Verzenio

Question 1

What is VERZENIO?

Accepted Answer

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

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

Can VERZENIO be taken during lactation?

Accepted Answer

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.

Question 6

Can VERZENIO affect fertility in males of reproductive potential?

Accepted Answer

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

Question 7

Should females of reproductive potential use contraception during VERZENIO treatment?

Accepted Answer

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

Question 8

Is VERZENIO safe and effective for use in pediatric patients?

Accepted Answer

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

Question 9

Is VERZENIO safe and effective for use in geriatric patients?

Accepted Answer

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.

Question 10

Is dosage adjustment necessary for patients with renal impairment?

Accepted Answer

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.

Question 11

Is dosage adjustment necessary for patients with hepatic impairment?

Accepted Answer

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).