If you or a loved one has prostate cancer, you may be interested in learning about medicines used to treat it. One option is a medicine called Erleada (apalutamide).
The FDA approved Erleada in 2018. It is commonly used to treat prostate cancer along with treatment that lowers testosterone.
Testosterone is an androgen hormone that can help fuel the growth of prostate cancer. Treatments that lower testosterone, including certain medicines and surgeries, are often used to treat prostate cancer. But over time, as the cancer learns how to grow despite very low testosterone levels, these treatments may not work as well.
Erleada works to block the effects of testosterone from reaching cancer cells. It belongs to a class of medicines called androgen receptor blockers, also known as anti-androgens. Erleada is a newer medicine in this class and is considered a second-generation anti-androgen.
Below are common questions and answers about Erleada for prostate cancer.
Is Erleada Right for Me?
Your health care provider will likely do testing to check the type of prostate cancer you have and whether it has spread outside of the prostate. The results, along with your past medical history, can help your health care team find out if Erleada is right for you. Erleada is FDA-approved to treat the following types of prostate cancer in adults:
- Prostate cancer that has not spread outside of the prostate (non-metastatic) and no longer responds to treatment that lowers testosterone. This type of prostate cancer is called non-metastatic castration-resistant prostate cancer, or nmCRPC for short.
- Prostate cancer that has spread to other areas of the body (metastatic) and still responds to treatment that lowers testosterone. This is called metastatic castration-sensitive prostate cancer, or mCSPC.
“Castration” refers to either a surgery that removes the testicles (the main source of testosterone) or a medicine that lowers testosterone by reducing how much your body makes.
Unless you have had castration surgery, your health care provider will likely prescribe Erleada along with a medicine that lowers testosterone. Common examples are goserelin (Zoladex) and leuprolide (Lupron Depot).
Even if your prostate cancer no longer responds to a medicine that lowers testosterone, it is important to continue using it to keep your testosterone levels low. Keep using it as prescribed while taking Erleada.
How Does Erleada Work for Prostate Cancer?
Androgen hormones, such as testosterone, can help prostate cancer cells grow. Erleada works by blocking certain receptors (binding sites) so that androgens cannot attach to them. This blocks the effect of testosterone from reaching cancer cells, which can help slow the growth of prostate cancer and may shrink tumors in some cases.
Erleada belongs to a class of medicines called androgen receptor blockers, also known as anti-androgens. Some examples of medicines in this class that have been around for a long time are bicalutamide (Casodex) and flutamide (Eulexin). Erleada is a newer, second-generation anti-androgen. These newer medicines are generally better at slowing the spread of prostate cancer and can help people live longer – even if an older anti-androgen medicine didn’t help them.
How Do I Take Erleada?
Erleada is available as an oral tablet. It comes in two strengths: 60 milligrams (mg) and 240 mg. The recommended dosage of Erleada is 240 mg once daily. You will take it as either one 240-mg tablet or four 60-mg tablets. Your dose may be taken with or without food.
Ideally, you will swallow Erleada tablets whole. Do not crush, split, or chew the tablets.
If you have trouble swallowing pills, or if you use a feeding tube, there are other ways to take Erleada. See the Instructions for Use enclosed with your medicine, which provides step-by-step guidance on how to prepare Erleada for use through a feeding tube. It also offers instructions for taking Erleada after dissolving your dose in plain water then mixing it into orange juice, applesauce, or more plain water. These steps are also available on the drugmaker’s website at www.janssenlabels.com/package-insert/product-instructions-for-use/ERLEADA-ifu.pdf.
Ask your pharmacist or health care provider if you have questions about taking Erleada.
How Was Erleada Studied for Prostate Cancer?
Two clinical studies were done to test how well Erleada works for prostate cancer by comparing its effects to a placebo (a “fake” pill that contains no medicine). Both studies also looked at the safety of Erleada by collecting information about side effects.
The TITAN study tested the effect of Erleada in adult males whose prostate cancer had spread to other areas of the body but was still responding to a treatment that lowered testosterone (metastatic castration-sensitive prostate cancer, or mCSPC). About half of the people in the study were randomly chosen to take Erleada, while the rest took a placebo.
Another study called SPARTAN tested the effect of Erleada in adult males whose prostate cancer had not yet spread and no longer responded to a treatment that lowered testosterone (non-metastatic castration-resistant prostate cancer, or nmCRPC). As in the TITAN study, about half of the people were randomly chosen to take Erleada, while the rest took a placebo.
The median ages of people in both studies were 68-74 years, meaning that half were younger and half were older. Their ages ranged from 43 to 97 years. About 67% of the people in the studies were White, 12%-22% were Asian, and 2%-6% were Black. Most of the people already tried an anti-androgen medicine, such as bicalutamide, in the past.
During both studies, no one knew at first if the pill they were given was Erleada or a placebo. Everyone in the study also received medicine or had surgery to lower testosterone. After a certain amount of time, people in both studies were told which treatment they received. Those who were getting a placebo could switch to Erleada, and the researchers continued to track everyone’s progress to learn more about how well the medicine worked and how safe it was.
What Were the Main Benefits Seen in Clinical Studies of Erleada?
The main benefit of Erleada is that it can help people live longer without their prostate cancer spreading or getting worse. Results from two clinical studies showed that Erleada worked better than a placebo for treating prostate cancer, along with a treatment that lowers testosterone. Some of the main results of these studies are described below.
The TITAN study aimed to measure how well Erleada treated metastatic castration-sensitive prostate cancer (mCSPC), which is prostate cancer that has spread to other areas of the body and still responds to a treatment that lowered testosterone. The study mainly measured how well the drug worked by looking at how long people lived without their cancer getting worse, known as progression-free survival, and how long people lived in general, known as overall survival. The results from the TITAN study were as follows:
- Erleada helped people live longer than a placebo. The study showed that taking Erleada reduced the risk of death by 33%.
- Erleada also helped some people live longer without their cancer getting worse. People taking Erleada reduced the risk of their cancer getting worse by 52%.
After 44 months of follow-up, a final analysis of the TITAN study showed the following results:
- Taking Erleada helped people live longer than a placebo and reduced the risk of death by 35%.
- After adjusting for those who switched from a placebo to Erleada, the risk of death was lowered by 48%.
The SPARTAN study aimed to measure how well Erleada treated non-metastatic castration-resistant prostate cancer (nmCRPC), which is prostate cancer that has not spread and no longer responds to treatment that lowers testosterone. The study mainly looked at how long people lived without their cancer spreading, known as metastasis-free survival. (Note that this measures how long the cancer took to get worse, not overall survival.) The results of the SPARTAN study were as follows:
- People who took Erleada had a median of two more years (24 months) before their cancer spread, compared to those taking a placebo. This means that half of the people had their cancer get worse before this time frame, and half after.
- Half of the people taking Erleada did not have their cancer spread for at least 40.5 months, while people taking a placebo had less than 17 months before this happened.
After 32 months of follow-up, a final analysis of the SPARTAN study showed the following results:
- Taking Erleada helped people live a median of 14 months longer than those taking a placebo. This means that half of the people lived for less time, and half longer.
- People taking Erleada lived longer than six years (median of 73.9 months), while those who took a placebo lived nearly five years (median of 59.9 months).
Keep in mind that everyone in both studies also received a treatment to lower testosterone (either a medicine or a surgery). Your results may be different from what was seen in studies.
What Can I Do to Manage Side Effects of Erleada?
The list below includes common side effects of Erleada and possible ways to manage them.
Tiredness. Feeling very tired (fatigue) is the most common side effect of Erleada. Physical activity can help lessen fatigue. Be as active as you are able, such as going for a walk or stretching. Eating a healthy diet can also boost your energy and help you feel better.
Joint pain. Pain in your joints can happen with Erleada. Being active and stretching may help. You may be able to treat joint pain with an over-the-counter pain reliever, such as acetaminophen, or a topical pain relief medicine that you apply to the joints, such as a cream or gel.
Rash. A rash can be a common side effect of Erleada. It is important to tell your health care provider if you get a rash. In some cases, it can be a symptom of a severe skin reaction or an allergy. If you think you are having an allergic reaction to Erleada, stop the medicine and seek medical care right away.
Reduced appetite or weight loss. Erleada commonly causes reduced appetite. It may also cause weight loss for some people. Eating a healthy diet can help you maintain your weight while taking Erleada. Regular exercise may lessen the loss of muscle mass. Tell your health care provider if you feel concerned about weight loss. They may recommend diet changes, such as adding a daily supplement shake to boost your intake of calories or certain nutrients.
High blood pressure. Erleada may cause high blood pressure. This side effect may not cause any symptoms. Your health care provider will check your blood pressure at each visit. They may also recommend that you check your blood pressure at home. In some cases, they may prescribe medicine to lower your blood pressure.
Hot flashes. Erleada may cause hot flashes, which are short periods of feeling warm and sweaty. Hot flashes can be uncomfortable, but they only last for a short time. It can help to use a fan to cool yourself off and drink fluids to stay hydrated.
Diarrhea. Diarrhea can be a side effect of Erleada. Mild diarrhea often goes away on its own. It can be helpful to eat a bland diet and drink fluids to stay hydrated.
Falls or fractures. Erleada may raise your risk of falling, which can lead to injuries. Erleada may also cause your bones to become weaker, which can cause them to break (fracture) more easily. This risk may be increased in people ages 65 and older. Your health care provider may monitor your bone density during Erleada treatment. They may also prescribe a medicine to help prevent bone loss and recommend exercises to improve bone strength.
Other side effects are possible. If these tips do not help enough, or if your symptoms feel severe, contact your health care provider right away. In some cases, they may lower your dosage of Erleada. Or they may recommend that you pause or stop Erleada.
How Can I Get Erleada?
Erleada requires a prescription from a health care provider. Your local pharmacy is unlikely to have Erleada. Instead, your health care provider will send your prescription to a specialty pharmacy. They will arrange with you to ship the medicine to your home.
Is There Any Cost Assistance Available?
A cost assistance program is available from Janssen, the maker of Erleada. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured.
For more information about Erleada costs and copay savings, visit www.erleada.com/assistance-and-support/. You can also contact the drugmaker at 844-628-1234 to connect with a representative for financial support information and other resources.
