ESTABLISHEDSAFETY PROFILE1-4
INCIDENCE OF ADVERSE REACTIONS1
Adverse Reactions (All Grades) With ≥10% Incidence in the ERLEADA® + ADT Arm That Occurred With at Least 2% Greater Frequency Than in the Placebo + ADT Arm in the TITAN Study1
Adverse Reactions ERLEADA® + ADT (n=524) Placebo + ADT (n=527) Rash 28% 9% Hot flush 23% 16% Hypertension 18% 16% Arthralgia 17% 15% Pruritus 11% 4.6% Grades 3 and 4 Adverse Reactions in the TITAN Study1
Adverse Reactions ERLEADA® + ADT (n=524) Placebo + ADT (n=527) Hypertension 8% 9% Rash 6% 0.6% Pruritus 0.2% 0.2% Arthralgia 0.4% 0.9% Hot flush 0% 0% Additional Safety Information in the TITAN Study2
Treatment-Emergent
Adverse EventsERLEADA® + ADT (n=524) Placebo + ADT (n=527) Any mental impairment disorder 2.7% 1.5% Memory impairment 1.3% 1.1% Amnesia 0.8% 0.2% Cognitive disorder 0.8% 0.2% Disturbance in attention 0.2% 0.2%
Serious adverse reactions occurred in 20% of patients in the ERLEADA® + ADT arm and 20% of patients in the placebo + ADT arm.1 The discontinuation rate due to adverse reactions was 8% in the ERLEADA® + ADT arm.1
In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1
INCIDENCE OF ADVERSE REACTIONS1
Adverse Reactions (All Grades) With ≥10% Incidence in the ERLEADA® + ADT Arm That Occurred With at Least 2% Greater Frequency Than in the Placebo + ADT Arm in the SPARTAN Study1
Adverse Reactions ERLEADA® + ADT (n=803) Placebo + ADT (n=398) Fatigue 39% 28% Hypertension 25% 20% Rash 25% 6% Diarrhea 20% 15% Nausea 18% 16% Weight decreased 16% 6% Arthralgia 16% 8% Fall 16% 9% Hot flush 14% 9% Decreased appetite 12% 9% Fracture 12% 7% Peripheral edema 11% 9% Grades 3 and 4 Adverse Reactions in the SPARTAN Study1
Adverse Reactions ERLEADA® + ADT (n=803) Placebo + ADT (n=398) Hypertension 14% 12% Rash 5.2% 0.3% Fracture 2.7% 0.8% Fall 1.7% 0.8% Weight decreased 1.1% 0.3% Diarrhea 1.1% 0.5% Fatigue 1.4% 0.3% Decreased appetite 0.1% 0% Arthralgia 0% 0% Hot flush 0% 0% Nausea 0% 0% Peripheral edema 0% 0% Additional Safety Information in the SPARTAN Study3,4
Treatment-Emergent Adverse Events ERLEADA® + ADT (n = 803) Placebo + ADT (n=398) Any mental impairment disorder* 3.9%† 3.4%† Amnesia 1.9% 1.0% Memory impairment 1.6% 1.5% Disturbance in attention 1.2% 0.3% Cognitive disorder 0.7% 0.8% To evaluate the potential effect of ERLEADA® on cognitive deficits, events of amnesia, cognitive disorder, memory impairment, and disturbance in attention were assessed.3,4
*All mental impairment disorders were Grades 1 or 2.4
†Exposure-adjusted rate. An exposure-adjusted rate is 100 times the number of distinct mental impairment disorder treatment - emergent adverse events divided by total years of exposure.4
In the SPARTAN study, 25% of patients in the ERLEADA® + ADT arm experienced serious adverse reactions and 23% of patients in the placebo + ADT arm.1
In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1
Patient-reported outcomes for health-related quality of life
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ADT = androgen deprivation therapy; AE = adverse event; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509; TEAEs = treatment-emergent adverse events; TITAN = Targeted Investigational Treatment Analysis of Novel Anti-androgen.
REFERENCES:
- ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.
- U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical StudyReport. Accessed December 22, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/rev_210951_arn-509-003_CSR_Redacted.pdf