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KISQALI

RIBOCICLIB

Manufacturer: Novartis Pharmaceuticals Corporation

Score: 141.0

Quick Summary

KISQALI (ribociclib) is a kinase inhibitor used in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence, and for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant. Key clinical findings include increased progression-free survival and overall survival in patients with advanced or metastatic breast cancer. Important safety information includes warnings for interstitial lung disease/pneumonitis, severe cutaneous adverse reactions, QT interval prolongation, hepatobiliary toxicity, and neutropenia. The recommended starting dose is 400 mg orally once daily for 21 consecutive days followed by 7 days off treatment for early breast cancer, and 600 mg orally once daily for 21 consecutive days followed by 7 days off treatment for advanced or metastatic breast cancer. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • KISQALI is used in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
  • KISQALI is used for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant
  • Increased progression-free survival and overall survival in patients with advanced or metastatic breast cancer

Important Safety Information

Warning

Interstitial lung disease/pneumonitis, severe cutaneous adverse reactions, QT interval prolongation, hepatobiliary toxicity, and neutropenia

Contraindications

  • None

Adverse Reactions

  • Neutropenia, nausea, fatigue, diarrhea, vomiting, alopecia, rash, and pruritus

Dosing Recommendations

General Guidance

Dose interruptions, reductions, and discontinuations may be necessary based on individual patient safety and tolerability

Early breast cancer

Adult Dose

400 mg orally once daily for 21 consecutive days followed by 7 days off treatment

Pediatric Dose

Not applicable

Advanced or metastatic breast cancer

Adult Dose

600 mg orally once daily for 21 consecutive days followed by 7 days off treatment

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

  • KISQALI can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to a fetus

Nursing Mothers

  • Not applicable

Pediatric Use

  • The safety and efficacy of KISQALI in pediatric patients has not been established

Geriatric Use

  • No overall differences in safety or effectiveness of KISQALI were observed between older and younger adults