Palbociclib (pal-boe-SYE-klib)

Treats breast cancer. This medicine is given together with letrozole or fulvestrant.

Brand Name(s):

Ibrance

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Capsules: It is best to take this medicine with food or milk. The tablets may be taken with or without food.
• Swallow the capsule or tablet 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 on the same day. Wait until your next dose and take it 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 medicines can affect how palbociclib works. Tell your doctor if you are using alfentanil, carbamazepine, clarithromycin, cyclosporine, dihydroergotamine, enzalutamide, ergotamine, everolimus, fentanyl, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, midazolam, modafinil, nefazodone, nelfinavir, phenytoin, pimozide, posaconazole, quinidine, rifampin, ritonavir, saquinavir, sirolimus, St John's wort, tacrolimus, telaprevir, telithromycin, or voriconazole.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Women must have a pregnancy test before using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. Males who are using this medicine with female partners who can become pregnant must use effective birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment and for 3 weeks after your last dose.
• Tell your doctor if you have kidney disease, liver disease, lung disease, or any type of infection.
• This medicine may cause lung or breathing problems, including interstitial lung disease or pneumonitis, which can be life-threatening.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
• 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 or trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches

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

• Diarrhea, nausea
• Hair loss
• 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