Lorlatinib (Lorviqua) is an inhibitor targeting ALK and ROS1 kinases, indicated for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).

How to Use Lorlatinib (Lorviqua)

Recommended Dosage

Standard Dosage: 100 milligrams (mg) orally once daily, either on an empty stomach or with food.

Administration Method: Swallow the tablet whole; do not chew, crush, or split it. If a tablet is broken, replace it with an intact one.

Missed Dose Handling: If a dose is missed, take the missed dose within 4 hours before the next scheduled dose. If less than 4 hours remain until the next dose, skip the missed dose—do not take a double dose to make up for it.

Vomiting Handling: If vomiting occurs after taking the medication, no additional dose is needed; follow the original schedule for the next dose.

Dosage Adjustment of Lorlatinib (Lorviqua)

Central Nervous System (CNS) Adverse Reactions

Grade 1: Maintain the original dosage, or suspend treatment until symptoms resolve and then continue with the original dosage.

Grades 2-3: Suspend medication; after symptoms resolve, reduce the dosage to 75mg or 50mg once daily.

Grade 4: Permanently discontinue the medication.

Hyperlipidemia

Grade 4 Elevation of Cholesterol or Triglycerides: Suspend medication until levels return to ≤ Grade 2, then resume with the original dosage.

If Recurrence Occurs: Reduce the dosage to 75mg or 50mg once daily.

Cardiac Conduction Block

Second-Degree Atrioventricular Block: Suspend treatment until the PR interval is < 200 milliseconds, then resume with a reduced dosage.

First Occurrence of Third-Degree Block: Suspend treatment; after a pacemaker is implanted, resume with the original dosage. If no pacemaker is implanted, resume with a reduced dosage.

Recurrent Third-Degree Block: Permanently discontinue the medication.

Lorlatinib (Lorviqua) Use in Special Populations

Patients with Hepatic Impairment

Mild Impairment (bilirubin ≤ upper limit of normal [ULN] with AST > ULN, or bilirubin 1-1.5 times ULN): No dosage adjustment is required.

Moderate to Severe Impairment: Safety has not been confirmed; careful assessment is necessary.

Patients with Renal Impairment

Mild to Moderate Impairment (creatinine clearance 30-89mL/min): No dosage adjustment is required.

Severe Impairment (creatinine clearance < 30mL/min): Data are insufficient; use with caution.

Pregnant and Lactating Women

Pregnancy: May cause fetal malformation. Pregnancy status must be confirmed before starting medication. Highly effective non-hormonal contraceptive measures are required during treatment and for 6 months after discontinuing the drug.

Lactation: Breastfeeding is prohibited during treatment and for 7 days after the last dose.

Children and Male Fertility

Children: Efficacy data have not been established.

Males: Contraceptive measures are required during treatment and for 3 months after discontinuing the drug, as the medication may temporarily affect fertility.