What To Expect | Lorbrena® (lorlatinib) Patient Site

Understanding side effects

Open communication with your healthcare team is key. Be honest about how you are feeling so you can help optimize your treatment journey. Remember, you are not alone. Partner with your healthcare team to help manage side effects.

Serious side effects
Most common side effects
Other important information

LORBRENA can cause serious side effects, including:

Liver problems due to interactions with other medicines. Liver problems can be severe. It is important to know what medicines not to take during treatment with LORBRENA.

Central nervous system (CNS) effects. CNS effects can be severe. Tell your healthcare provider if you get any new or worsening symptoms of CNS effects, including:

problems with thinking, such as forgetfulness or confusion
changes in mood, such as depression and thoughts about suicide or dying
psychotic effects, such as seeing or hearing things that are not real (hallucinations)
seizures
changes in speech
changes in sleep

Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will get an increase in the lipid levels in their blood during treatment with LORBRENA.

If you get increases in the lipid levels in your blood, your healthcare provider may start you on a new medicine or increase your dose if you are already taking a medicine to lower the lipid levels in your blood.
Your healthcare provider will do blood tests to check the lipid levels in your blood before starting treatment, 1 and 2 months after starting treatment, and during treatment with LORBRENA.

Heart problems. LORBRENA can cause very slow or abnormal heartbeats. Your healthcare provider will check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. In some people, these problems are severe, and you may need to get a pacemaker. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats.

Lung problems. LORBRENA can cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be like those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.

High blood pressure (hypertension). Your healthcare provider will check your blood pressure before starting treatment, 2 weeks after starting treatment, and then at least every month during treatment with LORBRENA. Your healthcare provider may start or change your blood pressure medicine if you get high blood pressure. Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including: headaches, dizziness, blurred vision, chest pain, or shortness of breath.

High blood sugar (hyperglycemia). LORBRENA can cause new or worsening increases in your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may start or change your blood sugar medicine if you get high blood sugar. Tell your healthcare provider right away if you get any signs and symptoms of high blood sugar, including feeling very thirsty, needing to urinate more than usual, or feeling very hungry, sick to your stomach, weak or tired, or confused.

If you get serious side effects during treatment, your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LORBRENA.

The most common side effects of LORBRENA include:

swelling in your arms, legs, hands, and feet (edema)
numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
weight gain
problems with thinking, such as forgetfulness or confusion
tiredness (fatigue)
difficulty breathing
pain in your joints
diarrhea
changes in mood, such as depression and irritability
increased cholesterol and triglyceride levels in the blood
cough

LORBRENA may cause decreased fertility in males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Taking LORBRENA with certain other medicines may increase your risk of side effects and may affect the way LORBRENA or the other medicines work.

Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.

Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems
have liver problems
have had episodes of depression or seizures
have high levels of cholesterol or triglycerides in your blood
have problems with your heartbeat
have lung or breathing problems
have high blood pressure
have diabetes or high blood sugar
are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.
- Use effective non-hormonal birth control during treatment and for at least 6 months after the final dose of LORBRENA.
- Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.
Males with female partners who are able to become pregnant:
- Use effective birth control during treatment and for at least 3 months after the final dose of LORBRENA.
are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment and for 7 days after the final dose of LORBRENA. Talk to your healthcare provider about the best way to feed your baby during this time.

It’s important to remember that everyone responds to treatment differently, so you may or may not experience the side effects described here.

If you have serious side effects during treatment with LORBRENA, your doctor may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.

When certain side effects happened in the studies and how common they were

The first step to managing side effects is learning what to expect, when to expect them, and what to do. If side effects are addressed early, it may help you continue to take your medicine.

How to understand the timeline

The side effects on this page are not all of the possible side effects of LORBRENA. All of the information here is from what patients experienced in the LORBRENA clinical trials (see Important Safety Information). You may or may not experience the side effects described below. If you do experience these side effects, you may not experience them in the same time frame or for the same amount of time.

The values listed below represent the median (middle) time from the first dose of LORBRENA to when patients first reported the side effect. “Median” means about half of the patients reported it earlier and half reported it later than this time point.

Likelihood of having side effect of any severity (based on clinical studies)

Low (0%-25%)

Medium (26%-50%)

High (51%-75%)

Start treatment dot

Month 1

Month 2Month 3 dot

Month 4Month 5 dot

Month 6

Week 2

High cholesterol or triglycerides(hyperlipidemia)

Likelihood: 91%-95% of patients

Week 5

Changes in mood(for example, depression and irritability)

Likelihood: 21% of patients

Week 6

Swelling(edema)

Likelihood: 56% of patients

Week 6

Psychotic effects(for example, hallucinations)

Likelihood: 7% of patients

Week 15

Tingling and numbness(nerve sensitivity or peripheral neuropathy)

Likelihood: 44% of patients

Week 15

Changes in speech

Likelihood: 11% of patients

Week 16

Weight gain

Likelihood: 31% of patients

Week 22

Problems with thinking(for example, forgetfulness and confusion)

Likelihood: 28% of patients

Likelihood of other common side effects

Tiredness (fatigue)

Likelihood: 27% of patients

Difficulty breathing (dyspnea)

Likelihood: 27% of patients

Pain in your joints (arthralgia)

Likelihood: 24% of patients

Diarrhea

Likelihood: 23% of patients

Cough

Likelihood: 21% of patients

For more information on the likelihood of symptoms, please refer to the Full Prescribing Information.

Information about when certain side effects occurred is data from published medical journal articles.

Tips on how to manage select side effects

To manage side effects, you and your healthcare team will develop a personalized strategy aimed at preserving your overall well-being while staying on treatment. That plan could include diet or lifestyle changes, other medicines, or visits to other specialists.

In some cases, your healthcare team may decide to lower your dose or pause treatment until symptoms improve. Taking a lower dose of LORBRENA may help lessen side effects.

Only your healthcare team can make this type of decision; never take a lower dose or pause treatment without talking to them first.

High cholesterol and/or triglycerides

What is it?An increase in the levels of cholesterol and/or triglycerides in the blood

What can be done?

Your doctor will check your cholesterol and triglyceride levels by doing regular blood tests
You may be prescribed a medicine to lower cholesterol, such as statins, and/or asked to consider lifestyle and diet changes. If needed, your doctor may increase the dose of your cholesterol-lowering medicine or prescribe a different medicine
Let your doctor know about all the medicines and supplements you are taking. They will ensure everything works safely together

Changes in mood

What is it?Feeling depressed or irritable

What can be done?

If you or your care partner notice any change in your mood—even if it seems minor—talk to your doctor right away. Letting them know early can help protect your well-being
Keep track of changes in mood by writing down how you feel: Download the Treatment Journal
Practice mindfulness or meditation
Your doctor may recommend working with a therapist to treat certain behaviors
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose
In the clinical study, these side effects were often mild and, with proper management, reversible

Swelling (edema)

What is it?Swelling of the arms, legs, hands, or feet

What can be done?

Talk to your doctor if you notice any swelling. They can recommend strategies that work best for you
Wear compression garments
Elevate your legs and stay active to help reduce swelling
Your doctor may tell you to limit salt intake
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose, or prescribe a diuretic

Psychotic effects (hallucinations)

What is it?Smelling, hearing, or seeing things that are not real

What can be done?

If you or your care partner notice any episodes of hallucination, talk to your doctor right away. Letting them know early can help protect your well-being
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose. In some cases, they may recommend seeing a specialist
In the clinical study, these side effects were often mild and, with proper management, reversible

Tingling and numbness (nerve sensitivity or peripheral neuropathy)

What is it?Pain, numbness, tingling, or muscle weakness

What can be done?

Let your doctor know if you feel numbness, tingling, or discomfort
A night splint can improve carpal tunnel syndrome
Your doctor may recommend working with a physical therapist for pain or numbness
Your doctor may tell you to limit salt intake
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose, or prescribe vitamin B1 or B6
In the clinical study, these side effects were typically reversible following a dose reduction

Changes in speech

What is it?Trouble finding the right words or slurred speech

What can be done?

Report any speech changes to your doctor as soon as you or your care partner notice them—even if they seem mild
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose
In the clinical study, these side effects were often mild and, with proper management, reversible

Weight gain

What is it?Increase in your body weight

Important information:

Treatment may make you more hungry, but there are also other factors that may cause you to gain weight
Edema (swelling), which is extra fluid in the body, may play a role in weight gain

What can be done?

Preventing weight gain is a helpful management strategy: Download this brochure for helpful advice and resources
Talk with your doctor about nutrition, exercise, and other steps that have been proven to help manage weight gain and maintain your well-being
Your doctor may check your weight regularly and suggest therapy management strategies that work for you

Problems with thinking

What is it?Forgetfulness or confusion

What can be done?

If you or your care partner notice any changes in memory or ability to think—even if they seem minor—talk to your doctor right away. Letting them know early can help protect your well-being
Keep a diary or calendar with key information to remember: Download the Treatment Journal
Create a system of keeping objects in the same place
Practice mindfulness or meditation
Your doctor may recommend working with a therapist to treat certain behaviors
To manage these symptoms, your doctor may pause treatment and/or reduce your LORBRENA dose
In the clinical study, these side effects were often mild and, with proper management, reversible

Turn to Pfizer Oncology Together for financial assistance resources and personalized support.

Call 1-877-744-5675
(Monday–Friday 8 AM–8 PM ET)

Visit PfizerOncologyTogether.com

Important Safety Information

LORBRENA can cause serious side effects, including:

Liver problems due to interactions with other medicines. Liver problems can be severe. It is important to know what medicines not to take during treatment with LORBRENA.
Central nervous system (CNS) effects. CNS effects can be severe. Tell your healthcare provider if you get any new or worsening symptoms of CNS effects, including: problems with thinking, such as forgetfulness or confusion, changes in mood, such as depression and thoughts about suicide or dying, psychotic effects, such as seeing or hearing things that are not real (hallucinations), seizures, changes in speech, and changes in sleep.
Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will get an increase in the lipid levels in their blood during treatment with LORBRENA.
- If you get increases in the lipid levels in your blood, your healthcare provider may start you on a new medicine or increase your dose if you are already taking a medicine to lower the lipid levels in your blood.
- Your healthcare provider will do blood tests to check the lipid levels in your blood before starting treatment, 1 and 2 months after starting treatment, and during treatment with LORBRENA.
Heart problems. LORBRENA can cause very slow or abnormal heartbeats. Your healthcare provider will check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. In some people, these problems are severe, and you may need to get a pacemaker. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats.
Lung problems. LORBRENA can cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be like those from lung cancer. Tell your healthcare provider right away if you get any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever.
High blood pressure (hypertension). Your healthcare provider will check your blood pressure before starting treatment, 2 weeks after starting treatment, and then at least every month during treatment with LORBRENA. Your healthcare provider may start or change your blood pressure medicine if you get high blood pressure. Tell your healthcare provider right away if you get signs or symptoms of high blood pressure, including headaches, dizziness, blurred vision, chest pain, or shortness of breath.
High blood sugar (hyperglycemia). LORBRENA can cause new or worsening increases in your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may start or change your blood sugar medicine if you get high blood sugar. Tell your healthcare provider right away if you get any signs and symptoms of high blood sugar, including: feeling very thirsty, needing to urinate more than usual, feeling very hungry, feeling sick to your stomach, feeling weak or tired, and feeling confused.

If you get serious side effects during treatment, your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LORBRENA.

Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems
have liver problems
have had episodes of depression or seizures
have high levels of cholesterol or triglycerides in your blood
have problems with your heartbeat
have lung or breathing problems
have high blood pressure
have diabetes or high blood sugar
are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with LORBRENA.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LORBRENA.
- Use effective non-hormonal birth control during treatment and for at least 6 months after the final dose of LORBRENA.
- Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with LORBRENA. Talk to your healthcare provider about birth control choices that are right for you during this time.
Males with female partners who are able to become pregnant:
- Use effective birth control during treatment and for at least 3 months after the final dose of LORBRENA.
are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment and for 7 days after the final dose of LORBRENA. Talk to your healthcare provider about the best way to feed your baby during this time.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Do not take LORBRENA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider for a list of these medicines if you are not sure.

The most common side effects of LORBRENA include:

swelling in your arms, legs, hands, and feet (edema)
numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
weight gain
problems with thinking, such as forgetfulness or confusion
tiredness (fatigue)
difficulty breathing
pain in your joints
diarrhea
changes in mood, such as depression and irritability
increased cholesterol and triglyceride levels in the blood
cough

LORBRENA may cause decreased fertility in males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is LORBRENA?

Indication

LORBRENA is a prescription medicine that is used to treat adults with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body (metastatic).

Your healthcare provider will perform a test to make sure that LORBRENA is right for you.

It is not known if LORBRENA is safe and effective in children.

Please see Full Prescribing Information and Patient Information.

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Pfizer, PO Box 29387, Mission, KS 66201.

Last Updated: April 2026 PP-LOR-USA-1068

LORBRENA ^® is a registered trademark of Pfizer Inc.

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How to take LORBRENA

The best advice I could give someone starting LORBRENA is to have open and honest conversations with your doctor about any side effects you experience, so you can work towards a plan to help manage them.

Understanding side effects

When certain side effects happened in the studies and how common they were

How to understand the timeline

Tips on how to manage select side effects

Tips for everyday well-being

Download these helpful resources

What to Expect Brochure

Treatment Journal

Important Safety Information

LORBRENA can cause serious side effects, including:

Before taking LORBRENA, tell your healthcare provider about all of your medical conditions, including if you:

The most common side effects of LORBRENA include:

What is LORBRENA?

Indication