What Are the Dosage and Administration Guidelines for Kisqali

Kisqali, also known as ribociclib, is a prescription medication used in combination with an aromatase inhibitor as a first-line treatment for hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. To ensure optimal efficacy and minimize potential risks, it is crucial to follow the recommended dosage and administration guidelines for Kisqali.

Dosage and Administration Guidelines: 1. Recommended Dose: - The recommended starting dose of Kisqali is 600 mg (three 200 mg tablets) taken orally once daily. - It should be taken with or without food consistently at approximately the same time every day. 2. Combination Therapy: - Kisqali should be administered in combination with an aromatase inhibitor such as letrozole or anastrozole unless contraindicated. - The dosage and administration of the aromatase inhibitor should follow its specific prescribing information. 3. Treatment Cycle: - Kisqali is administered in a 28-day treatment cycle, consisting of 21 days of treatment followed by 7 days without treatment (the treatment-free interval). - The treatment-free interval allows for recovery from potential side effects and helps maintain treatment efficacy. 4. Missed Dose: - If a dose of Kisqali is missed or cannot be taken as scheduled, it should not be made up with an additional dose. - The next prescribed dose should be taken at the usual time. 5. Dosage Modifications: - Depending on the individual patient's tolerability and safety, dosage modifications may be necessary. - Temporary interruption, dose reduction, or permanent discontinuation of Kisqali may be required based on the severity of adverse reactions. 6. Hepatic Impairment: - For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B), no dosage adjustment is necessary. - Kisqali has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), so caution should be exercised. 7. Renal Impairment: - No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance [CrCl] ≥30 mL/min). - Kisqali has not been clinically evaluated in patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. 8. Geriatric Patients: - No specific dosage adjustment is necessary based on age alone. - However, elderly patients may have a higher incidence of adverse reactions, so close monitoring is recommended. 9. Pediatric Use: - The safety and efficacy of Kisqali in pediatric patients have not been established, and its use is not recommended in this population. 10. Co-administration with Strong CYP3A Inhibitors: - Strong CYP3A inhibitors may increase the exposure of Kisqali, leading to potential toxicity. - Avoid concomitant use of strong CYP3A inhibitors, or consider dose reduction of Kisqali if unavoidable. 11. Co-administration with Strong CYP3A Inducers: - Strong CYP3A inducers may decrease the exposure of Kisqali, reducing its efficacy. - Avoid concomitant use of strong CYP3A inducers, or consider alternative therapies if unavoidable. 12. Blood Cell Count Monitoring: - Regular monitoring of complete blood cell counts, including neutrophils, platelets, and hemoglobin, is recommended during treatment with Kisqali. - Temporary interruption or dosage adjustments may be required based on laboratory parameters. 13. Drug Interactions: - Kisqali may interact with various drugs, including strong CYP3A inhibitors, inducers, and medications that prolong the QT interval. - Consult the prescribing information for specific drugs to assess potential interactions. 14. Storage and Handling: - Kisqali tablets should be stored at controlled room temperature (20°C to 25°C or 68°F to 77°F) in the original package to protect from moisture. - Keep Kisqali out of reach of children and safely discard any unused or expired medication. 15. Global Price References (for informational purposes only): - United States: The average monthly cost of Kisqali is approximately $12,000. - United Kingdom: The average monthly cost of Kisqali is approximately £8,500. - South Korea: The average monthly cost of Kisqali is approximately KRW 13,000,000. - Japan: The average monthly cost of Kisqali is approximately ¥1,000,000. - China: The average monthly cost of Kisqali is approximately CNY 75,000.

Frequently Asked Questions: 1. Q: What common side effects may occur with Kisqali? - A: Common side effects of Kisqali may include neutropenia, nausea, fatigue, diarrhea, alopecia, vomiting, and headache. 2. Q: Can Kisqali be taken during pregnancy or while breastfeeding? - A: Kisqali can cause fetal harm, and its use during pregnancy or breastfeeding is not recommended. 3. Q: Are there any specific dietary considerations while taking Kisqali? - A: There are no specific dietary restrictions; however, it is advisable to maintain a healthy diet and stay adequately hydrated. 4. Q: Can Kisqali be taken with other over-the-counter medications? - A: It is essential to consult with a healthcare professional regarding the concomitant use of Kisqali and any over-the-counter medications to avoid potential drug interactions. 5. Q: Can patients travel while on Kisqali treatment? - A: Patients can travel while taking Kisqali. It is advisable to carry the medication in its original packaging and consult healthcare professionals for any necessary precautions.

References: 1. Kisqali Prescribing Information. Novartis Pharmaceuticals Corp. 2. National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines.