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

SUPPORT OPTIONS FOR YOU
AND YOUR PATIENTS

A range of services are available to help your patients access therapy

2-month free trial

2-month free trial*

Patients new to NUBEQA are eligible for up to 2 months of free treatment.

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

$0 copay

$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

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.

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 2 months’ 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 visit NUBEQAhcp.com to download the Patient Service Request Form with full terms and conditions.

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

 

CONTACT A BAYER REPRESENTATIVE

CONTACT A BAYER REPRESENTATIVE

To help 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

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.

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.

Contact a Bayer Representative

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 – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate 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.

All rights reserved. BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer, and DUDE Access Services is a trademark of Bayer.

Date of last update: 20/04/2020