Kisqali (ribociclib)

What are the Indications for Kisqali?

Kisqali is indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer in postmenopausal women or in men. This type of breast cancer is fueled by estrogen, which binds to the estrogen receptor on cancer cells and promotes their growth. Kisqali can help slow the growth and spread of HR+/HER2- breast cancer.

• If starting initial endocrine therapy, Kisqali is taken in combination with an aromatase inhibitor.
• In either men or postmenopausal women, Kisqali is administered in conjunction with fulvestrant as the initial endocrine-based treatment or after endocrine therapy failure.

Kisqali is not recommended if you are allergic to Kisqali or any ingredients in Kisqali.

How is Kisqali used?

Storage

Kisqali tablets should be stored at room temperature between 68°F and 77°F (20°C – 25°C) in its original container.

Keep out of reach of children.

Instruction

Take Kisqali by mouth as directed by your doctor, with or without food. Do not chew or crush the tablets. If any tablet is cracked or broken, discard and replace with a table fully intact.

If you miss a dose, skip the missed dose, and take your next dose at your next scheduled time.

Dosage

Kisqali is available in tablet form: 200 mg.

The recommended dosage is to take three 200 mg tablets (totaling 600 mg), to be taken once every day at the same time for 21 consecutive days, followed by a 7-day break from treatment.

If taking Kisqali in combination with an aromatase inhibitor or fulvestrant, your doctor may also prescribe an luteinizing hormone-releasing hormone (LHRH) to be taken as directed.

Side Effects

It’s important to understand that although Kisqali is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Kisqali, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Kisqali, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Feeling tired
• Rash
• Nausea
• Headache
• Diarrhea
• Constipation
• Cough
• Headache
• Hair loss
• Infections
• Low blood sugar level
• Decreased white blood cell counts
• Decreased red blood cell counts
• Decreased platelet counts
• Abnormal liver function tests

Serious Side Effects

Severe adverse reactions while taking Kisqali can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Fast or pounding heartbeats
• Jaundice (yellowing of the eyes)
• Blurred vision or vision loss
• Severe stomach pain, bloating, or constipation
• Headache with chest pain and fast or pounding heartbeats

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before taking Kisqali, tell your doctor or pharmacist:

• If you are allergic to any medications such as Kisqali
• If you have liver problems
• If you have an infection or signs of an infection
• If you have or have had heart problems, including irregular heartbeats, heart failure, and QT prolongation
• If you have had a heart attack
• If you have unusual amount of potassium, calcium, phosphorus, or magnesium in your blood
• If you are pregnant or expect to become pregnant or conceive
• If you are breastfeeding or plan to breastfeed

Liver Problems

Taking Kisqali may increase the levels of liver enzymes in your blood, which can be a sign of liver damage. In rare cases, Kisqali can cause severe liver damage or liver failure. Your doctor will monitor your liver function regularly. Symptoms of liver failure include feeling tired, loss of appetite, dark urine, yellowing of the skin or eyes, pain on the right side of your stomach, or bruising easily. Contact your doctor right away if you experience any symptoms of liver damage or failure.

Abnormal Heart Rhythm (QT Prolongation)

Taking Kisqali may cause abnormal heart rhythm where there is a longer than normal pause between heart beats. Your doctor will monitor your heart regularly while taking Kisqali. Contact your doctor right away if you experience any of these symptoms or these symptoms have increased.

Lung Problems

Taking Kisqali may increase the risk of developing interstitial lung disease (ILD) or pneumonitis, which are conditions that cause inflammation and scarring of the lungs. Symptoms of lung problems include chest pain, coughing with or without mucus, trouble breathing, or shortness of breath. Contact your doctor right away if you experience any of these symptoms or these symptoms have increased.

Low White Blood Cell Counts (Neutropenia)

Taking Kisqali may decrease the number of white blood cells, red blood cells, and platelets in your blood, which can increase your risk of infections, anemia, and bleeding. Your doctor should monitor your blood counts regularly and may adjust or discontinue your dose if low blood cell counts occur.

Skin Reactions

Taking Kisqali can cause severe skin reactions as a possible side effect. It may cause rash, blistering, or peeling of the skin, which can be a sign of a serious condition called Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Contact your doctor right away if you experience any of these symptoms or these symptoms have increased.

Infertility

Taking Kisqali may decrease sperm count and motility, which can cause infertility in men. If you plan to have children, consult with your doctor about fertility preservation options before starting Kisqali.

Pregnant or Plan to Become Pregnant

If you are able to become pregnant, use effective contraceptives while taking Kisqali and for at least three weeks after the last dose. Kisqali should not be taken while pregnant as it can harm your unborn baby. If you become pregnant while taking Kisqali, let your doctor know immediately.

Breastfeeding or Plan to Breastfeed

If you are breastfeeding, taking Kisqali is not recommended as there is no research to show if Kisqali will pass into breast milk. Wait three weeks to breastfeed after the last dose of Kisqali.

Interactions & Contraindications

Before taking Kisqali, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

CYP3A4 Inducers

Taking a CYP3A4 inducer with Kisqali may result in the decrease of ribociclib present in blood plasma. Maintaining therapeutic levels of ribociclib is important for Kisqali to be effective. The use of CYP3A4 inducers should be avoided when taking Kisqali unless otherwise directed by your doctor.

CYP3A Inhibitors

Taking CYP3A inhibitors that have a narrow therapeutic index with Kisqali may significantly increase the potency of these drugs. The dose for the following drugs may need to be reduced to prevent overexposure: ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, alfentanil, tacrolimus, cyclosporine, and dihydroergotamine.

Antiarrhythmic Drugs

Taking Kisqali with antiarrhythmic drugs such as sotalol and quinidine may cause irregular heart beats or prolonged QT interval. Antiarrhythmic drugs or drugs known to cause irregular heart beats should be avoided while taking Kisqali unless otherwise directed by your doctor.