Medically reviewed by Drugs.com. Last updated on Feb 10, 2022.
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Uses for Erleada
Apalutamide is used to treat patients with metastatic castration-sensitive prostate cancer (prostate cancer that responds to medical or surgical treatments that lower testosterone and has spread to other parts of the body), and non-metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has not yet spread to other parts of the body).
This medicine is available only with your doctor's prescription.
Before using Erleada
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Apalutamide is not indicated for use in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apalutamide in the elderly.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Dabigatran Etexilate
- Ethinyl Estradiol
- Sirolimus Protein-Bound
- Vincristine Sulfate Liposome
Interactions with food/tobacco/alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Brain injury or tumor, history of or
- Diabetes or
- Dyslipidemia (high cholesterol in the blood) or
- Heart disease, history of or
- Hypertension (high blood pressure) or
- Seizures, history of or
- Stroke, history of—Use with caution. May cause side effects to become worse.
Proper use of Erleada
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have questions.
Swallow the tablet whole. Do not break, crush, or chew it.
If you cannot swallow the tablet whole:
- You may place the medicine in a container with 4 ounces (120 mL) of applesauce and stir. Do not crush the tablets.
- Wait for 15 minutes and stir the mixture.
- Wait for another 15 minutes and stir the mixture well until there are no chunks of tablets remaining.
- Swallow the mixture right away with a spoon.
- Rinse the container with 2 ounces (60 mL) of water and drink it right away. Repeat this step to make sure that you take the full dose.
- Swallow the mixture within 1 hour of preparing. Do not store this mixture.
You may take this medicine with or without food.
Your doctor may give you other medicines (eg, a gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For metastatic castration-sensitive prostate cancer and castration-resistant prostate cancer:
- Adults—The usual dose is 240 milligrams (mg) (four 60 mg tablets) once a day. Your doctor may adjust your dose as tolerated.
- Children—Use is not recommended.
- For metastatic castration-sensitive prostate cancer and castration-resistant prostate cancer:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep this medicine in its original package.
Precautions while using Erleada
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Women and children should not use this medicine. Apalutamide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use an effective method of birth control during treatment with this medicine and for 3 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
Do not donate sperm during treatment with this medicine and for 3 months after your last dose.
Do not stop using this medicine, even for a short time, without first asking your doctor.
This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.
This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Erleada side effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- depressed mood
- difficulty with moving
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- joint pain
- muscle cramp, pain, and stiffness
- pain in the legs
- pounding in the ears
- rapid weight gain
- slow or fast heartbeat
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
- weight gain
- Bloody urine
- chest pain or discomfort
- decreased urine output
- dilated neck veins
- irregular breathing or heartbeat
- pain in the shoulders, arms, jaw, or neck
- tightness in the chest
- trouble breathing
Incidence not known
- Blistering, peeling, loosening of the skin
- joint or muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Decreased appetite
- decreased weight
- feeling of warmth
- itching, skin rash
- redness of the face, neck, arms, and occasionally, upper chest
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Frequently asked questions
- Erleada vs. Xtandi What's the difference?
- How long do you have to take Erleada (apalutamide) for?
- How effective is Erleada (apalutamide)?
- What type of prostate cancer is Erleada used to treat?
More about Erleada (apalutamide)
- Side effects
- Drug interactions
- Dosage information
- During pregnancy
- Reviews (3)
- Drug images
- Compare alternatives
- Pricing & coupons
- En español
- Drug class: antiandrogens
- FDA approval history
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