$PRE_HEADERS$         Dear {{FirstName}} {{LastName}}, {{Credentials}},       Novartis would like to share some information regarding the new KISQALI Care Patient Support program. This program is designed to help your eligible patients start and stay on treatment with KISQALI® (ribociclib).       Sincerely, Novartis             KISQALI Care Patient Support program offers the following resources to your eligible patients:       • KISQALI Care Patient Navigator   • KISQALI® (ribociclib) and/or FEMARA® (letrozole) $0 Co-Pay*   • 1 FREE Treatment Cycle of KISQALI and/or FEMARA†   • KISQALI 5-Treatment Cycle Access Program‡   • KISQALI Care @ Home Monitoring§       Brought to you by Novartis Patient Assistance Now Oncology.       Read about all the patient support     resources or call 1‑8‍00‑2‍82‑7‍630            AI=aromatase inhibitor; CDK=cyclin-dependent kinase; FDA=U.S. Food and Drug Administration.       *Limitations apply. Patients must have commercial insurance. Commercially insured patients pay $0 per month. Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product. This program is available for patients with a valid prescription for KISQALI and/or FEMARA (including generic letrozole), including for patients who have not been prescribed KISQALI or another Novartis product. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, visit www.CoPay.NovartisOncology.com or call 1-8‍77-5‍77-7‍756.       †All patients can use this voucher to receive an immediate 1-treatment cycle supply of KISQALI and/or FEMARA (including generic letrozole). To receive vouchers, please see your sales representative, call 1-8‍00-2‍82-7‍630, or visit www.FreeTreatmentVoucher.com. This offer is available for patients with a valid prescription for FEMARA (including generic letrozole), including for patients who have not been prescribed KISQALI or another Novartis product.       ‡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.       §Limitations apply. Commercially insured patients may be eligible to receive certain monitoring at their home for free. KISQALI Care @ Home Monitoring is not available for patients with Medicare, Medicaid, or any other federal or state program. Program not available for residents of Michigan, Minnesota, or Rhode Island. This program is subject to termination or modification at any time.       Indication     KISQALI® (ribociclib) is indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.       Important Safety Information     QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner, with estimated mean increase in QTc interval exceeding 20 ms (22.9 ms [90% CI: 21.6-24.1]) at the mean steady-state Cmax following administration at the 600-mg once-daily dose. In MONALEESA-2, one patient (0.3%) had >500 msec postbaseline QTcF value (average of triplicate), and 9 of 329 patients (3.0%) had a >60 msec increase from baseline in QTcF intervals (average of triplicate). These electrocardiogram (ECG) changes occurred within the first 4 weeks of treatment and were reversible with dose interruption. There were no reported cases of Torsades de Pointes. Syncope occurred in 9 patients (2.7%) in the KISQALI + letrozole arm vs 3 patients (0.9%) in the placebo + letrozole arm. In the KISQALI + letrozole treatment arm, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation.       Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values <450 msec. 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 QTc 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 QTc interval and/or strong CYP3A inhibitors, as this may lead to prolongation of the QTcF interval. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation.       Hepatobiliary toxicity. In MONALEESA-2, increases in transaminases were observed. Grade 3 or 4 increases in alanine aminotransferase (ALT) (10% vs 1%) 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 57 days for the KISQALI + letrozole treatment group. The median time to resolution to grade ≤2 was 24 days in the KISQALI + letrozole treatment group.       Concurrent elevations in ALT or AST >3 times the upper limit of normal (ULN) and total bilirubin >2 times the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 4 patients (1%) in MONALEESA-2, and all patients recovered after discontinuation of KISQALI.       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. In MONALEESA-2, neutropenia was the most frequently reported adverse reaction (AR) (75%), and a grade 3/4 decrease in neutrophil count (based on laboratory findings) was reported in 60% of patients receiving KISQALI + letrozole. 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 15 days in the KISQALI + letrozole treatment group. Febrile neutropenia was reported in 1.5% of patients receiving KISQALI and letrozole. Treatment discontinuation due to neutropenia was 0.9%.       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.       Embryo-fetal 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 embryo-fetal 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. The most common ARs reported in the KISQALI + letrozole arm (frequency ≥20%) were neutropenia (‍75%‍), nausea (‍52%‍), fatigue (‍37%‍), diarrhea (‍35%‍), leukopenia (‍33%‍), alopecia (‍33%‍), vomiting (‍29%‍), constipation (‍25%‍), headache (‍22%‍), and back pain (‍20%‍). The most common grade 3/4 ARs (reported at a frequency >2%) were neutropenia (60%), leukopenia (‍21%‍), abnormal LFTs (‍10%‍), lymphopenia (‍7%‍), and vomiting (‍4%‍).       Laboratory abnormalities. The most common laboratory abnormalities occurring in patients receiving KISQALI + letrozole (all grades, incidence ≥20%) were leukocyte count decrease (‍93%‍), neutrophil count decrease (93%), hemoglobin decrease (‍57%‍), lymphocyte count decrease (51%), ALT increase (46%), AST increase (44%), platelet count decrease (29%), and creatinine increase (20%). The most common grade 3/4 laboratory abnormalities (incidence >2%) were neutrophil count decrease (‍60%‍), leukocyte count decrease (‍34%‍), lymphocyte count decrease (‍14%‍), ALT increase (‍10%‍), AST increase (‍7%‍), and phosphorus decrease (‍6%‍).       Please see full Prescribing Information for KISQALI.       This is a sponsored message from DMD on behalf of Novartis Pharmaceuticals Corporation. DMD provides sponsored health care–related messages from trusted third parties. This material is intended specifically and exclusively for US health care professionals. You are receiving this e‑mail because you have subscribed and agreed to receive information from the DMD e-mail list.       If you prefer not to receive further information from this sender, please click here and confirm your request.       DMD 1‌0255 W. H‌iggins R‌oad Suite 280 Rosemont, IL 60018       DMD Privacy Policy       The information provided in this e-mail is intended for health care professionals in the United States and Puerto Rico. The products discussed herein may have different product labeling in different countries.         Novartis Pharmaceuticals Corporation          © 2017 Novartis        4/1‍7        KIS-‍1156848