Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Lorviqua 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:
Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
The recommended dose is 100 mg lorlatinib taken orally once daily.
Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity.
If a dose of Lorviqua 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.
Dosing interruption or dose reduction may be required based on individual safety and tolerability.
Lorlatinib dose reduction levels are summarised below:
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 1.
Table 1. Recommended lorlatinib dose modifications for adverse reactions:
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 section 4.5). 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 sections 4.5 and 5.2). 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.
Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older (see section 5.2).
No dose adjustment is 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 (see section 5.2).
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 section 5.2).
The safety and efficacy of lorlatinib in paediatric patients below 18 years have not been established. No data are available.
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 section 5.2). 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.
Treatment of overdose with the medicinal product consists of general supportive measures. Given the dose-dependent effect on PR interval, ECG monitoring is recommended. There is no antidote for lorlatinib.
3 years.
This medicinal product does not require any special storage conditions.
OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.
Lorviqua 25 mg film-coated tablets: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Lorviqua 100 mg film-coated tablets: Each pack contains 30 film-coated tablets in 3 blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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