The following information summarizes current U.S. IBRANCE labeling and is not an individualized prescription. The applicable product label should always be consulted.
Standard starting dose
The current U.S. labeled starting dose of IBRANCE is 125 mg once daily for 21 consecutive days followed by 7 days off treatment, forming a 28-day cycle.
| Treatment component | Current U.S. labeled approach |
|---|---|
| Starting dose | 125 mg once daily |
| Treatment days | Days 1–21 |
| Treatment break | Days 22–28 |
| Cycle length | 28 days |
| Administration | Depends on formulation |
| Dose modification | Based on safety/tolerability |
Formulation-specific food instructions
Current U.S. labeling specifies that capsules are taken with food, while tablets may be taken with or without food.
This distinction is important because a product’s dosage form should be established before administration instructions are applied.
Dose reductions
Dose interruption and reduction can be required because of adverse reactions, particularly hematologic toxicity. Current IBRANCE labeling provides a dose-modification framework for neutropenia and other clinically significant toxicity.
Complete blood-count monitoring
CBC monitoring is recommended before treatment, at the beginning of each cycle, on Day 15 of the first two cycles and as clinically indicated.
Renal impairment
The palbociclib prescribing information includes specific considerations for patients with renal impairment. Dose recommendations should be taken from the applicable current product label rather than inferred from the 125 mg starting dose.
Hepatic impairment
Hepatic function can affect palbociclib exposure. The prescribing information should be consulted for dose recommendations according to the severity of hepatic impairment.
Drug interactions
Strong CYP3A inhibitors should generally be avoided. If unavoidable, the IBRANCE dose may need to be reduced. Strong CYP3A inducers should also be avoided.
Important limitation
The 125 mg dose is a labeled starting dose for IBRANCE in relevant regimens; it does not mean that every patient should receive 125 mg.