Pronunciation:

pal-boe-SYE-klib

Brand Names:

• Ibrance

Dosage Forms:

• Tablet
• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Cyclin-Dependent Kinase Inhibitor

Uses of This Medicine:

Palbociclib is used to treat hormone receptor (HR)-positive, HER-2 negative advanced or metastatic (cancer that has spread) breast cancer. This medicine is used in combination with an aromatase inhibitor (eg, letrozole) as first hormonal based treatment or with fulvestrant in patients with disease progression following hormonal treatment. It belongs to the group of medicines called antineoplastics.

Palbociclib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of palbociclib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palbociclib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Amiodarone
• Atorvastatin
• Benzhydrocodone
• Boceprevir
• Buprenorphine
• Carbamazepine
• Clarithromycin
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Cyclosporine
• Dexlansoprazole
• Dihydrocodeine
• Dihydroergotamine
• Dofetilide
• Eliglustat
• Enzalutamide
• Ergotamine
• Eslicarbazepine Acetate
• Esomeprazole
• Everolimus
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Flibanserin
• Fosphenytoin
• Hydrocodone
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lansoprazole
• Lemborexant
• Lopinavir
• Mavacamten
• Meperidine
• Methadone
• Mitotane
• Nefazodone
• Nelfinavir
• Omaveloxolone
• Omeprazole
• Oxcarbazepine
• Oxycodone
• Pantoprazole
• Pentazocine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Posaconazole
• Primidone
• Quinidine
• Rabeprazole
• Rifampin
• Ritonavir
• Saquinavir
• Sirolimus
• Sirolimus Protein-Bound
• St John's Wort
• Sufentanil
• Tacrolimus
• Telaprevir
• Telithromycin
• Temsirolimus
• Tipranavir
• Tramadol
• Ubrogepant
• Verapamil
• Voriconazole
• Zolpidem

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight infection.

• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Lung problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Palbociclib is given together with letrozole or fulvestrant. It is important that you take each medicine at the right time. Follow your doctor's instructions on when to take these medicines.

Your doctor may also give you other medicines (eg, luteinizing hormone-releasing hormone agonists) in combination with palbociclib plus letrozole or fulvestrant if you are a pre/perimenopausal woman or a man.

Swallow the capsule or tablet whole. Do not open, crush, break, or chew it.

Take the oral capsules with food. Take the oral tablets with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or tablets):
  • For metastatic breast cancer with letrozole or fulvestrant:
    • Adults—125 milligrams (mg) once a day for 21 days, followed by 7 days without medicine. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or vomit after you take this medicine, do not take another dose on the same day. Wait until your next dose and take it when you normally would.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women must have a pregnancy test before using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. Males who are using this medicine with female partners who can become pregnant must use effective birth control during treatment and for at least 3 months after the last dose. If you think you or your partner have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Palbociclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Interstitial lung disease or pneumonitis can occur while using this medicine. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills while using this medicine.

Do not change your dose or stop using this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

chills

cough

difficulty breathing

fever

hoarseness

loss of voice

lower back or side pain

nosebleeds

painful or difficult urination

pale skin

pinpoint red spots on the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling or inflammation of the mouth

swollen glands

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

General feeling of discomfort or illness

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

thickening of bronchial secretions

tingling of the hands and feet

ulceration of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision

decreased appetite

diarrhea

dry skin

hair loss or thinning of the hair

increased tearing

lack or loss of strength

loss of or change in taste

nausea

skin rash

vomiting

Less common

Dry eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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