Xtandi

The recommended adult dose of Xtandi (Enzalutamide) is 160 mg (four 40 mg capsules) taken once daily as a single dose. Xtandi (Enzalutamide) may be taken with food or on an empty stomach. Swallow the capsules whole, with water.

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 Xtandi (Enzalutamide) 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 or constipation, depending on the person; it may cause joint pain; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause redness of the face. 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 white-to-off-white, oblong, liquid-filled, soft capsule with the letters "ENZ" printed in black, contains 40 mg of Xtandi (Enzalutamide). Nonmedicinal ingredients: caprylocaproyl macrogolglycerides, butylhydroxyanisole (E320), butylhydroxytoluene (E321); capsule shell: gelatin, sorbitol sorbitan solution, glycerol, titanium dioxide (E171), and purified water; printing ink: ethanol, ethyl acetate, propylene glycol, iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl, alcohol, macrogol 400, and ammonia solution concentrated.

Do not take Xtandi (Enzalutamide) if you:

• are allergic to Xtandi (Enzalutamide) or any ingredients of the medication
• are breast-feeding
• are or may be pregnant

There may be an interaction between Xtandi (Enzalutamide) and any of the following:

• Abiraterone acetate
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Apixaban
• Apremilast
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Clobazam, Clonazepam, Diazepam, Lorazepam)
• Bisoprolol
• Bosentan
• Buprenorphine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• cancer medications (e.g., docetaxel, Doxorubicin, Etoposide, Ifosfamide, Vinblastine, Vincristine)
• cannabis
• Carbamazepine
• Celecoxib
• chloroquine
• clindamycin
• Clopidogrel
• Cobicistat
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Methylprednisolone, Prednisone)
• Cyclosporine
• Dantrolene
• Dapsone
• Darifenacin
• Deferasirox
• Diclofenac
• Disopyramide
• Dronedarone
• Eltrombopag
• Eplerenone
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• estrogens (e.g., Estradiol, ethinyl estradiol)
• Ethosuximide
• Everolimus
• Exemestane
• Flutamide
• fosaprepitant
• 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 (e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isosorbide dinitrate or mononitrate
• Ivabradine
• Ivacaftor
• Leflunomide
• lidocaine
• Losartan
• Macitentan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• mefloquine
• Methadone
• Mirtazapine
• Modafinil
• Naloxegol
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Ondansetron
• Oxcarbazepine
• Perampanel
• Phenobarbital
• Phenytoin
• praziquantel
• Primaquine
• primidone
• progestins (e.g., Norethindrone, norgestrel, medroxyprogesterone)
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• Rivaroxaban
• Roflumilast
• Romidepsin
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sildenafil
• Silodosin
• siltuximab
• siponimod
• Sirolimus
• Solifenacin
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• St. John's wort
• sulfonylureas (e.g., Glyburide, Gliclazide)
• suvorexant
• tacrolimus
• Tadalafil
• Teriflunomide
• Tetracycline
• Ticlopidine
• Ticagrelor
• Tocilizumab
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• Warfarin
• Zolpidem
• Zopiclone

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 Xtandi (Enzalutamide). 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 Xtandi (Enzalutamide).

Abnormal heart rhythms: Xtandi (Enzalutamide) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Xtandi (Enzalutamide). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or if you are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Xtandi (Enzalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xtandi (Enzalutamide), and whether any special monitoring is needed.

Blood disorders: Xtandi (Enzalutamide) can cause the levels of certain blood cells to drop. This may lead to problems with blood clotting, or the immune system. Contact your doctor immediately if you develop a fever, chills, easy bruising, or bleeding (symptoms may include black and tarry stools, blood in the urine, or cuts that won't stop bleeding) while taking this medication. Your doctor will arrange periodic blood testing to monitor various blood components.

Blood pressure: Xtandi (Enzalutamide) may cause high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking this medication.

Bone health/fractures: Xtandi (Enzalutamide) may increase the risk of bone fractures. If you have Osteoporosis or bone loss, discuss with your doctor how Xtandi (Enzalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xtandi (Enzalutamide), and whether any special monitoring is needed.

Fructose intolerance: Xtandi (Enzalutamide) contains sorbitol. People who have rare hereditary fructose intolerance problems should not take Xtandi (Enzalutamide).

Heart problems: Xtandi (Enzalutamide) may cause or worsen symptoms of heart disease. If you have heart disease or risk factors for developing heart disease, such as high blood pressure, diabetes, or high levels of fat in the blood (High Cholesterol or triglycerides), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xtandi (Enzalutamide), and whether any special monitoring is needed.

Posterior Reversible Encephalopathy Syndrome: Very rarely, Xtandi (Enzalutamide) can cause a reversible brain problem called PRES (posterior reversible encephalopathy syndrome). If you develop a seizure, headache, weakness, confusion, loss of vision, or other vision changes while using this medication, get immediate medical attention.

Reduced alertness: Xtandi (Enzalutamide) may affect the mental abilities needed to drive or operate machinery, such as concentration, problem solving, and focused attention. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Xtandi (Enzalutamide) affects you.

Seizures: There have been reports of seizures occurring with Xtandi (Enzalutamide). Seizures are more likely to occur when higher doses of this medication are taken or when people have previously taken Docetaxel. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Xtandi (Enzalutamide) 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: Xtandi (Enzalutamide) should not be used by women. It is not known if Xtandi (Enzalutamide) is found in semen. If you are engaged in sexual activity with a pregnant woman, a condom should be used. If you are engaged in sexual activity with a woman who may become pregnant, you should use a condom and a second effective method of birth control. Condoms must be used during treatment with Xtandi (Enzalutamide) and for 3 months after treatment has ended to avoid possible contact between a developing fetus and the medication. To prevent accidental exposure to Xtandi (Enzalutamide), women who handle these tablets should wear gloves.

Breast-feeding: Xtandi (Enzalutamide) should not be used by women. It is not known if Xtandi (Enzalutamide) passes into breast milk. To prevent accidental exposure to Xtandi (Enzalutamide), women who handle these tablets should wear gloves.

Children: The safety and effectiveness of using Xtandi (Enzalutamide) 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. The capsule of this medication should not be opened, crushed or chewed. 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 -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food.