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Ibrance

Generic name Palbociclib (palboe-Sye-klib)
Drug class: CDK 4/6 inhibitors

What is Ibrance?

Ibrance is an anti-cancer medicine that inhibits the growth and spreading of cancerous cells.Ibrance can be used to treat breast cancer in women and men who are HER2-negative but HR-positive.

Ibrance can be given to postmenopausal women in conjunction with a hormone medicine like letrozole (Femara). Ibrance can also be given in combination with fulvestrant (Faslodex).

Warnings

Ibrance can affect your lungs or immune system. You are more susceptible to infections, including serious and fatal ones.

Before you take this drug

Ibrance should not be used if you have an allergy to palbociclib. If you experience any signs of infection, such as fever or chills, tell your doctor.

Tell your doctor about any of the following to ensure that Ibrance will be safe for you:

  • Liver disease
  • Kidney disease is a serious condition.

Palbociclib may harm a baby in utero or cause birth defects if either the mother or father uses this medicine.

  • Do not take palbociclib if you're a woman. Before starting treatment, you may need a negative pregnancy result. Use birth control to avoid pregnancy during the time you use this medication and for at least three weeks following your last dose.
  • Use effective birth control if you're a man and your partner can get pregnant. Continue to use birth control for at least three months following your last dose.
  • If you become pregnant while using Ibrance, either as a mother or father, tell your doctor immediately.

This medication may have an effect on male fertility (the ability of men to reproduce). It is still important to use birth control to avoid pregnancy, as palbociclib may harm the unborn child.While using palbociclib, you should not breastfeed for 3 weeks following your last dose.

Similar/related drugs

Kisqali, Piqray, Keytruda, Tamoxifen, Arimidex, Femara, and Xeloda

How to take Ibrance?

Follow the directions on your prescription label and read all medication guides or instruction sheets. Read all the instructions and directions that come with your prescription. Sometimes your doctor will change the dose.

Ibrance can be taken for up to three weeks in each 28-day cycle. Ibrance treatment duration is determined by your doctor.Take Ibrance caps along with food. Do not consume grapefruit products. Palbociclib may cause unwanted side effects.Ibrance tablets can be taken with or without food.Take your medicine every day at the same time.

Do not open, crush, chew, or break the tablet or capsule. Swallow it whole. Never use a pill that is broken or damaged.Wait until the following day before taking your next dose if you vomit immediately after taking Ibrance.Palbociclib can affect your immune system. You could get more infections, including serious or deadly infections. You will need to be examined by your doctor on a regular schedule.Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for breast cancer:

28-day cycle: 125 mg orally, once daily for 21 days in a row, followed by 7 rest days.
Comments:
When given in conjunction with the drug, administer the recommended dose. Consult the prescribing instructions for the aromatase inhibitor being used.
When given in conjunction with this medication, the recommended dosage of fulvestrant for days 1, 15, 29, and thereafter is 500mg once a month. Consult the prescribing information for fulvestrant.
According to local protocols, women who are pre-perimenopausal and treated with this drug in combination with fulvestrant may also be treated with LHRH agonists.
Use: In women who have advanced, metastatic, or HR-positive breast cancer combined with an aromatase inhibitor as the initial endocrine treatment.

What happens if I miss the dose?

Do not take the medication again until the following day. Do not take two doses of the same medication at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Avoid being around people who are ill or infected. If you notice any signs of an infection, tell your doctor immediately.

Side-effects of Ibrance

If you experience any of the following symptoms of an allergy to Ibrance, seek immediate medical attention: itching; difficulty breathing; swelling in your face, lips, or throat; or hives.

If you experience:

  • Blisters or ulcers on your lips, red or swollen gingiva, difficulty swallowing
  • Low blood cell counts: fever, chills, weakness, and dizziness Mouth sores or skin sores Easy bruising. Unusual bleeding. Pale skin. Cold hands and feet.
  • Signs of Inflammation in the Lungs: new or worsening symptoms of coughing, difficulty breathing or pain, wheezing, or feeling short of breath even when resting.
  • Signs of a Blood Clot in the Lung: chest pain, sudden wheezing, and coughing up blood

If you experience certain side effects, your cancer treatment may be halted or delayed.

Side effects of alcohol include:

  • Low blood cell count, infection
  • Easy bruising and bleeding
  • Feeling tired or weak
  • Nausea; vomiting; diarrhea; and loss of appetite.
  • Mouth sores;
  • Abnormal liver function tests
  • Rash, dry skin
  • Changed sense of taste
  • Nosebleed
  • Hair loss or thinning hair.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Palbociclib may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the medicines you are taking and those that you stop or start using.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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