Erleada (apalutamide)

Erleada generic

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 side effects

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, refer to this article. Or talk with your doctor or pharmacist. They can share tips on how to manage bothersome side effects.

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 that you’ve had with Erleada, you can do so through MedWatch.

More common side effects

The more common side effects of Erleada include:*

• fatigue
• skin rash, which is described in the “Side effect details” section below
• diarrhea
• nausea
• loss of appetite
• weight loss
• joint pain
• flushing
• edema (swelling) in your hands, ankles, feet, lymph nodes, or genitals

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 with 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 prescribing 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 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms include the following:

• Cerebrovascular events (brain injuries that are due to blood vessel problems), such as stroke. Symptoms can include:
  • sudden and severe headache
  • confusion
  • paralysis on one side of the body
  • slurred speech
• Ischemic heart disease (a type of heart disease in which part of the heart doesn’t receive enough blood). Symptoms can include:
  • shortness of breath
  • dizziness
  • chest pain
  • swelling in your feet and ankles
• Hypertension (high blood pressure). Symptoms can include:
  • headaches
  • dizziness
  • vision changes
  • chest pain
• Seizures. Symptoms can include:
  • loss of consciousness
  • muscle spasms
  • loss of bowel and bladder control
  • drooling
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. Symptoms can include:
  • serious skin rash
  • blistering or peeling skin
  • fever
  • swollen lymph nodes
  • a general feeling of being unwell
• Increased risk of falls, which can lead to bone fractures.
• Severe allergic reaction, which is described in the “Side effect details” section below.

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:

• skin rash
• itchiness
• flushing

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

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling (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 of Erleada. Rashes that result from taking Erleada may cause discoloration or bumps on your skin.

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, including a severe skin reaction. (For more information about this, see the “Allergic reaction” section just above.)

If you think you may be having an allergic reaction to Erleada, call your doctor right away. If you have symptoms of a severe skin reaction, immediately call 911 or go to the closest emergency room. (For examples of symptoms of this side effect, see the “Serious side effects” section above.)

Erleada cost

As with all medications, the cost of Erleada can vary. Your actual cost will depend on your insurance plan, your location, and other factors.

To learn more about Erleada and cost, refer to this article.

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 Compass 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 844-628-1234 or visit the program website.

Erleada dosage

The following information describes the Erleada 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.

For more details about Erleada’s dosage, refer to this article.

Drug forms and strengths

Erleada comes as an oral tablet. It’s available in two strengths: 60 milligrams (mg) and 240 mg.

Dosage for nonmetastatic castration-resistant prostate cancer (nmCRPC)

The typical dosage of Erleada for nmCRPC is 240 mg taken once daily.

If you have serious side effects while taking Erleada, your doctor may lower your dosage. Or they may have you stop taking Erleada permanently, depending on the severity of the side effect. For example, if you experience a severe cerebrovascular event (brain injury due to blood vessel problems) or a severe skin reaction such as Stevens-Johnson syndrome, your doctor will likely halt treatment with Erleada.

Dosage for metastatic castration-sensitive prostate cancer (mCSPC)

The typical dosage of Erleada for mCSPC is 240 mg taken once daily.

If you have serious side effects while taking Erleada, your doctor may lower your dosage. Or they may have you stop taking Erleada permanently, depending on the severity of the side effect.

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.

Do not take two doses of Erleada on the same day. Doing this can increase your risk of 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.

Alternatives to Erleada

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 with 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 the condition in question. 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, Yonsa)
• 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 (Taxotere)
• enzalutamide (Xtandi)
• luteinizing hormone-releasing hormone agonists, such as leuprolide (Lupron Depot, Eligard) or histrelin
• LHRH antagonists, such as degarelix (Firmagon)
• flutamide
• nilutamide (Nilandron)
• prednisone

Erleada vs. Xtandi

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.

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

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 the body. And it’s called castration-resistant because therapy to reduce levels of testosterone (a hormone) in the 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 the 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 castration-resistant prostate cancer
• nmCRPC that has a high risk of becoming metastatic
• mCSPC

Drug forms and administration

Erleada comes as 60-milligram (mg) and 240-mg tablets. Xtandi comes as 40-mg capsules and 40-mg and 80-mg tablets. Both medications are taken by mouth once each day.

People who’ve had surgery to remove their testicles may take either Erleada or Xtandi alone. People who haven’t had this surgery must take Erleada or Xtandi 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).

• Can occur with Erleada:
  • skin rash
  • diarrhea
  • nausea
  • edema (swelling) in your hands, ankles or feet
• Can occur with Xtandi:
  • feeling weak
  • dizziness
  • vertigo
  • headache
• Can occur with both Erleada and Xtandi:
  • loss of appetite
  • weight loss
  • joint pain
  • fatigue
  • flushing

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).

• Can occur with Erleada:
  • cerebrovascular events (brain injuries that are due to blood vessel problems), such as stroke
• Can occur with Xtandi:
  • swelling in your brain, which may lead to seizures
• Can occur with both Erleada and Xtandi:
  • severe allergic reaction
  • increased risk of falls, which lead to bone fractures
  • seizures
  • hypertension (high blood pressure)
  • ischemic heart disease (a type of heart disease in which part of the heart doesn’t receive enough blood)

Effectiveness

Erleada and Xtandi have not been directly compared in clinical trials. 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. Also, both drugs are recommended as treatment options for mCSPC by the National Comprehensive Cancer Network.

Costs

The actual cost you pay for either Erleada or Xtandi will depend on your insurance plan, your location, and other factors. Your doctor or pharmacist can tell you more about how the costs of these drugs compare.

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

Erleada vs. Zytiga

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.

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

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 the body. And it’s called castration-resistant because therapy to reduce levels of testosterone (a hormone) in the 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 the 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 prostate cancer:

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

Drug forms and administration

Erleada comes as 60-milligram (mg) and 240-mg oral tablets. Zytiga comes as 250-mg and 500-mg oral tablets. Both medications are taken 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.

People who’ve had surgery to remove their testicles can take either Erleada or Zytiga alone to treat their prostate cancer. But people who haven’t had this surgery must take Erleada or Zytiga in combination with another type of drug to treat their prostate cancer.

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).

• Can occur with Erleada:
  • loss of appetite
  • weight loss
• Can occur with Zytiga:
  • cough
  • headache
  • vomiting
  • upper respiratory infections (such as the common cold or sinus infection)
• Can occur with both Erleada and Zytiga:
  • skin rash
  • fatigue
  • diarrhea
  • nausea
  • joint pain
  • flushing
  • edema (swelling) in your hands, legs, and feet

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).

• Can occur with Erleada:
  • increased risk of falls, which can lead to bone fractures
  • cerebrovascular events (brain injuries that are due to blood vessel problems), such as stroke
  • ischemic heart disease (a type of heart disease in which part of the heart doesn’t receive enough blood)
  • seizures
• Can occur with Zytiga:
  • liver damage and failure
  • heart disorders, such as an atypical heart rhythm or heart attack
  • adrenal gland problems
  • anemia (low red blood cell count)
  • increased triglyceride and cholesterol levels
  • increased blood sugar levels
  • electrolyte imbalances
• Can occur with both Erleada and Zytiga:
  • severe allergic reaction
  • hypertension (high blood pressure)

Effectiveness

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

Erleada is recommended by the National Comprehensive Cancer Network as a treatment option for people with nmCRPC. Also, both Erleada and Zytinga are recommended as treatment options for mCSPC by the National Comprehensive Cancer Network.

Costs

The actual cost you pay for either Erleada or Zytiga will depend on your insurance plan, your location, and other factors.

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.

Erleada for prostate cancer

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 males who:

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

To learn more about prostate cancer, visit our prostate cancer hub.

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

Erleada for nonmetastatic castration-resistant prostate cancer

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

Nonmetastatic prostate cancer is only found in the prostate gland. It hasn’t metastasized (spread) 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 trials, Erleada was found to be effective in treating nmCRPC. For details of these trials, refer to Erleada’s prescribing information.

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 the body.

And castration-sensitive prostate cancer is a type of prostate cancer that responds to treatment that reduces the level of testosterone in the 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 trials, Erleada was found to be effective in treating mCSPC. For details of these trials, refer to Erleada’s prescribing information.

Erleada use with other drugs

People who’ve had surgery to remove their testicles can take Erleada alone to treat prostate cancer. But people who haven’t had this surgery must take Erleada in combination with another type of drug to treat prostate cancer.

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:

• luteinizing hormone-releasing hormone agonists, such as leuprolide (Lupron Depot, Eligard) or histrelin
• 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.

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

Erleada and alcohol

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

Consuming alcohol and Erleada together can increase your risk of:

• fatigue
• falls
• diarrhea
• nausea

If you drink alcohol, talk with your doctor about how much may be safe to consume during Erleada treatment.

Erleada interactions

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 the body. Higher levels of the drug can increase the risk of side effects.

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

• certain cholesterol medications, such as gemfibrozil (Lopid)
• certain antibiotics, including clarithromycin
• certain HIV treatments, including:
  • cobicistat (Tybost)
  • ritonavir (Norvir)
• certain antifungals, including:
  • ketoconazole
  • voriconazole (Vfend)

If you take 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:
  • simvastatin (FloLipid, Zocor)
  • rosuvastatin (Crestor, Ezallor)
• certain blood thinners, including:
  • dabigatran (Pradaxa)
  • warfarin (Jantoven)
• 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. Or they may just monitor you for any drug interactions and make changes to your medications if needed.

How to take Erleada

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

You’ll typically take Erleada tablets by mouth. But if you have difficulty swallowing pills, see the “Can Erleada be crushed?” section below.

Timing

Erleada should be taken once each day. 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 difficulty swallowing pills, try the steps outlined below for taking the 60-milligram (mg) or 240-mg tablets. Your doctor or pharmacist can also provide tips on how to take Erleada.

Taking the 60-mg tablets with applesauce

To make the 60-mg Erleada tablets easier to take, you can mix them in applesauce to dissolve them. (Depending on your dosage, you may need to take two or three 60-mg tablets at the same time.) To do this, follow these steps:

1. Place the tablets in 4 ounces (oz), or 120 milliliters (mL), of applesauce and stir. But do not crush or split the tablets.
2. After 15 minutes, stir the mixture again.
3. After another 15 minutes, stir the mixture 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. Add 2 oz (60 mL) of water to the container that held the applesauce mixture and swirl it. 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. Do not store the mixture and take it later.

Taking the 240-mg tablets with orange juice, applesauce, or water

To make the 240-mg Erleada tablets easier to swallow, try these steps:

1. Place a tablet in a cup. (But do not crush or split the tablet.)
2. Add 0.34 ounces (10 mL) of water so that the tablet is fully covered.
3. Wait 2 minutes for the table to start to dissolve, then stir the mixture.
4. Add 1 oz (30 mL) of orange juice, applesauce, or water, and stir the mixture.
5. Swallow the mixture immediately.
6. Add water to the cup and swirl it. Drink this liquid right away. (Doing this helps to ensure you’ve taken the entire dose of Erleada.)

Erleada prepared using this method should be swallowed right away. Avoid storing Erleada that is mixed with water, orange juice, or applesauce for later use.

Note: A healthcare professional may administer dissolved 240-mg Erleada tablets through a feeding tube.

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 condition 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.

How Erleada works

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 adult males with one of these types of prostate cancer:

• nonmetastatic castration-resistant prostate cancer (nmCRPC)
• metastatic castration-sensitive prostate cancer (mCSPC).

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

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 reduce testosterone (the main male hormone) levels in the body. These treatments include using certain medications (called anti-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 the body.
• It’s castration-sensitive, which means that the cancer responds to treatment that reduces the level of testosterone in the 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 during Erleada treatment. They can give you more information about when Erleada is working for you.

Erleada and pregnancy

Erleada is not intended for use by females, and it hasn’t been studied in females. It should not be taken by someone who is 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 male animals during animal studies. In these studies, male animals who were given Erleada had less ability to produce offspring. It isn’t known whether Erleada reduces fertility in humans. Animal studies don’t always predict how a drug will affect humans.

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

Contraception during Erleada use

If you’re taking Erleada and have a sexual partner who can become pregnant, you should use contraception (such as condoms). It’s important to do this even if your partner is also using birth control. You should continue to use contraception for 3 months after completing treatment with Erleada.

Erleada and breastfeeding

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

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

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

Common questions about Erleada

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 assess 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 typical 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 find out whether you have any pain there.
• 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) to be 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 determine whether 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 of 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 medication to help strengthen your bones while you take Erleada.

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

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 “Erleada for prostate cancer” section above.

Erleada precautions

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 new or worsening ischemic 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, and diabetes. Your doctor may have you stop taking the drug if you experience severe heart-related side effects during treatment.

• Seizure disorders. Erleada may cause seizures. If you have a history of seizures or a seizure disorder, such as epilepsy, talk with 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 brain injuries. People who have had a brain injury, stroke, or brain tumor may have an increased risk of 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. If you experience severe brain-related side effects during Erleada treatment, your doctor may have you stop taking the drug.
• Falls and fractures. Erleada may increase your risk of 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 with 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.

Erleada overdose

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

Overdose symptoms

Symptoms of an overdose can include:

• seizures
• increased risk of falls, which may lead to bone fractures
• hypertension (high blood pressure)
• fatigue
• diarrhea
• skin rash
• nausea
• flushing
• edema (swelling) in your hands, ankles, feet, lymph nodes, or genitals
• loss of appetite

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 America’s Poison Centers at 800-222-1222 or through its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.