Palbociclib

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Generic Name: Palbociclib Brand Name(s): Generics only. No brands available.

Uses

What is Palbociclib used for?

Palbociclib is used to treat a certain type of breast cancer in women. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

How should I take Palbociclib?

Take this medication by mouth with food as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor. Swallow the capsules whole. Do not crush, chew, or open the capsules. Do not take capsules that are broken or look damaged. If you vomit after taking the medication, do not take another dose of the medication that day. Take the next dose at the usual time the next day.

The dosage is based on your medical condition, laboratory tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may stop your medication for a while or reduce your dose if you get any side effects. Talk to your doctor for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time on the days you are scheduled to take the medication.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

How do I store Palbociclib?

Palbociclib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Palbociclib in the bathroom or the freezer. There may be different brands of Palbociclib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Palbociclib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Palbociclib?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Palbociclib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using palbociclib. Palbociclib may harm an unborn baby. Women of childbearing age should have a pregnancy test before starting this medication. Women of childbearing age should also ask about reliable forms of birth control while using this medication and for at least 3 weeks after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding during treatment and for at least 3 weeks after treatment with this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Palbociclib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Palbociclib. Palbociclib is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Palbociclib?

Nausea, vomiting, loss of appetite, diarrhea, tiredness, weakness, hair loss, mouth sores, or numbness/tingling of arms/legs may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of anemia (such as unusual tiredness, pale skin, fast heartbeat), easy bruising/bleeding (such as nosebleed).

This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Palbociclib?

Other medications can affect the removal of palbociclib from your body, which may affect how palbociclib works. Examples include azole antifungals (such as itraconazole, ketoconazole), carbamazepine, phenytoin, rifamycins (such as rifampin), St. John’s wort, among others.

Palbociclib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Palbociclib?

Palbociclib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

What health conditions may interact with Palbociclib?

Palbociclib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Palbociclib.

What is the dose of Palbociclib for an adult?

Usual Adult Dose for Breast Cancer

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

Comments: Take with food in combination with letrozole 2.5 mg orally once a day throughout the 28-day cycle.

Use: In combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Adverse reactions:

-Starting dose: 125 mg orally once a day

-First dose reduction: 100 mg orally once a day

-Second dose reduction: 75 mg orally once a day

-Discontinue treatment if further dose reduction below 75 mg/day required

Hematologic Toxicities:

-Grade 1 or 2: No adjustment recommended

-Grade 3 (except lymphopenia unless associated with clinical events, e.g. opportunistic infections): Withhold initiation of next cycle until recovery to Grade 2 or below. Consider repeating complete blood count monitoring 1 week later.

-Grade 3 ANC (less than 1000 to 500/mm3) with Fever 38.5 degrees Celsius or higher and/or infection: Withhold drug and initiation of next cycle until recovery to Grade 2 or below (1000/mm3 or more). Resume at next lower dose upon restarting.

-Grade 4 (except lymphopenia unless associated with clinical events, e.g. opportunistic infections): Withhold drug and initiation of next cycle until recovery to Grade 2 or below (1000/mm3 or less). Resume at next lower dose upon restarting.

Non-Hematologic Toxicities:

-Grade 1 or 2: No adjustment recommended

-Grade 3 or higher (if persisting despite medical treatment): Withhold drug until symptoms resolve to Grade 1 or less, or Grade 2 or less if not considered a patient safety risk. Resume at next lower dose upon restarting.

Concomitant Use with Strong CYP450 3A Inhibitors:

-Avoid concomitant use if possible or reduce palbociclib dose to 75 mg orally once a day.

-If use of strong CYP450 3A inhibitor discontinued, increase palbociclib dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to initiation of the inhibitor.

Other Comments

Administration advice:

-This drug should be taken at approximately the same time each day.

-If a dose is missed, the next dose should be taken at the usual time without doubling up the dose.

-This drug should be swallowed whole; do not chew, crush, or open capsules.

-Drug capsules should not be ingested if broken, cracked, or otherwise not intact.

General:

-Accelerated FDA approval based on progression-free survival. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Monitoring:

-Hematologic: CBC (prior to treatment initiation, at beginning of each cycle, on Day 14 of first two cycles, and as clinically indicated)

-Infections/Infestations: Signs and symptoms of infection

-Respiratory: Signs and symptoms of pulmonary embolism

Patient advice:

-Avoid grapefruit, grapefruit juice, and grapefruit products during treatment.

What is the dose of Palbociclib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Palbociclib available?

Palbociclib is available in the following dosage forms and strengths:

  • Oral capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Palbociclib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 11, 2018 | Last Modified: April 11, 2018

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