Erleada

Erleada is a prescription medication used to treat prostate cancer that is non-metastatic (has not spread to other parts of the body) and castration-resistant (keeps growing even when testosterone levels are decreased). 

Erleada belongs to a group of drugs called androgen receptor inhibitors. These work by blocking androgens, such as testosterone, which can promote growth of prostate cancer. 

This medication comes in tablet form and is taken once daily, with or without food. One single dose is equal to 4 Erleada tablets. 

Do not chew, divide, or break Erleada. Swallow Erleada whole.

Common side effects of Erleada include feeling very tired, high blood pressure, rash, diarrhea and nausea.

Erleada is a prescription medication used to treat prostate cancer that is non-metastatic (has not spread to other parts of the body) and castration-resistant (keeps growing even when testosterone levels are decreased). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Erleada. See the “Erleada Precautions” section.

Common side effects of Erleada include the following:

• feeling very tired
• high blood pressure
• rash
• diarrhea
• nausea
• weight loss
• joint pain
• falls
• hot flashes 
• bone injury (fracture)

This is not a complete list of Erleada's side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the p-glycoprotein transporter such as digoxin (Lanoxin), loperamide (Imodium), quinidine (Cardioquine, Quinact, Duraquin), vinblastine (Velban), fexofenadine (Allegra), indinavir (Crixivan), colchicine (Colcrys), topotecan (Hycamtin), and paclitaxel (Abraxane, Onxol, Taxol)
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that block the enzyme CYP2C8 such as gemfibrozil (Lopid), fluvoxamine (Luvox), ketoconazole (Nizoral), trimethoprim (Bactrim, Septra, Primsol, Proloprim)
• medications that use the enzyme CYP2C9 such as warfarin (Coumadin), nonsteroidal antiinflammatory medications (NSAIDs; ibuprofen, meloxicam, naproxen, diclofenac, celecoxib), angiotensin receptor blockers (ARBs; losartan, valsartan, candesartan), montelukast (Singulair), rosuvastatin (Crestor), sulfonylureas (glimepiride, glipizide, glyburide)
• medications that use the enzyem CYP2C19 such as some antidepressants (citalopram, clomipramine, desipramine, doxepin, escitalopram, fluoxetine, imipramine, moclobemide, sertraline), some antipsychotics (aripiprazole, clozapine, olanzapine), some proton pump inhibitors (lansoprazole, omeprazole, pantoprazole, raberprazole), carisoprodol (Soma), clopidogrel (Plavix), diazepam (Valium), diphenhydramine (Benadryl), methadone, nelfinavir (Viracept), pentamidine, phenobarbital, pheytoin (Dilantin), thalidomide, voriconazole (Vfend)

This is not a complete list of Erleada drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Erleada including the following:

• Falls and factures. Erleada can cause bones and muscles to weaken which can increase your risk for falls and fractures. Your healthcare provider will monitor your risk for falls and fractures during treatment with Erleada.
• Seizures. Tell your healthcare provider right away if you have a seizure or lose consciousness (faint).

Do not take Erleada if you:

• are allergic to Erleada or to any of its ingredients
• are female
• are pregnant or plan on becoming pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Erleada, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Erleada, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Erleada or to any of its ingredients
• have a history of seizures, brain injury, stroke, or brain tumors
• have a partner who is pregnant or may become pregnant

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Erleada falls into category X. It is not indicated for use in females, so no animal or human studies were conducted to evaluate use in pregancy. Based on how Erleada works, it may cause harm to the unborn baby when administered during pregnancy. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Since Erleada is not indicated for use in women, no studies have been performed to evaluate the presence of Erleada in human milk or its effect on milk production. This medication should never be used by women. 

Take Erleada exactly as prescribed.

Erleada comes in tablet form and is taken once daily, with or without food. The recommended daily dose of Erleada is 4 tablets once daily. Erleada tablets must be swallowed whole and cannot be chewed or crushed. 

People who take Erleada should have had both testicles removed (called a bilateral orchiectomy) prior to treatment with Erleada, or they should be taking another medication, called a gonadotropin-releasing hormone analog, during treatment with Erleada. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Erleada at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose/dose range of Erleada for the treatment of certain types of prostate cancer is 4 tablets (60 mg each) by mouth once daily. If you experience an intolerable side effect or toxicity, your health care provider will pause treatment with Erleada until the side effect or toxicity goes away. After this, Erleada can be restarted at the original dose or at a lower dose (for example, 3 tablets once daily instead of 4 tablets once daily).

If you take too much Erleada, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Erleada at room temperature between 68°F to 77°F (20°C to 25°C). Keep Erleada in the original bottle. Inside the bottle is a desiccant package to help keep Erleada dry. Do not throw away this desiccant package. 

Keep Erleada away from light (do not leave the tablets out of the bottle) and moisture (do not store the bottle inside your bathroom).

Keep this and all medicines out of the reach of children.