Erleada (Apalutamide) Overview: Side Effects, Cost, and More

What are Erleada’s side effects?

Like most drugs, Erleada may cause mild or serious side effects. The lists below describe some of the more common side effects that Erleada may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Erleada. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a short list of some of the mild side effects that Erleada can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Erleada’s prescribing information.

Mild side effects of Erleada that have been reported include:

• changes in the way things taste
• decreased appetite
• diarrhea
• fatigue or weakness
• flushing (temporary warmth, redness, or deepening of skin color)
• joint pain
• muscle spasms
• nausea
• rash*
• swelling in your hands, feet, lymph nodes, or genitals
• weight loss

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* To learn more about this side effect, see “Side effect focus” below.

Serious side effects

Serious side effects from Erleada can occur, but they aren’t common. If you have serious side effects from Erleada, call your doctor right away. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects of Erleada that have been reported include:

• falls
• high blood pressure
• low thyroid level
• seizure
• stroke or ministroke
• bone fracture*
• heart disease*
• serious rash and other skin reactions*
• allergic reaction*

* To learn more about this side effect, see “Side effect focus” below.

Side effect focus

Learn more about some of the side effects Erleada may cause. In addition to the information above and below, you can refer to this in-depth side effects article about Erleada.

Rash

Taking Erleada may cause a skin rash, as well as other skin-related side effects. A rash was one of the more common side effects reported in studies of the drug.

In a few cases, people have stopped taking Erleada due to having a rash.

In studies, the most common kind of rash Erleada caused was maculopapular rash. This rash often appears as bumps on your skin, along with discoloration. As well as a rash, people taking Erleada in studies also reported these skin-related side effects:

• blisters
• hives
• itchiness
• mouth sores or mouth ulcers
• pink eye

Serious skin reactions are also possible, which can be life threatening. These conditions include:

• Stevens-Johnson syndrome (SJS)
• toxic epidermal necrolysis (TEN)
• drug reaction with eosinophilia and systemic symptoms (DRESS)

In addition to a rash, symptoms of these conditions may include:

• fever
• flu-like symptoms
• mouth sores
• swelling

What might help

Call your doctor right away if you develop a rash or any of the previously listed symptoms while taking Erleada. Keep in mind that a rash may be a symptom of an allergic reaction, a serious side effect that Erleada may cause. To learn about other symptoms of an allergic reaction, see “Allergic reaction” below.

If you experience a rash during Erleada treatment, your doctor will likely recommend treatment for this side effect. Examples of rash treatments used by people who had this side effect in studies include:

• an antihistamine such as loratadine (Claritin)
• a corticosteroid such as hydrocortisone (Ala-Cort, others) or prednisone (Rayos)

Your doctor may lower your Erleada dose if you develop a rash. Or they may have you temporarily or permanently stop taking the drug, especially if your rash is serious. Temporarily stopping Erleada treatment may cause the rash to go away, but it may come back if you start taking the drug again.

Heart disease

Erleada can cause a kind of heart disease in some people. Heart disease wasn’t a common side effect seen in studies. But in rare cases, heart disease caused by Erleada has led to death. If you have concerns about your risk of heart disease with Erleada, talk with your doctor.

Symptoms of heart disease can include:

• discomfort or pain in your chest
• dizziness
• shortness of breath
• swelling in your ankles or feet

Having certain other medical conditions can raise your risk of heart disease if you take Erleada. These include:

• diabetes
• high blood pressure
• high cholesterol

What might help

Before prescribing Erleada, your doctor will review your medical history to determine your risk of heart disease. If you have another condition that raises your risk of this side effect, your doctor will likely make sure the other condition is well managed before prescribing Erleada. Your doctor will also monitor you for symptoms of heart disease while you’re taking Erleada.

Bone fracture

Erleada can weaken your bones and muscles. In some cases, taking Erleada can result in a bone fracture (broken bone). But this side effect wasn’t common in studies of the drug.

Symptoms of a bone fracture can include any of the following where the fracture occurs:

• bruising
• discoloration of the skin
• not being able to move or put weight on the affected bone
• pain
• swelling

What might help

During your Erleada treatment, your doctor will monitor your risk of fractures. This includes assessing your risk of falls (which can lead to broken bones).

If you’re at risk of fractures, your doctor will likely check the health of your bones with a bone density test. This will then determine whether you need to take a drug to help strengthen your bones during Erleada treatment.

Seek medical care right away if you think you have a broken bone while taking Erleada. Then, talk with your doctor about whether you should continue taking Erleada.

Allergic reaction

Some people may have an allergic reaction to Erleada. But these reactions weren’t common in Erleada’s studies.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Erleada. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What does Erleada cost? Are savings available?

Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use. For detailed information, you can refer to this Erleada cost article.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Erleada manufacturer’s website to see support options.

You can also check out this article to learn more about saving money on prescriptions.

What is Erleada’s dosage?

Your doctor will recommend the dosage of Erleada that’s right for you. Below are commonly prescribed dosages, but always take the dosage your doctor prescribes.

Form and strength

Erleada comes as tablets (pills) that you swallow. It’s available in two strengths: 60 milligrams (mg) and 240 mg.

Recommended dosage

The recommended dosage of Erleada is 240 mg taken once per day.

Questions about Erleada’s dosage

Below are some common questions and answers about Erleada’s dosage.

• What if I miss a dose of Erleada? If you miss a dose of Erleada, try to take the missed dose as soon as you remember. But if it’s the next day when you remember, skip the missed dose and take your next dose at the regular time. You should not take more than one dose of Erleada at a time or in one day.
• Will I need to take Erleada long term? Yes. If you and your doctor agree that Erleada is working well for you, you’ll likely take the drug long term.
• How long does Erleada take to work? Erleada begins working as soon as you take a dose. But it’s not known how long it takes to begin affecting cancer cells. The drug may begin to block hormones such as testosterone after a few days to a few weeks.

You can refer to this in-depth dosage article about Erleada for details.

What are some frequently asked questions about Erleada?

Find answers to some commonly asked questions about Erleada.

How does Erleada work?

How a drug works is referred to as its mechanism of action. Erleada works to treat prostate cancer by blocking certain hormones called androgens, such as testosterone. Androgens are hormones that encourage prostate cells to grow, including cancerous prostate cells. Blocking androgens causes prostate cancer cells to die and stops them from spreading in your body.

If you’d like to learn more about how Erleada works, talk with your doctor or pharmacist.

Will Erleada cure my cancer?

No, Erleada doesn’t cure cancer. There currently isn’t a cure for prostate cancer.

But drugs such as Erleada can help people live longer without their cancer worsening or spreading. It can also delay the need for chemotherapy (traditional drugs prescribed to treat cancer).

If you have other questions about what to expect from Erleada treatment, talk with your doctor.

Is Erleada a chemotherapy drug?

No, Erleada isn’t a chemotherapy drug. It’s a kind of hormone therapy that works by reducing the levels of androgen hormones, including testosterone, in your body.

In comparison, chemotherapy drugs work by attacking cells in your body that grow rapidly. This includes cancer cells, but it also includes healthy cells that are rapidly growing. Because of this, chemotherapy often causes many side effects, such as hair loss or mouth sores.

According to American Cancer Society guidelines, drugs such as Erleada may be prescribed with chemotherapy in certain people with prostate cancer. To learn more about the treatment option that’s right for you, talk with your doctor.

What is Erleada used for?

Erleada is prescribed for adults with the following conditions:

• Metastatic, castration-sensitive prostate cancer: “Metastatic” means the cancer has spread beyond your prostate to other parts of the body. “Castration-sensitive” means the cancer may be treated with drugs that lower the testosterone level in your body.
• Nonmetastatic, castration-resistant prostate cancer: “Nonmetastatic” means the cancer hasn’t spread beyond your prostate. “Castration-resistant” means treatments that lower the testosterone level in your body don’t work to treat the cancer.

Prostate cancer affects the prostate, which is a small gland located under the bladder in males.

Erleada treats prostate cancer by blocking certain hormones called androgens, such as testosterone. Androgens are hormones that encourage prostate cells to grow, including cancerous prostate cells. Blocking androgens causes prostate cancer cells to die, and it stops them from spreading in your body.

If you’ve had surgery to remove your testicles, you’ll likely take Erleada by itself. If you haven’t had this surgery, you’ll take Erleada with other drugs to treat your prostate cancer. To learn more, see “How is Erleada taken?” below.

Note: In this article, we use the term “males” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

What should I know about Erleada vs. Zytiga?

Both Erleada and Zytiga are prescribed to treat prostate cancer in adults, but they may be used to treat different types. They also both come as tablets that you swallow.

To find out more about these drugs, check out the “Erleada vs. Zytiga” section in this article. You can also talk with your doctor about the treatment that’s right for your condition.

What should I know about Erleada vs. Xtandi?

Erleada and Xtandi are both drugs that treat prostate cancer in adults. They work the same way to treat cancer, which is by blocking the hormone testosterone. They both come as pills that you swallow. But these drugs do differ in some ways.

See the “Erleada vs. Xtandi” section in this article to learn more about how these drugs compare. Also, ask your doctor whether one of these drugs may be right for you.

How is Erleada taken?

Your doctor will explain how you should take Erleada. They will also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Erleada

Erleada comes as tablets that you swallow whole.

Accessible medication containers and labels

Certain pharmacies may provide medication labels that:

• have large print
• use braille
• contain a code you can scan with a smartphone to change the text into audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Also, if your pharmacist may be able to put Erleada in an easy-open container. They may also recommend tools to help make it simpler to open the drug’s container.

Taking Erleada with other drugs

Erleada may be taken with other drugs to treat prostate cancer. If you haven’t had surgery to remove your testicles to treat prostate cancer, you’ll take Erleada with a kind of drug called a gonadotropin-releasing hormone (GnRH) analog.

Examples of GnRH analogs include:

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

Your doctor can tell you more about other medications you may take with Erleada.

Questions about taking Erleada

Below are common questions about taking Erleada.

• Can Erleada be chewed, crushed, or split? No, you should not chew, crush, or split Erleada tablets. They should be swallowed whole. However, if you have trouble swallowing pills, talk with your doctor or pharmacist. You can mix the 60-mg tablets into applesauce, and you can dissolve the 240-mg tablet in 2 teaspoons of water and then mix it with applesauce, orange juice, or more water. But in both of these cases, you should not crush or split the tablets. Talk with your doctor or pharmacist for instructions, or check out the drug’s step-by-step instructions for use. (These instructions also describe how to administer Erleada via feeding tube, if needed.)
• Should I take Erleada with food? You may take Erleada doses with or without food.

Questions for your doctor

You may have questions about Erleada and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions such as:
  • How will Erleada affect my body, mood, or lifestyle?
• Bring someone with you to your appointment if doing so will help you feel more comfortable.
• If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

What should be considered before taking Erleada?

There are important considerations to discuss with your doctor before you begin treatment with Erleada. It’s important that you tell your doctor about your overall health and any medical conditions you may have.

You should also tell your doctor about all medications you take, including any over-the-counter (OTC) medications. They’ll want to check for any interactions with Erleada.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before taking Erleada, be sure to tell your doctor about all medications you take, including prescription and OTC kinds. Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Erleada.

Interactions with drugs or supplements

Erleada can interact with several kinds of drugs. These drugs include:

• certain antifungal medications, including ketoconazole and voriconazole (Vfend)
• the antibiotic drug clarithromycin
• the cholesterol drug gemfibrozil (Lopid)
• certain blood thinners, including clopidogrel (Plavix), warfarin (Jantoven), and dabigatran (Pradaxa)
• the antipsychotic medication quetiapine (Seroquel)
• certain cholesterol medications, including simvastatin (Zocor) and rosuvastatin (Crestor)
• the seizure drug carbamazepine (Tegretol, Equetro)

This list does not contain all kinds of drugs that may interact with Erleada. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Erleada. You can also refer to this in-depth interactions article for Erleada.

Warnings

Erleada may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Erleada. Factors to consider include those in the list below.

• Heart disease: Erleada can cause heart disease and, in some cases, may lead to a heart attack. If you already have heart disease, taking Erleada could make your condition worse. Your doctor can determine whether Erleada is safe for you to take.
• Diabetes: If you have diabetes, you have a higher risk of developing heart disease from Erleada. Your doctor can help determine whether Erleada is safe for you to take.
• High cholesterol: People with high cholesterol have a higher risk of developing heart disease during Erleada treatment. If you have high cholesterol, talk with your doctor about whether Erleada is right for you.
• Past stroke, brain injury, or brain tumor: In rare cases, Erleada can cause a stroke or ministroke. You may have a higher risk of this side effect if you’ve had a stroke, brain tumor, or brain injury in the past. Talk with your doctor about whether Erleada is a safe treatment option for you.
• Seizures: In rare cases, Erleada can cause seizures. You may have a higher risk of this side effect if you already have seizures or epilepsy. Your doctor can help determine whether Erleada is safe for you to take.
• Allergic reaction: If you’ve had an allergic reaction to Erleada or any of its ingredients, your doctor will likely not prescribe Erleada. Ask your doctor what other medications are better options for you.

Erleada and alcohol

It should be safe to drink alcohol during Erleada treatment. But drinking large amounts of alcohol can cause many of the same side effects as Erleada.

Drinking alcohol while taking Erleada can raise your risk of:

• diarrhea
• falls
• fatigue
• nausea

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

Pregnancy and breastfeeding

Erleada is not intended for use in females, since it’s prescribed to treat prostate cancer.

If you’re a male taking Erleada who has a sexual partner who may become pregnant, you should use birth control, such as condoms, during treatment. You’ll need to continue using birth control for at least 3 months after your last dose of Erleada. If you have other questions about Erleada and pregnancy, talk with your doctor.

Note: In this article, we use the terms “females” and “males” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

What should be done in case of overdose?

Do not take more Erleada than your doctor prescribes. Taking more than this can lead to serious side effects.

What to do in case you take too much Erleada

Call your doctor if you think you’ve taken too much Erleada. You can also call 800-222-1222 to reach America’s Poison Centers, or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.

What to ask your doctor

If you’re considering treatment with Erleada, talk with your doctor or pharmacist. Ask questions to help feel comfortable about the risks and benefits of taking this drug. Some examples of questions you may want to ask include:

• What should I know about alternative drugs for Erleada?
• Does Erleada cause sexual side effects?
• How will I know whether Erleada is working for me?
• Will I need to have lab tests done while taking Erleada? If so, how often will I have them done?

You can also learn more about treatments for prostate cancer.