Class Name(s):

• 10:00 Antineoplastic Agents

Pronunciation:

• (pal'' boe sye' klib)

Brand Name(s):

• Ibrance^®

WHY is this medicine prescribed?

Palbociclib is used in combination with another medication as an initial treatment for a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) that has spread to other parts of the body. Palbociclib is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) that has spread to other parts of the body in people who have been treated successfully with an antiestrogen medication such as tamoxifen (Soltamox). 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.

HOW should this medicine be used?

Palbociclib comes as a capsule and a tablet to take by mouth. It is usually taken once daily for the first 21 days of a 28-day cycle. Palbociclib capsules are usually taken with food. Palbociclib tablets may be taken with or without food 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 and tablets whole; do not open, split, chew, or crush them. Do not take capsules or tablets that are broken, cracked, or damaged.

If you vomit after taking palbociclib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop 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.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

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 and tablets. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with palbociclib: St. John's wort. Be sure to let your healthcare provider know that you are taking this medication before you start taking palbociclib. Do not start this medication while taking palbociclib without talking to your healthcare provider.
• tell your doctor if you have fever, chills, or any other signs of an infection or if you have or have ever had lung or breathing problems or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 3 weeks after your final dose. If you are a male, you and your partner should use birth control during your treatment with palbociclib and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking palbociclib, call your doctor immediately. Palbociclib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking palbociclib and for 3 weeks after the final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking palbociclib.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking palbociclib.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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
• changes in taste
• tiredness
• sores on the lips, mouth, or throat
• unusual hair thinning or hair loss
• dry skin
• rash
• eye tearing, blurred vision, or dry eye

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
• difficulty breathing or shortness of breath
• cough with or without mucus
• chest pain
• dizziness
• fast, irregular, or pounding heartbeat
• weakness
• unusual bleeding or bruising
• nosebleeds
• redness, pain, swelling or blisters on the palms of the hands or soles of the feet
• skin blistering and peeling
• skin redness

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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.

What should I know about STORAGE and DISPOSAL of 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).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2024.