Ribociclib is used to treat hormone-related breast cancer in women. Ribociclib is used only if your cancer tests negative for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Ribociclib is used when the cancer has progressed or has spread to other parts of the body after other treatments.

Ribociclib is given in combination with another cancer medicine such as letrozole (Femara) or fulvestrant (Faslodex).

Ribociclib may also be used for purposes not listed in this medication guide.

Ribociclib can cause serious side effects on your heart, liver, or lungs. Call your doctor at once if you have chest pain, fast or pounding heartbeats, trouble breathing, cough (with or without mucus), sudden dizziness, right-sided upper stomach pain, loss of appetite, unusual bleeding or bruising, dark urine, or yellowing of your skin or eyes.

You will need frequent medical tests while taking ribociclib. Your cancer treatments may be delayed based on the results of these tests. Tell your doctor if you have signs of infection, such as fever or chills.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ribociclib is given in a 28-day treatment cycle. You will take the medicine for the first 21 days of each cycle, followed by 7 days off. Your doctor will determine how long to treat you with ribociclib.

Swallow the tablet whole and do not crush, chew, or break it.

Take the medicine at the same time each morning, with or without food.

If you vomit after taking the medicine, wait until the next day to take your next dose.

Do not use a broken or damaged pill.

You may need frequent medical tests to be sure ribociclib is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Store ribociclib in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Breast Cancer:

600 mg orally once a day for 21 consecutive days followed by 7 days off for a complete cycle of 28 days; continue until disease progression or unacceptable toxicity

Comments:
-Refer to the manufacturer product information for dosing and administration recommendations for the co-administered aromatase inhibitor (e.g., letrozole).
-When given with this drug, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
-Pre/perimenopausal women treated with the combination of this drug plus an aromatase inhibitor or fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

Uses:
-In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
-In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

You should not use ribociclib if you are allergic to it, or if you also take tamoxifen.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ribociclib.

Tell your doctor if you have ever had:

• slow heartbeats;

• heart disease or prior heart attack;

• long QT syndrome;

• an electrolyte imbalance (such as low levels of calcium, magnesium, phosphorus, or potassium in your blood);

• liver disease;

• kidney disease; or

• signs of infection (fever, chills).

Tell your doctor whether or not you have gone through menopause.

You may need to have a negative pregnancy test before starting this treatment.

Do not use ribociclib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using ribociclib and for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in men. Talk with your doctor if you have concerns about this risk.

You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

Skip the missed dose. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit while taking this medication.

Grapefruit may interact with ribociclib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ribociclib.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Ribociclib may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• signs of inflammation in the lungs--new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or

• liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of ribociclib may include:

• low white blood cells, infections;

• cough;

• nausea, vomiting;

• diarrhea, constipation;

• feeling tired;

• rash;

• headache; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Ribociclib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect ribociclib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to ribociclib. Your doctor may also order an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Kisqali® Femera® (as a combination product containing Letrazole and Ribociclib)