Verzenio®(Abemaciclib)

Ibrance (Capsules)®(Palbociclib)

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...

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...

Dosage & Administration

Administration

Oral, with or without food. Learn more.

Dosing

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

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

Latin Shorthand

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

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

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

Annual Cap

$25,000. Learn more.

Assistance Expiration

12 months from patient qualification. Learn more.

Card expires at the end of each calendar year. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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.

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)

Kinase Inhibitors. Learn more.

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

Special Populations

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).

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.

Verzenio®(Abemaciclib)	Ibrance (Capsules)®(Palbociclib)

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...	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...
Dosage & Administration	Dosage & Administration comparison data
Administration
Oral, with or without food. Learn more.	Oral, with or without food. Learn more.
Dosing
150 mg twice daily (in combination with fulvestrant, tamoxifen, or an aromatase inhibitor) or 200 mg twice daily (as monotherapy). Learn more.	125 mg once daily (21 days on, 7 days off). Learn more.
Latin Shorthand
150 mg bid (w/ fulvestrant, tamoxifen, or AI) or 200 mg bid. Learn more.	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.	$0. Learn more.
Annual Cap
$25,000. Learn more.	$25,000. Learn more.
Assistance Expiration
12 months from patient qualification. Learn more.	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 ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.. Learn more.	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)
Kinase Inhibitors. Learn more.	Cytochrome P450 3A Inhibitor; Kinase Inhibitor . Learn more.
Special Populations
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).	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.

Verzenio® Alternatives