®() | Xalkori®(Crizotinib) |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Oral. Learn more. | |
Dosing | |
250 mg twice daily for metastatic NSCLC. Learn more. | |
Latin Shorthand | |
250 mg bid. Learn more. | |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
$25,000. Learn more. | |
Assistance Expiration | |
6/30/2023. Learn more. | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.
The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia.
The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema.
The most common adverse reactions (≥35%) in pediatric patients with IMT are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. . Learn more. | |
Mechanism of Actions (MoA) | |
Receptor tyrosine kinase inhibitors; Cytochrome P450 2B6 inhibitors; Cytochrome P450 3A inhibitors; OCT2 inhibitors; OCT1 inhibitors. Learn more. | |
Special Populations | |
Can XALKORI be used during pregnancy? XALKORI can cause fetal harm when administered to a pregnant woman based on findings from animal studies and its mechanism of action. There are no available data on the use of XALKORI during pregnancy. In animal reproduction studies, oral administration of crizotinib in pregnant rats during organogenesis at exposures similar to those expected with the maximum recommended human dose resulted in embryotoxicity and fetotoxicity. Therefore, pregnant women should be advised of the potential risk to fetus and XALKORI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. What is the estimated background risk of birth defects and miscarriage in the U.S. general population? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Is it safe to breastfeed while using XALKORI? There is no information regarding the presence of crizotinib or its metabolites in human milk, or the effects on the breastfed child or on milk production. Because of the potential for adverse reactions in breastfed children, women should not breastfeed during treatment with XALKORI and for 45 days after the final dose. Should pregnancy testing be performed before starting treatment with XALKORI? Yes, pregnancy testing should be performed prior to initiating XALKORI in females of reproductive potential. What should females of reproductive potential do during treatment with XALKORI? Females of reproductive potential should use effective contraception during treatment with XALKORI and for at least 45 days after the final dose because XALKORI can cause fetal harm when administered to a pregnant woman. What should males with female partners of reproductive potential do during treatment with XALKORI? Males with female partners of reproductive potential should use condoms during treatment with XALKORI and for at least 90 days after the final dose because of the potential for genotoxicity. Can XALKORI be used in pediatric patients? The safety and effectiveness of XALKORI have been established in pediatric patients 1 year of age and older with relapsed or refractory, systemic ALK-positive ALCL or with unresectable, recurrent, or refractory ALK-positive IMT. However, the safety and effectiveness have not been established in pediatric patients younger than 1 year. What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older? 16% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 65 years or older. What percentage of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older? 3.8% of the total number of patients with ALK-positive metastatic NSCLC in clinical studies of XALKORI were 75 years or older. Were there any overall differences in safety or effectiveness observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC? No overall differences in safety or effectiveness were observed between older patients and younger patients in clinical studies of XALKORI for ALK-positive metastatic NSCLC. Were there sufficient numbers of patients age 65 years and older in clinical studies of XALKORI for ROS1-positive metastatic NSCLC to determine if they respond differently from younger patients? No, clinical studies of XALKORI in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients. What happens to crizotinib concentrations in patients with pre-existing moderate or severe hepatic impairment? Crizotinib concentrations increase in patients with pre-existing moderate or severe hepatic impairment. How should XALKORI dosage be adjusted in patients with moderate or severe hepatic impairment? XALKORI dosage should be reduced in patients with moderate or severe hepatic impairment. Is a dose adjustment recommended in patients with pre-existing mild hepatic impairment? No, a dose adjustment is not recommended in patients with pre-existing mild hepatic impairment. What happens to crizotinib exposure in patients with pre-existing severe renal impairment? Increased exposure to crizotinib occurs in patients with pre-existing severe renal impairment. | |