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AROMASIN® (exemestane): Adjuvant Therapy for Early Stage ... AROMASIN® (exemestane): Adjuvant Therapy for Early Stage ... Presentation Transcript

  • AROMASIN ® (exemestane): Adjuvant Therapy for Early Stage Breast Cancer After 2 to 3 Years of Tamoxifen Please see full prescribing information.
  • Breast Cancer
    • Breast cancer is the most commonly diagnosed cancer among women in the United States
    • It is estimated that 212,930 new cases and 40,870 deaths will result from breast cancer in 2005
    • About 3/4 of breast cancers are estrogen receptor (ER) – and/or progesterone receptor (PR) – positive and are, therefore, suitable for hormonal therapy
    • The majority of women diagnosed with breast cancer are postmenopausal
    American Cancer Society. Cancer Facts and Figures 2005. Atlanta, Ga: American Cancer Society, Inc.; 2005 ; Johnston et al. Nat Rev Cancer. 2003;3 : 821-831.
  • Hormonal Therapy Options LHRH = luteinizing hormone-releasing hormone. Hayes DF et al. In: Robertson et al, eds. Endocrine Therapy of Breast Cancer . 2002:3-10. Robertson JF. Clin Ther . 2002;24(suppl A):A17-A30. Androgens, progesterone, progestational agents Other LHRH analogues, radiation, surgery Hormonal ablation (premenopausal women) Aromatase inhibitor/inactivator (AI) Estrogen synthesis suppression (postmenopausal women) Selective estrogen-receptor down-regulators (SERDs) Selective estrogen-receptor modulators (SERMs) ER blockade Therapeutic Modality Examples Mechanism
  • Tamoxifen Has Been the Standard of Care
    • 21%, 28%, and 50% relative risk reduction in 1-year, 2-year, and 5-year trials of tamoxifen therapy over placebo, respectively
    • 28% reduction of death with 5 years of tamoxifen therapy over placebo
    • 47% relative risk reduction of contralateral breast cancer with 5 years of therapy over placebo
    • Current standard of tamoxifen treatment is 5 years. However, the absolute benefit per year decreases over the duration of therapy
    Early Breast Cancer Trialists’ Collaborative Group. Lancet . 1998;351:1451-1467. Fisher B et al. J Natl Cancer Inst. 2001;93:684-690. Meta-analysis of 55 trials and approximately 30,000 women with ER+ tumors :
  • Resistance to Tamoxifen Over Time Hypothetical Model Based on Clinical Observation Mamounas E. Oncology (Huntingt) . 2001;15:35-39. ER+, Sensitive to Tamoxifen ER+, Stimulated by Tamoxifen Year ER+ Micrometastases (%)
  • Tamoxifen Has Both Antagonist and Agonist Effects Riggs L et al. N Engl J Med. 2003;348:618-629. Johnston SRD et al. Nat Rev Cancer . 2003;3:821-831. Tamoxifen Antagonis t Agonist
    • Tumor inhibition
    • Hot flashes
    • Potential tumor stimulation
    • ↑ Risk of endometrial cancer and thromboembolic effects
    • Lowers cholesterol
    • Preserves bone density
  • Aromatase Inhibition and Inactivation: Mechanism of Action Estrone Estradiol Testosterone AIs and inactivators Androstenedione Cholesterol
    • Cortisol
    Progesterone Aldosterone Pregnenolone Aromatase Miller WR et al. Cancer Control. 2002;9(suppl):9-15. Aromatase
  • Differences in AI and Tamoxifen Mechanism of Action EREs = estrogen response elements. Johnston SRD et al. Nat Rev Cancer. 2003;3:821-831. Adapted with permission: http://www.nature.com. Androgens AI (eg, exemestane) Aromatase Estrogens Tamoxifen
    • Proliferation
    ER target genes EREs ER ER
  • Differences in the Structures of Aromatase Inhibitors and Inactivators* Androstenedione Steroidal (inactivators) Androgen substrate Nonsteroidal (inhibitors) H O O *The clinical significance of these differences is unknown. Goss PE et al. J Clin Oncol. 2001;19:881-894; Goss P. Available at: http://www.medscape.com/viewprogram/1022_pnt. Accessed September 26, 2005. Aminoglutethimide O NH 2 C 2 H 5 O N Exemestane O CH 2 O Formestane O OH O Letrozole CN NC N N N Anastrozole CH 3 CH 3 CH 3 CH 3 N N N CN NC
  • AROMASIN ® (exemestane) Tablets: Adjuvant Indication
    • AROMASIN is indicated for adjuvant treatment of postmenopausal women with ER+ early breast cancer who have received 2 to 3 years of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive years of adjuvant hormonal therapy.
    Please see full prescribing information.
  • Important Safety Considerations
    • AROMASIN ® (exemestane) should not be used in women who are
      • Premenopausal
      • Nursing or pregnant
      • Known to be hypersensitive to the drug
      • Taking estrogen-containing agents
    • For patients receiving exemestane with a potent CYP 3A4 inducer, such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg qd after a meal
    • In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN
    • Reductions in bone mineral density over time are seen with use of AROMASIN
    Please see full prescribing information.
  • IES Trial Design Multinational, Double-Blinded, Randomized, Landmark Trial RANDOM I ZAT I ON Diagnosis and Initial Treatment of Early Breast Cancer Tamoxifen 2 to 3 years 20 mg po qd* (n = 2372) AROMASIN ® 2 to 3 years 25 mg po qd (n = 2352) Total of 5 Consecutive Years of Hormonal Therapy Tamoxifen Therapy 2 to 3 years N = 4724 Patient stratification: Node status Prior chemotherapy (CT) Hormone receptor status *Approximately 3% of patient population received tamoxifen 30 mg po qd. Median follow-up 34.5 months. Please see full prescribing information. Patient Ends Therapy and Continues Follow-up
  • IES: Collaboration Between 20 International Trials Groups A total of 367 hospitals in 37 countries Total number of patients = 4740 United States 364 South American Argentina 148 Peru 7 Africa South Africa 19 Egypt 7 Australia Australia 48 New Zealand 22 Asia Hong Kong 6 Europe United Kingdom 594 Ireland 58 France 398 Belgium 171 Switzerland 55 Germany 185 Denmark 136 Greece 41 Italy 616 Luxembourg 4 Netherlands 306 Bulgaria 83 Croatia 117 Czech Republic 64 Estonia 5 Hungary 77 Russia 48 Slovakia 61 Slovenia 40 Yugoslavia 41 Romania 63 Poland 311 Spain 254 Portugal 28 Malta 12 Norway 126 Sweden 163 Israel 62 Bosnia 2 Data on file. Pfizer Inc, New York, NY.
  • IES Study End Points
    • Primary end point
      • Disease-free survival (DFS) defined as:
        • Breast cancer recurrence at any site
        • Contralateral breast cancer (CLBC) (second primary)
        • Death from any cause (prior to breast cancer recurrence)
    • Secondary end points
      • Overall survival
      • Distant RFS
      • Contralateral breast cancer
      • Long-term tolerability
    Coombes RC et al. N Engl J Med . 2004;350:1081-1092.
  • IES Key Entry Criteria
    • Inclusion criteria
      • 2 to 3 years of adjuvant tamoxifen therapy
      • Confirmed postmenopausal status at time of diagnosis
      • Previous CT permitted
      • ER+/ER unknown status
    • Exclusion criteria
      • Known ER – status
      • Clinical evidence of local relapse or distant metastases
      • Osteoporosis and/or osteoporotic fractures
    Data on file. Pfizer Inc, New York, NY. Coombes RC et al. N Engl J Med . 2004;350:1081-1092.
  • Patient Characteristics *Includes not reported, unknown, or missing nodal status. Please see full prescribing information. 98.4 1.6 98.4 1.6 Race (%) Caucasian Other (including Hispanic, Asian, Black) 32.4 67.6 32.9 67.1 Adjuvant Chemotherapy (%) Yes No 51.8 44.0 29.8 10.3 3.6 4.5 51.7 44.7 30.7 10.2 3.7 3.7 Nodal status (%) Negative Positive 1 to 3 nodes positive 4 to 9 nodes positive >9 nodes positive Other* 63 63 Demographics Median age, years Continue on Tamoxifen (n = 2372) Switch to AROMASIN ® (n = 2352) Characteristic
  • Patient Characteristics (cont’d) *These include patients with tumors for which the ER status was unknown at randomization. Please see full prescribing information. 77.2% 13.5% 9.0% 75.6% 14.5% 9.8% Histologic type (%) Infiltrating ductal Infiltrating lobular Other Continue on Tamoxifen (n = 2372) Switch to AROMASIN ® (n = 2352) Characteristic 55.6% 29.2% 15.2% 12.3% 0.3% 2.4% 0.2% 56.6% 28.8% 14.6% 12.2% 0.3% 2.0% 0.1% ER status* (%) ER+/PR+ ER+/PR– or PR-unknown Other ER unknown/PR+ or PR unknown ER–/PR+ ER–/PR– or PR unknown Missing
  • Results From the 34.5 Month Follow-up: Label Data and NEJM Publication
    • N Engl J Med publication, March 2004 (N = 4742*; median f/u 30.6 mo; events = 449)
      • Cutoff date June 30, 2003
      • Events received by cutoff date
      • Safety reported as incidence case analysis after randomization
    • FDA approved label (N = 4740; median f/u 34.5 mo; events = 520)
      • Cutoff date June 30, 2003
      • Events occurred by cutoff date
      • Safety reported as treatment emergent
    *2 patients were found to be counted twice. f/u = follow-up. Data on file. Pfizer Inc, New York, NY; Coombes RC et al. N Engl J Med . 2004;350:1081-1092. Please see full prescribing information.
  • Number of Events to DFS at 34.5 Months * Includes deaths for other reasons and deaths missing or unknown. Please see full prescribing information. 520 307 (13.0%) 213 (9.1%) Total number of events 1 0 1 (0.04%) Ipsilateral breast cancer 99 54 (2.3%) 45 (1.9%) Deaths of any cause * 32 25 (1.0%) 7 (0.3%) Second primary —CLBC 309 183 (7.7%) 126 (5.4%) Distant recurrence 79 45 (1.9%) 34 (1.5%) Local-regional recurrence Total Continue on Tamoxifen (n = 2372) Switch to AROMASIN ® (n = 2352)
  • Efficacy Results: ITT Population ITT = intent-to-treat; HR = hazard ratio; CI = confidence interval; NS = not significant. NS 0.67-1.10 0.86 Overall survival .002 0.62-0.90 0.74 Distant RFS .0034 0.15-0.72 0.32 CLBC .00003 0.58-0.82 0.69 DFS P Value 95% CI HR ITT Population
  • Efficacy Results: Hormone-Receptor Positive Patients Please see full prescribing information. NS 0.67-1.17 0.88 Overall survival .00367 0.59-0.90 0.73 Distant RFS .00069 0.08-0.57 0.22 CLBC .00001 0.53-0.79 0.65 DFS P Value 95% CI HR Hormone-Receptor Positive Patients
  • Disease-Free Survival Months From Randomization Patients, DFS (%) 0 20 40 60 10 30 50 70 AROMASIN ® ITT Population Tamoxifen Please see full prescribing information. HR = 0.69 (0.58-0.82) P = .00003 100 80 60 40 20 0 13% 307 Tamoxifen (n = 2372) 9% 213 AROMASIN (n = 2352) Patients Events Median follow-up = 34.5 months
  • DFS Subgroup Analysis: Forest Plot *P = .00003; CT = chemotherapy; PgR = progesterone receptor. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. HR Log Scale 0.4 0.6 0.8 1.0 1.2 Hazard Ratio HR (95% CI) 0.69 (0.58-0.82)* 0.70 (0.56-0.88) 0.67 (0.51-0.88) 0.67 (0.46-0.96) 0.63 (0.46-0.85) 0.74 (0.54-1.02) 0.65 (0.53-0.79) Subgroup All patients No previous CT Previous CT 4-9 nodes positive 1-3 nodes positive Nodes negative ER and/or PgR+ >9 nodes positive 0.62 (0.36-1.07) 1.4 ER+/PgR – ER+/PgR+ 0.66 (0.51-0.84) 0.68 (0.45-1.02 )
  • Overall Survival Months From Randomization Patients Surviving (%) 0 20 40 60 10 30 50 70 Tamoxifen AROMASIN ® Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. ITT Population HR = 0.86 (0.67-1.10) P = NS 100 80 60 40 20 0 6% 137 Tamoxifen (n = 2372) 5% 116 AROMASIN (n = 2352) Patients Deaths Median follow-up = 34.5 months
  • Incidence (%) of Adverse Events*: All Grades *Adverse events occurring ≥5%. † Statistically significant. Please see full prescribing information. Continue on Tamoxifen (n = 2280) Switch to AROMASIN ® (n = 2252) Body System and Adverse Event 19.9% 8.4% 8.7% 8.6% 6.4% 7.2% 4.5% 14.7% 21.2% 9.8% 8.5% 14.6% † 9.0% † 8.6% 5.9% 16.1% Vascular Hot flushes Hypertension Musculoskeletal Arthralgia Pain in limb Back pain Osteoarthritis General Disorders Fatigue Gastrointestinal Nausea
  • Incidence (%) of Adverse Events*: All Grades *Adverse events occurring ≥5%. † Statistically significant. Please see full prescribing information. Continue on Tamoxifen (n = 2280) Switch to AROMASIN ® (n = 2252) Body System and Adverse Event 3.8% 10.4% 8.9% 5.6% 10.8% 8.4% 5.0% 11.8% 12.4% † 6.2% 13.1% 9.7% Eyes Visual disturbance Psychiatric Insomnia Depression Nervous Headache Dizziness Skin Sweating increased
  • Exemestane and Tamoxifen: Comparison of Adverse Events*
    • Exemestane was associated with a higher incidence of:
      • Osteoporosis (4.6% vs 2.8%)
      • Osteochondrosis and trigger finger (0.3% vs 0%)
      • Paresthesia (2.6% vs 0.9%)
      • Carpal tunnel syndrome (2.4% vs 0.2%)
      • Neuropathy (0.6% vs 0.1%)
      • Diarrhea (4.2% vs 2.2%)
    • Tamoxifen was associated with a higher incidence of:
      • Muscle cramps (3.1% vs 1.5%)
      • Thromboembolism (2.0% vs 0.9%)
      • Endometrial hyperplasia (1.7% vs 0.6%)
      • Uterine polyps (2.4% vs 0.4%)
    *Events occurring at a rate of <5%. Please see full prescribing information.
  • Other Event Rates *Events include: myocardial infarction, angina, and myocardial ischemia. Please see full prescribing information. 0.3% 1.4% .1% .1% 0.4% 1.3% .3% .2% Incidence of observed cardiac failure Deaths due to any cause Deaths due to stroke Deaths due to cardiac failure 0.6% 1.6% Incidence of cardiac ischemic events* Continue on Tamoxifen (n = 2372) Switch to AROMASIN ® (n = 2352) Adverse Event 5.1% 6.3% Discontinuation rate
  • AROMASIN ® (exemestane) Bone Profile Was Investigated in 2 Well-Controlled Studies * For patients who had 24-month data. Please see full prescribing information. IES Bone Subprotocol 027 No patient with normal BMD at baseline developed osteoporosis while on therapy − 2.59 − 4.57 − 0.33 − 4.15 Femoral Neck (%) − 2.35 − 3.51 − 0.18 − 3.14 Lumbar Spine (%) Placebo n=65 Exemestane n=59 Tamoxifen n=38 Exemestane n=29 BMD*
  • IES Trial 35-Month Follow-up Conclusions
    • Switching to AROMASIN ® after 2 to 3 years of tamoxifen results in significantly improved DFS and was generally safe and well tolerated
    Please see full prescribing information.
  • IES 52.4-Month Update
  • IES: 52.4-Month Update Overview
    • Median follow-up at 52.4 months
      • DFS events: 354 on AROMASIN ® ; 453 on tamoxifen
      • OS events: 222 on AROMASIN ® ; 262 on tamoxifen
    • Median duration of follow-up after completion of therapy: 25 months
    • Analyses presented here are for the ITT and ER+/ER unknown patients
    • 122 patients with previously ER unknown disease were subsequently found to be ER-negative; they were not eligible per protocol and were excluded from ER+/ER unknown analysis
    • ER+/ER unknown (as suggested by the IDMC of the study)
      • This subgroup, which specifically excludes ER-negative patients, was proposed by the ICCG CDC and endorsed by the IES IDMC based on the well-established knowledge that ER-negative patients are unlikely to benefit from either treatment
    IDMC=Independent Data Monitoring Committee; ICCG-CDC=International Collaborative Cancer Group Coordinating Data Center. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information.
  • ASCO 2006 and This Presentation SC=steering committee. *Excluding patients subsequently confirmed with ER negativity. Data on file. Pfizer Inc, New York, NY. Coombes et al. Presented at: the American Society of Clinical Oncology Annual Meeting; June 2-6, 2006; Atlanta, Ga. 484 (Date of death for 1 more pt now available) 483 OS events 807 (1 ipsilateral breast now angiosarcoma) 808 DFS events 52.4 months (No censoring, same weight to patients dead or alive) 55.7 months Median f/u in surviving patients Same data cutoff used for ASCO presentation ( Feb 27, 2006) IDMC & SC agreed – analyze at 95% ≥ 3 yrs f/u & ER+/unknown * Triggered by Pfizer Clinical Study Report ASCO Presented/published October 2006 June 2006 Date
  • Efficacy Results at 52.4 Months: ITT Population *When interpreting the HR information, it is important to note that on average patients had stopped taking either tamoxifen or AROMASIN ® therapy for 25 months. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. .07 0.71-1.02 0.85 Overall survival .03 0.70-0.98 0.83 Distant RFS .00041 0.33-0.99 0.57 CLBC .00015 0.67-0.88 0.76 DFS P Value 95% CI HR* ITT Population
  • Efficacy Results at 52.4 Months: ER+/ER Unknown Population *When interpreting the HR information, it is important to note that on average patients had stopped taking either tamoxifen or AROMASIN ® therapy for 25 months. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. .04 0.69-.99 0.83 Overall survival .02 0.69-0.97 0.82 Distant RFS .027 0.31-0.94 0.54 CLBC .00008 0.65-0.87 0.75 DFS P Value 95% CI HR* ER+/ER Unknown Population
  • Disease-Free Survival: 52.4 Months Patients, DFS (%) 1.0 0.8 0.6 0.4 0.2 0 0 20 40 60 10 30 50 80 AROMASIN ® ITT Population Tamoxifen HR = 0.76 (0.67-0.88) P = .00015 70 Months From Randomization Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 19% 453 Tamoxifen (n = 2372) 15% 354 AROMASIN (n = 2352) Patients Events Median follow-up: 52 months Median duration of therapy: 30 months
  • Disease-Free Survival: 52.4 Months HR = 0.75 (0.65-0.87) P = .00008 1.0 0.8 0.6 0.4 0.2 0 ER+/ER Unknown Population Months From Randomization AROMASIN ® Tamoxifen Patients, DFS (%) Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 0 20 40 60 10 30 50 80 70 19% 437 Tamoxifen (n = 2306) 15% 338 AROMASIN (n = 2295) Patients Events Median follow-up: 52 months Median duration of therapy: 30 months
  • Overall Survival: 52.4 Months HR = 0.85 (0.71-1.02) P = .07 1.0 0.8 0.6 0.4 0.2 0 Months From Randomization AROMASIN ® Tamoxifen ITT Population Patients Surviving (%) Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 0 20 40 60 10 30 50 80 70 11% 262 Tamoxifen (n = 2372) 9% 222 AROMASIN (n = 2352) Patients Events Median follow-up: 52 months Median duration of therapy: 30 months
  • Overall Survival: 52.4 Months Months From Randomization 1.0 0.8 0.6 0.4 0.2 0.0 0 20 40 60 10 30 50 80 Tamoxifen AROMASIN ® HR = 0.83 (0.69-0.99) P = .043 ER+/ER Unknown Population 70 Patients Surviving (%) Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 11% 252 Tamoxifen (n = 2306) 9% 209 AROMASIN (n = 2295) Patients Events Median follow-up: 52 months Median duration of therapy: 30 months
  • Adverse Events: 52.4 Months * P values achieving significance. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 4.7% 6.4% Pain in limb 6.1% 5.7% Weight increased 5.6% 6.2% Depression 7.7% 9.3% Back pain 9.1% 8.9% Nausea 8.4% 9.9% Hypertension 8.8% 10.0% Dizziness 9.0% 12.9% Insomnia* 10.6% 12.0% Sweating increased 11.2% 13.6% Headache 10.8% 17.6% Arthralgia* 15.1% 16.3% Fatigue 20.1% 21.8% Hot flushes 82.8% 84.7% Subjects with any illness or AE Tamoxifen (n=2279) AROMASIN ® (n=2249) MedDRA Preferred Term
  • Adverse Events: 52.4 Months (cont’d) * P values achieving significance. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. 4.9% 7.0% Fracture rate* <0.1% 0.7% Gastric ulcer* 0.9% <0.1% Endometrial hyperplasia* 0.8% 0.2% Uterine polypectomy* 1.8% 0.4% Uterine polyp* 1.8% 0.7% Thromboembolism* 0.2% 2.8% Carpal tunnel syndrome* 1.0% 2.8% Paraesthesia* 3.2% 1.4% Muscle cramp* 2.2% 4.2% Diarrhea* 2.9% 5.2% Osteoporosis* 5.3% 4.0% Vaginal hemorrhage 82.8% 84.7% Subjects with any illness or AE Tamoxifen (n=2279) AROMASIN ® (n=2249) MedDRA Preferred Term
  • Cardiovascular Events: 52.4 Months * P values achieving significance. Data on file. Pfizer Inc, New York, NY. Please see full prescribing information. < 0.1% < 0.1% Pulmonary embolism 2.2% 0.8% Deep vein thrombosis* 2.2% 0.9% Venous thromboembolic event* 5.3% 4.9% Other cardiovascular event 0.4% 0.6% Peripheral vascular disease 8.5% 10.0% Hypertension 0.8% 1.0% Heart failure 13.6% 15.2% Other cardiovascular event 0.2% 0.1% Other isch. cerebrovasc. dis. 0.3% 0.5% Transient ischemic attack 0.5% 0.3% Stroke 1.0% 0.8% Ischemic cerebrovascular dis. 0.1% 0.3% Other ischemic CVD 0.1% 0.4% Myocardial infarction 4.0% 4.1% Angina 4.2% 4.5% Ischemic cardiovascular disease Tamoxifen (n=2279) AROMASIN ® (n=2249)
  • Conclusions: 52.4-Month Update
    • At 25 months after the completion of therapy, switching to AROMASIN ® (exemestane) showed significant improvement in DFS in early breast cancer patients treated with 2 to 3 years of tamoxifen
    • Switching to AROMASIN reduced the risk of dying by 15% for the ITT population ( P =.07) and by 17% in ER+/ER unknown early breast cancer ( P =.04)
    • AROMASIN was generally safe and well tolerated after 52.4 months.
    Please see full prescribing information.
  • AROMASIN ® (exemestane) Adjuvant Indication
    • AROMASIN is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received 2 to 3 years of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive years of adjuvant hormonal therapy.
    Please see full prescribing information.
  • Important Safety Considerations
    • AROMASIN ® (exemestane) should not be used in women who are
      • Premenopausal
      • Nursing or pregnant
      • Known to be hypersensitive to the drug
      • Taking estrogen-containing agents
    • For patients receiving exemestane with a potent CYP 3A4 inducer, such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg qd after a meal
    • In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN
    • Reductions in BMD over time are seen with use of AROMASIN
    Please see full prescribing information.