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), SURVIVAL IS JUST HALF OF IT

Metastasis-free survival (MFS) was the primary endpoint, and overall survival (OS) was a key secondary endpoint.

INDICATION

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

EXTENDED SURVIVAL AND PROVEN TOLERABILITY
in men with nmCRPC1-3

Efficacy in men with non-metastatic CRPC

40
months MFS

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

Secondary endpoint in men with nmCRPC

Extended
overall survival

31% reduction in the risk of death with NUBEQA + ADT vs ADT alone

HR: 0.69; 95% CI: 0.53-0.88; P=0.003. Medians not estimable.

Proven tolerability in men with non-metastatic CRPC

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 low rate of permanent discontinuation in men with non-metastatic CRPC

Same low 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

When PSA doubling time causes concern,
 consider NUBEQA as a 1st option for your nmCRPC patients on ADT

*95% CI: 34.3-NE.

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 PSA 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, defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Treatment continued until radiographic disease progression, as assessed by CT, MRI, 99mTc bone scan by BICR, unacceptable toxicity, or withdrawal. The final analysis of OS and time to initiation of cytotoxic chemotherapy was event-driven and conducted after 254 OS events had occurred and 14 months after MFS analysis.1,2

PSA=prostate-specific antigen; ADT=androgen deprivation therapy; HR=hazard ratio; CI=confidence interval; NE=not estimable; AST=aspartate transaminase; GnRH=gonadotropin-releasing hormone; BICR=blinded independent central review; CT=computed tomography; MRI=magnetic resonance imaging.

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

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*93% coverage across commercial and Medicare lives, as of June 2021. Reimbursement, access, and other types of support are available.

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.

References:

  • NUBEQA (darolutamide) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; January 2021.
  • Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246.
  • Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049.