LORBRENA® What is the most important information I should know about LORBRENA?

(lorlatinib)

What is the most important information I should know about LORBRENA?

LORBRENA may cause serious side effects, including:

•
Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
•
Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including:
o
problems with thinking, such as forgetfulness or confusion
o
changes in mood, such as depression and thoughts about suicide or dying
o
psychotic effects, such as seeing or hearing things that are not real (hallucinations)
o
seizures
o
changes in speech
o
changes in sleep

Tell your healthcare provider if you experience new or worsening symptoms of these CNS effects during treatment with LORBRENA.

•
Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their blood during treatment with LORBRENA.
o
If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
o
Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
•
Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some people, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
•
Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to 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 should 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 need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. 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 may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of high blood sugar, including:
o
feeling very thirsty
o
needing to urinate more than usual
o
feeling very hungry
o
feeling sick to your stomach
o
feeling weak or tired
o
feeling confused

If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.
See "What are possible side effects of LORBRENA?" for more information about side effects.

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Health Professional Information

What is the most important information I should know about LORBRENA?

What is the most important information I should know about LORBRENA?

LORBRENA may cause serious side effects, including:

•
Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
•
Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including:
o
problems with thinking, such as forgetfulness or confusion
o
changes in mood, such as depression and thoughts about suicide or dying
o
psychotic effects, such as seeing or hearing things that are not real (hallucinations)
o
seizures
o
changes in speech
o
changes in sleep

Tell your healthcare provider if you experience new or worsening symptoms of these CNS effects during treatment with LORBRENA.

•
Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their blood during treatment with LORBRENA.
o
If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
o
Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
•
Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some people, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
•
Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to 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 should 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 need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. 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 may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of high blood sugar, including:
o
feeling very thirsty
o
needing to urinate more than usual
o
feeling very hungry
o
feeling sick to your stomach
o
feeling weak or tired
o
feeling confused

If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.
See "What are possible side effects of LORBRENA?" for more information about side effects.
Prescribing Information
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Health Professional Information

What is the most important information I should know about LORBRENA?

What is the most important information I should know about LORBRENA?

LORBRENA may cause serious side effects, including:

•
Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
•
Central nervous system (CNS) effects. LORBRENA may cause CNS effects, including:
o
problems with thinking, such as forgetfulness or confusion
o
changes in mood, such as depression and thoughts about suicide or dying
o
psychotic effects, such as seeing or hearing things that are not real (hallucinations)
o
seizures
o
changes in speech
o
changes in sleep

Tell your healthcare provider if you experience new or worsening symptoms of these CNS effects during treatment with LORBRENA.

•
Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most people will have an increase in the lipid levels in their blood during treatment with LORBRENA.
o
If you have increases in the lipid levels in your blood during treatment with LORBRENA, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
o
Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with LORBRENA.
•
Heart problems. LORBRENA may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram or EKG) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some people, these problems are severe and your healthcare provider may need to have you stop taking LORBRENA or have a pacemaker placed.
•
Lung problems. LORBRENA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to 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 should 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 need to start or change your blood pressure medicine if you have high blood pressure during treatment with LORBRENA. 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 may increase your blood sugar levels. Your healthcare provider should do blood tests to check your blood sugar levels before starting and during treatment with LORBRENA. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of high blood sugar, including:
o
feeling very thirsty
o
needing to urinate more than usual
o
feeling very hungry
o
feeling sick to your stomach
o
feeling weak or tired
o
feeling confused

If you have serious side effects during treatment with LORBRENA, your healthcare provider may change your dose, stop your treatment for a period of time, or completely stop treatment with LORBRENA.
See "What are possible side effects of LORBRENA?" for more information about side effects.

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