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

What is Ibrance?

Ibrance (palbociclib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Ibrance is used together with letrozole (Femara) or fulvestrant (Faslodex) to treat certain types of advanced breast cancer in postmenopausal women. Ibrance is given in combination with another cancer medicine, either letrozole (Femara) or fulvestrant (Faslodex).

Ibrance was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, palbociclib appeared to improve survival time. However, further studies are needed to determine if this medicine can lengthen survival time.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Ibrance if you are allergic to palbociclib.

To make sure Ibrance is safe for you, tell your doctor if you have:

  • liver disease; or

  • kidney disease.

Do not use Ibrance if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your treatment ends.

It is not known whether palbociclib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Ibrance?

Take Ibrance exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ibrance is given in a 28-day treatment cycle, and you may only need to take the medicine during the first 3 weeks of each cycle. Your doctor will determine how long to treat you with Ibrance.

Take with food.

Take the medicine at the same time each day.

Do not crush, chew, break, or open a Ibrance capsule. Swallow it whole.

If you vomit after taking the medicine, wait until the next day to take your next dose.

Do not use a broken or damaged pill.

Ibrance can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

Store at room temperature away from moisture and heat.

Ibrance dosing information

Usual Adult Dose for Breast Cancer:

28-day cycle: 125 mg orally once a day for 21 consecutive days followed by 7 days off treatment

Comments: Take with food in combination with letrozole 2.5 mg orally once a day throughout the 28-day cycle.

Use: In combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Skip the missed dose and do not take the medicine again until your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Ibrance?

Grapefruit and grapefruit juice may interact with palbociclib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Ibrance.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Ibrance side effects

Get emergency medical help if you have signs of an allergic reaction to Ibrance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low white blood cell counts - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Ibrance side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;

  • weakness, feeling tired;

  • numbness, tingling, or burning pain in your arms, legs, hands or feet;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • nosebleed; or

  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Ibrance?

Other drugs may interact with palbociclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Ibrance.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ibrance only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.02. Revision Date: 2016-02-29, 10:02:44 AM.