palbociclib

What is the most important information I should know about palbociclib?

What is palbociclib?

Palbociclib is used in men and women to treat HR-positive, HER2-negative breast cancer that has spread to other parts of the body.

In postmenopausal women, palbociclib is given in combination with a hormonal medicine such as letrozole (Femara). In others, palbociclib is given together with fulvestrant (Faslodex).

Palbociclib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking palbociclib?

Tell your doctor if you have signs of infection (such as fever or chills), or if you have ever had:

• liver disease; or
• kidney disease.

• If you are a woman, do not use palbociclib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using palbociclib.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because palbociclib can harm an unborn baby.

How should I take palbociclib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Palbociclib 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 palbociclib.

You may take palbociclib tablets with or without food.

Take the medicine at the same time each day.

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

Palbociclib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

What happens if I miss a dose?

Skip the missed dose and do not take the medicine again until the next day. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking palbociclib?

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

What are the possible side effects of palbociclib?

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• low blood cell counts --fever, chills, weakness, dizziness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of inflammation in the lungs --new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; 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 side effects may include:

• low blood cell counts, infections;
• easy bruising or bleeding;
• feeling weak or tired;
• nausea, vomiting, diarrhea, loss of appetite;
• mouth sores;
• abnormal liver function tests;
• dry skin, rash;
• altered sense of taste;
• nosebleed; or
• thinning hair or 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.

What other drugs will affect palbociclib?

Other drugs may affect palbociclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about palbociclib.