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For women with HR+, HER2– MBC with disease progression following endocrine therapy who have visceral disease* or primary ET resistance†

Do patients like her give you pause?1,2

  • Her survival is at higher risk due to visceral disease* or primary ET resistance.1,2†
  • She's worried about being there for her family.1

She needs confidence that her next treatment may give her more time.1

*Visceral disease: ≥1 lesion on an internal organ or in the third space (including lung, liver, pleural, or peritoneal metastatic involvement).2
†Primary resistance: relapse within the first 2 years of adjuvant ET or progressive disease within the first 6 months of first-line ET for MBC.3

In HR+, HER2– MBC

Verzenio is the only CDK4 & 6 inhibitor proven to significantly improve OS regardless of menopausal status in combination with fulvestrant1,4

OS in ITT population1,3


OS in ITT population chart
  • Results are based on a preplanned interim analysis and considered to be definitive due to the occurrence of 77% (338/441) of the planned OS events needed for the final analysis1,5
  • The percentage of deaths at the time of analysis was 47.3% (n=211) and 57.0% (n=127) in the Verzenio plus fulvestrant and fulvestrant alone arms, respectively1,5
  • Primary endpoint of median PFS was met: 16.4 months (95% CI: 14.4-19.3) with Verzenio + fulvestrant vs 9.3 months (95% CI: 7.4-12.7) with fulvestrant alone (HR=0.553; 95% CI: 0.449-0.681; P<0.0001)3
  • The percentage of events at the time of analysis was 49.8% (n=222) and 70.4% (n=157) in the Verzenio plus fulvestrant and fulvestrant alone arms, respectively3

9.4 months increase in median OS with Verzenio plus fulvestrant vs fulvestrant alone1

In HR+, HER2– MBC

Even women with visceral disease achieved overall survival results consistent with the overall study population1

OS in patients with visceral disease1


OS in patients with visceral disease chart

Visceral disease: >=1 lesion on an internal organ or in the third space (including lung, liver, pleural, or peritoneal metastatic involvement).2

  • Prespecified subgroup analyses of PFS and OS were performed for the stratification factor of disease site, including visceral disease
  • Risk reduction reflective of the median. Analyses were not adjusted for multiplicity, and the study was not powered to test the effect of Verzenio plus fulvestrant among subgroups

Verzenio reduced risk of death by 33% in women with visceral disease.1

In HR+, HER2– MBC

Even women with primary ET resistance achieved overall survival results consistent with the overall study population1

OS in patients with primary ET resistance1


OS in patients with primary ET resistance chart

Primary resistance: relapse within the first 2 years of adjuvant ET or progressive disease within the first 6 months of first-line ET for MBC.3

  • Prespecified subgroup analyses of PFS and OS were performed for the stratification factor of endocrine resistance (including primary ET resistance)
  • Risk reduction reflective of the median. Analyses were not adjusted for multiplicity, and the study was not powered to test the effect of Verzenio plus fulvestrant among subgroups

Verzenio reduced risk of death by 31% in women with primary ET resistance.1

SELECT IMPORTANT SAFETY INFORMATION

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.

In HR+, HER2– MBC

Verzenio delayed time to chemotherapy1,6

Exploratory analysis: Time to chemotherapy (in ITT population)1,6


Exploratory analysis: Time to chemotherapy (in ITT population) chart
  • Time to chemotherapy: time from randomization to initiation of first post-discontinuation chemotherapy. Patients who died prior to receiving chemotherapy (n=111) did not contribute an event to this analysis1
  • This analysis was not controlled for type I error, and the study was not powered to test this endpoint1
  • Risk reduction reflective of the median

Verzenio reduced risk of progression to chemotherapy by 38% in the ITT population1

In HR+, HER2– MBC

Verzenio significantly improved median PFS in the ITT population7

PFS in ITT population3


PFS in ITT population chart
  • The percentage of events at the time of PFS analysis was 49.8% (n=222) and 70.4% (n=157) in the Verzenio plus fulvestrant and fulvestrant alone arms, respectively3

Verzenio reduced risk of progression or death by 45% in the ITT population7

In HR+, HER2– MBC

Even women with visceral disease achieved improved median PFS consistent with the overall study population7,8

Preplanned subgroup analysis: PFS in women with visceral disease8


PFS in women with visceral disease chart
  • The percentage of events at the time of analysis in the ITT population was 49.8% (n=222) and 70.4% (n=157) in the Verzenio plus fulvestrant and fulvestrant alone arms, respectively3
  • Prespecified subgroup analyses of PFS were performed for the stratification factor of disease site, including visceral disease7,8
  • Risk reduction reflective of the median. Analyses were not adjusted for multiplicity and the study was not powered to test the effect of Verzenio plus fulvestrant among subgroups8

Verzenio reduced risk of progression or death by 52% in women with visceral disease8

In HR+, HER2– MBC

Even women with primary resistance achieved improved median PFS consistent with the overall study population7,8

Preplanned subgroup analysis: PFS in women with primary resistance7,8


PFS in women with primary resistance chart
  • The percentage of events at the time of PFS analysis in the ITT population was 49.8% (n=222) and 70.4% (n=157) in the Verzenio plus fulvestrant and fulvestrant alone arms, respectively3
  • Prespecified subgroup analyses of PFS were performed for the stratification factor of primary endocrine resistance7,8
  • Risk reduction reflective of the median. Analyses were not adjusted for multiplicity and the study was not powered to test the effect of Verzenio plus fulvestrant among subgroups8

Verzenio reduced risk of progression or death by 55% in women with primary ET resistance.7

Verzenio + fulvestrant (MONARCH 2) trial design

MONARCH 2 included women with worse prognoses1,3,7*

Visceral Disease Percentage
Primary ET Resistance Percentage

All patients in the trial had prior endocrine therapy7§

  • 59% had ET in the adjuvant or neoadjuvant setting and had progressed from early-stage disease to metastatic7
  • 38% had ET in the first-line metastatic setting and had progressed on first-line treatment7

*Patients with disease progression following ET who had "a worse prognosis" (defined as the presence of visceral disease† or primary ET resistance‡, which are associated with decreased overall survival) were included in the MONARCH 2 clinical trial.1,7,10-12
†Visceral disease: ≥1 lesion on an internal organ or in the third space (including lung, liver, pleural, or peritoneal metastatic involvement).2
‡Primary resistance: relapse within the first 2 years of adjuvant ET or progressive disease within the first 6 months of first-line ET for MBC.3
§ET history was not available for 12 patients in the Verzenio arm and 5 patients in the placebo arm.7

pink flower image

Verzenio + fulvestrant: Phase III, randomized, double-blind, placebo-controlled trial (N=669)3,7

MONARCH 2 was a phase III, randomized, double-blind, placebo-controlled trial that enrolled 669 patients with HR+, HER2– MBC who progressed on or after ET. Pre/perimenopausal women (17%) were rendered postmenopausal prior to the study. Patients had received no chemotherapy and no more than 1 prior ET in the metastatic setting. Patients were randomized 2:1 to Verzenio + fulvestrant (n=446) or placebo + fulvestrant (n=223). Verzenio and placebo were dosed PO BID on a continuous dosing schedule until disease progression or unacceptable toxicity. 500 mg fulvestrant was administered by IM injection on days 1, 15, and 29 of the first month and once monthly thereafter. The primary endpoint was PFS. Key secondary endpoints were ORR, OS, and DoR.3,7

Verzenio + fulvestrant safety

Verzenio single-agent efficacy


References:

  1. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor–positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial [published online September 29, 2019]. JAMA Oncol. 2020;6(1):116-124. doi:10.1001/jamaoncol.2019.4782.
  2. Data on file. Lilly USA, LLC. ONC20171128a.
  3. Verzenio (abemaciclib). Prescribing Information. Lilly USA, LLC.
  4. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379:1926-1936.
  5. Data on file. Lilly USA, LLC. DOF-AL-US-0088.
  6. Supplement to: Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor–positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: a randomized clinical trial [published online September 29, 2019]. JAMA Oncol. 2020;6(Suppl2):1-7. doi:10.1001/jamaoncol.2019.4782.
  7. Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2– advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35:2875-2884.
  8. Data on file. Lilly USA, LLC. ONC20180103a.
  9. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638-3646.
  10. Yamamura J, Kamigaki S, Fujita J, Osato H, Komoike Y. The difference in prognostic outcomes between de novo stage IV and recurrent metastatic patients with hormone receptor-positive, HER2–negative breast cancer. In Vivo. 2018;32(2):353-358.
  11. Gong Y, Liu Y-R, Ji P, Hu X, Shao ZM. Impact of molecular subtypes on metastatic breast cancer patients: a SEER population-based study. Sci Rep. 2017;7:45411.
  12. Wang R, Zhu Y, Liu X, Liao X, He J, Niu L. The clinicopathological features and survival outcomes of patients with different metastatic sites in stage IV breast cancer. BMC Cancer. 2019;19(1):1091.

IMPORTANT SAFETY INFORMATION

Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.

Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in EBC (monarchE), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in MBC (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.

Grade ≥3 increases in alanine aminotransferase (ALT) (2 to 6%) and aspartate aminotransferase (AST) (2 to 3%) were reported in patients receiving Verzenio. Across three clinical trials in 3559 patients (monarchE, MONARCH 2, MONARCH 3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.

Monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation.

Venous thromboembolic events (VTE) were reported in 2 to 5% of patients across three clinical trials in 3559 patients treated with Verzenio (monarchE, MONARCH 2, MONARCH 3). VTE included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. In clinical trials, deaths due to VTE have been reported in patients treated with Verzenio.

Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for EBC patients with any grade VTE and for MBC patients with a Grade 3 or 4 VTE.

Verzenio can cause fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥10%) observed in monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of ≥2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7 %).

The most frequently reported ≥5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of ≥2% were increased serum creatinine (99% vs 91%; .5% vs <.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2 % vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole with a difference between arms of ≥2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant with a difference between arms of ≥2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min).

Please see full Prescribing Information for Verzenio.

AL HCP ISI 12OCT2021

INDICATIONS

VERZENIO (abemaciclib) is a kinase inhibitor indicated1:

  • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
  • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
  • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
  • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
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