lorlatinib

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

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is lorlatinib?

Lorlatinib is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body.

Lorlatinib is used only if your cancer has a specific genetic marker (an abnormal "ALK" gene). Your doctor will test you for this gene.

Lorlatinib is given after other cancer treatments did not work or have stopped working.

Lorlatinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Lorlatinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking lorlatinib?

Some medicines can cause unwanted or dangerous effects when used with lorlatinib. Tell your doctor about all your current medicines and any you start or stop using.

Tell your doctor if you have ever had:

• heart problems, such as "AV block" (unless you have a pacemaker);
• lung disease, breathing problems;
• liver disease;
• depression;
• seizures; or
• high cholesterol or triglycerides (a type of fat in the blood).

• If you are a woman, do not use lorlatinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using lorlatinib.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because lorlatinib can harm an unborn baby.

How should I take lorlatinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Do not use a broken or cracked tablet.

If you vomit shortly after taking lorlatinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not change your dose or stop taking lorlatinib without your doctor's advice.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 4 hours. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking lorlatinib?

Avoid taking an herbal supplement containing St. John's wort.

What are the possible side effects of lorlatinib?

• sudden chest pain, wheezing, dry cough;
• shortness of breath or rapid breathing;
• fever, chills, cough with mucus;
• sudden dizziness (like you might pass out);
• numbness, tingling, or burning pain in your hands or feet;
• unusual changes in mood or behavior, thoughts of hurting yourself;
• hallucinations; or
• problems with speech, thought, or memory.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• swelling in your arms, hands, legs, or feet;
• numbness, tingling, or burning pain in your hands or feet;
• mood changes;
• feeling tired;
• weight gain;
• joint pain; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lorlatinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect lorlatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about lorlatinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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