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Lorbrena® Alternatives
Lorbrena®(lorlatinib) | Xalkori®(crizotinib) |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | |
Administration | |
Oral. Learn more. | Oral. Learn more. |
Dosing | |
100 mg once daily, 75 mg for severe renal impairment. Learn more. | 250 mg twice daily for metastatic NSCLC. Learn more. |
Latin Shorthand | |
100mg qd 75mg qd for renal impairment. Learn more. | 250 mg bid. Learn more. |
| Financial Assistance | |
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 | |
6/30/2023. Learn more. | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | |
Adverse Reactions | |
Most common (incidence ≥20%) adverse reactions and Grade 3-4 laboratory
abnormalities are edema, peripheral neuropathy, weight gain, cognitive
effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects,
hypercholesterolemia, hypertriglyceridemia, and cough.. Learn more. | 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) | |
Kinase inhibitors; Cytochrome P450 3A4 Inducers. Learn more. | Receptor tyrosine kinase inhibitors; Cytochrome P450 2B6 inhibitors; Cytochrome P450 3A inhibitors; OCT2 inhibitors; OCT1 inhibitors. Learn more. |
Special Populations | |
Is LORBRENA safe to use during pregnancy? Based on findings from animal studies and its mechanism of action, LORBRENA can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on LORBRENA use in pregnant women. Administration of lorlatinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations, increased post-implantation loss, and abortion at maternal exposures that were equal to or less than the human exposure at the recommended dose of 100 mg once daily based on AUC. Therefore, it is advised to inform pregnant women of the potential risk to a fetus. Is it safe to breastfeed while using LORBRENA? There are no data on the presence of lorlatinib or its metabolites in either human or animal milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants, women are instructed not to breastfeed during treatment with LORBRENA and for 7 days after the final dose. What precautions should be taken by females and males of reproductive potential? Before initiating LORBRENA, pregnancy status in females of reproductive potential should be verified. LORBRENA can cause embryo-fetal harm when administered to a pregnant woman, so female patients of reproductive potential are advised to use effective non-hormonal contraception during treatment with LORBRENA and for at least 6 months after the final dose. A non-hormonal method of contraception should be used, as LORBRENA can render hormonal contraceptives ineffective. For males with female partners of reproductive potential, effective contraception should be used during treatment with LORBRENA and for at least 3 months after the final dose, based on genotoxicity findings. LORBRENA may transiently impair male fertility, according to findings from animal studies. Is LORBRENA safe for pediatric use? The safety and effectiveness of LORBRENA in pediatric patients have not been established. Is LORBRENA safe for geriatric use? No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients in studies B7461001 and B7461006. However, caution is advised when treating elderly patients, as they may be more sensitive to the effects of LORBRENA. Is LORBRENA safe for patients with hepatic impairment? No dose adjustment is recommended for patients with mild hepatic impairment. The recommended dose of LORBRENA has not been established for patients with moderate or severe hepatic impairment. What is renal impairment? Renal impairment refers to a condition where the kidneys are not functioning properly, leading to a decrease in their ability to filter waste products and excess fluids from the body. What is CLcr? CLcr stands for creatinine clearance, which is a measure of kidney function. It is estimated using the Cockcroft-Gault equation based on a person's age, weight, and serum creatinine level. Who should have a reduced dose of LORBRENA due to renal impairment? Patients with severe renal impairment, which is defined as a CLcr of 15 to less than 30 mL/min, should have a reduced dose of LORBRENA when it is administered. Is a dose adjustment necessary for patients with mild or moderate renal impairment? No, a dose adjustment is not recommended for patients with mild or moderate renal impairment, which is defined as a CLcr of 30 to 89 mL/min. Where can I find more information on dosing for patients with renal impairment? More information on dosing for patients with renal impairment can be found in the 'Dosage and Administration' section (2.8) and the 'Clinical Pharmacology' section (12.3) of the LORBRENA prescribing information. | 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. |