Lorlatinib

What is lorlatinib used for?

• Lorlatinib is used to treat lung cancer.

Before taking lorlatinib, tell your doctor:

• If you are allergic to lorlatinib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with lorlatinib, like certain drugs that are used for HIV, infections, or seizures.
• If you are breast-feeding. Do not breast-feed while you take lorlatinib and for 1 week after your last dose.

This is not a list of all drugs or health problems that interact with lorlatinib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lorlatinib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take lorlatinib?

• Tell all of your health care providers that you take lorlatinib. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may need to have an ECG checked before starting lorlatinib and while taking it. Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may affect being able to father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
• If you are a man and your sex partner gets pregnant while you take lorlatinib or within 3 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting lorlatinib. Talk with your doctor.
• Use a non-hormone type of birth control like condoms to prevent pregnancy while taking lorlatinib and for at least 6 months after stopping lorlatinib. Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy.
• If you get pregnant while taking lorlatinib or within 6 months after your last dose, call your doctor right away.

How is lorlatinib best taken?

Use lorlatinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, or crush.
• Do not take chipped or broken tablets.
• Take lorlatinib at the same time of day.
• Keep taking lorlatinib as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If the next dose is less than 4 hours away, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of lorlatinib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Seizures.
• Trouble speaking.
• A burning, numbness, or tingling feeling that is not normal.
• Change in balance.
• Muscle weakness.
• Memory problems or loss.
• Not able to focus.
• Feeling very sleepy.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Swelling.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Fever or chills.
• Sore throat.
• Lung problems have rarely happened with lorlatinib. These can be very bad and may be life-threatening. Call your doctor right away if you have shortness of breath or a cough.
• Call your doctor right away if you have signs of nervous system problems. These may include anxiety, bad dreams, trouble sleeping, change in eyesight, dizziness, feeling confused, feeling nervous or agitated, feeling restless, hallucinations (seeing or hearing things that are not there), new or worse behavior or mood changes like depression or thoughts of killing yourself, seizures, or very bad headaches.

What are some other side effects of lorlatinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Weight gain.
• Muscle or joint pain.
• Diarrhea.
• Upset stomach or throwing up.
• Constipation.
• Back pain.
• Pain in arms or legs.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out lorlatinib?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about lorlatinib, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take lorlatinib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lorlatinib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.