Lorbrena
Lorbrena (lorlatinib) is an anticancer medication that's used to treat anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) that has spread to other parts of the body. It’s a pill that you take by mouth, so it’s more convenient than an injection. Some common side effects Lorbrena (lorlatinib) might cause include swelling in the face or hands and feet, weight gain, or nerve pain.
What is Lorbrena (lorlatinib)?
What is Lorbrena (lorlatinib) used for?
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer that has spread to other parts of the body
How Lorbrena (lorlatinib) works
Lorbrena (lorlatinib) is a targeted therapy anticancer medication that blocks a protein called anaplastic lymphoma kinase (ALK). The ALK protein is made by the ALK gene. This gene is something that everyone is born with. In people with ALK-positive NSCLC, this gene doesn’t work like it should. It ends up making abnormal proteins and causing cancer. Lorbrena (lorlatinib) works to block the ALK protein, so cancer cells can’t grow and spread as well.
Drug Facts
What are the side effects of Lorbrena (lorlatinib)?
Common Side Effects
- High cholesterol and fat levels in blood (up to 96%)
- Abnormal kidney labs (up to 81%)
- Swelling in the eyelids, face, and hands and feet (up to 57%)
- Abnormal liver protein labs (up to 52%)
- Abnormal blood cell counts (up to 52%)
- High blood sugar (up to 52%)
- Nerve pain (up to 47%)
- Weight gain (up to 38%)
- Problems with memory and attention (up to 27%)
- Trouble breathing (up to 27%)
- Tiredness (up to 26%)
- Abnormal pancreas labs (up to 24%)
- Changes in mood (up to 23%)
- Joint pain (up to 23%)
- Diarrhea (up to 22%)
- Changes in electrolyte levels (up to 21%)
Other Side Effects
- Cough
- Headache
- Nausea
- Changes in vision
- High blood pressure
- Constipation
- Fever
- Pain in muscles, back, arms or legs
- Dizziness
- Rash
- Vomiting
- Trouble speaking or slowed speech
- Sinus or throat infection
- Changes in sleep
- Chest pain
Serious Side Effects
- Suicidal thoughts and self-harm
- Severe lung problems: new or worsening breathing problems (e.g., coughing or trouble breathing) or fever
- Blocked heartbeat: feeling dizzy, faint, or a change in your heartbeat
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dry cough, shortness of breath or trouble breathing
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- Increase in blood pressure
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Joint pain
- Swelling of the ankles, hands, or feet
- Weight gain
Pros and cons of Lorbrena (lorlatinib)
Pros
First-choice option in ALK-positive NSCLC
Taken by mouth, so good for people who don't like needles
Doesn’t cause sensitivity to sunlight like other medications that treat ALK-positive NSCLC
Cons
Commonly causes side effects like changes in mood or problems with thinking
Can cause serious breathing problems
Might affect a male's ability to have children
Pharmacist tips for Lorbrena (lorlatinib)
Take Lorbrena (lorlatinib) with or without food at the same time every day. Swallow the tablet whole so that the medication works properly. Don’t cut, chew, or crush the tablet.
If you miss a dose of Lorbrena (lorlatinib) and you still have more than 4 hours until your next dose, you can take the missed dose. But if it’s less than 4 hours from your next dose, then skip the missed dose and take your dose at the next scheduled time.
If you vomit after taking your dose, don’t take another dose to make it up. Just take your next dose at the next scheduled time.
Taking Lorbrena (lorlatinib) can raise your blood sugar levels. This can start anytime from right after you start treatment to years after starting the medication. Your provider might ask you to check your blood sugar levels regularly during your Lorbrena (lorlatinib) treatment. - Let your provider know if you develop any symptoms of high blood sugar, like feeling more thirsty or hungry, urinating more often, feeling tired, or nausea.
It's not known if Lorbrena (lorlatinib) can pass into your breastmilk or affect your milk production. To avoid the risk of causing harm to your baby, don't breastfeed during your treatment and for 1 week after the last dose.
Ask your provider or pharmacist about the best way to handle and throw away Lorbrena (lorlatinib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Frequently asked questions about Lorbrena (lorlatinib)
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What are the risks and warnings for Lorbrena (lorlatinib)?
Lorbrena (lorlatinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious liver problems (from drug interactions)
During clinical trials, people who took Lorbrena (lorlatinib) while taking rifampin (Rifadin) at the same time experienced serious liver problems and had abnormal liver labs. This occurred as early as with their first dose of Lorbrena (lorlatinib). Typically, people saw their liver labs return to normal within a month after they stopped taking Lorbrena (lorlatinib).
Because of the risk of serious liver damage, you can’t take Lorbrena (lorlatinib) with other medications that can raise your risk of liver problems. Let your provider know of all medications (prescription and over-the-counter), vitamins, and herbal products you take so they can check for drug interactions.
Effects on the brain
About half of people who took Lorbrena (lorlatinib) in clinical trials experienced a wide range of side effects related to the brain. The most common side effects included problems with thinking and speech, changes in mood, and trouble sleeping. Less common, but more serious, side effects included delusions, hallucinations, and seizures. For most people, these problems typically started anywhere between a month to 3 years after they began Lorbrena (lorlatinib) treatment. Let your provider know if you develop any of these problems. Depending on how severe these problems are for you, your provider might temporarily stop Lorbrena (lorlatinib), lower your dose, or switch you to a different medication.
High cholesterol and fat in the blood
Lorbrena (lorlatinib) can raise the level of cholesterol and fat (triglycerides) in the blood. On average, people noticed this side effect about 2 weeks after starting treatment. Your provider will check your cholesterol or fat levels through lab work before you start treatment, for the first two months of treatment, and regularly after that. If the cholesterol or fat level in your blood gets too high, your provider might ask you to take medications to lower them. Depending on how high your blood cholesterol levels are, your provider might lower your dose of Lorbrena (lorlatinib).
Blocked heartbeat
Though uncommon, Lorbrena (lorlatinib) can cause a heart block (atrioventricular block), which can affect your heart beat. Your provider will monitor your heartbeat before your start treatment and periodically during treatment with an electrocardiogram (ECG). If you experience a blocked heartbeat your provider might consider placing a pacemaker, lowering your dose of Lorbrena (lorlatinib), or treating your cancer with a different medication. Let your provider know right away if you experience any symptoms of a problem with your heartbeat such as feeling dizzy or faint, or notice a change in your heartbeat.
Lung problems
Though not common, some people taking Lorbrena (lorlatinib) experienced serious lung problems, like inflammation of your lungs (pneumonitis) or interstitial lung disease. If you develop lung problems, your provider might ask you to stop taking Lorbrena (lorlatinib) permanently. Let your provider know right away if you start to have any new or worsening breathing problems (e.g., coughing, shortness of breath, or trouble breathing) or fever.
High blood pressure
People taking Lorbrena (lorlatinib) can experience high blood pressure while taking the medication. This can happen right after you start treatment or as late as 3 years after you begin Lorbrena (lorlatinib). Your provider will check your blood pressure before you start taking Lorbrena (lorlatinib) and regularly throughout treatment. If your blood pressure is high, your provider might ask you to stop taking Lorbrena (lorlatinib) temporarily. And if it’s dangerously high, your provider might lower your dose of Lorbrena (lorlatinib) or switch you to a different medication. Let your provider know right away if you experience any symptoms of high blood pressure such as headaches, dizziness, blurry vision, chest pain, or trouble breathing.
Lorbrena (lorlatinib) dosage forms
Typical dosing for Lorbrena (lorlatinib)
The typical starting dose of Lorbrena (lorlatinib) is 100 mg taken by mouth once daily.
Your dose might be different if you’re taking an interacting medication or if you have severe kidney problems.
Lorbrena (lorlatinib) contraindications
Medications that can cause serious liver damage when taken with Lorbrena (lorlatinib) (CYP3A inducers)
What are alternatives to Lorbrena (lorlatinib)?
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer that has spread to other parts of the body
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer that has spread to other parts of the body
Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in adults
Early stage ALK-positive NSCLC in adults after surgery
What is the latest news about Lorbrena (lorlatinib)?
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References
Best studies we foundALK Positive. (n.d.). What is ALK-positive lung cancer?
American Cancer Society. (n.d.). Chemotherapy.
American Cancer Society. (2023). Targeted drug therapy for non-small cell lung cancer.
American Lung Association. (2022). ALK and lung cancer.
American Lung Association. (2022). Brain metastasis from lung cancer.
Cancer.net. (2019). Safe storage and disposal of cancer medications.
Mitchell, L. B. (2023). Atrioventricular block. Merck Manual Professional Version.
National Cancer Institute. (n.d.). Anaplastic lymphoma kinase.
National Cancer Institute. (n.d.). Pneumonitis.
National Cancer Institute. (2022). Targeted therapy to treat cancer.
National Cancer Institute. (2023). Non-small cell lung cancer treatment (PDQ®)–Patient version.
National Comprehensive Cancer Network. (2023). Early and locally advanced non-small cell lung cancer.
National Comprehensive Cancer Network. (2023). Metastatic non-small cell lung cancer.
Omar, N. E., et al. (2021). Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: An analysis of the FDA Adverse Event Reporting System (FAERS). European Society for Medical Oncology Open.
Pfizer Laboratories Div Pfizer Inc. (2023). Lorbrena- lorlatinib tablet, film coated [package insert]. DailyMed.
Shaw, A.T., et al. (2020). First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. The New England Journal of Medicine.
U.S. Food and Drug Administration. (2016). CYP3A inducers.
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