This site is intended for US healthcare providers only.
This site is intended for US healthcare providers only.
XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).1
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XTANDI RESOURCES

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View and download useful resources about XTANDI for your office

US Full Prescribing Information for XTANDI,
Including Efficacy, Safety, and Dosing

Get information about XTANDI.

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Dosing Card

Get information on dosing and administration of XTANDI.

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Therapy Management Guide

Review guidance on managing therapy with XTANDI.

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nmCSPC With High-risk BCR Patient Profiles Brochure

Explore profiles of patients with nmCSPC with high-risk BCR who are eligible for XTANDI.
Not actual patients or patient cases; content for illustrative purposes only.

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mCSPC Patient Profiles Brochure

Explore profiles of patients with mCSPC who are eligible for XTANDI.
Not actual patients or patient cases; content is for illustrative purposes only.

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XTANDI Heritage Flashcard

Take a closer look at the details of 6 clinical trials that resulted in XTANDI label updates.

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Explore publications that report clinical trial data for XTANDI

nmCSPC WITH HIGH-RISK BCR (EMBARK)

Freedland SJ, de Almeida Luz M, De Giorgi U, et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med. 2023;389(16):1453-1465.

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mCSPC (ARCHES)

Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2019;37(32):2974-2986.

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Armstrong AJ, Azad AA, Iguchi T, et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2022;40(15):1616-1622.

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nmCRPC (PROSPER)

Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018;378(26):2465-2474.

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Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and survival in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2020;382(23):2197-2206.

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mCRPC (PREVAIL, TERRAIN, AFFIRM)

PREVAIL

Beer TM, Armstrong AJ, Rathkopf D, et al. Enzalutamide in men with chemotherapy-naïve metastatic castration-resistant prostate cancer: extended analysis of the phase 3 PREVAIL study. Eur Urol. 2017;71(2):151-154.

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TERRAIN

Shore ND, Chowdhury S, Villers A, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016;17(2):153-163.

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AFFIRM

Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187-1197.

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Download useful resources about XTANDI to share with your patients

Getting Started Brochure

This resource provides patients with information about XTANDI and advanced prostate cancer.

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Questions for Patients to Ask Their Doctor

Patients can use this guide to prepare for their next doctor visit.

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Side Effect Self-Management Card

Help patients find ways to self-manage the mild to moderate side effects of XTANDI treatment.

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XTANDI Support Solutions® Pamphlet

Patients can learn about XTANDI Support Solutions and get support.

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Help prescribed patients access XTANDI

Option 1: Submit an XTANDI prescription directly to a specialty pharmacy.

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Applicable to most insured patients. You may view the most up-to-date list of participants in the XTANDI specialty pharmacy network at XTANDISupportSolutions.com

Option 2: Request to access XTANDI through XTANDI Support Solutions®.*

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Applicable to patients without prescription drug benefits

*Program terms and conditions apply.

XTANDI Support Solutions is there to provide:

Money

Astellas Patient Assistance Program (PAP)*

Astellas PAP provides XTANDI at no cost to patients who meet the program eligibility requirements. Eligibility is determined on a patient-specific basis. XTANDI Support Solutions can quickly confirm whether your patient is eligible and answer any questions you may have. Your patients may be eligible for this program if they:

  • Are uninsured; a patient is considered uninsured when a patient has no prescription drug insurance
  • Have a verifiable shipping address in the United States
  • Have been prescribed XTANDI for an FDA-approved indication
  • Meet the program financial eligibility requirements
Hand with Money

Information about other assistance options, such as Medicare Part D Extra Help





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XTANDI Patient Connect

XTANDI Patient Connect helps connect patients and their caregivers to independent resources and third-party support services that may help them manage their disease and daily life while on treatment. XTANDI Patient Connect resources offer emotional, logistical, and informational support

*Subject to meeting eligibility requirements. Void where prohibited by law.

Other insured patients may be eligible for the program if they meet certain eligibility criteria.

Support is provided through third-party organizations that operate independently and are not controlled or endorsed by Astellas. Availability of support and eligibility requirements are determined by these organizations.

XTANDI Access

XTANDIaccess.com

XTANDI Access allows you to enroll your patients in XTANDI Support Solutions online. XTANDI Support Solutions offers access and reimbursement support to help patients overcome challenges accessing XTANDI.

Cost and copay support for XTANDI

XTANDI Patient Savings Program

Assistance for Commercially Insured Patients

The XTANDI Patient Savings Program* is for eligible commercially insured patients taking XTANDI tablets. The Program parameters are as follows:

XTANDI Support Solutions
  • Patients may pay as little as $0 per prescription
  • Patients will be enrolled in the Program for a 12-month period
  • There are no income requirements
  • There is a maximum copay assistance limit of $7000 per calendar year

Eligibility restrictions, terms, and conditions apply.

Initiating enrollment on behalf of your patients

HCPs can begin the Program enrollment process on behalf of their patients by following these steps:

STEP 1:

STEP 2:

  • CONFIRM if you are the HCP or specialty pharmacy enrolling on behalf of your patient

STEP 3:

  • ANSWER questions to confirm your patient's eligibility, including their insurance status and place of residence

STEP 4:

  • ATTEST that you have shared the terms and conditions for the XTANDI Patient Savings Program with the patient. Confirm that the patient has consented to comply with such terms and conditions

STEP 5:

  • PRINT your patient's copay program processing information. If you are the HCP, please send this information to your patient's specialty pharmacy. If you are the specialty pharmacy, please save this information to your patient’s records and process the copay program claim accordingly
  • INFORM your patient that they will receive a copy of their copay program details via a mailed letter and email (if provided during enrollment)

*By enrolling in the XTANDI Patient Savings Program ("Program"), the patient acknowledges that they currently meet the eligibility criteria and will comply with the following terms and conditions: The Program is for eligible patients with commercial prescription insurance coverage for XTANDI® (enzalutamide) and is good for use only with a valid prescription for the XTANDI tablet formulation. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Patients who move from commercial insurance to federal or state health insurance will no longer be eligible, and agree to notify the Program of any such change. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received by the patient through the Program. This offer is not conditioned on any past, present, or future purchase of XTANDI. This offer is not transferrable and cannot be combined with any other offer, free trial, prescription savings card, or discount. The full value of the Program benefits is intended to pass entirely to the eligible patient. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, Puerto Rico, Guam, and Virgin Islands. This offer is not valid for cash paying patients. This Program is void where prohibited by law. No membership fees. It is illegal to sell, purchase, trade, counterfeit, duplicate, or reproduce, or offer to sell, purchase, trade, counterfeit, duplicate, or reproduce the card. This offer will be accepted only at participating pharmacies. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice.

The Program has a maximum copay assistance limit of $7,000 per calendar year. After the annual maximum on copay assistance is reached, patient will be responsible for the remaining out-of-pocket costs for XTANDI. Astellas may reduce or discontinue the copay assistance available under the Program if it determines an enrolled patient is subject to a program offered by a third-party payer or pharmacy benefit manager, or an agent of either, that adjusts patients’ out-of-pocket cost-sharing obligations based on the copay assistance provided by this Program, or excludes the copay assistance provided under this Program from counting towards an enrolled patient’s out-of-pocket cost-sharing obligations (“maximizer” or “accumulator” program). The Program uses advanced logic to identify whether a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program. Unless prohibited by law, Astellas may reduce the cost-sharing assistance available under the Program to a per claim maximum of $25 if it determines a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program.

Subject to a maximum copay assistance limit of $7,000 per calendar year. Unless prohibited by law, Astellas may reduce the cost-sharing assistance available under the Program to a per claim maximum of $25 if it determines a claim for an enrolled patient is subject to a “maximizer” or “accumulator” program.

Links to patient support organizations

The organizations listed here offer a variety of services that include support, information, and advice to help your patients learn about living with prostate cancer.

Astellas and Pfizer are not affiliated with, do not own or control, and are not responsible for the content or services contained on the websites. The information provided by Astellas and Pfizer is for informational purposes only and is not meant to replace a doctor’s or nurse’s advice.

HELP PRESCRIBED
PATIENTS GET
STARTED
ON XTANDI
HELP PRESCRIBED PATIENTS
GET STARTED ON XTANDI
Xtandi Support Solutions Logo
XTANDISupportSolutions.com

Or call 1-855-8XTANDI
(1-855-898-2634)
Monday–Friday, 8 AM–8 PM ET

BCR, biochemical recurrence; GnRH, gonadotropin-releasing hormone; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer; nmCSPC, nonmetastatic castration-sensitive prostate cancer.

FDA, U.S. Food and Drug Administration; HCP, healthcare provider.

1-800-727-7003
AstellasAnswers.com

Indications

XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).1

Important Safety Information

Important Safety Information and Indications

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs ( 10%) that occurred more frequently ( 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs ( 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Indications

XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).1

XTANDI (enzalutamide) is indicated for the treatment of patients with:

  • nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
  • metastatic castration-sensitive prostate cancer (mCSPC)
  • castration-resistant prostate cancer (CRPC)

 

Reference: 1. XTANDI. Package insert. Northbrook, IL: Astellas Pharma US, Inc; 2025.

1-800-727-7003
AstellasAnswers.com

Indications

XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).1

Important Safety Information

Important Safety Information and Indications

Warnings and Precautions

Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.

Adverse Reactions (ARs)

In the data from the five randomized placebo-controlled trials, the most common ARs ( 10%) that occurred more frequently ( 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs ( 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Indications

XTANDI is indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR), metastatic castration-sensitive prostate cancer (mCSPC), or castration-resistant prostate cancer (CRPC).1

XTANDI (enzalutamide) is indicated for the treatment of patients with:

 

Reference: 1. XTANDI. Package insert. Northbrook, IL: Astellas Pharma US, Inc; 2025.