Erleada

The recommended adult dose of Erleada (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 Erleada (Apalutamide) 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 Erleada (Apalutamide) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause unusual tiredness; it may cause high blood sugar levels, you may experience excessive thirst, high urine output, increased appetite, tiredness; it may increase your blood pressure; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each slightly yellowish-to-greyish-green, oblong, film-coated tablet, debossed with "AR 60" on one side, contains 60 mg of Erleada (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.

Do not take Erleada (Apalutamide) if you:

• are allergic to Erleada (Apalutamide) or any ingredients of the medication
• are female and are or may become pregnant

Erleada (Apalutamide) is not intended to be used by women or children.

There may be an interaction between Erleada (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 Erleada (Apalutamide). 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.

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 Erleada (Apalutamide).

Abnormal heart rhythm: Erleada (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 Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Bone health and fractures: Long-term use of other anti-androgen medications similar to Erleada (Apalutamide) has been shown to cause reduced bone strength and may increase the risk of bone fractures. Erleada (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 Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Heart disease: The risk of heart attack or heart failure is increased for people taking Erleada (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 Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Seizures: There have been rare reports of seizures occurring with Erleada (Apalutamide) in studies. The safety of using Erleada (Apalutamide) 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 Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Thyroid disease: Erleada (Apalutamide) may cause decreased thyroid gland function. If you have problems with your thyroid gland, Erleada (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 Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Pregnancy: Erleada (Apalutamide) is not intended to be used by women. Erleada (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 Erleada (Apalutamide).

Breast-feeding: Erleada (Apalutamide) is not intended to be used by women.

Children: The safety and effectiveness of using Erleada (Apalutamide) have not been established for children.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Generally, the tablets should be swallowed whole. If you cannot swallow the tablets, ask your pharmacist for guidance. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember, but do not take two doses the same day. This medication may be taken with or without food.