Patient Support: XTANDI Support Solutions®

Help prescribed patients get started on XTANDI

XTANDI Support Solutions is there to provide:

Benefits Verification, Icon. Xtandi (enzalutamide) Risk info.

Benefits verification

Benefits verification helps evaluate a patient’s insurance coverage for XTANDI by providing them a summary of benefits
Prior Authorization Assistance, Icon. Xtandi (enzalutamide) Risk info.

Prior authorization assistance

In cases where a patient’s insurer requires prior authorization, XTANDI Support Solutions can provide information to the physician office regarding such insurer’s prior authorization process. Insurers approved XTANDI following receipt of a completed prior authorization request 97% of the time1
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Prior authorization denial appeals assistance

In those cases when a patient’s insurer denies a prior authorization request and the healthcare provider determines an appeal is appropriate, XTANDI Support Solutions can assist with the appeal by obtaining the reasons for the denial, determining what information/documentation is required for an appeal, and tracking the appeal status
XTANDI Quick Start+® Program, Icon. Xtandi (enzalutamide) Risk info.

XTANDI QUICK START+® Program

The XTANDI QUICK START+ Program provides a one-time, 14-day supply of XTANDI at no cost to new patients who experience an insurance-related access delay*
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XTANDI Patient Savings Program

The XTANDI Patient Savings Program is for eligible patients who have commercial prescription insurance. Under this Program:
  • Patients may pay as little as $0 per prescription
  • Patients are enrolled in the Program for a 12-month period
  • There are no income requirements
  • There is a maximum co-pay assistance limit of $7,000 per calendar year†
Astellas Patient Assistance Program, Icon. Xtandi (enzalutamide) Risk info.

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 or have insurance that excludes coverage for XTANDI§
  • Have a verifiable shipping address in the United States
  • Have been prescribed XTANDI for an FDA-approved indication
  • Meet the program financial eligibility requirements
Financial Assistance Information for Medicare Patients, Icon. Xtandi (enzalutamide) Risk info.

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

*To be eligible for XTANDI QUICK START+, patients must have prescription drug insurance, be new to XTANDI therapy, must have experienced a delay in insurance coverage, and must have been prescribed XTANDI for a US Food and Drug Administration–approved indication.

†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 for XTANDI. 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. 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 XTANDI Patient Savings Program has a maximum co-pay assistance limit of $7,000 per calendar year.

‡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.

XTANDI Support Solutions can help your patients obtain XTANDI through our network of specialty pharmacies, help problem-solve financial assistance, and provide educational resources included with prescription delivery

XTANDIaccess.com. Xtandi (enzalutamide) Risk info.

COST AND CO-PAY SUPPORT FOR XTANDI

Support for patients, regardless of coverage

Medicare Part D

XTANDI Support Solutions can provide information about other resources that might be able to help*

Uninsured

The Astellas Patient Assistance Program provides XTANDI at no cost to patients who meet the program eligibility requirements†

XTANDI Patient Savings Program

Assistance for Commercial Insurance Patients

The XTANDI Patient Savings Program‡ is for eligible patients who have commercial prescription insurance. The Program parameters are as follows:

The XTANDI Patient Savings Program - Commercial Patients Pay as Little as $0 per Perscription. Xtandi (enzalutamide) Risk info.

Eligibility restrictions, terms, and conditions apply.

  • 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 co-pay assistance limit of $7,000 per calendar year

Three ways to enroll in the XTANDI Patient Savings Program

Computer Screen Icon. Xtandi (enzalutamide) Risk info.
HCPs can initiate the enrollment process on behalf of their patients by going to ActivatetheCard.com/XTANDISavings and clicking HEALTHCARE PROVIDER OFFICE. However, only the patient can complete the enrollment process. The patient will be notified by email that their HCP has initiated Program enrollment, and they will be provided with instructions on how to complete the enrollment process.
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HCPs can inform patients that they can enroll themselves by going to ActivatetheCard.com/XTANDISavings and clicking on PATIENT.
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Patients can call 1-855-217-8311 for assistance enrolling.

For more information about the XTANDI Patient Savings Program:

Please call us at 1-855-217-8311 for additional information or for help enrolling into the Program.

We are available Monday – Friday, 8 AM – 8 PM ET.

*XTANDI Support Solutions has no control over the decisions of, and does not guarantee support from, independent third parties.

†Program subject to eligibility requirements. Void where prohibited by law.

‡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 for XTANDI. 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. 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 XTANDI Patient Savings Program has a maximum co-pay assistance limit of $7,000 per calendar year.

Reference: 1. Astellas. XTANDI. Data on File.

Important Safety Information

Warnings and Precautions

Seizure occurred in 0.5% of patients receiving XTANDI in seven 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 seven 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 four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% 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 four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% 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.

Adverse Reactions (ARs)

In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. 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 adverse events (AEs) 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 AEs 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 AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE 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 AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

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 neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% 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 (enzalutamide) is indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)

Please see Full Prescribing Information.

Important Safety Information

Warnings and Precautions

Seizure occurred in 0.5% of patients receiving XTANDI in seven 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 seven 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 four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% 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 four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% 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.

Adverse Reactions (ARs)

In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. 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 adverse events (AEs) 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 AEs 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 AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE 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 AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

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 neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.

Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% 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 (enzalutamide) is indicated for the treatment of patients with:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)

Please see Full Prescribing Information.