Lorviqua Dosage/Direction for Use

Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
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 thespecific technology being utilised. Improper assay performance can lead to unreliable test results.
Posology: The recommended dose is 100 mg lorlatinib taken orally once daily.
Duration of treatment: Treatment with lorlatinib should be continued until disease progression or 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 are summarised as follows: 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.
Dose modification recommendations for toxicities and for patients who develop atrioventricular (AV) block are provided in Table 4. (See Tables 4a and 4b.)

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Strong cytochrome P-450 (CYP) 3A4/5 inhibitors: Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and grapefruit juice products may increase lorlatinib plasma concentrations. An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered (see Interactions). If a strong CYP3A4/5 inhibitor must be co-administered, the starting lorlatinib dose of 100 mg once daily should be reduced to once daily 75 mg dose (see Interactions and Pharmacology: Pharmacokinetics under Actions). If concurrent use of the strong CYP3A4/5 inhibitor is discontinued, lorlatinib should be resumed at the dose used prior to the initiation of the strong CYP3A4/5 inhibitor and after a washout period of 3 to 5 half-lives of the strong CYP3A4/5 inhibitor.
Special populations: Hepatic impairment: No dose adjustments are 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 (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is needed for patients with normal renal function and mild or moderate renal impairment [absolute estimated glomerular filtration rate (eGFR): ≥30 mL/min]. A reduced dose of lorlatinib is recommended in patients with severe renal impairment (absolute eGFR <30 mL/min), e.g. a once daily starting dose of 75 mg taken orally (see Pharmacology: Pharmacokinetics under Actions). No information is available for patients on renal dialysis.
Elderly (≥65 years): Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of lorlatinib in paediatric patients below 18 years have not been established. No data are available.
Method of administration: Lorviqua is for oral use.
Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day with or without food (see Pharmacology: Pharmacokinetics under Actions). The 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.