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|Dosage & Administration|
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Most common (incidence ≥ 20%) adverse reactions, including laboratory abnormalities, are leukocytes decreased, neutrophils decreased, hemoglobin decreased, lymphocytes decreased, aspartate aminotransferase increased, gamma glutamyl transferase increased, alanine aminotransferase increased, infections, nausea, creatinine increased, fatigue, platelets decreased, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, back pain, and glucose serum decreased.. 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)
Is it safe to take KISQALI during pregnancy?
No, KISQALI can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. The background risk of major birth defects and miscarriage for the indicated population is unknown. Pregnant women should be advised of the potential risk to a fetus.
Can KISQALI be taken while breastfeeding?
It is not known if ribociclib, the active ingredient in KISQALI, is present in human milk. Ribociclib and its metabolites readily passed into the milk of lactating rats. Lactating women are advised not to breastfeed while taking KISQALI and for at least 3 weeks after the last dose.
Should females of reproductive potential take any precautions while taking KISQALI?
Females of reproductive potential should undergo pregnancy testing prior to starting treatment with KISQALI. Effective contraception methods that result in less than 1% pregnancy rates are recommended during treatment with KISQALI and for at least 3 weeks after the last dose.
Can KISQALI be used in pediatric patients?
No, the safety and efficacy of KISQALI in pediatric patients has not been established.
Can KISQALI be used in geriatric patients?
No overall differences in safety or effectiveness of KISQALI were observed between geriatric patients (≥65 years old) and younger patients in clinical studies.
Are there any dosage adjustments required for patients with hepatic impairment?
No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh class A). A reduced starting dose of 400 mg is recommended for patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C).
Are there any dosage adjustments required for patients with renal impairment?
No dose adjustment is necessary for patients with mild or moderate renal impairment. For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2), a starting dose of 200 mg is recommended based on a renal impairment study in healthy subjects and non-cancer subjects.
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).
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