Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Kisqali Femara Co-Pack Approved for HR+/HER2- BC
Novartis news release; 2017 May 8
The FDA approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women.
Indications: Kisqali Femara Co-Pack, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.
Dosage and administration:
- Kisqali recommended starting dose: 600 mg orally (3 200 mg tablets) taken once daily for 21 consecutive days followed by 7 days off Kisqali treatment.
- Femara: 2.5 mg (1 tablet) continuously for a 28-day cycle.
Side effects/risks: The most common adverse reactions are neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache and back pain.
Novartis receives FDA approval for first-of-its-kind Kisqali Femara Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer. [news release]. East Hanover, NJ: Novartis Pharmaceuticals Corporation May 8, 2017. https://www.pharma.us.novartis.com/news/media-releases/novartis-receives-fda-approval-first-its-kind-kisqalir-femarar-co-pack-initial. Accessed May 14, 2017.
Kisqali Femara Co-Pack [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. 2017. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqali_copack.pdf. Accessed May 14, 2017.