Erleada is a brand-name prescription medication. It’s used to treat these types of prostate cancer in adult males:

  • Nonmetastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer is nonmetastatic, which means it hasn’t spread to other parts of your body. And it’s called castration-resistant because therapy to reduce levels of testosterone (a hormone) in your body doesn’t work to treat it.
  • Metastatic castration-sensitive prostate cancer (mCSPC). This type of prostate cancer is metastatic, which means it has spread to other parts of your body. And it’s called castration-sensitive because therapy to reduce levels of testosterone can work to treat it.

Erleada is given to adult males with nmCRPC or mCSPC who belong to one of two groups. The first is men who are taking another medication (a type of androgen deprivation therapy) in combination with Erleada to lower testosterone levels in their body. The second is men who have already had surgery to remove their testicles.

Erleada contains the drug apalutamide. It comes as an oral tablet that’s taken once daily. And it’s available in one strength: 60 mg.

FDA approval

Erleada was the first drug approved by the Food and Drug Administration (FDA) to treat nmCRPC. The FDA approved Erleada for this use in February 2018. Then later, in September 2019, Erleada was approved to treat mCSPC.

Effectiveness

For information about Erleada’s effectiveness in treating prostate cancer, see the section below called “Erleada for prostate cancer.”

Erleada contains the drug apalutamide.

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

Erleada can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Erleada. This list does not include all possible side effects.

For more information on the possible side effects of Erleada, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

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

More common side effects

The more common side effects of Erleada can include*:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

* This is a partial list of the more common mild side effects from Erleada. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Erleada’s patient information.

Serious side effects

Serious side effects from Erleada 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 the following:

  • Hypertension (high blood pressure). Symptoms can include:
    • headaches
    • dizziness
    • vision changes
    • chest pain
  • Seizures. Symptoms can include:
    • loss of consciousness
    • muscle spasms
    • loss bowel and bladder control
    • drooling
  • Increased risk of falls, which can lead to bone fractures.
  • Severe allergic reaction, which is described below in the section called “Side effect details.”

Side effect details

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

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Erleada. It isn’t known for sure how often allergic reactions occur in people taking Erleada.

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 (edema) of your tongue, mouth, or throat
  • trouble breathing

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

Rash

A rash is a common side effect in men who take Erleada. Rashes caused by Erleada may cause redness or bumps on your skin.

In clinical studies, 26% of men who took Erleada developed a rash. In comparison, a rash occurred in 9% of men who took a placebo (treatment with no active drug). In 78% of men who took Erleada, their rash went away during the study. On average, it took about 78 days after the rash appeared for it to go away.

If you have any skin changes while you’re taking Erleada, talk with your doctor. They may be able to recommend ways to help reduce your symptoms.

Also, keep in mind that skin rash can sometimes be a sign of allergic reaction. (For more information about this, see the section just above called “Allergic reaction.”) If you think you may be having an allergic reaction to Erleada, call your doctor right away.

As with all medications, the cost of Erleada can vary.

Your actual cost will depend on your insurance plan, your location, and the pharmacy you choose.

Financial and insurance assistance

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

The manufacturer of Erleada, Janssen Biotech, Inc., offers a program called Janssen CarePath to help you find options for lowering the cost of Erleada. For more information on this program and to find out if you’re eligible for support, call 833-375-3232 or visit the program website.

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

Drug forms and strengths

Erleada comes as tablets that are taken by mouth. It’s available in one strength: 60 mg.

Dosage for nonmetastatic castration-resistant prostate cancer (nmCRPC)

The typical dosage of Erleada for nmCRPC is 240 mg taken once daily. On this dosage, you’ll take four 60-mg tablets one time each day.

If you have serious side effects while taking Erleada, your doctor may lower your dosage.

Dosage for metastatic castration-sensitive prostate cancer (mCSPC)

The typical dosage of Erleada for mCSPC is 240 mg taken once daily. On this dosage, you’ll take four 60-mg tablets one time each day.

If you have serious side effects while taking Erleada, your doctor may lower your dosage.

What if I miss a dose?

If you forget to take Erleada, take your next dose as soon as you remember. If you missed your dose for a whole day, just take your regular dose of Erleada the next day.

Don’t take two doses of Erleada on the same day. Doing this can increase your risk for side effects.

Will I need to use this drug long term?

Erleada is meant to be used as a long-term treatment. If you and your doctor determine that Erleada 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 better suited for you than others. If you’re interested in finding an alternative to Erleada, talk to your doctor to learn more about other medications that may work well for you.

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

Alternatives for nonmetastatic castration-resistant prostate cancer

Examples of other drugs that may be used to treat nonmetastatic castration-resistant prostate cancer (nmCRPC) include:

  • flutamide
  • nilutamide (Nilandron)
  • enzalutamide (Xtandi)
  • abiraterone acetate (Zytiga)
  • bicalutamide (Casodex)

Alternatives for metastatic castration-sensitive prostate cancer

Examples of other drugs that may be used to treat metastatic castration-sensitive prostate cancer (mCSPC) include:

  • abiraterone acetate (Zytiga)
  • bicalutamide (Casodex)
  • darolutamide (Nubeqa)
  • docetaxel
  • enzalutamide (Xtandi)
  • LHRH agonists, such as leuprolide (Lupron, Eligard) or histrelin (Vantas)
  • LHRH antagonists, such as degarelix (Firmagon)
  • flutamide
  • nilutamide (Nilandron)
  • prednisone

You may wonder how Erleada compares to other medications that are prescribed to treat prostate cancer. Here we look at how Erleada and Xtandi are alike and different.

General

Erleada contains the drug apalutamide, while Xtandi contains the drug enzalutamide.

Both drugs work by blocking testosterone (the main male hormone) from binding to attachment sites (called receptors). When testosterone attaches to receptors on prostate cancer cells, the cancer cells grow and spread. Erleada and Xtandi block this hormone from binding to cancer cells. This helps to stop the growth of prostate cancer.

Uses

Erleada is approved to treat two types of prostate cancer:

  • Nonmetastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer is nonmetastatic, which means it hasn’t spread to other parts of your body. And it’s called castration-resistant because therapy to reduce levels of testosterone (a hormone) in your body doesn’t work to treat it.
  • Metastatic castration-sensitive prostate cancer (mCSPC). This type of prostate cancer is metastatic, which means it has spread to other parts of your body. And it’s called castration-sensitive because therapy to reduce levels of testosterone can work to treat it.

Xtandi is approved to treat these three forms of prostate cancer:

  • metastatic and non-metastatic CRPC
  • mCSPC

Drug forms and administration

Erleada comes as 60-mg tablets, and Xtandi comes as 40-mg capsules. Both medications are taken by mouth once each day.

In people who’ve had surgery to remove their testicles, both Erleada and Xtandi can be taken alone. But in people who haven’t had this surgery, Erleada and Xtandi must be taken in combination with another type of drug.

This other type of drug is called a gonadotropin-releasing hormone (GnRH) analog. It belongs to a kind of treatment called analog androgen deprivation therapy (ADT). A GnRH analog works to help lower male hormone levels and stop prostate cancer cells from growing.

Side effects and risks

Erleada and Xtandi work in very similar ways in the body. Therefore, they have some similar common and serious side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Erleada, with Xtandi, or with both drugs (when taken individually).

Serious side effects

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

Effectiveness

Erleada and Xtandi have not been directly compared to each other in clinical studies. One study indirectly compared the two drugs as treatment options for people with nmCRPC. The study showed that both drugs may be equally effective in delaying the progression and spread of nmCRPC.

Both Erleada and Xtandi are recommended as treatment options for nmCRPC by the National Comprehensive Cancer Network and the American Urological Association.

Costs

Erleada and Xtandi are both brand-name drugs. They’re not currently available in generic forms. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Erleada and Xtandi generally cost about the same. The actual cost you pay for either drug will depend on your insurance plan, your location, and the pharmacy you choose.

Zytiga is another drug that’s used to treat prostate cancer. Here we look at how Erleada and Zytiga are alike and different.

General

Erleada contains the drug apalutamide, while Zytiga contains the drug abiraterone acetate. Both Erleada and Zytiga decrease the effect of testosterone (the main male hormone) in the body. But these medications work in different ways.

Erleada works by blocking testosterone from binding to attachment sites (called receptors). When testosterone attaches to receptors in prostate cancer cells, the cancer cells grow and spread. Erleada blocks this hormone from binding to the cancer cells. This helps to stop the growth of prostate cancer.

Zytiga helps stop the body from making male hormones. With lower levels of testosterone in the body, prostate cancer cells are less able to grow and spread. This helps to stop the growth of prostate cancer.

Uses

Erleada and Zytiga are used to treat different types of prostate cancer.

Erleada is approved to treat these types of prostate cancer:

  • Nonmetastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer is nonmetastatic, which means it hasn’t spread to other parts of your body. And it’s called castration-resistant because therapy to reduce levels of testosterone (a hormone) in your body doesn’t work to treat it.
  • Metastatic castration-sensitive prostate cancer (mCSPC). This type of prostate cancer is metastatic, which means it has spread to other parts of your body. And it’s called castration-sensitive because therapy to reduce levels of testosterone can work to treat it.

Zytiga is approved to treat these types of metastatic prostate cancer:

  • Castration-resistant. This type of cancer continues to grow after being treated with drugs or surgery to lower male hormone levels.
  • High-risk, castration-sensitive. This type of cancer improves after treatment with drugs or surgery that lower male hormone levels.

Drug forms and administration

Erleada comes as 60-mg tablets and Zytiga comes as 250-mg and 500-mg tablets. Both medications are taken by mouth once daily.

Zytiga is taken in combination with a corticosteroid called prednisone. Taking the steroid medication with Zytiga helps to reduce certain side effects of Zytiga.

In people who’ve had surgery to remove their testicles, both Erleada and Zytiga can be taken alone. But in people who haven’t had this surgery, Erleada and Zytiga must be taken in combination with another type of drug.

This other type of drug is called a gonadotropin-releasing hormone (GnRH) analog. It belongs to a kind of treatment called analog androgen deprivation therapy (ADT). A GnRH analog works to help lower male hormone levels and stop prostate cancer cells from growing.

Side effects and risks

Erleada and Zytiga both decrease male hormone levels but work in slightly different ways. These drugs have some similar and some different side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Erleada, with Zytiga, or with both drugs (when taken individually).

Serious side effects

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

Effectiveness

Erleada and Zytiga are approved for different uses. These drugs haven’t been directly compared to each other in clinical studies.

Erleada is recommended by the American Urological Association and the National Comprehensive Cancer Network as a treatment option for people with nonmetastatic castration-resistant prostate cancer (nmCRPC).

Zytiga is recommended by both organizations as a treatment option for metastatic castration-resistant prostate cancer (mCRPC).

Costs

Erleada and Zytiga are both brand-name drugs. There are currently no generic forms of Erleada available. Zytiga is available in a generic form. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, brand-name forms of Erleada and Zytiga generally cost about the same. The generic form of Zytiga costs less than the brand-name forms of either drug. The actual cost you pay for either drug will depend on your insurance plan, your location, and the pharmacy you choose.

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

Erleada is approved to treat two types of prostate cancer, which are described further below. Prostate cancer grows in the prostate gland (a part of the male reproductive system). Cancer cells are abnormal cells that typically grow quickly and can spread to other areas in the body.

For either of its approved uses, Erleada is prescribed for men who are either:

  • taking a medication in combination with Erleada to lower testosterone in their body, or
  • have already had surgery to remove their testicles

Erleada for nonmetastatic castration-resistant prostate cancer

Erleada is FDA-approved to treat nonmetastaticcastration-resistant prostate cancer (nmCRPC).

Nonmetastatic prostate cancer is only found in the prostate gland. It hasn’t spread (metastasized) to other parts of the body.

And castration-resistant prostate cancer is a type of prostate cancer that continues to grow after being treated by reducing the level of testosterone (the main male hormone). Treatments include using certain medications (called anti-androgens) or having surgery (to remove the testicles).

Effectiveness for nonmetastatic castration-resistant prostate cancer

In clinical studies, Erleada was effective in treating nmCRPC. In the studies, some people took Erleada, while other people took a placebo (treatment with no active drug). Both groups of people also took a drug to help lower their testosterone level, or they had already had surgery to remove their testicles.

Researchers looked at people’s metastasis-free survival (MFS). This measurement shows how long before the men’s prostate cancer spread to certain other parts of their body or they died. The study showed that:

  • half of the people taking Erleada had an MFS of at least 40.5 months
  • half of the people taking the placebo had an MFS of at least 16.2 months

Erleada for metastatic castration-sensitive prostate cancer

Erleada is FDA-approved to treat metastatic castration-sensitive prostate cancer (mCSPC).

Metastatic prostate cancer is cancer that has spread to other parts of your body.

And castration-sensitive prostate cancer is a type of prostate cancer that responds to treatment that reduces the level of testosterone in your body. Treatments include using certain medications (called anti-androgens) or having surgery to remove the testicles.

Effectiveness for metastatic castration-sensitive prostate cancer

In clinical studies, Erleada was effective in treating mCSPC. In the studies, some people took Erleada, while other people took a placebo (treatment with no active drug). Both groups of people also took a drug to help lower their testosterone level, or they had already had surgery to remove their testicles.

Researchers looked at people’s radiographic progression-free survival (r-PFS). This measurement shows how long people lived before they either had two or more new bone lesions* that showed up on a radiograph (a type of imaging test) or they died.

Not everyone stayed in the study for the same amount of time. People kept taking Erleada or a placebo until their condition got worse, they had intolerable side effects, they decided to leave the study, or they died during the study. Some people stayed in the study for up to 36 weeks.

At the conclusion, the researchers found that:

  • 26% of the people who took Erleada had their condition get worse or they died during the study (The researchers weren’t able to calculate the average time people taking Erleada experienced r-PFS, because fewer people experienced their condition worsening or died during the study.)
  • 44% of the people taking placebo had their condition get worse or died during the study. At least half of these people had an r-PFS of a little over 22 months.

* Bone lesions are areas of bone where people’s prostate cancer had spread.

In people who’ve had surgery to remove their testicles, Erleada can be taken alone. But in people who haven’t had this surgery, Erleada must be taken in combination with another type of drug.

This other type of drug is called a gonadotropin-releasing hormone (GnRH) analog. It belongs to a kind of treatment called analog androgen deprivation therapy (ADT).

Male hormones (called androgens) encourage prostate cancer cells to grow and spread. Erleada and GnRH analogs work in different ways to lower the level and effects of androgens in the body. This helps to stop prostate cancer cells from growing and spreading.

Most of the male hormones made in the body are produced in the testicles. GnRH analogs prevent the testicles from making androgens (including testosterone), which lowers the levels of androgens in the body.

Examples of GnRH analogs include:

  • LHRH agonists, such as leuprolide (Lupron, Eligard) or histrelin (Vantas)
  • LHRH antagonists, such as degarelix (Firmagon)

Small amounts of male hormones are made in other parts of the body besides the testicles and also inside cancer cells. Erleada works by blocking the effects of these hormones on prostate cancer cells. This prevents the hormones from helping the cells to grow and spread.

There aren’t any known interactions between Erleada and alcohol. However, drinking too much alcohol can cause many of the same side effects caused by Erleada.

Using alcohol and Erleada together can increase your risk for:

Erleada can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Erleada and other medications

Below are lists of medications that can interact with Erleada. These lists do not contain all drugs that may interact with Erleada.

Before taking Erleada, be sure to tell your doctor and pharmacist 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.

Erleada and drugs that can increase Erleada levels

Erleada can interact with many different medications. This is because Erleada and many other drugs are broken down (metabolized) in the body by a similar process. When metabolized together, the drugs can sometimes interact with each other.

Certain drugs slow down the metabolism of Erleada. This causes higher levels of Erleada in your body. Higher levels of the drug can increase your risk for side effects.

Examples of drugs that can increase Erleada levels in the body include:

  • certain cholesterol medications, such as gemfibrozil (Lopid)
  • certain blood thinners, such as clopidogrel (Plavix)
  • certain antibiotics, including:
  • certain HIV treatments, including:
    • cobicistat (Tybost)
    • ritonavir
  • certain antifungals, including:
    • voriconazole (Vfend)

If you are taking Erleada with a drug that slows down the breakdown of Erleada, your doctor will monitor your side effects. If you cannot tolerate the side effects, your doctor may have you take a lower dosage of Erleada or try a different medication.

Erleada and drugs whose levels can be decreased by Erleada

Erleada can interact with many different medications. This is because Erleada and many other drugs are broken down (metabolized) in the body by a similar process. When metabolized together, the drugs can sometimes interact with each other.

Erleada can cause some drugs to be metabolized quickly in the body. This lowers the levels of those drugs in the body. Drugs that are processed quickly may not work as well.

Examples of drugs whose level can be lowered if taken with Erleada include:

  • certain anti-inflammatory pain relievers, such as celecoxib (Celebrex)
  • certain anticonvulsant medications, such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • certain acid reflux medications, such as omeprazole (Prilosec)
  • certain cholesterol medications, including:
  • certain blood thinners, including:
    • dabigatran (Pradaxa)
  • certain antipsychotics, such as quetiapine (Seroquel, Seroquel XR)
  • certain vasodilators, such as sildenafil (Revatio, Viagra)
  • certain heart medications, such as digoxin (Lanoxin)
  • certain antihistamines, such as fexofenadine (Allegra Allergy)
  • certain herbal supplements, such as St. John’s wort

Review all of the medications and supplements you take with your doctor. They may suggest that you take other medications. They may also just monitor you for any drug interactions and make changes to your medications if needed.

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

Timing

Erleada should be taken once each day, either in the morning or at night. It’s best to take it at the same time every day.

Taking Erleada with food

Erleada can be taken with food or without food.

If you have nausea or stomach upset after taking Erleada, try taking it with a meal. This may help improve your symptoms.

Can Erleada be crushed?

Erleada tablets should not be crushed, split, or chewed. They should be swallowed whole.

However, if you have trouble swallowing pills, you can mix Erleada tablets in applesauce to dissolve them. To do this, follow these steps:

  1. Place Erleada tablets in 4 ounces (120 mL) of applesauce and stir. But don’t crush or split the tablets.
  2. After 15 minutes, stir the mixture again.
  3. After another 15 minutes, stir it again, making sure the tablets are completely dissolved in the applesauce.
  4. Using a spoon, place the mixture in your mouth and swallow it immediately.
  5. Then, use 2 ounces (60 mL) of water to rinse the container that held the applesauce mixture. Drink this liquid right away. Use the same amount of water to rinse the container a second time and drink the liquid again. (Doing this helps to ensure you’ve taken the entire dose of Erleada.)

If you dissolve Erleada in applesauce, be sure to take the mixture within 1 hour of preparing it. Don’t store the mixture and take it later.

How long do I have to take Erleada?

Erleada is typically taken long term for as long as your doctor recommends. You’ll likely take it until your disease worsens, or you have side effects that you find unacceptable.

Your doctor will monitor your condition and let you know when Erleada is working for your cancer.

Erleada is approved to treat certain types of prostate cancer, which grows in the prostate gland (a part of the male reproductive system). Cancer cells are abnormal cells that typically grow quickly and can spread to other areas in the body.

Specifically, Erleada is used in men with one of these types of prostate cancer:

About nmCRPC

Nonmetastatic CRPC has these key features:

  • It’s nonmetastatic, which means it’s only found in the prostate gland. It hasn’t spread (metastasized) to other parts of the body.
  • It’s castration-resistant, which is a type of prostate cancer that continues to grow after treatment to reducetestosterone (the main male hormone) levels in the body. These treatments include using certain medications (calledanti-androgens) or having surgery to remove the testicles.

About mCSPC

Metastatic CSPC has these key features:

  • It’s metastatic, which means it has spread from the prostate to other parts of your body.
  • It’s castration-sensitive, which means that the cancer responds to treatment that reduces the level of testosterone in your body. These treatments include using certain medications (called anti-androgens) or having surgery to remove the testicles.

What Erleada does

Testosterone binds to receptors (attachment sites) on prostate cancer cells. When testosterone does this, the cancer cells grow and spread. Erleada works by blocking testosterone from binding to these receptors. This helps to stop the growth of prostate cancer.

How long does it take to work?

It’s not known for sure how quickly Erleada begins to work on cancer cells.

Each person’s body will respond differently to Erleada. The drug may start blocking the activity of male hormones, such as testosterone, after a few days to a few weeks.

Your doctor will monitor you while take Erleada. They can give you more information about when Erleada is working for you.

Erleada is not intended for use by women, and it hasn’t been studied in women. It should not be taken by women who are pregnant or may become pregnant. Because of how the drug works, it could be harmful to a developing fetus. It may even cause fetal death.

Erleada reduced fertility in males during animal studies. In these studies, males who were given Erleada had less ability to father offspring. It isn’t known if Erleada reduces fertility in humans. Animal studies don’t always predict how a drug will affect humans.

Contraception during Erleada use

Men who are taking Erleada and have female sexual partners who can become pregnant should use contraception (such as condoms). It’s important to do this even if the female is also using birth control. Men should continue to use contraception for 3 months after completing treatment with Erleada.

Erleada is not intended for use by women, and it hasn’t been studied in women. It should not be taken by women who are breastfeeding.

It’s not known if Erleada passes into breast milk. So, it’s not known if the drug would affect a child who is breastfed.

Here are answers to some frequently asked questions about Erleada.

How will I be monitored while I take Erleada?

Before you start Erleada, your doctor will order certain tests to check your prostate cancer. During Erleada treatment, they will monitor your response to the medication on a regular basis.

They will use the following tests to monitor the cancer and see how it responds to treatment:

  • PSA test. Your doctor will likely order prostate-specific antigen (PSA) tests for you. A PSA test will check your prostate cancer’s response to treatment. Both normal prostate cells and abnormal cancer cells make a protein called PSA, which appears in your blood. The levels of PSA in your blood are higher when prostate cancer is growing. With this test, your doctor will take a blood sample and measure your PSA levels.
  • Digital rectal exam. Your doctor can check the size of your prostate by doing a digital rectal exam. (During this exam, your doctor inserts their finger into your rectum and examines your prostate.) This exam allows your doctor to check the size of your prostate and see if you have any pain in your prostate.
  • Imaging tests. Your doctor may order an imaging test (such as a CT or MRI scan) to check the size of your prostate. These tests also help your doctor see the organs around your prostate gland.
  • Prostate biopsy. Your doctor may order a biopsy (tissue sample is taken) from your prostate. The biopsy results help your doctor identify what type and stage of prostate cancer you have. This test is sometimes needed to see if the prostate cancer is improving with treatment.
  • Hormone levels. Your doctor may order blood tests to check your levels of male hormones (such as testosterone) during prostate cancer treatment.

If you’re at risk for bone fractures, your doctor will check the health of your bones. This is done by measuring your bone density on a special imaging test. This will help your doctor decide whether you need a medication to help strengthen your bones while you take Erleada.

What does castration-resistant mean?

The word “castration” refers to surgery or drug therapy that lowers levels of male hormones, such as testosterone. Castration-resistant cancer is a type of cancer that doesn’t respond to drug therapy or surgery that lowers these hormone levels.

Castration-resistant prostate cancer requires special types of treatment to stop the cancer from growing. Erleada is one example of a drug used to treat castration-resistant prostate cancer.

Does Erleada work to treat metastatic cancer?

Yes, Erleada does treat a type of metastatic prostate cancer called metastatic castration-sensitive prostate cancer (mCSPC). For details about this condition, see the section above called “Erleada for prostate cancer.”

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

  • Heart disease. Erleada may cause heart attack in some people with heart disease or risk factors for heart disease. If you have heart disease, talk with your doctor about whether Erleada is safe for you. And, if you have risk factors for heart disease, your doctor may monitor you more closely than usual while you’re taking Erleada. These risk factors include high blood pressure, high cholesterol, or diabetes.
  • Seizure disorders. Erleada may cause seizures. If you have a history of seizures or a seizure disorder, such as epilepsy, talk to your doctor about whether Erleada is safe for you. Taking the drug could possibly worsen your condition.
  • History of brain injury, stroke, or brain tumors. Erleada may cause seizures. People who have had a brain injury, stroke, or brain tumor may be at increased risk for seizures. If you have a history of any of these conditions, taking Erleada may worsen your risk. Be sure to tell your doctor about any history of brain injury, stroke, or brain tumors you may have before taking Erleada.
  • Falls and fractures. Erleada may increase your risk for falling. It can also increase the risk of having falls that cause bone fractures. If you have a history of falls or bone fractures, talk to your doctor about whether Erleada is safe for you. Your doctor may recommend using medication that helps strengthen your bones while you take Erleada. This could help prevent fractures.

If you take too much Erleada, you can increase your risk for side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

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

When you get Erleada 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 the effectiveness of the medication 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.

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

Disposal

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

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

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

Indications

Erleada (apalutamide) is FDA-approved for the treatment of both nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

Mechanism of action

Erleada is an androgen receptor inhibitor. It binds to androgen receptors and inhibits nuclear translocation, DNA binding, and transcription. Receptor inhibition causes decreased tumor cell growth and increased apoptosis.

Pharmacokinetics and metabolism

Oral bioavailability is approximately 100%. Median time to peak plasma concentrations is 2 hours. Administration with food produces no clinically relevant changes in maximum concentration or area-under-the-curve concentration, but it does delay time to peak plasma concentration by 2 hours. Steady-state concentrations are reached after approximately 4 weeks of daily dosing.

Metabolism of Erleada into an active metabolite occurs through enzymatic reaction with CYP2C8 and CYP3A4. The active metabolite has approximately one-third the activity of the parent drug. The parent drug and metabolite are both excreted in urine (65%) and feces (24%).

Contraindications

There are no contraindications to Erleada. However, it should be noted that Erleada may cause harm to a developing fetus, and it hasn’t been studied in women. Men with female partners of reproductive potential should use effective contraception, such as condoms, during Erleada treatment and for 3 months after receiving their final dose.)

Storage

Erleada should be stored in the original container at room temperature (68°F to 77°F, or 20°C to 25°C). Tablets should be protected from light and moisture. Desiccant should be kept in the container.

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.