Ribociclib; Letrozole Tablets

What is this medication?

RIBOCICLIB; LETROZOLE (rye boe SYE klib; LET roe zole) treats breast cancer. Ribociclib works by blocking a protein that causes cancer cells to grow and multiply. Letrozole works by decreasing the amount of estrogen hormone your body makes. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): KISQALI FEMARA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• History of irregular heartbeat
• Infection, such as chickenpox, cold sores, herpes
• Liver disease
• Low blood counts, such as low white cells, platelets, red cell counts
• Low levels of calcium, magnesium, potassium, or phosphorus in the blood
• Lung or breathing disease, such as asthma
• Weak bones
• An unusual or allergic reaction to ribociclib, letrozole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with foods or drinks that contain grapefruit.

This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Certain antivirals for HIV or hepatitis, such as atazanavir, cobicistat, darunavir, delavirdine, nelfinavir, saquinavir, tipranavir
• Certain medications for cholesterol, such as lovastatin, simvastatin
• Certain medications for fungal infections, such as fluconazole, isavuconazonium, posaconazole
• Conivaptan
• Cisapride
• Dronedarone
• Eletriptan
• Eplerenone
• Ergot alkaloids, such as dihydroergotamine or ergotamine
• Flibanserin
• Fosamprenavir
• Ivabradine
• Lomitapide
• Lurasidone
• Naloxegol
• Pimozide
• Ranolazine
• Silodosin
• Thioridazine
• Tolvaptan
• Triazolam
• Ubrogepant

This medication may interact with the following:

• Alfentanil
• Antiviral medications for HIV or AIDS
• Certain medications for fungal infections, such as ketoconazole, itraconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Clarithromycin
• Cyclosporine
• Everolimus
• Fentanyl
• Grapefruit juice
• Midazolam
• Nefazodone
• Other medications that cause heart rhythm changes, such as dofetilide, ziprasidone
• Pomegranate juice
• Quinidine
• Rifampin
• Sirolimus
• St. John's wort
• Tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

Do not take this medication close to bedtime. It may prevent you from sleeping.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your care team you are receiving this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 3 weeks after the last dose. Your will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 3 weeks after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 3 weeks after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Constipation
• Diarrhea
• Fatigue
• Hair loss
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original package. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.