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...
Rapid access, powerful support
As your patients start new treatment, they may feel overwhelmed and require assistance. That is where KISQALI Care can help them. KISQALI Care is a comprehensive patient support program that provides your patients with a dedicated navigator who can help them get the most out of the patient support available to them. For more information, please call 1-800-282-7630.
To find out if your patients are eligible for the Universal Co-Pay Program, visit www.CoPay.NovartisOncology.com or call 1-877-577-7756.
*Limitations apply. Limit $15,000 per calendar year, per product. Patient must have commercial insurance and 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. 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.
Please see your sales representative for vouchers. You can also visit www.FreeTreatmentVoucher.com or call 1-800-282-7630.
†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.
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 patient in this patient support service, submit a completed Novartis Oncology Service Request Form and select the KISQALI Access Program check box. The SRF is available for download below.
‡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.
For more information, please call 1-800-282-7630.
Enroll your patient in KISQALI Care @ Home Monitoring by submitting a completed Novartis Oncology Service Request Form. The SRF is available for download below.
For more information, call 1-866-206-7589 or e-mail KISQALI@USMMLLC.com.
§Limitations apply. KISQALI Care @ Home Monitoring is not available to patients with Medicare, Medicaid, or any other federal or state program, or residents of Michigan or Rhode Island. Novartis reserves the right to terminate or modify this program at any time. State restrictions include Michigan and Rhode Island.
║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. This program is not available to physicians in Massachusetts, Minnesota, or Vermont.
The one form you need to gain access to all the services described above. Call 1-800-282-7630 for help if you have any questions as you fill out the form.
KISQALI Care is brought to you by Novartis Patient Assistance Now Oncology.
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 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%).