Xtandi

Xtandi is a prescription medication used to treat men with prostate cancer that no longer responds to a medical or surgical treatment that lowers testosterone, and has spread to other parts of the body.

Xtandi belongs to a group of drugs called androgen receptor inhibitors. These work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Xtandi comes as a capsule to take by mouth. It is taken once daily, with or without food. Take Xtandi at the same time each day.

Common side effects include weakness, back pain, diarrhea, and joint pains. Xtandi can also cause seizures. Do not drive or operate machinery until you know how this medication affects you.

Xtandi is a prescription medication used to treat prostate cancer that has spread to other parts of the body in men.

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

• Astellas Pharma US, Inc.

Common side effects include the following:

• weakness
• tiredness
• joint pain
• muscle weakness or stiffness
• headache
• dizziness
• burning, numbness, or tingling in the arms, hands, or feet
• decreased sense of touch or ability to feel sensation
• hot flashes
• difficulty falling asleep or staying asleep
• anxiety
• difficulty remembering, thinking, or paying attention
• diarrhea
• itching
• dry skin
• nosebleeds
• frequent urination

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does 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:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• bosentan (Tracleer)
• carbamazepine (Carbatrol, Equetro, Tegretol)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• dihydroergotamine (D.H.E. 45, Migranal)
• efavirenz (Sustiva)
• ergotamine (in Migergot, in Cafergot)
• etravirine (Intelence)
• fentanyl (Abstral, Actiq, Duragesic, others)
• gemfibrozil (Lopid)
• itraconazole (Sporanox)
• omeprazole (Prilosec)
• midazolam (Versed)
• modafinil (Provigil)
• nafcillin (Nallpen)
• narcotic medications for pain
• phenobarbital
• phenytoin (Dilantin)
• pimozide (Orap)
• quinidine (in Nuedexta)
• rifabutin (Mycobutin)
• rifampin (Rimactane, in Rifamate, in Rifater)
• rifapentine (Priftin)
• sirolimus (rapamune)
• tacrolimus (Prograf)
• St. John's wort

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

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• swelling of the arms, legs, hands, or feet
• pain in the back and/or legs
• numbness or tingling in the buttocks or legs
• difficulty controlling urination or bowel movements
• difficulty breathing
• falling
• hallucinating (seeing things or hearing voices that do not exist)
• pink or red urine

Xtandi can cause seizures. Do not drive or operate machinery until you know how this medication affects you.

Do not take this medication if you are

• allergic to Xtandi 
• are 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 this medication, there are no specific foods that you must exclude from your diet.

Before taking Xtandi,

• tell your doctor and pharmacist if you are allergic to Xtandi, any other medications, or any of the ingredients in Xtandi capsules. Ask your pharmacist or check the manufacturer's information for the patient for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements you are taking or plan to take.
• tell your doctor if you have or have ever had seizures, a brain injury, a brain tumor, a brain arteriovenous malformation (abnormal connection between arteries and veins in the brain that forms before birth and may cause bleeding in the brain), or a stroke or ministroke.
• you should know that Xtandi is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breast-feeding. If taken by pregnant women, Xtandi may harm the fetus. If a pregnant woman takes Xtandi, she should call her doctor immediately.
• if your partner is pregnant, you must use a condom whenever you have sex during your treatment with Xtandi and for three months after your treatment. If your partner is not pregnant but could become pregnant, you must use a condom and another form of birth control whenever you have sex during your treatment and for 3 months after your treatment.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Xtandi.
• you should know that Xtandi may cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.

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. This medication falls into category X.

Female patients:

• Xtandi is only for use in men. You should not take this medication, especially if you are or may become pregnant or are breastfeeding. Xtandi may harm the fetus (unborn baby). If you become pregnant while taking Xtandi, call your doctor immediately.

Male patients:

• if your partner is pregnant, you must use a condom whenever you have sex during your treatment with Xtandi and for three months after your treatment. If your partner is not pregnant but could become pregnant, you must use a condom and another form of birth control whenever you have sex during your treatment and for 3 months after your treatment.

Xtandi is not indicated for use in women. It is not known if Xtandi can cross into human milk. Because many drugs can cross into human milk, and because of the potential for serious side effects in nursing infants from Xtandi, a decision should be made to either stop nursing or to stop taking the drug.

Xtandi comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take Xtandi at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Xtandi exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not chew, dissolve, or open them.

Your doctor may tell you to stop taking Xtandi for a short time or decrease your dose if you experience serious side effects during your treatment. Be sure to talk to your doctor about how you are feeling during your treatment with Xtandi.

If your doctor has prescribed another medication such as degarelix (Firmagon), goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Eligard, Lupron), or triptorelin (Trelstar) to treat your prostate cancer, you will need to continue receiving this medication during your treatment with Xtandi.

Continue to take Xtandi even if you feel well. Do not stop taking Xtandi without talking to your doctor.

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:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 160 mg (four 40 mg capsules) taken by mouth once daily. Swallow capsules whole. Xtandi can be taken with or without food.

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

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Store at room temperature and away from excess heat and moisture (not in the bathroom).