Palbociclib

Generic name: Palbociclib
Brand names: Ibrance
Dosage form: tablet, capsule
Drug class: CDK 4/6 inhibitors

Usage of Palbociclib

Palbociclib is an oral medicine that is used to treat specific types of breast cancer in adults. Your doctor will prescribe it for you if it has a proven benefit for your type of cancer. 

It is used in combination with other cancer treatments, either aromatase inhibitor or fulvestrant, which one you use will Depend on your clinical factors.  

It is a targeted therapy which blocks CDK4 and CDK6, which are enzymes in cells that are important for cell division. Blocking these proteins helps to slow down cells that are dividing, which slows down cancer growth.

Palbociclib side effects

Palbociclib may cause serious side effects. Also see “Important information’ on this page.

Common side effects of palbociclib when used with either Letrozole or fulvestrant include:

  • Low red blood cell counts and low platelet counts are common with this medicine. Call your healthcare provider right away if you develop any of these symptoms during treatment:
  • dizziness
  • bleeding or bruising more easily
  • shortness of breath
  • weakness
  • nosebleeds
  • infections (see ‘Important information’ above on this page)
  • tiredness
  • diarrhea
  • hair thinning or hair loss
  • vomiting
  • nausea
  • sore mouth
  • abnormalities in liver blood tests
  • rash
  • loss of appetite
  • Palbociclib may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting palbociclib if this is a concern for you.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all of the possible side effects of this medicine.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Palbociclib

    You should not take palbociclib if you are pregnant or planning a pregnancy, as it can harm your unborn baby.

  • Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of palbociclib.
  • Males with female partners who can become pregnant should use effective birth control during treatment with palbociclib for at least 3 months after the last dose of this medicine.
  • Talk to your healthcare provider about birth control methods that may be right for you during this time.
  • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • Palbociclib may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting palbociclib if this is a concern for you.
  • If you are breastfeeding or planning to breastfeed. It is not known if palbociclib passes into your breast milk. Do not breastfeed during treatment with palbociclib and for 3 weeks after the last dose.

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    How to use Palbociclib

    The usual dose of palbociclib is a 125 mg tablet or capsule swallowed once a day for 21 days in a row. You then have 7 days in a row of not taking Palbociclib tablets or capsules. This makes up a complete cycle of 28 days.

  • Take the recommended dose of an aromatase inhibitor when given with Palbociclib. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.
  • Take the recommended dose of fulvestrant on Days 1,15, 29, and once monthly  thereafter. Please refer to the Full Prescribing Information of fulvestrant.
  • If you are a pre/perimenopausal woman being treated with the combination palbociclib plus fulvestrant therapy you should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.
  • If you are a man being treated with combination palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards. 
  • Your doSage may be changed by your health professional if you are having side effects, changes in your blood tests, liver problems or if you are taking certain medications that interact with palbociclib.

    Warnings

    Palbociclib may cause serious side effects, including:

    Low white blood cell counts (Neutropenia). This increases your risk of serious infections. Low white blood cell counts are very common when taking palbociclib and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment.

    If you develop low white blood cell counts during treatment, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

    Lung problems (pneumonitis). Palbociclib may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

  • trouble breathing or shortness of breath
  • cough with or without mucus
  • chest pain
  • Other possible side effects are listed further down the page. 

    What other drugs will affect Palbociclib

    Some medications interact with palbociclib, so it is important to tell your doctor about any medicines that you are currently taking, or if you start or stop any medicine while you are having cancer treatment. Also tell your doctor about any over-the-counter medicines, vitamins, minerals or herbal products that you take.

    To find out more about interactions with palbociclib click the link below:

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