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How does the Erleada medication work? What will it do for me?

Apalutamide belongs to the class of medications called anti-androgens. Apalutamide is used to treat prostate cancer. Androgens are male hormones and include testosterone. Prostate cancer cells require testosterone in order to grow and reproduce. Apalutamide blocks the action of male hormones such as testosterone, slowing the growth of prostate cancer.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does the Erleada medication come in?

Each slightly yellowish-to-greyish-green, oblong, film-coated tablet, debossed with "AR 60" on one side, contains 60 mg of apalutamide. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate (HPMC- AS), magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose; tablet coating: iron oxide black (E172), iron oxide yellow (E172), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

How should I use the Erleada medication?

The recommended adult dose of apalutamide is 240 mg (four 60 mg tablets), taken by mouth, once daily. The tablets should be swallowed whole and may be taken with food or on an empty stomach.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take the Erleada medication?

Do not take this medication if you:

  • are allergic to apalutamide or any ingredients of the medication
  • are female and are or may become pregnant

This medication is not intended to be used by women or children.

What side effects are possible with the Erleada medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • changed sense of taste
  • decreased appetite
  • diarrhea
  • hot flushes
  • itching
  • joint pain
  • nausea
  • skin rash
  • tiredness
  • weight loss

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • broken bones
  • falls
  • high blood pressure
  • signs of heart problems (e.g., fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing; leg swelling)
  • swelling of hands, ankles, or feet
  • symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
  • symptoms of underactive thyroid gland (e.g., dry skin, constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, depression, memory problems)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for the Erleada medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Apalutamide can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, flecainide), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bone health and fractures: Long-term use of other anti-androgen medications similar to apalutamide has been shown to cause reduced bone strength and may increase the risk of bone fractures. Apalutamide appears to increase the risk of bone fractures. If you have osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: The risk of heart attack or heart failure is increased for people taking apalutamide. If you have a history of heart disease or risk factors for heart disease (obesity, high blood cholesterol, smoking), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: There have been rare reports of seizures occurring with apalutamide in studies. The safety of using this medication if you have a seizure disorder has not been determined. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thyroid disease: This medication may cause decreased thyroid gland function. If you have problems with your thyroid gland, apalutamide may make these problems worse. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication is not intended to be used by women. Apalutamide may cause harm to the developing baby and cause loss of pregnancy if the fetus is exposed to the medication. If you have a female partner who is or may become pregnant, it is important to use a condom, as well as a second effective method of birth control while receiving treatment and for 3 months after the last dose of apalutamide.

Breast-feeding: This medication is not intended to be used by women.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with the Erleada medication?

There may be an interaction between apalutamide and any of the following:

  • abiraterone
  • aliskiren
  • alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
  • antiarrythmics (e.g., amiodarone, disopyramide, dronedarone, propafenone, quinidine)
  • anticancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
  • anticoagulants (e.g., apixaban, clopidogrel, dabigatran, edoxaban, rivaroxaban, ticagrelor)
  • antipsychotics (e.g., aripiprazole, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aprepitant
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • benzodiazepines (e.g., chlordiazepoxide, clobazam, clonazepam, diazepam, lorazepam)
  • bisoprolol
  • buprenorphine
  • buspirone
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • carvedilol
  • cetirizine
  • chloroquine
  • ciprofloxacin
  • clindamycin
  • colchicine
  • conivaptan
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dantrolene
  • dapsone
  • darifenacin
  • digoxin
  • dronedarone
  • eliglustat
  • enzalutamide
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • everolimus
  • exemestane
  • fexofenadine
  • flibanserin
  • flutamide
  • gemfibrozil
  • "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • guanfacine
  • hepatitis C antivirals (e.g., asunaprevir, daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • ivabradine
  • ivacaftor
  • lidocaine
  • loperamide
  • losartan
  • lurasidone
  • macitentan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • methadone
  • mifepristone
  • mirtazapine
  • modafinil
  • nadolol
  • naloxegol
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
  • ondansetron
  • praziquantel
  • primaquine
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • protein kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib,)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quinine
  • ranitidine
  • repaglinide
  • rifabutin
  • rifampin
  • rilpivirine
  • roflumilast
  • romidepsin
  • seizure medications (e.g., carbamazepine, oxcarbazepine, perampanel, phenobarbital, phenytoin, primidone)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline)
  • sildenafil
  • sirolimus
  • solifenacin
  • "statin" anticholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • stiripentol
  • tacrolimus
  • tadalafil
  • tamoxifen
  • tetracycline
  • thyroid replacements (e.g., desiccated thyroid, levothyroxine)
  • tofacitinib
  • tolterodine
  • tolvaptan
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • ulipristal
  • venlafaxine
  • vitamin D analogues (e.g., calcifediol, calcitriol)
  • warfarin
  • zolpidem

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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