Description
COMPOSITION
Lorlagen 100 Tablet: Each film coated tablet contains Lorlatinib INN 100 mg.
INDICATIONS
Lorlatinib as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive
advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
• Alectinib or Ceritinib as the first ALK inhibitor therapy; or
• Crizotinib and at least one other ALK inhibitor.
DOSAGE & ADMINISTRATION
The recommended dose is 100 mg Lorlatinib taken orally once daily.
Duration of treatment
Treatment with Lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without
unacceptable toxicity .
Delayed or missed doses
If a dose of Lorlatinib is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours
before the next dose, in which case the patient should not take the missed dose. Patients should not take 2 doses at the
same time to make up for a missed dose.
Dose modifications
Dosing interruption or dose reduction may be required based on individual safety and tolerability. Lorlatinib dose reduction
levels aresummarized below:
• First dose reduction: 75 mg taken orally once daily.
• Second dose reduction: 50 mg taken orally once daily.
Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
Special Populations
Elderly(≥65 years)
Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older.
Renal impairment
No dose adjustments needed for patients with normal renal function and mild or moderate (CLcr:≥ 30mL/min) renal
impairment based on a population pharmacokinetic analysis. Information for Lorlatinib use in patients with severe
(CLcr:< 30 mL/min) renal impairment is very limited. Therefore, Lorlatinib is not recommended in patients with severe
renal impairment.
Hepatic impairment
No dose adjustments is recommended for patients with mild hepatic impairment. No information is available for Lorlatinib
in patients with moderate or severe hepatic impairment. Therefore, Lorlatinib is not recommended in patients with
moderate to severe hepatic impairment.
Paediatric population
The safety and efficacy of Lorlatinib in paediatric patients below 18 years have not been established. No data are available
Reviews
There are no reviews yet.