palbociclib 100 MG Oral Capsule [Ibrance]palbociclib 125 MG Oral Capsule [Ibrance]
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NO BLACK BOX WARNING
Dosage & administration
Ibrance clinical details
Genetic testing requirements were obtained from the NCCN guidelines for each cancer type.
OlaparibPALB2 (partner and localizer of BRCA2) NGS
OlaparibBRCA1/2 (breast cancer gene)NGS
PembrolizumabTMB-H (high tumor mutational burden)NGS
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Getting started on Ibrance
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people also ask
Is IBRANCE safe to use during pregnancy?No, IBRANCE can cause fetal harm when administered to a pregnant woman. Animal studies have shown embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC. There are no available data in pregnant women to inform the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus.
Can lactating women use IBRANCE?No, there is no information regarding the presence of palbociclib in human milk or its effects on milk production or the breastfed infant. Lactating women should be advised not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.
Should females of reproductive potential have a pregnancy test before taking IBRANCE?Yes, based on animal studies, IBRANCE can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a pregnancy test prior to starting treatment with IBRANCE. Effective contraception should be used during treatment with IBRANCE and for at least 3 weeks after the last dose.
Can male patients with female partners of reproductive potential use 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 due to the potential for genotoxicity. IBRANCE may also impair fertility in males of reproductive potential.
Has IBRANCE been studied in pediatric patients?No, the safety and efficacy of IBRANCE in pediatric patients have not been studied. Toxicities in teeth and altered glucose metabolism have been observed in immature rats receiving high doses of palbociclib.
Is IBRANCE safe for use in geriatric patients?No overall differences in safety or effectiveness of IBRANCE were observed between geriatric patients and younger patients in clinical trials.
Do patients with hepatic impairment require a dose adjustment when taking IBRANCE?No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). However, 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.
What are the pharmacokinetic effects of hepatic impairment on palbociclib?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.
Are there any dose adjustments needed for patients with renal impairment?No dose adjustment is required in patients with mild, moderate, or severe renal impairment (CrCl >15 mL/min). However, 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.
Are there any dose modifications related to hepatic impairment for other medications used with IBRANCE?Please review the Full Prescribing Information for the aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment.
Has the pharmacokinetics of palbociclib been studied in patients requiring hemodialysis?The pharmacokinetics of palbociclib have not been studied in patients requiring hemodialysis.
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