Ibrance (Tablets)®(Palbociclib) | ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Oral, with or without food. Learn more. | |
Dosing | |
125 mg once daily (21 days on, 7 days off). Learn more. | |
Latin Shorthand | |
125 mg qd (21 days on, 7 days off).. Learn more. | |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
$25,000. Learn more. | |
Assistance Expiration | |
Card expires at the end of each calendar year. Learn more. | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
Most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.. Learn more. | |
Mechanism of Actions (MoA) | |
Cytochrome P450 3A Inhibitor; Kinase Inhibitor. Learn more. | |
Special Populations | |
What is the risk of IBRANCE during pregnancy? Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC. Pregnant women should be advised of the potential risk to a fetus. What is the estimated background risk of major birth defects and miscarriage for IBRANCE? The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Is it safe to breastfeed while taking IBRANCE? There is no information regarding the presence of palbociclib in human milk, its effects on milk production, or the breastfed infant. Because of the potential for serious adverse reactions in breastfed infants from IBRANCE, advise a lactating woman not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose. Should females of reproductive potential use contraception during treatment with IBRANCE? Females of reproductive potential should use effective contraception during treatment with IBRANCE and for at least 3 weeks after the last dose, as IBRANCE can cause fetal harm when administered to a pregnant woman. Should male patients with female partners of reproductive potential use contraception during treatment with IBRANCE? Male patients with female partners of reproductive potential should use effective contraception during treatment with IBRANCE and for 3 months after the last dose, as IBRANCE may cause genotoxicity. Can IBRANCE impair fertility in males of reproductive potential? Based on animal studies, IBRANCE may impair fertility in males of reproductive potential. Is IBRANCE safe for pediatric use? The safety and efficacy of IBRANCE in pediatric patients have not been studied. What is the recommended dose of IBRANCE for patients with hepatic impairment? No dose adjustment is required in 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. It is recommended to review the Full Prescribing Information for the aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment. What are the pharmacokinetic changes observed in patients with hepatic impairment? Based on a pharmacokinetic trial in subjects with varying degrees of hepatic function, the palbociclib unbound exposure (unbound AUCINF) decreased by 17% in subjects with mild hepatic impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, relative to subjects with normal hepatic function. Peak palbociclib unbound exposure (unbound Cmax) increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function. Is dose adjustment required in patients with renal impairment? No dose adjustment is required in patients with mild, moderate, or severe renal impairment (CrCl >15 mL/min). However, the pharmacokinetics of palbociclib have not been studied in patients requiring hemodialysis. What are the pharmacokinetic changes observed in patients with renal impairment? Based on a pharmacokinetic trial in subjects with varying degrees of renal function, the total palbociclib exposure (AUCINF) increased by 39%, 42%, and 31% with mild (60 mL/min ≤ CrCl <90 mL/min), moderate (30 mL/min ≤ CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal renal function. Peak palbociclib exposure (Cmax) increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. | |