Ibrance

Ibrance Dosage/Direction for Use

palbociclib

Manufacturer:

Pfizer
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
When coadministered with palbociclib, the recommended dose of letrozole is 2.5 mg taken orally once daily continuously throughout the 28-day cycle. Please refer to the full prescribing information of letrozole.
Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see Precautions).
Patients should be encouraged to take their dose at approximately the same time each day. Continue the treatment as long as the patient is deriving clinical benefit from therapy.
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.
Method of administration: IBRANCE is for oral use. It should be taken with food, preferably a meal to ensure consistent palbociclib exposure (see Pharmacology: Pharmacokinetics under Actions). Palbociclib should not be taken with grapefruit or grapefruit juice (see Interactions). IBRANCE capsules should be swallowed whole (should not be chewed, crushed, or opened prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact.
Dose modifications: Dose modification of IBRANCE is recommended based on individual safety and tolerability.
Management of some adverse reactions may require temporary dosing interruptions/cycle delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules provided in Tables 2, 3, and 4 (see Precautions and Adverse Reactions). (See Table 2, Table 3 and Table 4.)


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No dose modifications are required on the basis of patient's age, sex, or body weight (see Pharmacology: Pharmacokinetics under Actions). Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD) or pneumonitis.
Special populations: Elderly population: No dose adjustment is necessary in patients ≥65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Pediatric population: The safety and efficacy of IBRANCE in children and adolescents ≤18 years of age have not been established.
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 on Schedule 3/1 (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Insufficient data are available in patients requiring hemodialysis to provide any dosing recommendation in this patient population (see Pharmacology: Pharmacokinetics under Actions).
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