Ibrance Dosage/Direction for Use

Recommended Dose and Schedule: The recommended dose of IBRANCE is a 125 mg capsule or tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE capsule should be taken with food and IBRANCE tablet may be taken with or without food [see Pharmacology: Pharmacokinetics under Actions].
Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Refer to the full prescribing information for the aromatase inhibitor being used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
Patients should be encouraged to take their dose of IBRANCE at approximately the same time each day.
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). Capsules and Tablets should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination IBRANCE plus fulvestrant therapy should also be treated with luteinizing hormone releasing hormone (LHRH) agonists according to current clinical practice standards.
Dose Modification: The recommended dose modifications for adverse reactions are listed in Tables 3, 4 and 5. (See Tables 3, 4 and 5.)

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Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.
Refer to the full prescribing information for co-administered endocrine therapy dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.
Dose Modifications for Use with Strong CYP3A Inhibitors: Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be co-administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Agents that may Increase Palbociclib Plasma Concentrations under Interactions and Pharmacology: Pharmacokinetics under Actions].
Dose Modifications for Hepatic Impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].