Lorlatinib (Lorviqua), a third-generation ALK inhibitor, demonstrates remarkable efficacy in the treatment of ALK-positive non-small cell lung cancer (NSCLC).

Dosage and Administration, Recommended Dose of Lorlatinib (Lorviqua)

Applicable Population

Lorlatinib is indicated for adult patients with metastatic ALK-positive non-small cell lung cancer confirmed by FDA-approved testing methods.

Patient selection shall be based on the ALK-positive status demonstrated in tumor specimens.

Recommended Dose

The standard recommended dose is 100 mg, administered orally once daily.

The timing of administration is not affected by food intake.

If a tablet is damaged, cracked, or incomplete, it must not be taken.

Precautions for Administration

If a dose is missed, take the missed dose immediately upon remembering. However, if less than 4 hours remain until the next scheduled dose, skip the missed dose.

If vomiting occurs after medication intake, do not take an additional dose; continue with the next scheduled dose as planned.

Dose Adjustment of Lorlatinib (Lorviqua)

Central Nervous System (CNS) Reactions

For Grade 1 reactions, the original dose may be maintained, or administration may be suspended until baseline status is restored, then resume the original dose or reduce the dose.

For Grade 2-3 reactions, suspend administration until the reaction resolves to Grade 0-1, then resume with a reduced dose. Grade 4 reactions require permanent discontinuation of treatment.

Atrioventricular (AV) Block

For second-degree AV block, suspend administration until the PR interval is < 200 ms, then resume with a reduced dose.

For the first occurrence of complete AV block, suspend administration until a pacemaker is implanted or the PR interval is < 200 ms. The original dose may be resumed after pacemaker implantation. For patients without pacemaker implantation, resume with a reduced dose.

For recurrent complete AV block, pacemaker implantation or permanent treatment discontinuation is required.

Hypertension

For Grade 3 hypertension, suspend administration until blood pressure is controlled to below Grade 1, then resume the original dose.

If hypertension recurs, reduce the dose.

For Grade 4 hypertension, suspend administration until blood pressure is controlled to below Grade 1, then either resume with a reduced dose or discontinue treatment permanently.

Use in Special Populations of Lorlatinib (Lorviqua)

Patients with Renal Impairment

For patients with severe renal impairment (creatinine clearance 15 to < 30 mL/min), the recommended dose should be reduced from 100 mg to 75 mg once daily.

Pregnant Women

Based on pharmacological mechanisms and animal experimental data, lorlatinib may cause fetal harm.

The risks of medication use during pregnancy must be fully explained to pregnant women. Females of childbearing potential should use effective non-hormonal contraceptive measures.