Palbociclib (Oral Route)

1. Ibrance

Palbociclib is used in combination with letrozole (postmenopausal women) or with fulvestrant (disease progression following hormonal therapy) in patients with hormone receptor (HR)-positive, HER-2 negative advanced metastatic breast cancer. 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.

This product is available in the following dosage forms:

• Capsule

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.

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.

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.

• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Enzalutamide
• Eslicarbazepine Acetate
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mitotane
• Nefazodone
• Nelfinavir
• Oxcarbazepine
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

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 form (capsules):
  • 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.