Enzalutamide

Enzalutamide is a prescription medication used for the treatment of prostate cancer.

• Enzalutamide is available under the following different brand names: Xtandi

 Adult dosage

Capsule

• 40mg

Tablet

• 40mg
• 80mg

Prostate Cancer

Adult dosage

• 160 mg orally every day.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Enzalutamide include:

• headache,
• dizziness,
• spinning sensation,
• feeling weak or tired,
• loss of appetite,
• weight loss,
• flushing (redness, hot feeling),
• joint pain, and
• high blood pressure

Serious side effects of Enzalutamide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• seizure,
• confusion,
• thinking problems,
• severe headache,
• buzzing in the ears,
• vision problems,
• weakness,
• loss of consciousness,
• red or pink urine,
• chest pain,
• shortness of breath,
• severe headache,
• blurred vision,
• pounding in the neck or ears,
• anxiety,
• nosebleed,
• fever,
• cough with yellow or green mucus,
• stabbing chest pain, and
• wheezing

Rare side effects of Enzalutamide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Enzalutamide has severe interactions with at least 25 other drugs.
• Enzalutamide has serious interactions with at least 220 drugs.
• Enzalutamide has moderate interactions with at least 112 drugs.
• Enzalutamide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Enzalutamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Enzalutamide?”

Cautions

• The seizure occurred in patients receiving enzalutamide in randomized clinical trials; advise patients of the risk of engaging in activities where sudden loss of consciousness could cause serious harm to themselves or others; permanently discontinue therapy in patients who develop a seizure during treatment
• Posterior reversible encephalopathy syndrome (PRES) reported with use; discontinue therapy in patients who develop PRES
• Hypersensitivity reactions, including edema of the face, tongue, or lip have been observed; pharyngeal edema reported in postmarketing cases; advise patients who experience any symptoms of hypersensitivity to temporarily discontinue treatment and promptly seek medical care; permanently discontinue drug for serious hypersensitivity reactions
• In clinical studies, ischemic heart disease occurred; monitor for signs and symptoms of ischemic heart disease; optimize management of cardiovascular risk factors (eg, hypertension, diabetes, or dyslipidemia); discontinue treatment for Grade 3-4 ischemic heart disease
• Falls and fractures occurred; evaluate patients for fracture and fall risk; monitor and manage patients at risk for fractures according to established treatment guidelines and consider the use of bone-targeted agents; routine bone density assessment and treatment of osteoporosis with bone-targeted agents were not performed in the studies
• Safety and efficacy not established in females (see Pregnancy)

Pregnancy and Lactation

• Safety and efficacy not established in females
• The drug should not be handled by females who are or may become pregnant
• Contraception
  • Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose
• Infertility
  • Based on animal studies, may impair fertility in males of reproductive potential
• Lactation
  • Not indicated for use in females; unknown whether distributed in breast milk