Ibrance

The recommended dose of Ibrance (Palbociclib) is 125 mg taken by mouth, once a day for 21 days, followed by 7 days without taking the medication. This forms a 28-day cycle, which is repeated as long as you are benefiting from the medication. Depending on the side effects you experience and how well you tolerate Ibrance (Palbociclib), your doctor may reduce the dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

There are two forms of Ibrance (Palbociclib): capsules and tablets. Ibrance (Palbociclib) capsules should be taken with food. Ibrance (Palbociclib) tablets may be taken with or without food. Try to take Ibrance (Palbociclib) the same way and at the same time each day, to make sure a constant amount of medication stays in your body.

Swallow Ibrance (Palbociclib) whole with some fluid. Do not crush, chew, or open the capsules or tablets before swallowing them. If you find a broken, cracked, or open capsule or tablet, discard it safely. Do not take any capsule or tablet that is not intact.

It is important to take Ibrance (Palbociclib) exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. If you vomit after taking your dose for the day, do not take another dose. Continue taking the medication the next day. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Ibrance (Palbociclib) at room temperature, in its original container, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause hair loss; it may cause diarrhea; it may cause a general feeling of weakness; it may cause unusual tiredness; it may cause nausea or, rarely, vomiting; it may cause numbness and discomfort in the arms or legs. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Capsules

75 mg
Each opaque, hard gelatin, size 2 capsule with light orange cap and body, printed with white ink "Pfizer" on the cap, "PBC 75" on the body, contains 75 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate; capsule shell: gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; printing ink: shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone.

100 mg
Each opaque, hard gelatin, size 1 capsule with caramel cap and light orange body, printed with white ink "Pfizer" on the cap, "PBC 100" on the body, contains 100 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate; capsule shell: gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; printing ink: shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone.

125 mg
Each opaque, hard gelatin, size 0 capsule with caramel cap and body, printed with white ink "Pfizer" on the cap, "PBC 125" on the body, contains 125 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells; capsule shell: gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; printing ink: shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone.

Tablets

75 mg
Each round, light purple, film-coated tablet, debossed with "Pfizer" on one side and "PBC 75" on the other side, contains 75 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide succinic acid, titanium dioxide, and triacetin.

100 mg
Each oval, green, film-coated tablet, debossed with "Pfizer" on one side and "PBC 100" on the other side, contains 100 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, succinic acid, titanium dioxide, triacetin, and yellow iron oxide.

125 mg
Each oval, light purple, film-coated tablet, debossed with "Pfizer" on one side and "PBC 125" on the other side, contains 125 mg of Ibrance (Palbociclib). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, succinic acid, titanium dioxide, and triacetin.

Who should not take Ibrance (Palbociclib)?

Do not take Ibrance (Palbociclib) if you are allergic to Ibrance (Palbociclib) or any ingredients of the medication.

Do not take Ibrance (Palbociclib) if you are allergic to Ibrance (Palbociclib) or any ingredients of the medication.

There may be an interaction between Ibrance (Palbociclib) and any of the following:

• 5-ASA medications (e.g., Mesalamine, Olsalazine, Sulfasalazine)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antipsychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baricitinib
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam, Triazolam)
• Bosentan
• Bromocriptine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Colchicine
• conivaptan
• corticosteroids (e.g., budesonide, Dexamethasone)
• Cyclosporine
• Cyproterone
• Darifenacin
• Deferasirox
• Denosumab
• Disopyramide
• Domperidone
• Dronedarone
• echinacea
• Eletriptan
• Eliglustat
• Enzalutamide
• Eplerenone
• ergotamine derivatives (e.g., Dihydroergotamine, ergonovine, ergotamine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Fingolimod
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Idelalisib
• Ivabradine
• Ivacaftor
• Leflunomide
• Lemborexant
• lidocaine
• Lomitapide
• Macitentan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• mifepristone
• Mirtazapine
• Modafinil
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Natalizumab
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimecrolimus
• other protein kinase inhibitors (e.g., Ceritinib, Dabrafenib, imatinib, Lapatinib)
• quinidine
• quinine
• rifabutin
• rifampin
• St. John's wort
• salmeterol
• Saxagliptin
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, Phenobarbital, Phenytoin, primidone, Topiramate)
• siltuximab
• Sirolimus
• Solifenacin
• "statin" anticholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• Tamoxifen
• Ticagrelor
• Tocilizumab
• Tofacitinib
• Tolterodine
• Tolvaptan
• Trazodone
• upadacitinib
• vaccines
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ibrance (Palbociclib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ibrance (Palbociclib).

Anemia: Ibrance (Palbociclib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Drowsiness/dizziness: Ibrance (Palbociclib) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Ibrance (Palbociclib) affects you.

Fruit/fruit juice: Certain fruits or their juices may change the amount of Ibrance (Palbociclib) in your body. Do not consume grapefruit, grapefruit juice, starfruit, pomegranate, or Seville oranges while taking Ibrance (Palbociclib).

Infection: As well as killing cancer cells, Ibrance (Palbociclib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: If you have liver problems, discuss with your doctor how Ibrance (Palbociclib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ibrance (Palbociclib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Ibrance (Palbociclib).

Lung inflammation: Rarely, some people taking Ibrance (Palbociclib) have experienced lung inflammation (interstitial lung disease), causing difficulty breathing. This problem can be severe and life-threatening. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Ibrance (Palbociclib), contact your doctor immediately.

Male fertility: Ibrance (Palbociclib) may impair male fertility. Men should consider sperm preservation prior to starting treatment with Ibrance (Palbociclib). Men whose partners could become pregnant should use effective birth control during treatment and for at least 97 days after the last dose of Ibrance (Palbociclib).

Pregnancy: Ibrance (Palbociclib) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ibrance (Palbociclib), contact your doctor immediately. If you are able to become pregnant, you should use effective birth control while you are taking Ibrance (Palbociclib) and for at least 21 days after stopping the medication. Men taking Ibrance (Palbociclib) whose partners could become pregnant should use effective birth control during treatment and for at least 97 days after the last dose of Ibrance (Palbociclib).

Breast-feeding: It is not known if Ibrance (Palbociclib) passes into breast milk. If you are breast-feeding and are taking Ibrance (Palbociclib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ibrance (Palbociclib) have not been established for children.

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. This medication is generally administered in a cyclical regimen that includes a period of use followed by a period of rest. To obtain the full benefits, it is important to complete each treatment cycle unless otherwise directed by your healthcare professional. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication should be swallowed whole. It should not be split, crushed or chewed. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.