When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to palbociclib, or if you are pregnant.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not open, crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose or vomit after you take this medicine, do not take another dose the same day. Wait and take your next dose when you normally would.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how palbociclib works. Tell your doctor if you are using carbamazepine, clarithromycin, enzalutamide, indinavir, itraconazole, ketoconazole, lopinavir, modafinil, nefazodone, nelfinavir, phenytoin, posaconazole, rifampin, ritonavir, saquinavir, St John's wort, telaprevir, telithromycin, or voriconazole.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Women should use an effective form of birth control during treatment and for at least 3 weeks after the last dose. Men who are taking this medicine should use birth control during treatment and for at least 3 months after the last dose. Tell your doctor right away if you or your partner becomes pregnant.
• Do not breastfeed while you are taking this medicine and for 3 weeks after your last dose.
• Tell your doctor if you have kidney disease, liver disease, or any type of infection.
• This medicine may cause the following problems:
  
  • Changes in the number of blood cells, which can increase your risk for infection or bleeding
  • Pulmonary embolism (blood clots in the lungs)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fast or pounding heartbeat, fast breathing, dizziness or lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache, nausea
• Sores or white patches on your lips, mouth, or throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088