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Palbociclib

Generic Name: palbociclib (PAL-boe-SYE-klib)
Brand Name: Ibrance

Palbociclib is used for:

Treating certain kinds of breast cancer in women past menopause. It may also be used for other conditions as determined by your doctor.

Palbociclib is a cyclin-dependent kinase (CDK) inhibitor. It works by stopping the growth of cancer cells.

Do NOT use palbociclib if:

  • you are allergic to any ingredient in palbociclib
  • you are taking bosentan, carbamazepine, efavirenz, etravirine, modafinil, nafcillin, phenytoin, rifampin, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using palbociclib:

Some medical conditions may interact with palbociclib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems, liver problems, or any symptoms of infection (eg, fever, chills, cough, sore throat)

Some MEDICINES MAY INTERACT with palbociclib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, or voriconazole because they may increase the risk of palbociclib's side effects
  • Bosentan , carbamazepine, efavirenz, etravirine, modafinil, nafcillin, phenytoin, rifampin, or St. John's wort because they may decrease palbociclib's effectiveness
  • Alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, midazolam, pimozide, quinidine, sirolimus, or tacrolimus because the risk of their side effects may be increased by palbociclib

This may not be a complete list of all interactions that may occur. Ask your health care provider if palbociclib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use palbociclib:

Use palbociclib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with palbociclib. Talk to your pharmacist if you have questions about this information.
  • Follow how to take palbociclib as you have been told by your doctor. Do not use more than you were told to use.
  • Take palbociclib by mouth with food.
  • Swallow palbociclib whole. Do not chew, crush, or open before swallowing.
  • Do not take capsules that are broken, cracked, or that look damaged.
  • Do not eat grapefruit or drink grapefruit juice while you use palbociclib.
  • Take palbociclib at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Take as you have been told, even if you feel well.
  • If you vomit after taking palbociclib, do not repeat the dose.
  • If you miss a dose of palbociclib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use palbociclib.

Important safety information:

  • Tell your doctor or dentist that you take palbociclib before you receive any medical or dental care, emergency care, or surgery.
  • Palbociclib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Palbociclib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Blood clots in the lungs have happened with palbociclib. Blood clots in the lungs may be serious or life-threatening. Call your doctor right away if you have chest pain or pressure, coughing up blood, fast breathing, fast heartbeat, or shortness of breath.
  • If you may become pregnant, you must use an effective form of birth control while you take palbociclib and for at least 2 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.
  • Lab tests may be performed while you use palbociclib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Palbociclib may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking palbociclib.

Possible side effects of palbociclib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; diarrhea; hair thinning or loss; mouth irritation or mouth sores; nausea; nose or throat irritation; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; dizziness; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; nosebleeds; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful urination, mouth sores, wound that will not heal, anal itching or pain); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of palbociclib:

Store palbociclib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep palbociclib out of the reach of children and away from pets.

General information:

  • If you have any questions about palbociclib, please talk with your doctor, pharmacist, or other health care provider.
  • Palbociclib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take palbociclib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about palbociclib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to palbociclib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using palbociclib.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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