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IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm...  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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GETTING PATIENTS STARTED ON NUBEQA IS EASY. START NOW.

RESOURCES TO HELP YOU CONNECT PATIENTS WITH NUBEQA

 
 

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*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

Alt tag

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)

Alt tag

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

*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

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.

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.