Palbociclib Oral capsule

What is this medicine?

PALBOCICLIB (pal boe SYE klib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat breast cancer.

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

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

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

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

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

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Avoid grapefruit and grapefruit juice while you are taking this medicine. Swallow the capsule whole. Do not cut, crush or chew this medicine. 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.

Overdosage: If you think you've 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 medicine?

This medicine may interact with the following medications:

• alfentanil

• antiviral medicines for HIV or AIDS

• boceprevir

• bosentan

• carbamazepine

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

• clarithromycin

• cyclosporine

• ergot alkaloids like dihydroergotamine, ergotamine

• everolimus

• fentanyl

• grapefruit juice

• midazolam

• modafinil

• nafcillin

• nefazodone

• phenobarbital

• phenytoin

• pimozide

• quinidine

• rifampin

• sirolimus

• St. John's Wort

• tacrolimus

• telaprevir

• telithromycin

• verapamil

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 medicine?

Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for at least 3 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Men should inform their doctors if they wish to father a child later. 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.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

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

• dizziness

• mouth sores

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• pain, tingling, numbness in the hands or feet

• severe or persistent diarrhea, nausea, vomiting

• 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 infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs of decreased platelets or bleeding - nosebleed, 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

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

• decreased appetite

• hair thinning or hair loss

• mild diarrhea

• nausea

• weak or tired

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 medicine?

Keep out of the reach of children.

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

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.