IBRANCE® tablets Patient Counseling Information

(palbociclib)

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)].

Interstitial Lung Disease/Pneumonitis

•
Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.2)].

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

•
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 tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). No 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 Dosage and Administration (2.1)].

Pregnancy, Lactation, and Infertility

•
Embryo-Fetal Toxicity
o
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 (5.3) and Use in Specific Populations (8.1 and 8.3)].
o
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)].

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Health Professional Information

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)].

Interstitial Lung Disease/Pneumonitis

•
Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.2)].

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

•
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 tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). No 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 Dosage and Administration (2.1)].

Pregnancy, Lactation, and Infertility

•
Embryo-Fetal Toxicity
o
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 (5.3) and Use in Specific Populations (8.1 and 8.3)].
o
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)].
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