Ibrance Patient Counseling 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 Neutropenia under Precautions].
Interstitial Lung Disease/Pneumonitis: Advise patients to immediately report new or worsening respiratory symptoms [see Interstitial Lung Disease (ILD)/Pneumonitis under Precautions].
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 Interactions].
Dosing and Administration: Advise patients to take IBRANCE capsule with food and inform patients that IBRANCE tablets may be taken with or without 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) and IBRANCE tablets should be swallowed whole (do not chew, crush or split them prior to swallowing). No capsule and tablet 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 Recommended Dose and Schedule under Dosage & Administration).
Pregnancy, Lactation, and Fertility: 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 Embryo-Fetal Toxicity under Precautions and Pregnancy, Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
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 Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose [see Lactation under Use in Pregnancy & Lactation].