Lorviqua Dosage/Direction for Use

Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
ALK testing: Detection of ALK positive NSCLC is necessary for selection of patients for treatment with lorlatinib because these are the only patients for whom benefit has been shown. Assessment for ALK positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results.
Recommended dosing: The recommended dose schedule of LORVIQUA is 100 mg taken orally once daily continuously. Continue treatment as long as the patient is deriving clinical benefit from therapy.
LORVIQUA may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day. Tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
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 and/or dose reduction may be required based on individual safety and tolerability. Dose reduction levels are summarized as follows.
First dose reduction: LORVIQUA 75 mg taken orally once daily.
Second dose reduction: LORVIQUA 50 mg taken orally once daily.
LORVIQUA should be permanently discontinued if the patient is unable to tolerate LORVIQUA 50 mg taken orally once daily.
Dose modification recommendations for toxicities and for patients who develop first-degree, second-degree, or complete atrioventricular (AV) block are provided in Table 4. (See Tables 4A and 4B.)

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Strong cytochrome P-450 (CYP)3A inhibitors: Concurrent use of LORVIQUA with strong CYP3A inhibitors may increase lorlatinib plasma concentrations. An alternative concomitant medicinal product with less potential to inhibit CYP3A should be considered (see Interactions and Pharmacology: Pharmacokinetics under Actions). If a strong CYP3A inhibitor must be administered concomitantly, the starting LORVIQUA dose of 100 mg once daily should be reduced to once daily 75 mg dose. If concurrent use of a strong CYP3A inhibitor is discontinued, LORVIQUA should be resumed at the dose used prior to the initiation of the strong CYP3A inhibitor and after a washout period of 3 to 5 half-lives of the strong CYP3A inhibitor.
Hepatic impairment: No dose adjustments are recommended for patients with mild hepatic impairment. Limited information is available for lorlatinib in patients with moderate or severe hepatic impairment. Therefore, LORVIQUA is not recommended in patients with moderate to severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment [absolute estimated glomerular filtration rate (eGFR): ≥30 mL/min]. A reduced dose of LORVIQUA is recommended in patients with severe renal impairment (absolute eGFR <30 mL/min), e.g., a starting dose of 75 mg taken orally once daily (see Pharmacology: Pharmacokinetics under Actions).
Elderly (≥65 years): The limited data on the safety and efficacy of lorlatinib in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Pediatric patients: The safety and efficacy of lorlatinib in pediatric patients has not been established.