Sorry, you need to enable JavaScript to visit this website.

IBRANCE® (palbociclib) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Myelosuppression/Infection

  • Advise patients to immediately report any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath, weakness, or any increased tendency to bleed and/or to bruise [see Warnings and Precautions (5.1)].

Drug Interactions

  • Grapefruit may interact with IBRANCE. Patients should not consume grapefruit products while on treatment with IBRANCE.
  • Inform patients to avoid strong CYP3A inhibitors and strong CYP3A inducers.
  • Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].

Dosing and Administration

  • Advise patients to take IBRANCE with food.
  • If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact.
  • Pre/perimenopausal women treated with IBRANCE should also be treated with LHRH agonists [see Dosage and Administration (2.1)].

Pregnancy, Lactation, and Infertility

  • Embryo-Fetal Toxicity
    • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with IBRANCE therapy and for at least 3 weeks after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1 and 8.3)].
    • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with IBRANCE and for at least 3 months after the last dose [see Use in Specific Populations (8.3)].
  • Lactation: Advise women not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].
  • Infertility: Inform males of reproductive potential that IBRANCE may cause infertility and to consider sperm preservation before taking IBRANCE [see Use in Specific Populations (8.3)].

What's New

No Current Announcements.

Therapeutic Area

Contact Pfizer Medical

Report an Adverse Event
1-800-438-1985

Search

Please enter your search term(s) for IBRANCE®

Contact Pfizer

Need to report an Adverse Event, Side Effect or Product Quality Concern?

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch

Have a Medical Question on a Pfizer Prescription Medicine?
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Have a Question on a Pfizer Over-the-Counter Product?
For Pfizer Consumer Healthcare non-prescription or over-the-counter products such as Advil, Centrum, Nexium or Thermacare, call (800) 322-3129
Have a Question about Pfizer Clinical Trials?
If you are looking for information about Pfizer studies currently recruiting new patients in your area, you can begin your search on our website. For questions about a Pfizer Clinical Trial, call (800) 718-1021 or email [email protected]
Need Information on Pfizer’s Patient Assistance Programs?

Pfizer RxPathways® connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. For more information, please call (844) 989-7284 or visit www.PfizerRxPathways.com.

Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Visit www.MyPfizerBrands.com for more information.