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Lorbrena® (lorlatinib)

Lorbrena® is a treatment for people with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have previously been treated with 1 or more ALK inhibitors and their cancer has gotten worse. These medications include:1,2

How does lorlatinib work?

In people with ALK-positive lung cancer, there is a mutation in the gene that produces the protein ALK, and this mutation causes cancer cells to grow more quickly and multiply. Lorlatinib blocks the ALK protein, which may slow or stop the growth of lung cancer cells.1

While there are other ALK inhibitors, many patients develop a resistance to the medication, and their lung cancer begins to worsen. Lorlatinib provides an additional option for patients who have already tried other ALK inhibitors.2

What are the possible side effects of lorlatinib?

The most common side effects experienced by patients receiving lorlatinib in clinical trials included included edema (swelling), tingling or pain in the hands or feet (peripheral neuropathy), cognitive effects, trouble breathing, fatigue, weight gain, joint pain, mood effects, and diarrhea. Serious side effects occurred in 32% of the patients in clinical trials. Serious side effects include risk of serious liver problems, seizures, hallucinations, or other mental problems, increases in cholesterol or lipids (triglycerides), slow or low heart rhythm, or lung problems (difficulty breathing, shortness of breath, or cough). Some of these serious side effects may be fatal.1,3

Things to know about lorlatinib

Before beginning treatment with lorlatinib, patients should talk to their doctor about all medications (prescription and over-the-counter), vitamins, and supplements they are taking. Some medications or supplements may interfere with each other or cause additional side effects.1,3

Lorlatinib should not be taken with certain other medicines called strong CYP3A inducers.1,3

Before starting treatment with lorlatinib, patients should talk to their doctor about all their medical conditions, including if they:1,3

  • Have a history of depression or seizures
  • Have high levels of cholesterol or triglycerides
  • Have problems with their heartbeat
  • Have lung or breathing problems
  • Are pregnant or planning to become pregnant
  • Are breastfeeding or plan to breastfeed

Lorlatinib can harm an unborn baby and should not be taken by women who are pregnant or planning to become pregnant. Women should have a pregnancy test before treatment with lorlatinib begins and should use effective birth control during treatment and for at least 6 months after the final dose. Some forms of birth control, including oral contraceptives, may not be effective while taking lorlatinib, and patients should talk to their doctor about birth control options. Men who have female partners that could become pregnant should use effective birth control during treatment and for at least 3 months after the final dose.1,3

It is not known if lorlatinib can pass into breast milk and possibly harm a breastfeeding child. Women should not breastfeed while taking Lorbrena and for at least 7 days after the last dose of lorlatinib.1,3

Lorlatinib may cause reduced fertility in men, which could affect their ability to father a child.1,3

Dosing information

Lorlatinib comes in a tablet that is taken by mouth once daily. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their lorlatinib regimen.1

For more information, read the full prescribing information of lorlatinib.

Written by: Emily Downward | Last reviewed: April 2019.
  1. Lorbrena prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf. Accessed 11/30/18.
  2. U.S. FDA approves Lorbrena (lorlatinib) for previously-treated ALK-positive metastatic NSCLC. Available at https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lorbrena_lorlatinib_for_previously_treated_alk_positive_metastatic_nsclc. Accessed 11/30/18.
  3. Lorbrena product website. Available at https://www.lorbrena.com/. Accessed 11/30/18.