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...

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Indications. KISQALI® (ribociclib) 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

Access

Financial Assistance

$0 Co-pay for your eligible patients

 
Novartis universal co-pay card

Patients may be eligible for immediate co-pay savings on their next prescription of KISQALI® (ribociclib) tablets, FEMARA® (letrozole) tablets, the KISQALI FEMARA Co-Pack tablets, and/or generic letrozole.

  • Eligible patients with private insurance may pay $0 per month
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product

Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Use of this offer for FEMARA (or generic letrozole) does not require a KISQALI prescription. Offer is NOT valid for purchases of FEMARA only by Massachusetts patients or for California patients that do not meet additional eligibility criteria. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756.

Encourage your patients to find out if they are eligible to enroll in the Novartis Oncology Universal Co-pay Program by visiting CoPay.NovartisOncology.com or calling 1-877-577-7756.

One free treatment cycle to get started

 
Free treatment voucher for KISQALI®  (ribociclib) and/or FEMARA
  • Your patients are eligible to receive a 1-treatment-cycle supply of KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole at no cost
  • No purchase required of KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole. This offer is available for patients with a valid prescription for KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole, including patients who have not been prescribed KISQALI or another Novartis product

Please see your sales representative for vouchers. You can also visit www.FreeTreatmentVoucher.com or call 1-800-282-7630.

Up to 5 free treatment cycles for uninterrupted access

 

Through the KISQALI Access Program, commercially insured patients waiting for their coverage to take effect for KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole may be eligible for an additional supply of KISQALI that could continue for up to 5 treatment cycles.

To enroll your eligible patient in this patient support service, submit a completed Novartis Patient Assistance Now Oncology (PANO) Service Request Form (SRF) and select the KISQALI Access Program check box. Follow this link to access the PANO SRF Form.

Limitations apply. Eligible patients must have commercial insurance, a completed Service Request Form, and be experiencing a delay in obtaining coverage for KISQALI. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. No purchase necessary. Participation is not a guarantee of insurance coverage. Once coverage is approved, patients will no longer be eligible. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this program without notice.

 

Patient Support

Novartis Patient Navigator Program for personalized support and education

 

The Novartis Patient Navigator Program is staffed by a dedicated team of specialists who support eligible patients during their treatment journey. Patients who enroll in the program receive a series of phone calls from a specially trained navigator who will support and guide them through various aspects of initiating their prescribed therapy.

Novartis Patient Navigators provide:

  • Access to disease and product education materials
  • Information about lifestyle support
  • Access to Novartis products via assistance with benefits investigation and other financial support
  • Support to help improve adherence to therapy and patient outcomes
  • Collaboration and coordination with other Novartis Oncology Patient Support programs

The Novartis Patient Navigator Program is available for select Novartis Oncology products. Patient Navigator services do not involve the practice of nursing or provide clinical advice and counseling. 

To learn more about the Patient Navigator Program and obtain information about enrollment, contact Patient Assistance Now Oncology at 1-800-282-7630, prompt 3.

 

Monitoring made accessible for your patients

Patient Support during COVID-19

Because we understand that in order to continue treatment, your patients need to have required monitoring, which may be difficult to obtain in typical health care settings during these uncertain times, we have instituted a temporary new program.

  • If you have a current or new-start patient for whom you've prescribed select Novartis breast cancer treatment that require monitoring tests (CBC, LFT, Electrolytes, ECG), and you would like to enroll them in the temporary In-Home Monitoring Program, please call 1-844-305-6158 to enroll your patient
  • This service is available for monitoring tests required by the Prescribing Information for select Novartis Oncology breast cancer products only. The program provides such tests at no cost to your patient or any third party, regardless of their insurance coverage. Both physician and patient consent is required

In-Office Monitoring

KISQALI Care In-Office Monitoring can provide you with an ECG monitoring device so your patients can receive their monitoring in minutes right in your office.

  • You may be eligible to receive a portable, easy-to-use ECG monitoring device to perform patient monitoring in your office for patients taking or being evaluated for KISQALI
  • There is no direct cost to you or your patients for participating in this program
  • Results from the ECG device are available in less than a minute, and a cardiology overread service is also available

Limitations apply. KISQALI Care In-Office Monitoring is only permitted to be used for monitoring or evaluating a patient for the current or potential administration of ribociclib. The equipment or services are not permitted to be used for any purpose outside of the scope of the program. You must not bill any entity or person for any equipment or services relating to the provision or interpretation of the ECG. In the event that you fail to abide by the rules of the KISQALI Care In-Office Monitoring program, your participation in the program may be terminated or modified at any time without prior notice, and you may be subject to additional remedies. Additional terms and conditions apply.

Sunshine costs may apply.

 

PANO Service Request Form

The PANO Service Request Form (SRF) is now customizable to your patient’s medication.

The PANO SRF is a single form with 2 parts:

  • The patient
  • The health care professional (HCP)

Both parts must be fully completed and submitted to open a case. PANO will then match the 2 parts and contact the HCP to initiate next steps.

To access the HCP SRF, visit HCP.Novartis.com/Access

KISQALI Care is brought to you by Novartis Patient Assistance Now Oncology.

KISQALI (ribociclib) Care patient support Program and Novartis Patient Assistance Now (PANO)

Patient Assistance Now Oncology (PANO) is a support center consisting of insurance specialists and case managers who provide access to information regarding an array of services. Consider PANO your first stop for information about Novartis Oncology Patient Support services. Dedicated support specialists help direct callers to the services that best fit their needs. To learn more, call 1-800-282-7630 or visit HCP.Novartis.com/Access.

 

 

To view the PK/PD data, continue to the next page >

CBC=complete blood count; ECG=electrocardiogram; LFT=liver function test.

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 

The KISQALI® (ribociclib) FEMARA® (letrozole) Co-Pack is indicated as initial endocrine-based therapy 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.

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.

QT interval prolongation. KISQALI® (ribociclib) and the KISQALI® (ribociclib) FEMARA® (letrozole) Co-Pack have 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 or the KISQALI FEMARA Co-Pack 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 or the KISQALI FEMARA Co-Pack therapy.

Avoid the use of KISQALI or the KISQALI FEMARA Co-Pack 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 or the KISQALI FEMARA Co-Pack 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 of 90 patients (7%) receiving tamoxifen, and in no patients receiving an NSAI. An increase of >60 ms from baseline in the QTcF interval was observed in 14 of 87 (16%) patients in the KISQALI and tamoxifen combination and in 18 of 245 (7%) 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 upper limit of normal (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 or the KISQALI FEMARA Co-Pack. 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 clinical trials in patients with advanced or metastatic breast cancer, 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 or the KISQALI FEMARA Co-Pack. 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. Letrozole caused embryofetal toxicities in rats and rabbits at maternal exposures that were below the maximum recommended human dose (MRHD) on a milligrams per square meter basis. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during therapy with KISQALI or the KISQALI FEMARA Co-Pack 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.