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Kisqali

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Kisqali (chemical name: ribociclib) is used in combination with an aromatase inhibitor to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet in premenopausal, perimenopausal, and postmenopausal women. Arimidex (chemical name: anastrozole), Aromasin (chemical name: exemestane), and Femara (chemical name: letrozole) are aromatase inhibitors. Premenopausal and perimenopausal women treated with Kisqali also should be treated with a luteinizing hormone-releasing hormone agonist, such as Zoladex (chemical name: goserelin), to suppress ovarian function.

Kisqali also is used in combination with the hormonal therapy Faslodex (chemical name: fulvestrant) to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet, or has grown while being treated with a different hormonal therapy, in postmenopausal women.

Kisqali is a pill taken by mouth.

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How Kisqali works

Cancer cells grow in uncontrolled fashion. Like Ibrance (chemical name: palbociclib) and Verzenio (chemical name: abemaciclib), Kisqali is a cyclin-dependent kinase (CDK) 4/6 inhibitor. A kinase is a type of protein in the body that helps control cell division. CDK4/6 inhibitors work by interfering with the kinase and stopping cancer cells from dividing and growing.

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Is Kisqali right for you?

Kisqali can work in combination with an aromatase inhibitor in premenopausal, perimenopausal, and postmenopausal women diagnosed with advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet.

Premenopausal and perimenopausal women treated with Kisqali also should be treated with a luteinizing hormone-releasing hormone agonist, such as Zoladex, to suppress ovarian function.

Kisqali also can work in combination with Faslodex in postmenopausal women diagnosed with advanced-stage or metastatic, hormone-receptor-positive, HER2-negative breast cancer that hasn’t been treated with hormonal therapy yet, or that has grown while be treated with a different hormonal therapy.

Advanced-stage breast cancer is cancer that has come back (recurred) or spread beyond the breast to the chest wall below the breast. Metastatic breast cancer is advanced-stage cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Both Faslodex, an estrogen receptor downregulator (ERD), and the aromatase inhibitors are types of hormonal therapy medicines used to treat hormone-receptor-positive breast cancer.

Faslodex and the aromatase inhibitors Arimidex, Aromasin, and Femara, are commonly used to treat postmenopausal women. The aromatase inhibitors can be used to treat premenopausal women if ovarian function is suppressed.

Hormonal therapy medicines treat hormone-receptor-positive breast cancers in two ways:

  • by lowering the amount of the hormone estrogen in the body
  • by blocking the action of estrogen on breast cancer cells

To find out if a cancer is estrogen-receptor-positive, most testing labs use a special staining process that makes the hormone receptors show up in a tissue sample. The test is called an immunohistochemical staining assay, or ImmunoHistoChemistry (IHC). Not all labs use the same method for analyzing the results of the test, and they do not have to report the results in exactly the same way. So you may see any of the following on your pathology report:

  • A percentage that tells you how many cells out of 100 stain positive for hormone receptors. You will see a number between 0% (none have receptors) and 100% (all have receptors).
  • An Allred score between 0 and 8. This scoring system is named for the doctor who developed it. The system looks at what percentage of cells test positive for hormone receptors, along with how well the receptors show up after staining (this is called “intensity”). This information is then combined to score the sample on a scale from 0 to 8. The higher the score, the more receptors were found and the easier they were to see in the sample.
  • The word “positive” or “negative.”

Learn more about how to read hormone receptor test results.

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What to expect when taking Kisqali

Kisqali is prescribed with either Faslodex or an aromatase inhibitor. Kisqali and the aromatase inhibitors are pills taken by mouth. Faslodex is a liquid that is given once a month as an injection into a muscle, usually at your doctor’s office.

If you are a premenopausal or perimenopausal woman prescribed Kisqali and an aromatase inhibitor, you also will be treated with a luteinizing hormone-releasing hormone agonist, such as Zoladex, to suppress ovarian function. Zoladex is given as an injection, usually in your doctor’s office, once a month for several months or every few months.

You take Kisqali and the aromatase inhibitor on a 28-day cycle:

  • for 21 days, you take the Kisqali and aromatase inhibitor pills at the same time each day, with or without food
  • then for 7 days, you take only the aromatase inhibitor

If you’re being treated with Kisqali and Faslodex, you also take Kisqali on a 28-day cycle:

  • for 21 days you take Kisqali at the same time each day, with or without food
  • then for 7 days, you don’t take Kisqali
  • on days 1, 15, and 29 of the 28-day cycle, you receive an injection of Faslodex; after that you receive an injection of Faslodex once per month

There are certain medicines, supplements, and foods you should not take or eat if you are taking Kisqali:

  • You should not take a type of medicine called a CYP3A inhibitor because it increases the effects of Kisqali. This class of medicines includes antifungal medicines such as Onmel (chemical name: itraconazole) and Biaxin (chemical name: clarithromycin), as well as antiretroviral drugs used to treat HIV such as Kaletra (chemical name: lopinavir and ritonavir).
  • You should not take a type of medicine called a CYP3A inducer because it decreases the effects of Kisqali. This class of medicines includes Rifamate (chemical name: rifampin), an antibiotic used to treat tuberculosis, and Carbatrol (chemical name: carbamazepine), which is used to control certain types of seizures in people with epilepsy.
  • You should not take Kisqali with medicines used to treat improper beating of the heart, whether too fast or too slow. These medicines include Cordarone (chemical name: amiodarone), Norpace (chemical name: disopyramide), procainamide, Quinaglute (chemical name: quinidine), and Betapace (chemical name: sotalol).
  • You should not eat grapefruit or pomegranate or drink grapefruit juice or pomegranate juice because they can increase the effects of Kisqali.

Kisqali can be used to treat both premenopausal and postmenopausal women. So it’s important to know that women who are pregnant or planning to get pregnant should not take Kisqali. Kisqali can harm the developing fetus. It’s important that you don’t get pregnant while taking Kisqali; if there is any chance you can become pregnant, you must use effective birth control while you’re taking Kisqali and for at least 3 weeks after your last dose.

Also, women who are breastfeeding or plan to breastfeed shouldn’t take Kisqali. Together, you and your doctor will decide if you should take Kisqali or breastfeed.

Visit Treatment for Breast Cancer During Pregnancy for more information.

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Paying for Kisqali

If your doctor prescribes Kisqali and you have problems getting it covered by insurance or you don’t have insurance, the Novartis Patient Assistance NOW program may be able to help you. To talk to a patient support representative, call 1-800-282-7630.

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Kisqali side effects

The most common side effects of Kisqali are:

Kisqali also may cause serious side effects, including:

Heart problems known as QT prolongation: This condition can cause an abnormal heartbeat and can be fatal. Tell your doctor right away if you have a change in heartbeat, including a fast or irregular heartbeat, or if you feel dizzy or like you might faint.

Liver problems: Tell your doctor right away if you have any of the following signs of liver problems:

  • yellowing of the skin or the whites of the eyes
  • dark or brown urine
  • feeling very tired
  • loss of appetite
  • pain on the upper right side of the abdomen
  • bleeding or bruising more easily than normal

Neutropenia (low white blood cell count): Low white blood cell counts are a common side effect of Kisqali. Still, some women’s white blood cell counts may drop so low that they have to decrease the dose of Kisqali or stop treatment. Your doctor will check your white blood cell count before and during treatment with Kisqali.

Rare but severe lung inflammation: In some women, Ibrance may lead to severe pneumonia or interstitial lung disease. Interstitial lung disease describes a large group of conditions that cause scarring of the lungs. The scarring makes the lungs stiff, which makes it difficult to breathe. Tell your doctor right away if you have difficulty breathing or discomfort when you breathe or have shortness of breath when you’re resting or doing an activity that requires little exertion.

Because Kisqali is given with an aromatase inhibitor and a luteinizing hormone-releasing hormone agonist, such as Zoladex, or Faslodex, you also may have aromatase inhibitor, Faslodex, or Zoladex side effects. Common side effects of aromatase inhibitors are joint stiffness and bone/joint pain. Common side effects of Faslodex are hot flashes, nausea, and vomiting. Common side effects of Zoladex are hot flashes, mood swings, and loss of libido.

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References

  1. Kisqali (ribociclib) prescribing information. Novartis. East Hanover, NJ. 2018. Available at https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqali.pdf.

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