Xtandi 40 mg capsule

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Medication name

Generic name:
Enzalutamide - oral

Pronunciation
(EN-za-LOO-ta-mide)

Brand name(s)
Xtandi

Uses

Enzalutamide is used to treat men with a certain type of prostate cancer. This type of prostate cancer has not responded to other treatments to lower the male hormone testosterone. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start taking enzalutamide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not chew, dissolve, or open the capsules.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side effects

Hot flashes, headache, dizziness, or decreased sexual interest/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • back pain
  • numbness/tingling/weakness/pain of the arms or legs
  • falls
  • broken bones
  • pink/red urine

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Get medical help right away if you have any very serious side effects, including:

  • persistent headache
  • decreased alertness
  • seizures
  • sudden vision changes
  • mental/mood changes (such as memory problems, confusion)
  • signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking enzalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • high blood pressure
  • seizures
  • risk factors for having seizures (such as brain injury, stroke, brain tumor)
  • heart disease (such as angina/chest pain, heart attack)
  • diabetes
  • high cholesterol or fats (triglycerides) in your blood
  • falls
  • broken bones

Since this medication may rarely cause seizures in some people, ask your doctor if you should avoid activities where a sudden loss of consciousness may cause serious harm to you or others.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Men who have a pregnant partner must use a condom during sexual activity during enzalutamide treatment and for 3 months after treatment has stopped. Men with a female partner of childbearing age who is not pregnant should use a condom and another form of birth control during enzalutamide treatment and for 3 months after treatment has stopped. Ask your doctor for more details. If your partner becomes pregnant or thinks she may be pregnant, tell the doctor right away.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of enzalutamide from your body, which may affect how enzalutamide works. Examples include rifamycins (such as rifabutin, rifampin), seizure medications (such as phenobarbital, phenytoin), St. John's wort, among others.

Enzalutamide can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include asunaprevir, cobicistat, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, lurasidone, pimozide, quinidine, sirolimus, suvorexant, tacrolimus, voriconazole, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include seizures.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in a tightly closed container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.