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IMPORTANT SAFETY INFORMATION

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients...  Continue reading »

NUBEQA (darolutamide) 300 mg tablets logo

IMPORTANT SAFETY INFORMATION

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Continue reading »

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GETTING PATIENTS STARTED ON NUBEQA IS EASY. START NOW.

CHOOSE NUBEQA FOR BEST-IN-CLASS COVERAGE

 

Most patients did not report any fatigue (84%), and 99.4% had no severe (grade 3-4) fatigue
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Access Services by Bayer offers savings and support options to make it easier for patients to start and stay on NUBEQA

$0 copay

$0 CO-PAY*

Commercially insured patients may qualify for $0 co-pay.

  • Annual auto-enrollment that helps avoid gaps in therapy
  • No income requirement

To enroll, call 1-800-288-8374 or visit NUBEQAcopayprogram.com

1-month free trial

MONTH
FREE TRIAL

Patients new to NUBEQA are eligible for up to 1 month of free treatment.

Enroll patients here or simply call 1-800-288-8374.

Enhanced support for NUBEQA

ENHANCED
SUPPORT

Reimbursement, access, and other types of support are available.

Access Services by Bayer connects you to representatives who can help with benefits verification, prior authorization assistance, and appeal support.

  • Electronic Benefit Verification (eBV)
  • Electronic Prior Authorization (ePA): PA requests can be submitted and approved in minutes
  • Online patient enrollment
  • Electronic signatures for prescribers and patients
  • Real-time patient updates for portal prescribers
  • Electronic Benefit Verification (eBV)
  • Electronic Prior Authorization (ePA): PA requests can be submitted and approved in minutes
  • Online patient enrollment
  • Electronic signatures for prescribers and patients
  • Real-time patient updates for portal prescribers
Access Services by Bayer™

To provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call:

1-800-288-8374

MONDAY - FRIDAY:

9:00 AM - 6:00 PM (ET)

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Access Services by Bayer™
ACCESS SERVICES BY BAYERTM IS READY TO HELP
Access Services by Bayer™
PSA mean reduction

Celebrating over a year of achieving on-par or better health-plan coverage

vs other second-generation androgen receptor inhibitors


Access Services by Bayer™

1-800-288-8375

MONDAY-FRIDAY:

9:00 AM-6:00 PM (ET)

Access Services by Bayer™
ACCESS SERVICES BY BAYERTM IS READY TO HELP
Access Services by Bayer™
PSA mean reduction

Celebrating over a year of achieving on-par or better health-plan coverage

vs other second-generation androgen receptor inhibitors


Health plan coverage includes commercial and Medicare plans nationally, which is accurate as of April 2021 per DRG. Better: NUBEQA formulary access has preferred formulary coverage criteria or fewer restrictions and/or step edits than Erleada or Xtandi. On par: NUBEQA formulary access is the same as Erleada or Xtandi. Formulary status does not imply a comparison of efficacy, safety or dosing. Restrictions may apply. Please confirm PA requirements by calling your patient's insurance provider. Erleada is a registered trademark of Janssen Biotech, Inc.

To provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call:

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Access Services by Bayer™
ACCESS SERVICES BY BAYERTM IS READY TO HELP

blue line

Access Services by Bayer
is ready to help.
Enroll now

Access Services by Bayer™

blue line

1-800-288-8374

MONDAY - FRIDAY:

9:00 AM - 6:00 PM (ET)

TESTETo provide these savings to your patients and benefit from the advantages of Access Services by Bayer, enroll now or call:

blue line

Access Services by Bayer™

blue line

1-800-288-8374

MONDAY - FRIDAY:

9:00 AM - 6:00 PM (ET)

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*The NUBEQA Free Trial Program provides 1 month’s supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions and to enroll patients, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com.

Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.

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WILL GIVE YOU THE OPPORTUNITY TO

  • Start your patients on NUBEQA right in your office
  • Provide your patients with a 30-day supply of NUBEQA at no cost
 

ORDERING A SAMPLE IS SIMPLE

  • Your sales representative will process your sample request
  • Your order will be shipped within 24 to 48 hours

Terms and conditions apply.

*Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As 
  a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.

The NUBEQA Free Trial Program provides 1 month's supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com. to enroll patients online and view full terms and conditions.

Terms and conditions apply.

 

*Restrictions may apply. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the copayment support provided under this program, eg, co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Eligibility and participation are subject to review and may be modified or discontinued at any time.

The NUBEQA Free Trial Program provides 1 month's supply of NUBEQA at no cost to patients who meet the program eligibility requirements and agree to the terms and conditions. For full terms and conditions, please call Access Services by Bayer at 1-800-288-8374 or visit NUBEQAhcp.com to enroll patients online and view full terms and conditions.

 

 

YOUR AREA, YOUR PATIENTS: INSTANTLY ACCESS LOCAL COVERAGE INFORMATION FOR NUBEQA

 

NUBEQA: Market-leading coverage across Commercial and Medicare Part D plans may allow you to focus more on treatment and less on your patients’ coverage1*

Source: Formulary data are provided by Fingertip Analytics and are current as of June 2021. This includes patients enrolled in the following plans within your area:

If you would like to see formulary coverage for another area, enter the ZIP code or a different NPI number

ZIP CODE


OR


NPI NUMBER

SEARCH

*Health plan coverage includes commercial and Medicare plans nationally, which is accurate as of April 2021 per DRG. Better: NUBEQA formulary access has preferred formulary coverage criteria or fewer restrictions and/or step edits than Erleada or Xtandi. On par: NUBEQA formulary access is the same as Erleada or Xtandi. Formulary status does not imply a comparison of efficacy, safety or dosing. Restrictions may apply. Please confirm PA requirements by calling your patient's insurance provider. Erleada is a registered trademark of Janssen Biotech, Inc. Xtandi is a registered trademark of Astellas Pharma US Inc.

CONTACT A BAYER REPRESENTATIVE

 

To stay informed on everything NUBEQA®, contact a Bayer Representative

A team of Bayer Representatives is available to answer any questions you might have about NUBEQA. Whether it takes place over an in-person visit, a phone call, or an e-mail, we’re happy to help.

To help stay informed on everything NUBEQA, contact a Bayer Representative

A team of Bayer representatives are available
to answer any questions you may have about
NUBEQA. Whether it takes place over an
in-person visit, a phone call, or an e-mail,
we’re happy to help.

Sales Consultants

Sales
Consultants

Provide information about the safety and
efficacy of NUBEQA, who it’s for, and how
to help patients gain access.

Sales Consultants

Sales Consultants

Provide information about the safety and efficacy of NUBEQA, who it’s for, and how to help patients gain access.

Medical Support

Medical
Support

Offers access to Clinical Nurse Educators who
provide patient education and support to nurses
in your practice who care for patients on NUBEQA,
and Medical Science Liaisons who are available for
information and consultation about NUBEQA.

Medical Support

Medical Support

Offers access to Clinical Nurse Educators who provide patient education and support to nurses in your practice who care for patients on NUBEQA, and Medical Science Liaisons who are available for information and consultation about NUBEQA.

Field Reimbursement Managers

Field
Reimbursement
Managers

Work to reduce reimbursement barriers, educate
staff, and serve as Bayer Representatives for
Medicare Administration Contractor policy and
claims professionals.

Field Reimbursement Managers

Field Reimbursement Managers

Work to reduce reimbursement barriers, educate staff, and serve as Bayer Representatives for Medicare Administration Contractor policy and claims professionals.

ISI - Important Safety Information

INDICATIONS
NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:
•    Non-metastatic castration-resistant prostate cancer (nmCRPC)
•    Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

IMPORTANT SAFETY INFORMATION
Warnings & Precautions
Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 2.9% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0.1% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity, and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

Please see additional Important Safety Information and the full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Reference:

  • Data on file. Bayer HealthCare Pharmaceuticals, Inc.; Whippany, NJ.

References: 1. Data on file. Bayer HealthCare Pharmaceuticals, Inc.; Whippany, NJ.