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12/15 ONC-1130276
This site is for US health care professionals only.
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This site is for US health care professionals only.
Other Therapies
Learn about: PIQRAY® (alpelisib) tablets Learn about: KISQALI® (ribociclib)
tablets Learn about: AFINITOR® (everolimus) tablets
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 * Efficacy—KISQALI + AI in Postmenopausal
 * Efficacy—KISQALI + AI in Premenopausal
 * Efficacy—KISQALI + Fulvestrant in Postmenopausal
 * Safety Profile
 * Dosing & Administration
 * Access
 * PK/PD Data
 * Medical Expert Perspectives
 * Resources



IMPORTANT SAFETY INFORMATION AND INDICATIONS


QUICK LINKS

 * Group Created with Sketch. Prescribing Information
 * Group Created with Sketch. KISQALI FEMARA Co-Pack Prescribing Info
 * Contact a Rep
 * Visit Patient Site

IMPORTANT SAFETY INFORMATION


Interstitial lung disease/pneumonitis. Severe, life-threatening, or fatal
interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated
with KISQALI and other CDK4/6 inhibitors...

See More

Indications. KISQALI® (ribociclib) is indicated 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: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant
as initial endocrine-based therapy or following disease progression on endocrine
therapy in postmenopausal women or in men. 


EFFICACY—KISQALI + AI IN POSTMENOPAUSAL

 * Overall Survival
 * Time to Chemotherapy
 * Quality of Life
 * NCCN


EFFICACY—KISQALI + AI IN PREMENOPAUSAL

 * Overall Survival
 * Time to Chemotherapy
 * Quality of Life


EFFICACY—KISQALI + FULVESTRANT IN POSTMENOPAUSAL

 * Overall Survival
 * Postmenopausal Patients With Liver Metastases
 * Time to Chemotherapy
 * Quality of Life


SAFETY PROFILE

 * Monitoring
 * MONALEESA-2: KISQALI + Letrozole in 1L Postmenopausal Patients
 * MONALEESA-7: KISQALI + AI in 1L Premenopausal Patients
 * MONALEESA-3: KISQALI + Fulvestrant in 1L/2L Postmenopausal Patients


DOSING & ADMINISTRATION

 * Straightforward Once-Daily Dosing
 * Dose Adjustments
 * Dose Reduction Data
 * The KISQALI FEMARA Co-Pack


ACCESS

 * Access Assistance
 * Patient Support


PK/PD DATA


MEDICAL EXPERT PERSPECTIVES

 * KISQALI + AI for Postmenopausal Patients
 * KISQALI + AI for Premenopausal Patients
 * KISQALI + Fulvestrant
 * Efficacy Across Clinical Trials
 * Patient Cases
 * Dosing and Patient Adherence
 * PK/PD Data


RESOURCES

 * HCP Resources
 * Patient Resources


Indications


KISQALI® (ribociclib) is indicated 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:

 * an aromatase inhibitor as initial endocrine-based therapy; or
 * fulvestrant as initial endocrine-based therapy or following disease
   progression on endocrine therapy in postmenopausal women or in men.

IMPORTANT SAFETY INFORMATION
Interstitial lung disease/pneumonitis. Severe, life-threatening, or fatal
interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated
with KISQALI and other CDK4/6 inhibitors.

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”), 1.1% of KISQALI-treated patients had
ILD/pneumonitis of any grade, 0.3% had grade 3 or 4, and 0.1% had a fatal
outcome. Additional cases of ILD/pneumonitis have been observed in the
postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis, which may
include hypoxia, cough, and dyspnea. In patients who have new or worsening
respiratory symptoms suspected to be due to ILD or pneumonitis, interrupt
treatment with KISQALI immediately and evaluate the patient. Permanently
discontinue treatment with KISQALI in patients with recurrent symptomatic or
severe ILD/pneumonitis.

Severe cutaneous adverse reactions. Severe cutaneous adverse reactions (SCARs),
including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and
drug-induced hypersensitivity syndrome (DiHS)/drug reaction with eosinophilia
and systemic symptoms (DRESS) have been reported in patients treated with
KISQALI in the postmarketing setting.

If signs or symptoms of SCARs occur, interrupt KISQALI until the etiology of the
reaction has been determined. Consultation with a dermatologist is recommended.

If SCARs is confirmed, permanently discontinue KISQALI. Do not reintroduce
KISQALI in patients who have experienced SCARs or other life-threatening
cutaneous reactions during KISQALI treatment.

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 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 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.


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