Kisqali Femara Co-Pack 600 mg-2.5 mg Daily Dose

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• liver problems--loss of appetite, right-sided stomach pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or
• low white blood cell counts--fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;
• headache;
• feeling tired;
• back pain; 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.

You should not use this medicine if you are allergic to letrozole (Femara) or ribociclib (Kisqali).

To make sure letrozole and ribociclib is safe for you, tell your doctor if you have ever had:

• heart disease, heart failure;

• a heart attack;

• heart rhythm problems, including slow heartbeats;

• long QT syndrome;

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

• liver disease.

Tell your doctor if you have any signs of infection, such as fever or chills.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using letrozole and ribociclib. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

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

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

Letrozole and ribociclib may affect fertility (your ability to have children), whether you are a man or a woman. Talk with your doctor if you have concerns about this risk.

It is not known whether letrozole and ribociclib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 3 weeks after your last dose.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

It is best to take this medicine in the morning. You may take letrozole and ribociclib with or without food.

Letrozole and ribociclib is given in a 28-day treatment cycle. On days 1 through 21, you will take both ribociclib and letrozole together at the same time each day. During the last 7 days you will take only letrozole each day.

When you start taking this medicine, you may need to take 3 ribociclib tablets per day during the first 21 days of each treatment cycle. Your doctor may gradually reduce your 21-day dose of ribociclib to only 2 tablets or 1 tablet per day, but you will continue to take 1 letrozole tablet every day for the full 28 days.

Follow your doctor's dosing instructions very carefully.

Swallow each tablet whole. Do not crush, chew, or break a tablet. Do not take any tablet that is broken or cracked.

If you vomit shortly after taking letrozole and ribociclib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

This medicine can cause a serious heart rhythm problem. Call your doctor at once if you have a fast or pounding heartbeats and severe dizziness.

You will need frequent medical tests while taking letrozole and ribociclib. Your cancer treatments may be delayed based on the results of these tests.

Store each medicine in its original container at room temperature, away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

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

• low white blood cell counts--fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;

• headache;

• feeling tired;

• back pain; 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.