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Kisqali® Alternatives
Kisqali®(ribociclib) | Ibrance (Capsules)®(palbociclib) |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | |
Administration | |
Oral, with or without food. Learn more. | Oral, with or without food. Learn more. |
Dosing | |
600 mg once daily (three 200 mg tablets) (21 days on, 7 days off). Learn more. | 125 mg once daily (21 days on, 7 days off). Learn more. |
Latin Shorthand | |
600 mg qd (3 tabs of 200 mg) (21 days on, 7 days off).. Learn more. | 125 mg qd (21 days on, 7 days off).. Learn more. |
| Financial Assistance | |
Out-Of-Pocket Costs With Copay Card | |
Up to $25. Learn more. | $0. Learn more. |
Annual Cap | |
$15,000. Learn more. | $25,000. Learn more. |
Assistance Expiration | |
Program may be rescinded, revoked, or amended by Novartis at any time. 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 | |
Adverse Reactions | |
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 ≥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) | |
Cytochrome P450 3A Inhibitor; Kinase Inhibitor . Learn more. | Cytochrome P450 3A Inhibitor; Kinase Inhibitor . Learn more. |
Special Populations | |
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. | 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. |