Kisqali
By Keith Black, MD
Medically Reviewed by Jordyn Higgins, PharmD, BCOP (Oncology Clinical Pharmacist)
Last Update: January 20, 2025
What is Kisqali?
Kisqali is a targeted therapy medication used to treat advanced or metastatic breast cancer. Its active ingredient, ribociclib, belongs to a class of drugs called CDK4/6 inhibitors, which work by blocking proteins that promote the growth and division of cancer cells. This drug is often prescribed in combination with hormonal therapies, such as letrozole or fulvestrant, to enhance its effectiveness in slowing cancer progression.
This oral medication is taken once daily, typically as part of a 21-day cycle followed by a 7-day break. This advanced medication has shown significant results in clinical trials, improving progression-free survival rates in patients with certain types of hormone receptor-positive, HER2-negative breast cancer. Regular monitoring by a healthcare provider ensures that the treatment is working effectively while managing any potential side effects.
FAQ
What is Kisqali prescribed for?
Kisqali is prescribed for the treatment of advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. It is commonly used in postmenopausal women, premenopausal women, and men as part of a combination therapy. The drug works by inhibiting CDK4/6 proteins, which are involved in the growth and division of cancer cells, helping to slow disease progression.
This medication is prescribed alongside hormonal therapies such as aromatase inhibitors (e.g., letrozole) or tamoxifen. In premenopausal or perimenopausal women, it is often combined with ovarian suppression therapy to enhance its effectiveness.
What does it do to your body?
Kisqali, or ribociclib, is a CDK4/6 inhibitor, a type of targeted therapy. It works by slowing down or stopping the growth of cancer cells. In hormone receptor-positive, HER2-negative breast cancer, these cancer cells grow and divide too quickly. The drug blocks specific proteins (CDK4 and CDK6) that control cell division, helping to prevent cancer from spreading further in the body.
By targeting these proteins, this medication mainly affects cancer cells while sparing most healthy cells. This targeted approach can reduce tumor growth and improve outcomes for people with advanced breast cancer. Regular monitoring by your doctor ensures the medication is working effectively and helps manage any side effects.
What is the life expectancy with Kisqali?
This drug has been shown to significantly extend life expectancy in patients with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Clinical trials have demonstrated notable improvements in overall survival:
- MONALEESA-2 Trial: Postmenopausal women receiving this cyclin-dependent kinase inhibitor combined with letrozole experienced a median overall survival of 63.9 months, compared to 51.4 months for those on letrozole alone. This indicates a survival extension of approximately 12.5 months.
- MONALEESA-3 Trial: Patients treated with ribociclib mesylate and fulvestrant had a median overall survival of 53.7 months, versus 41.5 months for the placebo group, reflecting a survival benefit of over 12 months.
- MONALEESA-7 Trial: Premenopausal women receiving the hormone receptor-positive breast cancer drug plus endocrine therapy achieved a median overall survival of 58.7 months, the longest reported for this patient group.
These results demonstrate the drug’s ability to significantly extend life expectancy in patients with advanced breast cancer across different populations. However, individual outcomes can vary depending on factors such as overall health, age, and the stage of the disease. Consulting with your healthcare provider is crucial to understanding how oral cancer therapy may impact your specific prognosis and treatment plan.
Is Kisqali like chemo?
This drug is not like traditional chemotherapy. While chemotherapy attacks rapidly dividing cells throughout the body, including healthy ones, Kisqali is a targeted therapy. It belongs to a class of drugs called CDK4/6 inhibitors, which work by blocking specific proteins that help cancer cells grow and divide. This targeted approach allows this medication to focus more on cancer cells, causing less harm to healthy cells compared to chemotherapy.
Because of this difference, the side effects of ribociclib mesylate are often milder than those of chemotherapy, though it can still cause issues like fatigue, nausea, or low blood cell counts. This small molecule inhibitor is typically used for advanced hormone receptor-positive, HER2-negative breast cancer in combination with hormonal therapies. It provides a more precise way to treat cancer without the broader effects of traditional chemo.
How effective is ribociclib?
Ribociclib, also known as Kisqali, is highly effective in treating advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Studies show that it works well when combined with hormonal therapies, helping patients live longer and slowing cancer progression.
In the MONALEESA-2 study, patients taking these pills with letrozole lived without cancer worsening for about 25.3 months, compared to 16.0 months for those on letrozole alone. The overall survival in this group was 63.9 months, compared to 51.4 months for those not taking ribociclib. This means this medication added more than 12 extra months of life for many patients.
How much does it cost per month?
As of 2025, the cost of Kisqali can range from $12,000 to $15,000 per month, depending on the dosage and pharmacy. These prices are for the brand-name medication and may vary based on insurance coverage and location. However, a much cheaper generic version of ribociclib is now available, providing a more affordable alternative for patients while maintaining the same effectiveness.
The exact cost for individuals depends on factors like insurance plans, co-pays, and patient assistance programs. If cost is a concern, talk to your doctor or pharmacist about exploring generic options or financial assistance to make the treatment more accessible.
Does this pill cause weight gain?
Weight gain is not commonly associated with Kisqali treatment. Clinical trials did not report weight gain as a direct side effect of the medication. However, some patients may experience edema (fluid retention and swelling) while taking these pills, which can lead to a temporary increase in weight. This swelling typically subsides with appropriate management.
If you notice unusual weight changes during your treatment, it’s important to discuss them with your healthcare provider. They can help determine the cause and recommend strategies to manage any side effects effectively.
Does it shrink tumors?
Yes, Kisqali has been shown to shrink tumors in patients with hormone receptor-positive, HER2-negative breast cancer. In clinical trials, patients treated with this cyclin-dependent kinase inhibitor in combination with endocrine therapy experienced significant tumor size reduction. For instance, the MONALEESA-2 trial reported that 42.5% of patients achieved a partial or complete response, indicating tumor shrinkage. This demonstrates Kisqali’s effectiveness in reducing tumor size and controlling disease progression.
Why is Kisqali so expensive?
The medication is expensive due to the costs associated with research, development, and clinical trials needed to bring this targeted cancer therapy to market. As a CDK4/6 inhibitor, Kisqali is part of a newer class of drugs that provide advanced treatment options for hormone receptor-positive, HER2-negative breast cancer. The high price also reflects its effectiveness and the significant investment required for innovation in cancer care.
However, many people are now saving money by switching to affordable generic ribociclib, which offers the same active ingredient and effectiveness at a much lower price. Discussing generic options or financial assistance programs with your doctor or pharmacist can help make this life-saving treatment more accessible.
What are the side effects?
Kisqali can cause side effects, ranging from mild to serious. Below is a detailed table showing common side effects, their frequency, how to manage them, and tips to avoid worsening symptoms.
| Side Effect | Frequency | How to Manage | How to Avoid |
|---|---|---|---|
| Fatigue | Up to 40% | Rest often, prioritize activities, stay hydrated. | Maintain a healthy sleep schedule and balanced diet. |
| Nausea | 30-35% | Eat small, frequent meals; take anti-nausea medicine. | Avoid heavy or greasy foods; eat bland, low-fat meals. |
| Diarrhea | 20-25% | Stay hydrated, use anti-diarrheal medication if needed. | Avoid spicy or high-fiber foods. |
| Neutropenia (low white blood cells) | 50-60% | Regular blood tests; reduce infection exposure. | Practice good hygiene; avoid crowded places. |
| Hair Thinning | 10-15% | Use gentle hair care products; avoid harsh treatments. | Keep hair moisturized and avoid excessive heat styling. |
| Liver Enzyme Elevation | 10-15% | Regular liver function tests; reduce alcohol intake. | Avoid alcohol and over-the-counter medications affecting the liver. |
| Headache | 10-15% | Use over-the-counter pain relievers as recommended. | Stay hydrated and manage stress levels. |
| Loss of Appetite | 15-20% | Try nutrient-dense, small meals throughout the day. | Avoid overly filling or bland foods; experiment with flavors. |
| Skin Rash | 10-15% | Use hypoallergenic skincare; consult your doctor for treatment. | Avoid harsh soaps and prolonged sun exposure. |
These side effects can often be managed effectively with the right precautions and regular communication with your healthcare team.
Why should I take the pill in the morning?
Taking Kisqali in the morning is recommended for convenience and consistency. This ensures that you take your medication at the same time every day, which is crucial for maintaining stable levels of the drug in your body. A consistent routine helps maximize the effectiveness of the medicine in slowing the growth of cancer cells.
Morning dosing also allows you to monitor how your body reacts throughout the day. For example, if you experience side effects such as fatigue or nausea, you can manage them more effectively during waking hours. Always follow your doctor’s instructions regarding the timing of your medication to achieve the best results.
What foods should you avoid while taking Kisqali?
While taking ribociclib medication, certain foods and beverages should be avoided as they can interfere with the medication’s effectiveness or increase the risk of side effects. Here’s a list of foods to avoid:
- Grapefruit and grapefruit juice: These can block enzymes in the liver that process the precision medicine for cancer, leading to higher drug levels in the body and increasing the risk of side effects.
- Seville oranges and marmalade: Like grapefruit, these also affect liver enzymes and may cause similar issues.
- Starfruit: This fruit has compounds that can interfere with how the CDK4/6 inhibitor is metabolized.
- Excessive alcohol: Alcohol can strain the liver, which is already processing this endocrine therapy enhancer, increasing the risk of liver-related side effects.
- High-fat meals: While not strictly prohibited, extremely fatty meals may slow down drug absorption.
Stick to a balanced diet with fruits (excluding grapefruit and Seville oranges), vegetables, lean proteins, and whole grains. Consult your healthcare provider or a dietitian for personalized dietary advice while on this cell cycle inhibitor.
Is ribociclib toxic to the liver?
Ribociclib (Kisqali) has been associated with liver toxicity in some patients, though severe cases are relatively uncommon. Clinical studies have reported varying frequencies of liver-related side effects:
- A multi-center study involving 845 patients found that 9.2% developed liver toxicity. Specifically, 0.6% experienced grade 4 toxicity, 2.2% had grade 3, and 6.4% had grade 1-2 toxicity.
- Another study reported that 9.3% of patients experienced grade 3 or 4 elevations in liver enzymes (ALT and AST), indicating liver dysfunction.
These findings suggest that while this drug can cause liver toxicity, the incidence of severe cases is relatively low. Regular monitoring of liver function tests is recommended during treatment to detect and manage potential issues promptly. If significant liver enzyme elevations occur, dose adjustments or discontinuation of treatment may be necessary.
About the Author
Dr. Keith L. Black, MD, is a world-renowned neurosurgeon and a leader in brain tumor treatment, serving as Chairman of the Department of Neurosurgery and Director of the Maxine Dunitz Neurosurgical Institute at Cedars-Sinai Medical Center in Los Angeles. With over 5,000 brain surgeries performed, he is recognized for tackling complex, inoperable tumors and for his groundbreaking discovery that the peptide bradykinin can open the blood-brain barrier, revolutionizing targeted cancer therapies. Featured on the cover of Time magazine’s “Heroes of Medicine” issue in 1997, Dr. Black is celebrated for his innovative contributions and dedication to patient care. His career also includes leadership roles at UCLA and Cedars-Sinai and recognition in outlets like PBS and Esquire. Dr. Black’s autobiography, Brain Surgeon, details his remarkable journey and the barriers he overcame to become a pioneer in neurosurgery.
Disclaimer: This information is provided solely for educational purposes and should not replace professional medical advice, diagnosis, or treatment. For personalized guidance about your medications, treatment plans, or overall health, consult a licensed healthcare provider. If you have any specific concerns about your health, seek immediate advice from your doctor or a qualified medical professional.