IMPORTANT SAFETY INFORMATION


QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner. Based on the observed QT prolongation during treatment, KISQALI may require...

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Indications. KISQALI is a kinase inhibitor indicated in combination with: an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; or fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy

Efficacy

Compelling first-line evidence for women with HR+/HER2- mBC, including those with aggressive disease Compelling first-line evidence for women with HR+/HER2- mBC, including those with aggressive disease

Efficacy Across 3 Phase III Trials

Largest body of first-line, phase III evidence for a CDK4/6 inhibitor in women with HR+/HER2- mBC1,2

KISQALI efficacy summary KISQALI efficacy summary
MONALEESA-7 Study Description

MONALEESA-7 was a randomized, double-blind, placebo-controlled, multicenter, phase III trial in premenopausal women with HR+/HER2- mBC who received no prior endocrine therapy for advanced disease. Patients (N=672) were stratified by the presence of liver and/or lung metastases, prior chemotherapy for advanced disease, and endocrine combination partner. Patients were randomized (1:1) to receive either KISQALI 600 mg (3 weeks on, 1 week off), an NSAI (letrozole 2.5 mg or anastrozole 1 mg, tamoxifen 20 mg once daily on a continuous basis), and goserelin 3.6 mg (monthly subcutaneous injection) or placebo (3 weeks on, 1 week off), an NSAI (letrozole 2.5 mg or anastrozole 1 mg, tamoxifen 20 mg once daily on a continuous basis), and goserelin 3.6 mg (monthly subcutaneous injection). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety. The efficacy and safety results presented are from a pre-specified subgroup analysis of patients who had received KISQALI or placebo with an NSAI plus goserelin.1,3

MONALEESA-3 Study Description

MONALEESA-3 was a randomized, double-blind, placebo-controlled, multicenter, phase III trial in postmenopausal women with HR+/HER2- mBC who received no or only 1 prior line of endocrine therapy for advanced disease. Patients (N=726) were stratified by presence of liver and/or lung metastases and prior endocrine therapy for advanced disease. Patients were randomized (2:1) to receive either KISQALI 600 mg (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter) or placebo (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter).The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety.1,5,6

MONALEESA-2 Study Description

MONALEESA-2 was a randomized, double-blind, placebo-controlled, multicenter, phase III trial in postmenopausal women with HR+/HER2- mBC who received no prior therapy for advanced disease. Patients (N=668) were stratified by presence of liver and/or lung metastases and randomized 1:1 to receive either KISQALI 600 mg (3 weeks on, 1 week off) and letrozole 2.5 mg (continuously) or placebo (3 weeks on, 1 week off) and letrozole 2.5 mg (continuously). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety; exploratory end points included tumor size reduction and DOR.1,7,8

AI=aromatase inhibitor; CDK=cyclin-dependent kinase; CI=confidence interval; DOR=duration of response; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; HR=hazard ratio; ITT=intent to treat; mBC=metastatic breast cancer; mPFS=median progression-free survival; NR=not reached; NSAI=nonsteroidal aromatase inhibitor; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaulation Criteria In Solid Tumors; QOL=quality of life.

 

IMPORTANT SAFETY INFORMATION
QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. Across clinical trials in patients with advanced or metastatic breast cancer treated with KISQALI in combination with an aromatase inhibitor or fulvestrant (“KISQALI treatment groups”), 14 of 1054 patients (1%) had >500 ms postbaseline QTcF value, and 59 of 1054 (6%) had a >60 ms increase from baseline in QTcF intervals. These ECG changes were reversible with dose interruption and most occurred within the first 4 weeks of treatment. No cases of torsades de pointes were reported. In MONALEESA-2, on the KISQALI + letrozole treatment arm, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation. No cases of sudden death were reported in MONALEESA-7 or MONALEESA-3.

Please see additional Important Safety Information below.

 

1L Results in Premenopausal Women With KISQALI + an NSAI

MONALEESA-7 premenopausal 1L with an NSAI MONALEESA-7 premenopausal 1L with an NSAI

Rapid and sustained FIRST-LINE efficacy for younger women1

mPFS sustained for nearly 28 months with KISQALI + NSAI1

PFS PER INVESTIGATOR ASSESSMENT (NSAI)1

KISQALI premenopausal curve rapid and sustained FIRST-LINE efficacy KISQALI premenopausal curve rapid and sustained FIRST-LINE efficacy
  • The efficacy results are based on a prespecified subgroup analysis of 495 patients who received KISQALI or placebo with an NSAI + goserelin1
Rapid separation of the PFS curves evident at 8 weeks1
  • Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error
Meaningful responses with KISQALI + NSAI in patients with measurable disease1
  • 50.5% ORR (95% CI: 43.4-57.6) in patients who received KISQALI + NSAI (n=192)
  • 36.2% ORR (95% CI: 29.5-42.9) in patients who received placebo + NSAI (n=199)

 

IMPORTANT SAFETY INFORMATION (continued)
QT interval prolongation (continued). Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values <450 ms. Repeat ECG at approximately Day 14 of the first cycle, at the beginning of the second cycle, and as clinically indicated. Monitor serum electrolytes (including potassium, calcium, phosphorus, and magnesium) prior to the initiation of treatment, at the beginning of each of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting therapy with KISQALI.

Avoid the use of KISQALI in patients who already have or who are at significant risk of developing QT prolongation, including patients with:
  • long QT syndrome
  • uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina, and bradyarrhythmias
  • electrolyte abnormalities

Avoid using KISQALI with drugs known to prolong the QT interval and/or strong CYP3A inhibitors, as this may lead to prolongation of the QTcF interval.

Please see additional Important Safety Information below.

 

1L/2L Results in Postmenopausal Women With KISQALI + Fulvestrant

MONALEESA-3 postmenopausal 1L/2L with fulvestrant MONALEESA-3 postmenopausal 1L/2L with fulvestrant

Rapid and sustained efficacy with KISQALI + fulvestrant1

20.5 months mPFS with KISQALI + fulvestrant vs 12.8 months with fulvestrant alone1

PFS PER INVESTIGATOR ASSESSMENT1

KISQALI postmenopausal fulvestrant curve KISQALI postmenopausal fulvestrant curve
  • Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error

KISQALI delivered sustained strength in women with visceral disease and those with TFI ≤12 months1,6

KISQALI sustained strength in women with visceral disease and those with TFI<12 months KISQALI sustained strength in women with visceral disease and those with TFI<12 months
  • Patients with TFI ≤12 months (defined as those with prior [neo]adjuvant ET who progressed on or within 12 months) and patients with visceral disease were prespecified subgroups that included both first- and second-line patients1,6

 

IMPORTANT SAFETY INFORMATION (continued)
Increased QT Prolongation With Concomitant Use of Tamoxifen. KISQALI is not indicated for concomitant use with tamoxifen. In MONALEESA-7, the observed mean QTcF increase from baseline was ≥10 ms higher in the tamoxifen + placebo subgroup compared with the NSAI + placebo subgroup. In the placebo arm, an increase of >60 ms from baseline occurred in 6/90 (7%) of patients receiving tamoxifen, and in no patients receiving an NSAI. An increase of >60 ms from baseline in the QTcF interval was observed in 14/87 (16%) of patients in the KISQALI and tamoxifen combination and in 18/245 (7%) of patients receiving KISQALI plus an NSAI.

Please see additional Important Safety Information below.

 

1L Results in Postmenopausal Women With KISQALI + an AI

MONALEESA-2 postmenopausal 1L with an AI MONALEESA-2 postmenopausal 1L with an AI

Rapid and sustained efficacy in first line with KISQALI + an AI1,4

44% reduction in risk of progression or death1

KISQALI + letrozole vs placebo + letrozole (HR=0.556 [95% CI: 0.429-0.720]; P<0.0001) (primary end point, interim analysis).

PFS PER INVESTIGATOR ASSESSMENT (SUBSEQUENT PREPLANNED OS ANALYSIS)4
KISQALI postmenopausal curve rapid and sustained efficacy in first line with an Al KISQALI postmenopausal curve rapid and sustained efficacy in first line with an Al

mPFS Nearly 29 Months (US Cohort)[4]
  • mPFS 27.6 months with KISQALI + letrozole (n=100) vs 15.0 months with placebo + letrozole (n=113)
  • Based on a post hoc analysis
Rapid separation of the PFS curves evident at 8 weeks
  • Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error

 

IMPORTANT SAFETY INFORMATION (continued)
Hepatobiliary toxicity. Across clinical trials in patients with advanced or metastatic breast cancer, increases in transaminases were observed. Across all trials, grade 3 or 4 increases in alanine aminotransferase (ALT) (10% vs 2%) and aspartate aminotransferase (AST) (7% vs 2%) were reported in the KISQALI and placebo arms, respectively.

Among the patients who had grade ≥3 ALT/AST elevation, the median time to onset was 85 days and median time to resolution to grade ≤2 was 22 days for the KISQALI treatment groups.

Please see additional Important Safety Information below.

 

Meaningful responses with KISQALI + letrozole—More than half of patients with measurable disease achieved a response4,9

 

Meaningful responses with KISQALI + letrozole- more than half of patients achieved a response Meaningful responses with KISQALI + letrozole- more than half of patients achieved a response

NR=not reached.

aInterim analysis: ORR was 52.7% (95% CI: 46.6-58.9) in the KISQALI + letrozole arm (n=256) vs 37.1% (95% CI: 31.1-43.2) in the placebo + letrozole arm (n=245) (secondary end point in patients with measurable disease).1,7
bDOR was an exploratory end point assessed in patients with measurable disease who achieved a complete or partial response.8,10

 

3 out of 4 patients with measurable disease experienced tumor size reduction at 8 weeks8

TUMOR SIZE REDUCTION FROM BASELINE AT 8 WEEKS (INVESTIGATOR ASSESSMENT)8
Tumor size reduction from baseline at 8 weeks

Dotted lines represent a +25% and -30% change in tumor size.

  • Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.
  • Of patients with measurable disease at baseline who had an assessment at 8 weeks, 76% (180/238) in the KISQALI + letrozole arm vs 67% (152/227) in the placebo + letrozole arm had a tumor size reduction
  • Tumor size reduction was an exploratory end point and defined as any amount of tumor shrinkage from baseline

 

IMPORTANT SAFETY INFORMATION (continued)
Hepatobiliary toxicity (continued). In MONALEESA-2 and MONALEESA-3, concurrent elevations in ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 6 (1%) patients and all patients recovered after discontinuation of KISQALI. No cases occurred in MONALEESA-7.

Perform liver function tests (LFTs) before initiating therapy with KISQALI. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the transaminase elevations, KISQALI may require dose interruption, reduction, or discontinuation. Recommendations for patients who have elevated AST/ALT grade ≥3 at baseline have not been established.

Please see additional Important Safety Information below.

 

MONALEESA-2 postmenopausal 1L with an AI MONALEESA-2 postmenopausal 1L with an AI

Quality of life preserved throughout treatment11

  • EORTC QLQ-C30 was one of the questionnaires used to assess HRQOL
    • Compliance rate was >90% to 76 weeks (Cycle 19), and the sample size decreased over time as patients progressed or stopped treatment
  • During treatment, overall HRQOL was maintained from baseline and was similar in both arms. There was no significant difference in the time to deterioration of global health status/QOL by ≥10% (HR=0.944 [95% CI: 0.720-1.237])
  • At disease progression or EOT, overall HRQOL worsened in both arms

 

Clinically meaningful reduction in pain for more than 1 year11

  • Reduction in pain was one component of the composite EORTC QLQ-C30 score*
  • 60 weeks of clinically meaningful improvement in pain from baseline (>5 points) observed starting at 8 weeks with KISQALI + letrozole vs nonmeaningful improvement in pain (≤5 points) in the placebo + letrozole arm over the same time period, except for Cycles 7 and 15
    • Beyond 60 weeks, the pain reduction compared to baseline was not clinically meaningful in either arm. Pain scores increased slightly above baseline at time of disease progression/EOT in both arms
  • KISQALI is not approved for pain reduction

EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EOT=end of treatment; HRQOL=health-related quality of life; PRO=patient-reported outcome.

*The secondary QOL PRO end point was defined as the time to definitive deterioration of the global health status/QOL scale score of the EORTC by at least 10%. EORTC QLQ-C30 is a standard QOL patient-reported outcome tool that includes 5 functional scales: physical, role, emotional, cognitive, and social; 3 symptom scales: fatigue, nausea and vomiting, and pain; 6 single items: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.11

 

For information about the safety profile, continue to the next page >

 

References: 1. Kisqali [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. ClinicalTrials.gov. Search results for fulvestrant; combination advanced breast cancer studies; recruiting; not yet recruiting; active, not recruiting, completed, enrolling by invitation, suspended, terminated, withdrawn, unknown status; phase 3; breast cancer; CDK; NCT01942135; NCT02102490. Search conducted July 2018. 3. Tripathy D, Im SA, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomized phase 3 trial [published online ahead of print May 24, 2018]. Lancet Oncol. 2018. doi:10.1016/S1470-2045(18)30292-4. 4. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer [published online ahead of print April 27, 2018]. Ann Oncol. 2018. doi:10.1093/annonc/mdy155. 5. Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3 [published online ahead of print June 3, 2018]. J Clin Oncol. 2018. doi:10.1200/JCO.2018.78.9909. 6. Data on file. Novartis Pharmaceuticals Corp. 7. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748. 8. Janni W, Alba E, Bachelot T, et al. First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2– advanced breast cancer: tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018;169(3):469-479. 9. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib + letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Poster presented at: American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL. Abstract 1038. 10. Janni W, Alba E, Bachelot T, et al. Duration of response and tumor shrinkage with first-line ribociclib + letrozole in postmenopausal women with HR+, HER2– advanced breast cancer. Poster presented at: European Society for Medical Oncology Congress; September 8-12, 2017; Madrid, Spain. Poster 245PD. 11. Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2 [published online ahead of print April 13, 2018]. Breast Cancer Res Treat. 2018. doi:10.1007/s10549-018-4769-z.

 

Indications
KISQALI is a kinase inhibitor indicated in combination with:
  • an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; or
  • fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy

IMPORTANT SAFETY INFORMATION
QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. Across clinical trials in patients with advanced or metastatic breast cancer treated with KISQALI in combination with an aromatase inhibitor or fulvestrant (“KISQALI treatment groups”), 14 of 1054 patients (1%) had >500 ms postbaseline QTcF value, and 59 of 1054 (6%) had a >60 ms increase from baseline in QTcF intervals. These ECG changes were reversible with dose interruption and most occurred within the first 4 weeks of treatment. No cases of torsades de pointes were reported. In MONALEESA-2, on the KISQALI + letrozole treatment arm, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation. No cases of sudden death were reported in MONALEESA-7 or MONALEESA-3.

Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values <450 ms. Repeat ECG at approximately Day 14 of the first cycle, at the beginning of the second cycle, and as clinically indicated. Monitor serum electrolytes (including potassium, calcium, phosphorus, and magnesium) prior to the initiation of treatment, at the beginning of each of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting therapy with KISQALI.

Avoid the use of KISQALI in patients who already have or who are at significant risk of developing QT prolongation, including patients with:
  • long QT syndrome
  • uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina, and bradyarrhythmias
  • electrolyte abnormalities

Avoid using KISQALI with drugs known to prolong the QT interval and/or strong CYP3A inhibitors, as this may lead to prolongation of the QTcF interval.

Increased QT Prolongation With Concomitant Use of Tamoxifen. KISQALI is not indicated for concomitant use with tamoxifen. In MONALEESA-7, the observed mean QTcF increase from baseline was ≥10 ms higher in the tamoxifen + placebo subgroup compared with the NSAI + placebo subgroup. In the placebo arm, an increase of >60 ms from baseline occurred in 6/90 (7%) of patients receiving tamoxifen, and in no patients receiving an NSAI. An increase of >60 ms from baseline in the QTcF interval was observed in 14/87 (16%) of patients in the KISQALI and tamoxifen combination and in 18/245 (7%) of patients receiving KISQALI plus an NSAI.

Hepatobiliary toxicity. Across clinical trials in patients with advanced or metastatic breast cancer, increases in transaminases were observed. Across all trials, grade 3 or 4 increases in alanine aminotransferase (ALT) (10% vs 2%) and aspartate aminotransferase (AST) (7% vs 2%) were reported in the KISQALI and placebo arms, respectively.

Among the patients who had grade ≥3 ALT/AST elevation, the median time to onset was 85 days and median time to resolution to grade ≤2 was 22 days for the KISQALI treatment groups.

In MONALEESA-2 and MONALEESA-3, concurrent elevations in ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 6 (1%) patients and all patients recovered after discontinuation of KISQALI. No cases occurred in MONALEESA-7.

Perform liver function tests (LFTs) before initiating therapy with KISQALI. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the transaminase elevations, KISQALI may require dose interruption, reduction, or discontinuation. Recommendations for patients who have elevated AST/ALT grade ≥3 at baseline have not been established.

Neutropenia. Across trials, neutropenia was the most frequently reported adverse reaction (AR) (74%), and a grade 3/4 decrease in neutrophil count (based on laboratory findings) was reported in 58% of patients in the KISQALI treatment groups. Among the patients who had grade 2, 3, or 4 neutropenia, the median time to grade ≥2 was 16 days. The median time to resolution of grade ≥3 (to normalization or grade <3) was 12 days in the KISQALI treatment groups. Febrile neutropenia was reported in 1% of patients in the KISQALI treatment groups. Treatment discontinuation due to neutropenia was 0.8%.

Perform complete blood count (CBC) before initiating therapy with KISQALI. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the neutropenia, KISQALI may require dose interruption, reduction, or discontinuation.

Embryofetal toxicity. Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of KISQALI to pregnant rats and rabbits during organogenesis caused embryofetal toxicities at maternal exposures that were 0.6 and 1.5 times the human clinical exposure, respectively, based on area under the curve. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during therapy with KISQALI and for at least 3 weeks after the last dose.

Adverse reactions. Across clinical trials of patients with advanced or metastatic breast cancer, the most common ARs reported in the KISQALI treatment groups (pooled incidence ≥20%) were neutropenia (74% vs 5%), nausea (45% vs 27%), infections (41% vs 30%), fatigue (33% vs 30%), diarrhea (30% vs 22%), leukopenia (30% vs 3%), vomiting (27% vs 16%), alopecia (24% vs 12%), headache (24% vs 22%), constipation (24% vs 16%), rash (21% vs 9%), and cough (21% vs 16%). The most common grade 3/4 ARs (reported at a pooled frequency >5%) were neutropenia (59% vs 1%), leukopenia (16% vs 3%), abnormal LFTs (9% vs 2%), and lymphopenia (5% vs 1%).

Laboratory abnormalities. Across clinical trials of patients with advanced or metastatic breast cancer, the most common laboratory abnormalities reported in the KISQALI-containing arm vs placebo arm (all grades, pooled incidence ≥20% and ≥5% higher than placebo arm) were leukocyte count decrease (94% vs 30%), neutrophil count decrease (93% vs 25%), hemoglobin decrease (66% vs 38%), lymphocyte count decrease (61% vs 26%), AST increase (47% vs 38%), ALT increase (44% vs 36%), creatinine increase (38% vs 13%), and platelet count decrease (31% vs 9%). The most common grade 3/4 laboratory abnormalities (incidence >5%) were neutrophil count decrease (59% vs 2%), leukocyte count decrease (32% vs 1%), lymphocyte count decrease (15% vs 4%), ALT increase (10% vs 2%), and AST increase (7% vs 2%).

Please see full Prescribing Information.