Ibrance (Palbociclib)

(pal'' boe sye' klib)

Palbociclib is used in combination with letrozole (Femara) to treat a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) in women who have experienced menopause (change of life; end of monthly menstrual periods). Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Palbociclib comes as a capsule to take by mouth. It is usually taken with food once daily for the first 21 days of a 28-day cycle. Your doctor will decide how many times you should repeat this cycle. Take palbociclib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take palbociclib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole; do not open, chew, or crush them. Do not take capsules that are broken or cracked. If you vomit after taking palbociclib, do not take another dose. Continue your regular dosing schedule. Your doctor may gradually decrease or stop your dose of palbociclib during your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with palbociclib. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking palbociclib,
• tell your doctor and pharmacist if you are allergic to palbociclib, any other medications, or any of the ingredients in palbociclib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics such as clarithromycin (Biaxin, in Prevpac), nafcillin, and telithromycin (Ketek); antifungals such as itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); bosentan (Tracleer); certain medications to treat seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others) and phenytoin (Dilantin, Phenytek); ergot alkaloids such as dihydroergotamine (D.H.E 45, Migranal) and ergotamine (Ergomar, in Cafergot, in Migergot); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), and telaprevir (no longer available in the U.S.); fentanyl (Fentora, Lazanda, Subsys, others); immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Prograf, Protopic); modafinil (Provigil); nefazodone; pimozide (Orap); quinidine (in Nuedexta); rifampin (Rifadin, Rifater, Rifamate); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with palbociclib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have an infection or if you have or have ever had liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking palbociclib and for at least 2 weeks after taking the last dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking palbociclib, call your doctor immediately. Palbociclib may harm the fetus.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose on the same day to make up for a missed one.

Palbociclib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• diarrhea
• vomiting
• decreased appetite
• tiredness
• numbness or tingling in your arms, hands, legs, and feet
• sore mouth or throat
• unusual hair thinning or hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fever, chills, or signs of infection
• shortness of breath
• sudden, sharp chest pain that may become worse with deep breathing
• fast, irregular, or pounding heartbeat
• rapid breathing
• weakness
• unusual bleeding or bruising
• nosebleeds

Palbociclib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to palbociclib. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.