. In fact, because this early information looks promising, the FDA designated Zejula as a “breakthrough therapy” for this type of prostate cancer.

Because of this designation, the FDA’s process for approving Zejula for this condition will be prioritized. Typically, the FDA only does this prioritizing when a certain drug may be a much better treatment option than other drugs that are currently available.

However, this doesn’t mean that Zejula is known for sure to be effective in treating metastatic, castration-resistant prostate cancer. There’s still more research that needs to be completed.

If you have questions about using Zejula for prostate cancer, talk with your doctor.

Zejula and children

Zejula hasn’t been studied in children. This drug isn’t approved for use in anyone younger than 18 years of age.

There isn’t a known interaction between Zejula and alcohol.

However, the American Cancer Society recommends that some people avoid consuming alcohol while being treated for cancer. This is because it’s thought that drinking alcohol could worsen some side effects of certain cancer treatments.

If you have questions about whether it’s safe for you to drink alcohol while you’re taking Zejula, talk with your doctor.

Zejula is approved to treat certain types of ovarian cancer. For information on Zejula’s approved uses, see the “Zejula uses” section above.

What happens with cancer

Normally, the cells in your body multiply (make more cells) and die at a normal rate. But with cancer, certain cells start growing and multiplying more quickly than normal.

Eventually, these cancer cells can spread to other parts of your body. And because cancer cells are growing and multiplying faster than healthy cells, they take away nutrients and other resources from healthy cells.

What Zejula does

Zejula treats cancer by inhibiting (stopping) certain enzymes from working. Enzymes are proteins that help speed up chemical reactions in your body.

Specifically, Zejula inhibits a group of enzymes called PARP (poly [ADP-ribose] polymerase) enzymes. These enzymes help repair DNA (genetic material) inside cancer cells.

By inhibiting PARP enzymes, Zejula stops the cancer cells from fixing problems with their DNA. So the cancer cells’ DNA stays damaged, which causes the cells to die.

This action of Zejula also stops the cancer cells from multiplying as they typically would. And this helps to stop the cancer from spreading inside your body.

How long does it take to work?

Zejula begins working as soon as you take your first dose of the drug. However, you likely won’t feel the drug working as it fights off your cancer.

There aren’t any known interactions between Zejula and other medications, herbs, supplements, or foods. However, that doesn’t mean interactions can’t occur.

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.

Before taking Zejula, 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.

As with all medications, the cost of Zejula 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 Zejula 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 Zejula, 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 Zejula, contact your insurance company.

Financial and insurance assistance

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

GlaxoSmithKline PLC, the manufacturer of Zejula, offers a program called Together with GSK Oncology. Through this program, you’ll have assistance in understanding insurance coverage of Zejula. In addition, you may be eligible for financial assistance to help lower the cost of the drug.

For more information and to find out if you’re eligible for support, call 844-4GSK-ONC (844-447-5662) or visit the program website.

Generic version

Zejula 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.

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

When to take

Zejula should be taken once daily. You should try to take your dose at the same time every day.

If you have nausea with Zejula, try taking your dose at bedtime. This may help reduce your nausea.

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

Taking Zejula with food

Zejula may be taken with or without food.

Can Zejula be crushed, split, or chewed?

No, Zejula capsules shouldn’t be crushed, split, or chewed. You also shouldn’t open the capsules or sprinkle their contents on food. Instead, Zejula capsules need to be swallowed whole.

You shouldn’t take Zejula if you’re pregnant. Taking Zejula during pregnancy may cause fetal harm. Doing so can also lead to miscarriage.

There haven’t been any studies of Zejula in pregnant women or pregnant animals. This is because, based on how the drug works, it can possibly cause serious harm to a developing fetus. So doing these studies wouldn’t be appropriate.

If you’re able to become pregnant, your doctor may have you take a pregnancy test before you start taking Zejula. This helps ensure you aren’t pregnant when you start Zejula treatment. And your doctor may recommend that you use birth control during Zejula treatment. For information about this, see the “Zejula and birth control” section below.

If you have additional questions about using Zejula during pregnancy, talk with your doctor.

Zejula isn’t safe to use during pregnancy. Below, we review birth control recommendations for both men and women using Zejula.

If you’re sexually active and you can become pregnant, talk with your doctor about your birth control needs while you’re using Zejula.

For women using Zejula

If you’re a women who’s sexually active and able to become pregnant, you should use an effective form of birth control while you’re taking Zejula. And you should continue using birth control for least 6 months after your last dose of the drug.

For men using Zejula

The manufacturer of Zejula hasn’t given birth control recommendations for men using the medication. If you’re a man using Zejula and you’re sexually active with a female who’s able to become pregnant, talk with your doctor. They can discuss your birth control needs while you’re using this medication.

You shouldn’t breastfeed while you’re taking Zejula. It’s not known if Zejula passes into human breast milk. However, based on how the drug works, it’s possible that it could cause harm in children who are breastfed.

The manufacturer of Zejula recommends that you avoid breastfeeding while you’re taking Zejula. And you should continue to avoid breastfeeding for at least 1 month after your last dose of the drug.

If you have questions about breastfeeding while you’re taking Zejula, talk with your doctor. They can recommend safe and healthy ways to feed your child.

Here are answers to some frequently asked questions about Zejula.

Is Zejula a type of chemotherapy?

No, Zejula isn’t a type of chemotherapy.

Chemotherapy can refer to any drug that’s used to treat cancer. But it usually refers to traditional medications that can affect your entire body (systemic treatments).

Chemotherapy drugs affect cells that are rapidly multiplying (making more cells). While this includes cancer cells, it also includes some healthy cells. This is why chemotherapy often leads to many unwanted side effects, such as hair loss.

Zejula, on the other hand, is a targeted therapy. This means the drug targets certain parts of specific cells, such as cancer cells. It does this instead of attacking all the rapidly multiplying cells in your body.

Because Zejula is targeted to only attack certain cells, it usually has different and fewer side effects than chemotherapy drugs do.

Will Zejula cure my cancer?

No, unfortunately, Zejula won’t cure your cancer. In fact, there’s currently no known cure for cancer. However, Zejula may help you live longer without your cancer growing or getting worse.

For more information on Zejula’s effectiveness in treating cancer, see the “Zejula uses” section above.

How can I reduce my risk of nausea from Zejula?

Nausea is a frequent side effect of Zejula. For example, in clinical trials, 57% to 74% of people who took Zejula had nausea. (This percentage varied depending on the type of cancer being treated.)

If you have nausea with Zejula, the drug’s manufacturer recommends that you try taking your doses at bedtime. Doing so may be helpful in reducing your nausea.

If you try taking Zejula at bedtime, and you still have nausea, talk with your doctor. They may recommend other ways to treat your nausea. In some cases, they may recommend that you stop taking Zejula and use a different drug for your cancer.

Do I need to have special testing done before I can take Zejula?

It depends on what condition you’re using Zejula to treat.

For example, certain tests might be done if you have advanced* ovarian cancer† that’s been treated with three or more chemotherapy regimens in the past. (Chemotherapy describes traditional drugs used to treat cancer.)

These tests check for a certain mutation (abnormal gene change). Zejula only works for this type of cancer if the cancer is caused by a specific genetic mutation. So your doctor will order these tests to see if your cancer can be treated with Zejula.

In addition, if you’re a woman who’s able to become pregnant, your doctor may also order a pregnancy test for you before you start using Zejula. This is because Zejula can cause harm to a developing fetus. For more information about this, see the “Zejula and Pregnancy” section above.

Before starting therapy with Zejula, your doctor will also check your complete blood count (CBC). For more information about this test, see the question below, “Will I need to have certain lab tests done while I’m taking Zejula?”

If you have additional questions about tests that are needed before taking Zejula, talk with your doctor.

* With advanced ovarian cancer, the cancer has spread out of the ovaries.
† This includes certain cancers in the fallopian tubes and peritoneum. Because they can be so similar to ovarian cancer, they’re sometimes labeled as ovarian cancer.

Will I need to have certain lab tests done while I’m taking Zejula?

Yes, you’ll need to have certain lab tests done while you’re taking Zejula.

During Zejula treatment, your doctor will order a test called a complete blood count (CBC). This test reports your blood cell counts, and it can be used to check for certain blood disorders. Although it’s rare, Zejula can cause serious blood disorders in some people. For information about these blood disorders, see the “Zejula side effects” section above.

During your first month taking Zejula, you’ll have a CBC each week. Then, over the next 11 months of treatment, you’ll have a CBC each month.

If you continue taking Zejula for longer than 12 months, your doctor will check your CBC as needed. For example, they may check it three or four times each year.

Depending on your CBC results, your doctor may have you temporarily stop taking Zejula. Then you could possibly restart the drug once your CBC returns to normal. Also, depending on your test results, your doctor may reduce your Zejula dosage or have you switch to a different drug for your cancer.

If you have additional questions about lab testing while you’re taking Zejula, talk with your doctor.

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

  • Heart disease or high blood pressure. Zejula can cause high blood pressure. People who already have heart disease, an abnormal heart rhythm, or high blood pressure may need close monitoring while using Zejula. If you have a history of high blood pressure or heart disease, talk with your doctor before using Zejula.
  • Allergic reaction. If you’ve had an allergic reaction to Zejula or any of its ingredients, you shouldn’t take Zejula. Ask your doctor what other medications are better options for you. If you’re unsure about your medication allergies, talk with your doctor.
  • Pregnancy. You shouldn’t take Zejula if you’re pregnant. For more information, please see the “Zejula and pregnancy” section above.
  • Breastfeeding. You shouldn’t breastfeed while taking Zejula. For more information, please see the “Zejula and breastfeeding” section above.

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

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

It’s important to note that if you vomit right after taking a dose of Zejula, just skip that dose. Then take your next dose at the usual time. Don’t “double up” your dose by taking an extra dose of Zejula. Doing so can increase your risks of side effects from the drug.

What to do in case you take too much Zejula

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 their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Zejula 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.

Zejula tablets should be stored at room temperature between 68°F and 77°F (20°C and 25°C). It should be kept in a tightly sealed container away from light.

You can temporarily keep Zejula stored between 59°F and 86°F (15°C and 30°C) for short periods of time, such as during travel, as long as you bring the drug back to room temperature as soon as possible. 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 Zejula 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

Zejula is approved for the maintenance treatment of recurrent epithelial fallopian tube, ovarian, or primary peritoneal cancer. For this use, Zejula can be prescribed for adults who are in complete or partial response following the use of platinum-based chemotherapy.

In addition, Zejula is approved as a first-line maintenance treatment in adults with advanced fallopian tube, ovarian, or primary peritoneal cancer. For this use, Zejula can be prescribed for adults who are in complete or partial response following the use of platinum-based chemotherapy.

Zejula is also approved for use in adults with homologous recombination deficiency (HRD)-positive advanced fallopian tube, ovarian, or primary peritoneal cancer who have received prior treatment with three or more prior chemotherapy regimens.

For this use, HRD-positive status is defined by either:

  • deleterious (or suspected deleterious) mutation in the BRCA gene, or
  • genomic instability and progression experienced more than 6 months following a response to the last administered platinum-based chemotherapy regimen

Administration

Zejula is supplied as capsules that are taken by mouth once daily. Zejula may be taken with or without food.

Administering Zejula at bedtime may provide relief for nausea caused by the drug.

Mechanism of action

Niraparib, the active ingredient in Zejula, inhibits poly (ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in cellular DNA repair. It is believed that niraparib-induced PARP enzyme activity inhibition results in DNA damage and cell death.

Pharmacokinetics and metabolism

Peak plasma niraparib concentrations are reached within 3 hours of oral administration. The mean half-life is 36 hours. Niraparib is primarily metabolized by carboxylesterases to its inactive metabolites.

Contraindications

There are no known contraindications to Zejula.

Storage

Zejula tablets should be stored at room temperature, between 68°F and 77°F (20°C and 25°C). Temperature excursions between 59°F and 86°F (15°C and 30°C) are allowed for short periods of time.

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.

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