Erleada (apalutamide)

What is Erleada?

Erleada is a brand-name prescription medication that’s used to treat nonmetastatic castration-resistant prostate cancer (NM-CRPC) in adult men. This type of prostate cancer:

• is not metastatic, which means it has not spread to other parts of your body
• is castration-resistant, which means that therapy to reduce levels of testosterone (a hormone) in your body doesn’t work to treat it

Erleada contains the drug apalutamide. It comes as an oral tablet that’s taken once daily. Erleada is given to people with NM-CRPC who are either:

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

Clinical studies showed that Erleada reduced the risk of NM-CRPC progression and spread by 72%. During studies, people with NM-CRPC who took Erleada had no spreading of cancer for 40 months. People with NM-CRPC who did not take Erleada had cancer spreading after 16 months.

FDA approval

Erleada was the first drug approved by the Food and Drug Administration (FDA) to treat NM-CRPC. The FDA approved Erleada in February 2018. A similar drug called Xtandi was FDA-approved in July 2018. Xtandi can also be used to treat NM-CRPC.

Erleada generic

Erleada is available only as a brand-name medication. It’s not currently available in a generic form.

Erleada contains the drug apalutamide.

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, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Erleada can include:

• fatigue (feeling very tired)
• skin rash
• diarrhea
• nausea
• loss of appetite
• weight loss
• joint pain
• flushing of the skin
• 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 to your doctor or pharmacist.

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
• Increased risk of falls, which can lead to bone fractures
• Seizures. Symptoms can include:
• loss of consciousness
• muscle spasms
• loss bowel and bladder control
• drooling
• Severe allergic reaction (for details, see below).

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 (warmth and redness in your skin)

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

• angioedema (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. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Erleada cost

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

The cost you find on GoodRx.com is what you would pay without insurance. Your actual cost will depend on your insurance coverage.

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.

Erleada uses

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

Erleada for prostate cancer

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

• 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.
• Nonmetastatic prostate cancer is only found in the prostate gland. It hasn’t spread (metastasized) to other parts of the body.
• Castration-resistant prostate cancer is a type of prostate cancer that continues to grow after being treated by reducing levels of testosterone (the main male hormone). Treatments include using certain medications (called anti-androgens) or having surgery (to remove the testicles).

Erleada is used to treat NM-CRPC in people 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 dosage

The following information describes the dosage that is 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 an oral tablet. It’s available in one strength: 60 mg of apalutamide.

Dosage for nonmetastatic castration-resistant prostate cancer (NM-CRPC)

The typical dosage 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 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 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.

Alternatives for nonmetastatic castration-resistant prostate cancer

Examples of other drugs that may be used to treat this type of prostate cancer include:

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

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. 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 FDA-approved to treat nonmetastatic castration-resistant prostate cancer (NM-CRPC). This type of cancer:

• is not metastatic, which means it has not spread to other parts of your body.
• is castration-resistant, which means that therapy to reduce levels of testosterone in your body doesn’t work to treat it. These treatments include using certain medications (called anti-androgens) or having surgery to remove the testicles.

Xtandi is FDA-approved to treat both NM-CRPC and metastatic castration-resistant prostate cancer. This means Xtandi can treat castration-resistant prostate cancer that has spread (metastasized) to other parts of the body.

Drug forms and administration

Erleada and Xtandi both come as pills that are taken by mouth once each day:

• Erleada comes as 60-mg tablets. The usual dosage of Erleada is 240 mg (four 60-mg tablets) taken once daily.
• Xtandi comes as 40-mg capsules. The usual dosage of Xtandi is 160 mg (four 40-mg capsules) taken once daily.

Both Erleada and Xtandi should be taken in combination with another drug that lowers testosterone levels in the body. The drugs work together to further reduce male hormone levels. This helps to stop the growth of prostate cancer cells.

Erleada and Xtandi can each be used alone (not in combination with another drug) in people who have already had surgery to remove their testicles.

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 (feeling very tired)
• flushing of the skin

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:
• few unique serious side effects
• Can occur with Xtandi:
• swelling in your brain, which may lead to seizures
• ischemic heart disease
• Can occur with both Erleada and Xtandi:
• severe allergic reaction
• increased risk of falls, which lead to bone fractures
• seizures
• hypertension (high blood pressure)

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 NM-CRPC. The study showed that both drugs may be equally effective in delaying the progression and spread of NM-CRPC.

Both Erleada and Xtandi are recommended as treatment options for NM-CRPC 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 GoodRx.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.

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. Zytiga contains the drug abiraterone acetate. Both Erleada and Zytiga decrease the effect of testosterone (the main male hormone) in the body, but they 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 FDA-approved to treat nonmetastatic castration-resistant prostate cancer (NM-CRPC).

Nonmetastatic prostate cancer has not spread (metastasized) from the prostate to other parts of the body. Castration-resistant prostate cancer continues to grow after being treated by reducing levels of male hormones (androgens). Treatments include using certain medications (called anti-androgens) or having surgery to remove the testicles.

Zytiga is FDA-approved to treat metastatic prostate cancer. Metastatic prostate cancer has spread from the prostate to other areas in the body. Zytiga can treat two 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 and Zytiga both come as tablets that are taken by mouth once daily.

• Erleada comes as a 60-mg tablet. The usual dosage of Erleada is 240 mg (four 60-mg tablets) taken once each day.
• Zytiga comes as a 250-mg tablet or a 500-mg tablet. The usual dosage of Zytiga is 1,000 mg (four 250-mg tablets or two 500-mg tablets) taken once each day.

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

Both Erleada and Zytiga should be taken in combination with another drug that lowers testosterone levels in the body. The drugs work together to further reduce male hormone levels. This helps to stop the growth of prostate cancer cells.

Erleada and Zytiga can each be used without a drug to lower testosterone levels in people who have already had surgery to remove their testicles.

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 common cold or sinus infection)
• Can occur with both Erleada and Zytiga:
• skin rash
• fatigue (feeling very tired)
• diarrhea
• nausea
• joint pain
• flushing of your skin
• 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
• seizures
• electrolyte imbalances, such as high potassium
• Can occur with Zytiga:
• electrolyte imbalances, such as low potassium
• liver damage and failure
• heart disorders, such as abnormal heart rhythm or heart attack
• adrenal gland problems
• Can occur with both Erleada and Zytiga:
• anemia (low red blood cell count)
• increased triglyceride and cholesterol levels
• increased blood sugar levels
• 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 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 (NM-CRPC).

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

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 GoodRx.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.

Erleada vs. Casodex

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

General

Erleada contains the drug apalutamide. Casodex contains the drug bicalutamide.

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

Uses

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

Nonmetastatic prostate cancer has not spread (metastasized) from the prostate to other parts of the body. Castration-resistant prostate cancer continues to grow after being treated by reducing levels of testosterone. Treatments include using certain medications (called anti-androgens) or having surgery (to remove the testicles).

Casodex is FDA-approved to treat stage D2 metastatic prostate cancer. This type of prostate cancer has spread (metastasized) from the prostate to other parts of the body. Prostate cancer commonly spreads to the bones and liver. Stage D2 metastatic prostate cancer is the hardest stage to cure.

Drug forms and administration

Erleada and Casodex both come as tablets that are taken by mouth once daily.

• Erleada comes as a 60-mg tablet. The usual dosage of Erleada is 240 mg (four 60-mg tablets) taken once each day.
• Casodex comes as a 50-mg tablet. The usual dosage of Casodex is 50 mg (one tablet) taken once each day.

Both Erleada and Casodex should be taken in combination with another drug that lowers testosterone levels in the body. The drugs work together to further reduce male hormone levels. This helps to stop the growth of prostate cancer cells.

Erleada and Casodex can each be used alone (not in combination with another drug) in people who have already had surgery to remove their testicles.

Side effects and risks

Erleada and Casodex both decrease the action of male hormones in the body. 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 Casodex, or with both drugs (when taken individually).

• Can occur with Erleada:
• fatigue (feeling very tired)
• weight loss
• joint pain
• Can occur with Casodex:
• frequent infections (such as urinary tract infections)
• pain in your back, abdomen (belly area), or pelvis
• feeling weak
• constipation
• trouble breathing
• dizziness
• blood in urine
• urinating frequently at night
• Can occur with both Erleada and Casodex:
• diarrhea
• nausea
• flushing of the skin
• loss of appetite
• skin rash
• 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 Casodex, or with both drugs (when taken individually).

• Can occur with Erleada:
• increased risk of falls, which can lead to bone fractures
• seizures
• Can occur with Casodex:
• breast growth and pain
• liver damage and failure
• Can occur with both Erleada and Casodex:
• anemia (low red blood cell count)
• hypertension (high blood pressure)
• increased blood sugar levels
• severe allergic reaction

Effectiveness

Erleada and Casodex haven’t been directly compared to each other in clinical studies. Both drugs are considered effective at treating certain types prostate cancer.

The National Comprehensive Cancer Network recommends either Erleada or Casodex as a treatment option for nonmetastatic castration-resistant prostate cancer (NM-CRPC). Casodex is used off-label when treating NM-CRPC.

Costs

Erleada and Casodex are both brand-name drugs. A generic form of Casodex is also available. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Erleada generally costs more than either the generic form or brand form of Casodex. The actual cost you pay for either drug will depend on your insurance plan, your location, and the pharmacy you choose.

Erleada use with other drugs

Erleada should be taken with a second type of hormone therapy, called androgen deprivation therapy (ADT).

Male hormones (called androgens) encourage prostate cancer cells to grow and spread. Erleada and ADT drugs 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. ADT drugs prevent the testicles from making androgens (including testosterone), which lowers the levels of androgens in the body. Examples of ADT drugs include:

• leuprolide acetate (Eligard)
• goserelin acetate (Zoladex)
• histrelin acetate (Vantas)
• 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.

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 caused by Erleada.

Using alcohol and Erleada together can increase your risk of:

• fatigue (feeling very tired)
• falling down
• diarrhea
• nausea

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.

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 of 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:
• clarithromycin (Biaxin XL)
• certain HIV treatments, including:
• cobicistat (Tybost)
• ritonavir
• certain antifungals, including:
• ketoconazole (Extina, Ketozole, Nizoral)
• 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, you may need to take a lower dose of Erleada or try a different medication.

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 (Coumadin, 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. They may also 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 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. If you have trouble swallowing pills, talk with your doctor or pharmacist about other ways to take your medication.

How Erleada works

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

About NM-CRPC

NM-CRPC is a type 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. NM-CRPC has these key features:

• Nonmetastatic prostate cancer is only found in the prostate gland. It hasn’t spread (metastasized) to other parts of the body.
• Castration-resistant prostate cancer is a type of prostate cancer that continues to grow after being treated by reducing levels of testosterone (the main male hormone). 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 it 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 and pregnancy

Erleada is not intended for use by women, and 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 three months after completing treatment with Erleada.

Erleada and breastfeeding

Erleada is not intended for use by women, and 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. Therefore, it’s not known if the drug would affect a child who is breastfed.

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 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 rectal exam. This also lets them check for any pain 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 collect a biopsy (tissue sample) from your prostate. The biopsy results help your doctor know 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 are 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?

Erleada isn’t FDA-approved to treat metastatic prostate cancer. This means that if your prostate cancer has spread to other parts of your body, Erleada may not be a choice for treatment.

One small clinical study found that Erleada was safe for use in people with metastatic castration-resistant prostate cancer. Erleada helped to delay prostate cancer growth in these people.

There is one ongoing clinical study looking at the use of Erleada in people with a certain type of metastatic prostate cancer (hormone-sensitive prostate cancer). The results of this study haven’t been published yet.

Another ongoing clinical study is looking at the use of Erleada in combination with Zytiga (abiraterone acetate), which is a different drug used to treat prostate cancer. This study focuses on people with metastatic castration-resistant prostate cancer. The results of this study haven’t been published yet.

The results of these ongoing trials will provide information on how effective Erleada is for treating metastatic prostate cancer.

Erleada warnings

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:

• Seizure disorders. Erleada may cause seizures. If you have a history of seizures or a seizure disorder, talk to your doctor about whether Erleada is safe for you. Taking the drug could possibly worsen your condition.
• 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 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.

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 (feeling very tired)
• diarrhea
• skin rash
• nausea
• flushing of the skin
• 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 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.

Erleada expiration, storage, and disposal

When you get Erleada from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one 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 (68⁰F to 77⁰F, or 20⁰C to 25⁰C) in a tightly sealed container away from light. Avoid storing this medication in areas where the tablets could get damp or wet, such as 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.

Professional information for Erleada

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

Indications

Erleada (apalutamide) is FDA-approved for the treatment of nonmetastatic castration-resistant prostate cancer (NM-CRPC).

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

Erleada is contraindicated during pregnancy.

(Note: Men with female partners of reproductive potential should use effective contraception, such as condoms, during Erleada treatment and for three months after receiving their final dose.)

Storage

Erleada should be stored in the original container at room temperature (68⁰F to 77⁰F, or 20⁰C to 25⁰C). 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.