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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When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

When treating non-metastatic castration-resistant prostate cancer (nmCRPC),

METASTASIS-FREE SURVIVAL (MFS) IS

JUST THE HALF OF IT

NUBEQA®—focus on both MFS* and tolerability.1,2

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

*Metastasis-free survival is defined as the time from randomization to the time of first evidence of blinded independent central review–confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.

INDICATION

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

EXTENDED MFS AND TOLERABILITY
for men with nmCRPC1,2

Efficacy

40
months

More than double the median MFS with NUBEQA + ADT* vs 18 months with ADT alone†‡

PROVEN TOLERABILITY

Proven
tolerability

Three adverse reactions occurred more frequently with NUBEQA + ADT (≥2% over ADT alone): fatigue (16% vs 11%), pain in extremity (6% vs 3%), and rash (3% vs 1%)§

SAME RATE OF PERMANENT DISCONTINUATION

Same rate of
permanent discontinuation

9% of men permanently discontinued due to adverse reactions whether on NUBEQA + ADT or ADT alone||

Dose interruptions and reductions due to adverse reactions occurred in 13% and 6%, respectively, of patients treated with NUBEQA + ADT

*95% CI: 34.3-NR.

95% CI: 15.5-22.3.

HR: 0.41; 95% CI: 0.34-0.50; P<0.0001.

§Overall, serious adverse reactions occurred in 25% of men receiving NUBEQA + ADT and in 20% of men receiving ADT alone. Serious adverse reactions in ≥1% of men who received NUBEQA + ADT included urinary retention, pneumonia, and hematuria.

Additionally, clinically significant adverse reactions occurring in ≥2% of men treated with NUBEQA + ADT vs ADT alone included ischemic heart disease (4.0% vs 3.4%) and heart failure (2.1% vs 0.9%).

All-grade laboratory abnormalities in patients treated with NUBEQA + ADT vs ADT alone were, respectively, decreased neutrophil count (20% vs 9%), increased AST (23% vs 14%), and increased bilirubin (16% vs 7%). Grade 3-4 for same lab abnormalities were, respectively, 4% vs 0.6%, 0.5% vs 0.2%, and 0.1% vs 0%.

||The most frequent adverse reactions requiring permanent discontinuation in patients treated with NUBEQA + ADT included cardiac failure (0.4%) and death (0.4%).

In patients treated with NUBEQA + ADT, the most frequent adverse reactions requiring dose interruption included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%); the most frequent adverse reactions requiring dose reduction included fatigue (0.7%), hypertension (0.3%), and nausea (0.3%).

 

The efficacy and safety of NUBEQA were assessed in a randomized, double-blind, placebo-controlled, international, multicenter phase III study (ARAMIS) in nmCRPC patients with a prostate-specific antigen doubling time of ≤10 months. 1509 patients were randomized 2:1 to receive either 600 mg NUBEQA twice daily (n=955) or matching placebo (n=554). All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy). The primary endpoint was MFS. Treatment continued until radiographic disease progression, as assessed by CT, MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. OS data were not mature at the time of final MFS analysis (57% of the required number of events).1,2 The planned final OS analysis has been conducted and mature data on OS will be presented at an upcoming scientific meeting.

ADT=androgen deprivation therapy; CI=confidence interval; NR=not reached; HR=hazard ratio; GnRH=gonadotropin-releasing hormone; BICR=blinded independent central review; CT=computed tomography; MRI=magnetic resonance imaging; OS=overall survival; AST=aspartate transaminase.

MEN IN YOUR PRACTICE MAY BENEFIT
from NUBEQA

MEN IN YOUR PRACTICE MAY BENEFIT FROM NUBEQA (darolutamide)
  • Prostate cancer has not yet metastasized
  • Rising PSA despite treatment with ADT

DUDE ACCESS SERVICES™
is ready to support you and your patients

DUDE Access Services, Darolutamide User Drug Experience

833-337-DUDE (3833)

MONDAY – FRIDAY:

9:00 AM – 7:00 PM (EST)

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.

References:

  • NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; July 2019. Return to content
  • Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. Return to content

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Date of last update: 20/04/2020