Compare drug alternatives
|Dosage & Administration|
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
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.
Mechanism of Actions (MoA)
What is the risk of taking ALUNBRIG during pregnancy?
Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to a pregnant woman. There are no clinical data on the use of ALUNBRIG in pregnant women. Administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies, increased post-implantation loss, malformations, and decreased fetal body weight. Advise pregnant women of the potential risk to a fetus.
What is the estimated background risk of birth defects and miscarriage in pregnant women?
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 take ALUNBRIG while breastfeeding?
There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential for adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG and for 1 week following the final dose.
What precautions should females and males of reproductive potential take while taking ALUNBRIG?
Females of reproductive potential should verify pregnancy status prior to initiating ALUNBRIG and use effective contraception during treatment and for at least 4 months after the final dose. Males with female partners of reproductive potential should also use effective contraception during treatment and for at least 3 months after the final dose. ALUNBRIG may cause reduced fertility in males based on findings in animal studies.
Is ALUNBRIG safe for use in pediatric patients?
The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.
Is ALUNBRIG safe for use in geriatric patients?
No overall differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients in clinical studies.
Are dose adjustments necessary for patients with hepatic or renal impairment?
Reduce the dose of ALUNBRIG for patients with severe hepatic impairment (Child-Pugh C) and severe renal impairment (creatinine clearance 15 to 29 mL/min). No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh A or B) or mild or moderate renal impairment (creatinine clearance 30 to 89 mL/min).
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.