Pronunciation:

a-pah-LOO-ta-mide

Brand Names:

• Erleada

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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 This Medicine:

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:

Allergies—

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.

Children—

Apalutamide is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apalutamide in the elderly.

Breast-feeding—

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.

Other 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.

• Fostemsavir
• Lenacapavir
• Lopinavir
• Mavacamten
• Nirmatrelvir
• Ombitasvir
• Pacritinib
• Paritaprevir
• Ritonavir

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
• Abrocitinib
• Acalabrutinib
• Adagrasib
• Afatinib
• Alpelisib
• Amiodarone
• Apixaban
• Aripiprazole
• Atogepant
• Avacopan
• Avapritinib
• Belumosudil
• Berotralstat
• Betrixaban
• Bictegravir
• Boceprevir
• Bortezomib
• Brigatinib
• Buprenorphine
• Cabozantinib
• Cannabidiol
• Capmatinib
• Clarithromycin
• Clopidogrel
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Copanlisib
• Crizotinib
• Dabigatran Etexilate
• Daridorexant
• Darolutamide
• Desogestrel
• Dexamethasone
• Dienogest
• Dronedarone
• Drospirenone
• Duvelisib
• Elacestrant
• Elexacaftor
• Encorafenib
• Entrectinib
• Erdafitinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Fenfluramine
• Fexinidazole
• Finerenone
• Futibatinib
• Gemfibrozil
• Gepirone
• Gestodene
• Gilteritinib
• Glasdegib
• Ibrexafungerp
• Idelalisib
• Indinavir
• Infigratinib
• Istradefylline
• Itraconazole
• Ixabepilone
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lemborexant
• Leniolisib
• Levoketoconazole
• Levonorgestrel
• Linagliptin
• Lumateperone
• Lurbinectedin
• Macitentan
• Maribavir
• Medroxyprogesterone
• Mestranol
• Midostaurin
• Mirtazapine
• Mitapivat
• Mobocertinib
• Nefazodone
• Nelfinavir
• Neratinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Oxycodone
• Palovarotene
• Pemigatinib
• Pexidartinib
• Phenobarbital
• Pimavanserin
• Pirtobrutinib
• Pitolisant
• Ponatinib
• Posaconazole
• Pralsetinib
• Pretomanid
• Primidone
• Quizartinib
• Relugolix
• Rimegepant
• Ripretinib
• Risperidone
• Ritlecitinib
• Rivaroxaban
• Romidepsin
• Ruxolitinib
• Samidorphan
• Saquinavir
• Segesterone
• Selpercatinib
• Selumetinib
• Sirolimus Protein-Bound
• Sotorasib
• Sparsentan
• Sunitinib
• Tacrolimus
• Tasimelteon
• Tazemetostat
• Telaprevir
• Telithromycin
• Tenofovir Alafenamide
• Tezacaftor
• Ticagrelor
• Tivozanib
• Tofacitinib
• Tucatinib
• Ubrogepant
• Ulipristal
• Upadacitinib
• Valbenazine
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Voclosporin
• Vonoprazan
• Voriconazole
• Vortioxetine
• Voxelotor
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuranolone

Other interactions—

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 This Medicine:

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 60 mg 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.

If you cannot swallow the 240 mg tablet whole:

• Place the tablet in a cup. Do not crush or split the tablet.
• Add 2 teaspoons (10 mL) of non-carbonated water to make sure the tablet is completely covered in water.
• Wait for 2 minutes until the tablet has broken up, then stir the mixture well.
• Add 2 tablespoons (30 mL) of orange juice, applesauce, or non-carbonated water to the cup and stir the mixture.
• Swallow the mixture right away.
• Rinse the cup with enough non-carbonated water to make sure you that you take your full dose and drink it right away.
• Do not store this mixture.

You may also give the 240 mg tablet through feeding tube:

• Place the tablet in the barrel of the syringe (at least 20 mL syringe) and draw up 10 mL of non-carbonated water.
• Wait for 10 minutes and shake the syringe well until the tablet is completely broken up.
• Attach the syringe to the feeding tube and give the mixture right away.
• Add non-carbonated water into the same syringe and flush through the feeding tube.
• Repeat this step until no pieces of tablet are left in the syringe or feeding tube.

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.

Dosing—

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) once a day. Your doctor may adjust your dose as tolerated.
    • Children—Use is not recommended.

Missed dose—

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.

Storage—

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 This Medicine:

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.

Serious skin reactions (eg, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis), which can be life-threatening can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

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.

Side Effects of This Medicine:

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:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

constipation

depressed mood

difficulty with moving

dizziness

dry skin and hair

falls

feeling cold

hair loss

headache

hoarseness or husky voice

joint pain

muscle cramp, pain, and stiffness

nervousness

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

Less common

Bloody urine

chest pain, discomfort, or tightness

decreased urine output

dilated neck veins

irregular breathing or heartbeat

nausea

pain in the shoulders, arms, jaw, or neck

sweating

trouble breathing

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

chills

cough

diarrhea

fever

itching

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

swollen glands

unusual bleeding or bruising

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:

More common

Decreased appetite

decreased weight

diarrhea

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.