Uses
What is Erleada used for?
Erleada (apalutamide) is commonly used to treat prostate cancer.
Learn more about Erleada for prostate cancer.
Erleada may also be used for other conditions as determined by your healthcare provider.
How does Erleada work (mechanism of action)?
Prostate cancer cells need certain hormones, called androgens, to grow. Erleada works by blocking the effects of androgens, which can help slow the growth of prostate cancer.
How is Erleada supplied (dosage forms)?
Erleada is available in the following dosage forms that are taken by mouth.
- 60 mg oral tablets
- 240 mg oral tablets
How should I store Erleada?
Erleada should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store it in a cool, dry place.
Keep the Erleada bottle tightly closed in the original container after you open it. This is because it has a desiccant that will protect the medicine from moisture and keep it dry. Do not remove the desiccant from the bottle.
Side Effects
What are the most common side effects of Erleada?
The most common side effects of Erleada are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Tiredness
- Joint pain
- Rash (see below)
- Reduced appetite
- Weight loss
- High blood pressure
- Short periods of feeling warm and sweating (hot flashes)
- Diarrhea
- Broken bones and falls (see below)
There may be other side effects of Erleada that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Erleada?
While less common, the most serious side effects of Erleada are described below, along with what to do if they happen.
Stroke and Heart Attack. Erleada can increase your risk of a heart attack or stroke that can lead to death. This risk may be higher in people who already have heart disease or had a stroke in the past. Get help right away if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Problems with your vision in one or both eyes
Broken Bones and Falls. Erleada may cause your bones to become weaker, which can cause them to break (fracture) more easily. Erleada may also increase your risk of falling, which can cause injuries. This risk may be higher in people aged 65 and older. Your healthcare provider may monitor your bone density during Erleada treatment. They may also recommend a medicine to help prevent weakened bones. Call your healthcare provider right away if you have any of the following symptoms of a broken bone, especially after a fall.
- Bruising or swelling
- Pain in an injured area that gets worse when you move it or apply pressure
- Problems standing or putting weight on a painful leg or foot
- Unable to move a painful area of your body
Seizures. Some people who have taken Erleada have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Call your healthcare provider if you have any of the following signs that a seizure is happening or could happen.
- Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
- Stiffening of your arms and legs
- Feeling anxious, nervous, confused, or a sense of dread
- Feeling dizzy or lightheaded
- Falling or losing consciousness
Severe Skin Reactions, Including Rash. Erleada can cause severe skin reactions, called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop taking Erleada and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS or TEN.
- Painful red or purple skin that looks burned and peels off
- Flat red rash or blisters on your skin, mouth, nose, and genitals
- Red, painful, watery eyes
Severe Allergic Reactions. Erleada can cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking Erleada and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin (hives)
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Dark colored urine
- Your skin or the whites of your eyes turning yellowish in color (jaundice)
Lung Inflammation. Erleada can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain.
Warnings & Precautions
Who should not use Erleada?
Allergies to Ingredients. People who are allergic to any of the following should not take Erleada.
- Erleada
- Apalutamide
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Erleada.
What should I know about Erleada before taking it?
Do not take Erleada unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Erleada with other people, even if they have the same condition as you. It may harm them.
Keep Erleada out of the reach of children.
People who are 65 and older can be at greater risk for some side effects from Erleada, such as falls. Talk to your healthcare provider about your risks if you are in this age group.
Do not chew, cut, or crush Erleada. Swallow the tablets whole.
If you have trouble swallowing Erleada tablets whole or use a feeding tube, read the Instructions for Use that comes with your medicine. It provides detailed steps on how to prepare and take Erleada through a feeding tube. It also provides detailed steps on how to dissolve the tablet in plain water without crushing it. Then you mix it in orange juice, applesauce, or non-carbonated water and swallow the mixture right away. Refill the cup with plain water and drink it to make sure all of the medicine is swallowed.
Erleada can cause harm to an unborn baby. If your partner is pregnant, use condoms while taking Erleada and for three months after your last dose. If your partner is able to get pregnant, use effective birth control while taking Erleada and for three months after your last dose.
Erleada may affect your ability to father a child. It may also damage sperm. Do not donate sperm while taking Erleada or for three months after your last dose. Talk with your healthcare provider if you have concerns about this.
What should I tell my healthcare provider before taking Erleada?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Erleada is right for you.
In particular, make sure that you discuss any of the following.
Other Medicines and Supplements. Erleada may interact with other medicines and supplements. Before taking Erleada, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Heart problems
- High blood pressure
- Diabetes
- High cholesterol or other lipid problems
- Brain problems, such as seizures, brain injury, stroke, or brain tumors
Pregnancy. People who can become pregnant are not usually prescribed Erleada. Erleada can cause harm to an unborn baby and should not be taken while pregnant. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. People who can breastfeed are not usually prescribed Erleada. It is not known if Erleada passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Erleada?
For more information about Erleada, you can visit the manufacturer’s website at www.erleada.com or call them at 844-628-1234.
Interactions
Does Erleada interact with foods or drinks?
There are no known interactions between Erleada and foods or drinks.
It is unknown if drinking alcohol will affect Erleada.
Does Erleada interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are taking any of the following before taking Erleada.
- Fexofenadine (Allegra), which is a medicine used to treat allergy symptoms
- Rosuvastatin (Crestor), which is a medicine used to lower cholesterol
Many other medicines may alter the blood levels of Erleada, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Erleada. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally take too much Erleada?
If you or someone else has taken too much Erleada, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Erleada?
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and only take the next dose as scheduled. Do not take double or extra doses.