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

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

Ibrance affects your lungs or your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, chest pain, shortness of breath, or cough with or without mucus.

Before taking this medicine

You should not use Ibrance if you are allergic to palbociclib. Tell your doctor if you have signs of infection (such as fever or chills).

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

• liver disease; or

• kidney disease.

Palbociclib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• 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 Ibrance.

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.

You should not breastfeed while using palbociclib and for at least 3 weeks after your last dose.

Take Ibrance exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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 Ibrance capsules with food. Avoid grapefruit products. Grapefruit may interact with palbociclib and lead to unwanted side effects.

You may take Ibrance tablets with or without food.

Take the medicine at the same time each day.

Swallow the capsule or tablet whole and do not crush, chew, break, or open it. Do not use a broken or damaged pill.

If you vomit after taking Ibrance, 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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Breast Cancer:

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

Comments:
-Administer the recommended dose of an aromatase inhibitor when given with this drug. Refer to the prescribing information for the aromatase inhibitor being used.
-When given with this drug, the recommended dose of fulvestrant is 500 mg on Days 1, 15, 29, and once monthly thereafter. Refer to the prescribing Information for fulvestrant.
-Pre/perimenopausal women treated with the combination of this drug plus fulvestrant should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to local protocol.

Use: For HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women OR fulvestrant in women with disease progression following endocrine therapy.

You should not use Ibrance if you are allergic to palbociclib. Tell your doctor if you have signs of infection (such as fever or chills).

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

• liver disease; or

• kidney disease.

Palbociclib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• 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 Ibrance.

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.

You should not breastfeed while using palbociclib and for at least 3 weeks after your last dose.

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

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

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

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:

• 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 Ibrance 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.

Other drugs may interact with 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.