Non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK)-positive

Active Ingredient: Lorlatinib

Indication for Lorlatinib

Population group: only adults (18 - 65 years old)
Therapeutic intent: Curative procedure

Lorlatinib as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Lorlatinib as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after:

  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
  • crizotinib and at least one other ALK TKI.

For this indication, competent medicine agencies globally authorize below treatments:

100 mg once daily

For:

Dosage regimens

Oral, 100 milligrams lorlatinib, once daily.

Detailed description

The recommended dose is 100 mg lorlatinib taken orally once daily.

Duration of treatment

Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without 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 below:

  • 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.

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. 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. 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.

Dosage considerations

Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day with or without food.

Active ingredient

Lorlatinib

Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.

Read more about Lorlatinib

Related medicines

Develop a tailored medication plan for your case, considering factors such as age, gender, and health history

Ask the Reasoner

Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.