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|Dosage & Administration|
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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)
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 ALECENSA be used during pregnancy?
No, ALECENSA can cause fetal harm when administered to a pregnant woman. It is advised to avoid using ALECENSA during pregnancy and advise pregnant women of the potential risk to a fetus.
Can ALECENSA be used during lactation?
No, there are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed infant, or its effects on milk production. It is advised to not breastfeed during treatment with ALECENSA and for 1 week after the final dose.
Should females and males of reproductive potential use contraception during treatment with ALECENSA?
Yes, females of reproductive potential should use effective contraception during treatment with ALECENSA and for 1 week after the final dose. Males with female partners of reproductive potential should also use effective contraception during treatment with ALECENSA and for 3 months following the final dose.
Is ALECENSA safe for pediatric use?
The safety and effectiveness of ALECENSA in pediatric patients have not been established.
Is ALECENSA safe for geriatric use?
Clinical studies of ALECENSA did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects.
Is ALECENSA safe for use in patients with renal or hepatic impairment?
No dose adjustment is recommended for patients with mild or moderate renal impairment or mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. However, the safety of ALECENSA in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease and severe hepatic impairment (Child-Pugh C) is unknown.