ribociclib 200 mg/day (200 mg x 1) and letrozole 2.5 mg tablet

Generic name:
Ribociclib/letrozole - oral

Pronunciation
(RYE-boe-SYE-klib/LET-roe-zole)

Brand name(s)
Kisqali Femara Co-Pack

This product contains 2 medications: ribociclib tablets and letrozole tablets. This product is used to treat breast cancer. Ribociclib works by slowing or stopping the growth of cancer cells. Letrozole works by decreasing the amount of estrogen the body makes, which helps slow down or reverse the growth of some breast cancers.

Read the Patient Information Leaflet if available from your pharmacist before you start taking ribociclib and letrozole tablets and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take ribociclib by mouth with or without food as directed by your doctor, usually once daily in the morning for 21 days, then stopping the medication for 7 days. Take letrozole by mouth with or without food as directed by your doctor, usually once daily in the morning for 28 days. This is one cycle of treatment. Keep taking these medications this way as directed by your doctor.

Swallow the tablets whole. Do not crush, chew, or break the tablets. Also, do not take a tablet that is damaged or broken.

If you vomit after taking a dose, do not take another dose on that day. Take your next dose at the regular time.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use these medications regularly to get the most benefit from them. To help you remember, take them at the same time(s) each day.

Do not increase your dose or use these drugs more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Avoid eating grapefruit or drinking grapefruit juice while taking these medications unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with ribociclib. Ask your doctor or pharmacist for more details.

Since these drugs can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle these medications or breathe the dust from the tablets.

Tiredness, nausea, loss of appetite, vomiting, diarrhea, headache, constipation, back pain, hot flashes, unusual sweating, dizziness, or trouble sleeping may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

People using these medications may have serious side effects. However, you have been prescribed these drugs because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• bone fractures
• pain/swelling of the joint/muscle/tendon
• mental/mood changes (such as depression, anxiety)
• swelling of arms/legs
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

Letrozole may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• confusion
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes
• unusual sweating
• sudden dizziness/fainting

This product may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough).

A very serious allergic reaction to these drugs is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to ribociclib or letrozole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using these medications, tell your doctor or pharmacist your medical history, especially of:

• high cholesterol
• bone problems (such as osteoporosis)
• heart problems (such as angina, previous heart attack)
• liver disease
• kidney disease

These drugs may make you tired or dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ribociclib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ribociclib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics "water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ribociclib safely.

Ribociclib can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using this medication before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of these drugs, especially QT prolongation (see above).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ribociclib and letrozole. Ribociclib/letrozole may harm an unborn baby. Your doctor should order a pregnancy test before your start these medications. Ask about reliable forms of birth control while using these medications and for 3 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of these medications.

Since these drugs can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle these medications or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for at least 3 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with these drugs are:

• estrogens (such as estradiol)
• tamoxifen
• tibolone

Other medications can affect the removal of ribociclib from your body, which may affect how ribociclib works. Examples include lonafarnib, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Ribociclib can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alprazolam, eplerenone, ergot alkaloids (such as ergotamine), estazolam, flibanserin, irinotecan, ivabradine, mavacamten, naloxegol, ticagrelor, tolvaptan, triazolam, among others.

Many drugs besides ribociclib may affect the heart rhythm (QT prolongation), such as amiodarone, chloroquine, clarithromycin, domperidone, dronedarone, haloperidol, methadone, moxifloxacin, pacritinib, pimozide, ranolazine, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share these medications with others.

Lab and/or medical tests (such as EKG, liver function, complete blood count, bone density, cholesterol, potassium and magnesium blood levels) should be done before you start taking these medications and while you are taking them. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture for up to 2 months. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.