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  • Full Prescribing Information
  • Patient Prescribing Information
  • Full Prescribing Information
  • Indication
  • Important Safety Information
 

LORBRENA® (lorlatinib) is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

 

Indication

 

LORBRENA® (lorlatinib) is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC)

  • that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and
  • has spread to other parts of the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Indication

LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information and Indication

Important Safety Information

LORBRENA may cause serious side effects, including:

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

Scroll for Important Safety Information and Indication

Important Safety Information and Indication

Important Safety Information

 

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 21 days 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

 

Now FDA Approved

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

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Copyright © 2018 Pfizer Inc. All rights reserved.

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 (U.S. only). If you prefer, you may contact the U.S. 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: November 2018 PP-LOR-USA-0023-01

LORBRENA® is a registered trademark of Pfizer Inc.

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Continue

Important Safety Information

Indication

LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information and Indication

Important Safety Information

LORBRENA may cause serious side effects, including:

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

Scroll for Important Safety Information and Indication

Important Safety Information and Indication

Important Safety Information

 

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 21 days 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Indication

LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information and Indication

Important Safety Information

LORBRENA may cause serious side effects, including:

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

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Important Safety Information and Indication

Important Safety Information

 

LORBRENA® (lorlatinib) 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.

Problems with brain (central nervous system [CNS]) function. Many patients experience problems with brain function, including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with LORBRENA. If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

    • 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.
    • 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 [EKG]) before starting and during treatment with LORBRENA. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. If these problems are severe, 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.

If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.

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

  • are taking other medications
  • 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
  • are pregnant or plan to become pregnant. LORBRENA can harm your unborn baby.
    • 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.
      • Females who are able to become pregnant should use effective non-hormonal birth control during treatment with LORBRENA and for at least 21 days 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 who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA 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 with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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)
  • difficulty thinking or confusion
  • difficulty breathing
  • tiredness (fatigue)
  • weight gain
  • pain in your joints
  • changes in mood, feeling sad or anxious
  • diarrhea

LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.

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

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Please see Full Prescribing Information and Patient Information.

Indication

LORBRENA is a prescription medicine that is used to treat people 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 the body, and
  • who have taken the medicine:
    • alectinib, or ceritinib, or
    • both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
  • that is no longer responding to these treatments.

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

The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.