Ibrance (Tablets)®(Palbociclib)

Verzenio®(Abemaciclib)

Prescription Only

Ibrance is a medication that inhibits CDK4/6 and can be used to treat advanced or metastatic hormone-receptor-positive (HR+), human epidermal growth factor receptor 2 negative...

Prescription Only

Verzenio (abemaciclib) is a medication that targets cancer cells and helps to slow their growth and spread in the body. It can be used to treat early breast cancer in adults that...

Dosage & Administration

Administration

Oral, with or without food. Learn more.

Dosing

125 mg once daily (21 days on, 7 days off). Learn more.

150 mg twice daily (in combination with fulvestrant, tamoxifen, or an aromatase inhibitor) or 200 mg twice daily (as monotherapy). Learn more.

Latin Shorthand

125 mg qd (21 days on, 7 days off).. Learn more.

150 mg bid (w/ fulvestrant, tamoxifen, or AI) or 200 mg bid. Learn more.

Financial Assistance

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.

12 months from patient qualification. Learn more.

Generics

No lower-cost generic available

Physician Advisory

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.

Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.. Learn more.

Mechanism of Actions (MoA)

Cytochrome P450 3A Inhibitor; Kinase Inhibitor. Learn more.

Kinase Inhibitors. 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.

What is VERZENIO?

VERZENIO is a medication used to treat certain types of breast cancer.

Can VERZENIO cause harm to a fetus if taken during pregnancy?

Yes, based on animal studies and its mechanism of action, VERZENIO can cause fetal harm when administered to a pregnant woman. There are no available human data informing the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus.

What are the potential risks to a fetus if a pregnant woman takes VERZENIO?

In animal reproduction studies, administration of abemaciclib (the active ingredient in VERZENIO) during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on AUC at the maximum recommended human dose. Doses ≥4 mg/kg/day in pregnant rats caused decreased fetal body weights and increased incidence of cardiovascular and skeletal malformations and variations.

What is the background risk of major birth defects and miscarriage for the indicated population?

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Can VERZENIO be taken during lactation?

No, there are no data on the presence of abemaciclib (the active ingredient in VERZENIO) in human milk, or its effects on the breastfed child or on milk production. Lactating women should be advised not to breastfeed during VERZENIO treatment and for 3 weeks after the last dose.

Can VERZENIO affect fertility in males of reproductive potential?

Yes, based on findings in animals, VERZENIO may impair fertility in males of reproductive potential.

Should females of reproductive potential use contraception during VERZENIO treatment?

Yes, females of reproductive potential should use effective contraception during VERZENIO treatment and for 3 weeks after the last dose.

Is VERZENIO safe and effective for use in pediatric patients?

The safety and effectiveness of VERZENIO have not been established in pediatric patients.

Is VERZENIO safe and effective for use in geriatric patients?

No overall differences in safety or effectiveness of VERZENIO were observed between older patients (65 years of age or older) and younger patients. However, the most common adverse reactions in older patients were neutropenia, diarrhea, fatigue, nausea, dehydration, leukopenia, anemia, infections, and ALT increased.

Is dosage adjustment necessary for patients with renal impairment?

No dosage adjustment is required for patients with mild or moderate renal impairment (CLcr ≥30-89 mL/min, estimated by Cockcroft-Gault [C-G]). The pharmacokinetics of abemaciclib in patients with severe renal impairment (CLcr <30 mL/min, C-G), end stage renal disease, or in patients on dialysis is unknown.

Is dosage adjustment necessary for patients with hepatic impairment?

No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B). Reduce the dosing frequency when administering VERZENIO to patients with severe hepatic impairment (Child-Pugh C).

Ibrance (Tablets)®(Palbociclib)	Verzenio®(Abemaciclib)

Prescription Only Ibrance is a medication that inhibits CDK4/6 and can be used to treat advanced or metastatic hormone-receptor-positive (HR+), human epidermal growth factor receptor 2 negative...	Prescription Only Verzenio (abemaciclib) is a medication that targets cancer cells and helps to slow their growth and spread in the body. It can be used to treat early breast cancer in adults that...
Dosage & Administration	Dosage & Administration comparison data
Administration
Oral, with or without food. Learn more.	Oral, with or without food. Learn more.
Dosing
125 mg once daily (21 days on, 7 days off). Learn more.	150 mg twice daily (in combination with fulvestrant, tamoxifen, or an aromatase inhibitor) or 200 mg twice daily (as monotherapy). Learn more.
Latin Shorthand
125 mg qd (21 days on, 7 days off).. Learn more.	150 mg bid (w/ fulvestrant, tamoxifen, or AI) or 200 mg bid. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$25,000. Learn more.	$25,000. Learn more.
Assistance Expiration
Card expires at the end of each calendar year. Learn more.	12 months from patient qualification. 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.	Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.. Learn more.
Mechanism of Actions (MoA)
Cytochrome P450 3A Inhibitor; Kinase Inhibitor. Learn more.	Kinase Inhibitors. 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.	What is VERZENIO? VERZENIO is a medication used to treat certain types of breast cancer. Can VERZENIO cause harm to a fetus if taken during pregnancy? Yes, based on animal studies and its mechanism of action, VERZENIO can cause fetal harm when administered to a pregnant woman. There are no available human data informing the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus. What are the potential risks to a fetus if a pregnant woman takes VERZENIO? In animal reproduction studies, administration of abemaciclib (the active ingredient in VERZENIO) during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on AUC at the maximum recommended human dose. Doses ≥4 mg/kg/day in pregnant rats caused decreased fetal body weights and increased incidence of cardiovascular and skeletal malformations and variations. What is the background risk of major birth defects and miscarriage for the indicated population? The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Can VERZENIO be taken during lactation? No, there are no data on the presence of abemaciclib (the active ingredient in VERZENIO) in human milk, or its effects on the breastfed child or on milk production. Lactating women should be advised not to breastfeed during VERZENIO treatment and for 3 weeks after the last dose. Can VERZENIO affect fertility in males of reproductive potential? Yes, based on findings in animals, VERZENIO may impair fertility in males of reproductive potential. Should females of reproductive potential use contraception during VERZENIO treatment? Yes, females of reproductive potential should use effective contraception during VERZENIO treatment and for 3 weeks after the last dose. Is VERZENIO safe and effective for use in pediatric patients? The safety and effectiveness of VERZENIO have not been established in pediatric patients. Is VERZENIO safe and effective for use in geriatric patients? No overall differences in safety or effectiveness of VERZENIO were observed between older patients (65 years of age or older) and younger patients. However, the most common adverse reactions in older patients were neutropenia, diarrhea, fatigue, nausea, dehydration, leukopenia, anemia, infections, and ALT increased. Is dosage adjustment necessary for patients with renal impairment? No dosage adjustment is required for patients with mild or moderate renal impairment (CLcr ≥30-89 mL/min, estimated by Cockcroft-Gault [C-G]). The pharmacokinetics of abemaciclib in patients with severe renal impairment (CLcr <30 mL/min, C-G), end stage renal disease, or in patients on dialysis is unknown. Is dosage adjustment necessary for patients with hepatic impairment? No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B). Reduce the dosing frequency when administering VERZENIO to patients with severe hepatic impairment (Child-Pugh C).

Ibrance (Tablets)® Alternatives