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letrozole and ribociclib

Pronunciation: LET roe zol and RYE boe SYE klib

Brand: Kisqali Femara Co-Pack 200 mg-2.5 mg Dose, Kisqali Femara Co-Pack 400 mg-2.5 mg Dose, Kisqali Femara Co-Pack 600 mg-2.5 mg Dose

What is the most important information I should know about letrozole and ribociclib?

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.

Letrozole and ribociclib may also affect your liver or blood cells. Tell your doctor if you have right-sided stomach pain, tiredness, easy bruising or bleeding, dark urine, and jaundice (yellowing of the skin or eyes).

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

Other serious side effects of this medicine include fever, chills, and flu symptoms.

What is letrozole and ribociclib?

Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Ribociclib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Letrozole and ribociclib are used together in combination to treat a certain type of breast cancer that has spread to other parts of the body. This medicine is used in postmenopausal women.

Letrozole and ribociclib are two different medicines that are packaged together. Letrozole tablets are yellow and ribociclib tablets are violet.

Letrozole and ribociclib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking letrozole and ribociclib?

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

Tell your doctor if you have ever had:

  • heart disease, heart failure;
  • a heart attack;
  • heart rhythm problems, including slow heartbeats;
  • long QT syndrome;
  • low levels of calcium, potassium, or magnesium in your blood; or
  • liver disease.

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

Letrozole and ribociclib may harm an unborn baby. Use effective birth control to prevent pregnancy and tell your doctor if you become pregnant. Keep using birth control for at least 3 weeks after your last dose.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because letrozole and ribociclib may harm the baby if a pregnancy does occur.

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

How should I take letrozole and ribociclib?

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

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

It is best to take this medicine in the morning, 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.

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 and do not crush, chew, or break it. Do not take any tablet that is broken or cracked.

If you vomit shortly after taking a tablet, 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

What should I avoid while taking letrozole and ribociclib?

Grapefruit and pomegranate may interact with letrozole and ribociclib and lead to unwanted side effects. Avoid the use of grapefruit or pomegranate products (fruit or juice) while taking letrozole and ribociclib.

What are the possible side effects of letrozole and ribociclib?

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:

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

What other drugs will affect letrozole and ribociclib?

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.

Many drugs can affect letrozole and 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.

Where can I get more information?

Your pharmacist can provide more information about letrozole and ribociclib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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