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Below is essential safety and warning information regarding the use of Lorbrena (lorlatinib). This information outlines potential risks, necessary precautions, and guidance for specific populations. Please consult your healthcare provider if you have any questions or concerns.

• Serious Liver Issues: Lorbrena (lorlatinib), when taken with rifampin (Rifadin), may cause significant liver problems, including abnormal liver function tests. This can occur as soon as the first dose. Liver function typically returns to normal within a month after discontinuing Lorbrena.

• Neurological Effects: Approximately 50% of users in clinical trials reported neurological side effects, including cognitive and speech difficulties, mood changes, and insomnia. More severe effects such as delusions, hallucinations, and seizures were less common. These effects may begin between one month and three years into treatment. If you experience these symptoms, your provider may adjust your dosage, pause treatment, or switch medications.

• High Cholesterol and Triglycerides: Treatment with Lorbrena can lead to increased cholesterol and triglycerides, often noticeable around two weeks after starting. Regular monitoring of these levels will occur before and during treatment. If elevated, medications to lower these levels may be prescribed, or your Lorbrena dosage may be adjusted.

• Heart Blockage: Lorbrena may occasionally cause a heart block, affecting heartbeat regularity. Heart function will be monitored through ECGs during treatment. If symptoms occur, such as dizziness or changes in heartbeat, a pacemaker may be considered, or treatment may be adjusted.

• Respiratory Concerns: Though rare, serious lung issues like pneumonitis or interstitial lung disease can occur. If you develop breathing difficulties or a fever, immediate medical attention is necessary, and discontinuation of Lorbrena might be advised.

• Hypertension: Lorbrena can lead to high blood pressure, possibly emerging soon after starting or up to three years later. Blood pressure will be regularly checked, and if elevated, treatment may be paused, dosage adjusted, or a different medication prescribed. Report any symptoms like headaches, dizziness, blurred vision, chest pain, or breathing trouble to your provider.

• Contraindications: Avoid using Lorbrena with CYP3A inducers, as this combination can cause serious liver damage. Always consult with your healthcare provider before starting Lorbrena if you are on such medications.

When taking this medication, some common side effects might occur, but they are often mild and manageable. You may experience tiredness, constipation, nausea, vomiting, diarrhea, joint and muscle pain, as well as dizziness and headaches. Some patients also report swelling in the eyelids, face, hands, and feet, along with weight gain and changes in sleep or mood. It is important to stay aware of changes in vision, such as blurred or decreased vision, and if these persist, consult your healthcare provider. Elevated cholesterol and blood sugar levels, abnormal kidney and liver labs, nerve pain, and changes in memory and attention can also occur, so regular monitoring and communication with your healthcare provider are recommended.

There are also other side effects that could arise, such as high blood pressure, cough, fever, and sinus or throat infections. If you notice symptoms like trouble speaking, slowed speech, chest pain, or changes in electrolyte levels, it’s advisable to seek medical advice, especially if these issues are severe or persistent.

More serious side effects, though rare, require immediate medical attention. These include suicidal thoughts, severe lung problems, or a blocked heartbeat characterized by dizziness, fainting, or changes in heartbeat. Additionally, signs of liver problems, such as persistent nausea, vomiting, loss of appetite, stomach pain, yellowing eyes/skin, or dark urine, should prompt urgent medical consultation. Allergic reactions are also rare but serious, and symptoms like rash, severe dizziness, swelling, or trouble breathing necessitate quick medical intervention. Always keep a close watch on your health and report any unusual symptoms to your healthcare provider.