Ribociclib; Letrozole oral tablets co-pack

What is this medicine?

RIBOCICLIB (rye boe SYE klib) is a medicine that target proteins in cancer cells. LETROZOLE (LET roe zole) is a medicine that blocks the production of estrogen. They are used together to treat breast cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Do not take with grapefruit juice, pomegranates, or pomegranate juice. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone fracture

• cough

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs of low calcium like fast heartbeat, muscle cramps or muscle pain; pain, tingling, numbness in the hands or feet; seizures

• signs and symptoms of low magnesium like muscle cramps, pain, or weakness; tremors; seizures; or fast, irregular heartbeat

• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

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

• constipation

• diarrhea

• hair loss

• headache

• hot flashes, night sweats

• loss of appetite

• mouth sores

• nausea/vomiting

• red spots on the skin

• sore throat

• stomach pain

• swelling of the ankles, feet, hands

• trouble sleeping

• vaginal bleeding

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alfuzosin

• certain antivirals for HIV or hepatitis like atazanavir, cobicistat, darunavir, delavirdine, nelfinavir, saquinavir, or tipranavir

• certain medicines for cholesterol like lovastatin or simvastatin

• certain medicines for fungal infections like fluconazole, isavuconazonium, or posaconazole

• conivaptan

• cisapride

• dronedarone

• eletriptan

• eplerenone

• ergot alkaloids like dihydroergotamine or ergotamine

• flibanserin

• fosamprenavir

• ivabradine

• lomitapide

• lurasidone

• naloxegol

• pimozide

• ranolazine

• silodosin

• thioridazine

• tolvaptan

• triazolam

• ubrogepant

This medicine may interact with the following medications:

• alfentanil

• antiviral medicines for HIV or AIDS

• certain medicines for fungal infections like ketoconazole, itraconazole, voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• clarithromycin

• cyclosporine

• everolimus

• fentanyl

• grapefruit juice

• midazolam

• nefazodone

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone

• pomegranate juice

• quinidine

• rifampin

• sirolimus

• St. John's Wort

• tacrolimus

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• heart disease

• history of irregular heartbeat

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• low levels of calcium, magnesium, potassium, or phosphorus in the blood

• lung or breathing disease, like asthma

• weak bones

• an unusual or allergic reaction to ribociclib, letrozole, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 3 weeks after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 3 weeks after the last dose.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Be careful brushing and 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 dentist you are receiving this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.