IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Continue reading »

NUBEQA (darolutamide) 300 mg tablets logo

IMPORTANT SAFETY INFORMATION

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. Continue reading »

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DUDE ACCESS SERVICES

STRONG COVERAGE AND SUPPORT OPTIONS FOR YOU AND YOUR PATIENTS

Experience NUBEQA now with a range of services available to help your patients access therapy

1-month free trial for new NUBEQA patients

1-month free trial*

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

Enroll patients by downloading and completing the Patient Service Request Form or calling the number below.

$0 co-pay for NUBEQA

$0 co-pay

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

Patients can determine whether they qualify by calling the number below or visiting NUBEQAcopayprogram.com.

Other support for NUBEQA

Other support

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

DUDE Access ServicesTM will connect you to representatives who can help with benefits verification, prior authorization assistance, and appeal support.

93% COVERAGE ACROSS COMMERCIAL AND MEDICARE LIVES without step edit, as of June 2020

To provide these savings to your patients and benefit from the advantages of DUDE Access Services, complete and fax the Patient Service Request Form or call:

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DUDE™ Access Services, Darolutamide User Drug Experience

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833-337-DUDE (3833)

MONDAY - FRIDAY:

9:00 AM - 7:00 PM (EST)

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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, please call DUDE Access Services at 1-833-337-DUDE (1-833-337-3833) or download the Patient Service Request Form above.

Restrictions may apply. For full terms and conditions, please call DUDE Access Services at 1-833-337-DUDE (1-833-337-3833). 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.

 

RESOURCES

RESOURCES AVAILABLE TO HELP YOU 
CONNECT PATIENTS WITH NUBEQA

Resources for you and your practice

*Bayer, the manufacturer of darolutamide, is providing you with the published articles. These peer-reviewed articles contain data, conclusions, and recommendations that may not be consistent with the FDA-approved labeling. Darolutamide is only approved for the indication specified in the Prescribing Information. Before prescribing the product, please read the enclosed full Prescribing Information.

This study was supported by Bayer HealthCare and Orion Pharma. Authors’ affiliations can be found in the full text of the article. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. There are authors of this journal article who have declared financial interest or reported compensation from Bayer.

Visit openpaymentsdata.cms.gov for specific financial disclosures. Additional significant safety risks not listed in the NEJM Fizazi 2019 & 2020 reprint are included in the Prescribing Information. For more information, please call 888-84-BAYER (22937) or submit a product information request.

 

CONTACT A BAYER REPRESENTATIVE

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.

Sales Consultants for NUBEQA

Sales
Consultants

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

Medical Support for NUBEQA

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 for NUBEQA

Field Reimbursement
Managers

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

INDICATION

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION

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
Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

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.

For important risk and use information about NUBEQA, please see 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.