Ibrelyn Dosage/Direction for Use

Recommended Dose and Schedule: The recommended dose of palbociclib capsules is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib capsules should be taken with food [see Pharmacology: Pharmacodynamics under Actions]. Administer the recommended dose of an aromatase inhibitor when given with palbociclib capsules. Refer to the full prescribing information for the aromatase inhibitor being used. When given with palbociclib capsules, 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 palbociclib capsules 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. Palbociclib capsules should be swallowed whole (do not chew, crush or open them prior to swallowing). Capsules should not be ingested if they are broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination palbociclib capsules 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 1, 2 and 3. (See Tables 1, 2 and 3.)

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Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Permanently discontinue palbociclib capsules 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 palbociclib capsules dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the palbociclib capsules dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see 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 palbociclib capsules is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Pharmacology: Pharmacokinetics under Actions].
Route of Administration: Oral.