The innovative packaging of the Kisqali Femara Co-Pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay. The Kisqali Femara Co-Pack is available at the same cost as Kisqali alone.
The Kisqali Femara Co-Pack is available in three dosage strengths: Kisqali 600 mg plus Femara 2.5 mg, Kisqali 400 mg plus Femara 2.5 mg, and Kisqali 200 mg plus Femara 2.5 mg. The Kisqali Femara Co-Pack will be available in the US later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.
Kisqali was approved on March 13, 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer2. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR+ or unknown advanced breast cancer3. Developed by Novartis, Femara has been a standard of care option for more than a decade in early and advanced breast cancer.
About Kisqali® (ribociclib)
Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About Femara® (letrozole)
Femara® (letrozole) is a form of hormone therapy known as an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women. Femara was first approved in 1997 for treatment of postmenopausal women with HR+ or unknown advanced breast cancer that progressed after antiestrogen therapy. In 2001, Femara was approved as first-line treatment of postmenopausal women with HR+ or unknown locally advanced or metastatic breast cancer.
Kisqali Femara Co-Pack（letrozole/ribociclib）
CLASSES
Cytostatic Aromatase Inhibitors
Protein Kinase Inhibitors
DEA CLASS
Rx
DESCRIPTION
Ribociclib is an oral, selective inhibitor of cyclin-dependent kinases (CDKs) 4 and 6; letrozole is a nonsteroidal aromatase inhibitor
Used for the initial endocrine-based treatment of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women
Avoid coadministration with strong CYP3A inhibitors and inducers and with medications that prolong the QT interval
COMMON BRAND NAMES
KISQALI FEMARA
HOW SUPPLIED
KISQALI FEMARA Oral Tab: 2.5-200mg
DOSAGE & INDICATIONS
For the initial endocrine-based treatment of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women.
Oral dosage
Adults
Ribociclib 600 mg PO once daily on days 1 to 21, followed by 7 days of rest, in combination with letrozole 2.5 mg PO daily on days 1 to 28; repeat cycle every 28 days. Administer ribociclib and letrozole at approximately the same time daily, preferably in the morning. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. In a multicenter, randomized, double-blind clinical trial, postmenopausal women with previously untreated HR-positive, HER2-negative, advanced breast cancer were randomized to treatment with letrozole plus ribociclib (n = 334) versus letrozole plus placebo (n = 334). At a pre-planned interim analysis, treatment with combination therapy significantly improved the primary endpoint of median progression-free survival (PFS) based on blinded independent central radiological review (not reached vs. 14.7 months); these results were consistent with investigator assessment. The overall response rate in patients with measurable disease was 52.7% in patients treated with letrozole plus ribociclib, compared with 37.1% in patients who received letrozole plus placebo. At the time of the interim analysis, overall survival data were not yet mature.
MAXIMUM DOSAGE
Adults
Ribociclib: 600 mg by mouth once daily.
Letrozole: 2.5 mg by mouth once daily.
Geriatric
Ribociclib: 600 mg by mouth once daily.
Letrozole: 2.5 mg by mouth once daily.
DOSING CONSIDERATIONS
Hepatic Impairment
Dosage Adjustments for Baseline Hepatic Impairment:
Mild hepatic impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate hepatic impairment (Child-Pugh class B): Reduce the starting dose of ribociclib to 400 mg orally once daily. No dosage adjustment of letrozole is necessary.
Severe hepatic impairment (Child-Pugh class C): Reduce the starting dose of ribociclib to 400 mg orally once daily. If the patient has cirrhosis, reduce the dose of letrozole to 2.5 mg by mouth every other day; the effect of hepatic impairment on letrozole exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.
Dosage Adjustments for Treatment-Related Hepatotoxicity:
NOTE: Dose modifications are not recommended for letrozole when administered with ribociclib for the adverse reactions of ribociclib, including hepatobiliary toxicity.
AST/ALT greater than ULN to 3 times ULN (grade 1); total bilirubin less than 2 times ULN: No dosage adjustment necessary.
AST/ALT 3.01 to 5 times ULN (grade 2); total bilirubin less than 2 times ULN: If baseline hepatic impairment was grade 2, continue t |
