RESOURCES TO HELP YOU CONNECT PATIENTS WITH NUBEQA
Resources for you and your practice
Coverage and Access
Patient Service Request Form
Download and complete this form to request support from Access Services by Bayer, which includes enrolling new patients into the NUBEQA Free Trial Program.
NUBEQA Free Sample Program
An overview of the NUBEQA 30-Day Free Sample Program to help start your patients on NUBEQA right in your office.
Appeal Checklist
and Sample Letter
An overview of actions to take if a payer denies coverage for NUBEQA; includes a sample letter.
NUBEQA (darolutamide) Specialty Distributor Network
A list of specialty distributors within the NUBEQA network that bring a higher level of comprehensive, coordinated care to your patients.
NUBEQA (darolutamide) Specialty Pharmacy Network
A list of specialty pharmacies that partner with Bayer to provide reliable prescription delivery and a higher level of coordinated care.
Tips and Guides
NUBEQA Free Trial Patient Information Guide
An overview of the NUBEQA Free Trial Program for your patients who are prescribed NUBEQA.
Pill Size and Dosing Card
Learn more about pill size and recommended dosage for NUBEQA.
Prior Authorization Tips
Helpful tips when collecting patients' clinical information and submitting a prior authorization request.
Sample Letter of Medical Necessity
A sample letter as a guide for specific patient clinical information when requesting coverage for NUBEQA.
Publications
ARAMIS Pivotal Phase III Trial Publication*
The results from the first analysis, published in 2019 in The New England Journal of Medicine.
ARAMIS Final Analysis Publication*
The results from the final analysis, published in 2020 in The New England Journal of Medicine.
Patient resources
Patient Brochure (English)
A patient-friendly explanation of what NUBEQA is, how it works, and its efficacy, safety, and more.
*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.
These studies were supported by Bayer HealthCare and Orion Pharma. Authors' affiliations can be found in the full text of each article. Disclosure forms provided by the authors are available with the full text of each article at NEJM.org. There are authors of these journal articles 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 1-888-84-Bayer (22937) or submit a product information request.
CHOOSE NUBEQA WHEN ADT IS NO LONGER ENOUGH1
DEAN
AGE: 55
Financial advisor and and
recreational cyclist
Presence of pelvic lymph node
<2 cm observed on a recent
CT scan
ECOG PS
Gleason Score
Current PSA Level
PSA Doubling Time
Time on ADT
0*
8
12.2 ng/mL
8 mo
32 mo
JEREMY
AGE: 73
Avid bridge player and camper
No evidence of metastatic disease
On antithrombotic
agent
(dabigatran)
ECOG PS
Gleason Score
Current PSA Level
PSA Doubling Time
Time on ADT
1†
9
5.8 ng/mL
6 mo
23 mo
*Fully active, able to carry on all pre-disease performance without restriction.2
†Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, eg, light housework, office work.2
ARAMIS studied patients ranging in age from 48
to 95. All patients were ECOG PS 0-1 at study entry.1
WHETHER YOUNGER OR OLDER, NUBEQA OFFERS YOUR PATIENTS SIGNIFICANT EFFICACY AND PROVEN TOLERABILITY
Start your patients with
1 month of free medication
Patients new to NUBEQA are eligible for up to 1 month of free
treatment. Enroll here or contact your sales representative
for a 30-day free sample.
*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
CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group performance status; PSA=prostate-specific antigen; ADT=androgen deprivation therapy.
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: 1. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. 2. Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
