Ibrance

(palbociclib)
palbociclib 100 MG Oral Capsule [Ibrance]palbociclib 125 MG Oral Capsule [Ibrance]
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NO BLACK BOX WARNING

Dosage & administration

IBRANCE capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant.

biomarker testing

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

drug label

Ibrance prescribing information

samples

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prior authorization

Ibrance prior authorization resources

Most recent Ibrance prior authorization forms

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Verified: Sep 28, 2023Paramount - Ibrance Prior Authorization Form
Verified: Sep 28, 2023Johns Hopkins Healthcare - Ibrance Prior Authorization Form
Verified: Sep 28, 2023Sooner Care - Ibrance Prior Authorization Form
Verified: Sep 28, 2023United Health Care - Community Plan Washington Ibrance Prior Authorization Form

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Complete Letter of Medical Necessity

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Coverage Authorization Appeals

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Formulary Exception Letter
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Benefits investigation

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Pfizer Oncology Together Form

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Pfizer Oncology Together Form - Spanish
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Reimbursement help (FRM)

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Receive Assistance from an FRM Regarding Reimbursement Information
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pharmacy

Ibrance preferred pharmacy

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Pharmacy List

financial assistance

Ibrance financial assistance options

Co-pay savings program

commercial only
Enroll in Patient Savings Program

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HCP Office: Attest & Print Co-Pay Card
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Foundation programs

under insured
no insurance
goverment insurance
65+

PDF
Pfizer Oncology Together Form

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Pfizer Oncology Together Form - Spanish

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Pfizer Patient Assistance Program
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patient education

Ibrance patient education

Getting started on Ibrance

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Patient toolkit

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Pfizer Oncology Patient Access Guide
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Pfizer Oncology Patient Access Guide - Spanish
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BRAND PAGE
About Ibrance
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View How to Take Ibrance
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Managing Side Effects
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Patient Stories
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Patient Resources
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View How to Take Care - A Guide For Caregivers
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Ibrance Ambassador or Caregiver Ambassador Mentor Program
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Doctor Discussion Guide - Considering Ibrance
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Doctor Discussion Guide - Taking Ibrance
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Patient Guide
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Ibrance Support Overview
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Dosing Tracker: Ibrance + Aromatase Inhibitor (AI)
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Dosing Tracker: Ibrance + Fulvestrant
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Ibrance Spanish Website
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View How to Take Ibrance
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Other resources

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people also ask

Ibrance FAQs

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.
FAQ Data Source