Lorlatinib is a kinase inhibitor for oral administration used to treat cancer. A kinase inhibitor is an enzyme inhibitor that can block the action of protein kinases.

Lorlatinib is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body. It 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 lorlatinib, but further studies are needed.

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.

Take lorlatinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Swallow the tablet whole and do not crush, chew, or break it.

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.

Store at room temperature away from moisture and heat.

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

Usual Adult Dose for Non-Small Cell Lung Cancer:

100 mg orally once a day until disease progression or unacceptable toxicity

Use: For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease OR alectinib as the first ALK inhibitor therapy for metastatic disease
OR ceritinib as the first ALK inhibitor therapy for metastatic disease.

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.

To make sure lorlatinib is safe for you, tell your doctor if you have:

• 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).

Lorlatinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• 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.

Lorlatinib can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings). Ask your doctor about the best form of birth control to use during treatment with this medicine.

Do not breastfeed while using this medicine, and for at least 7 days after your last 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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

Get emergency medical help if you have signs of an allergic reaction to lorlatinib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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 lorlatinib 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.

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 interact with 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment to check your body's response to lorlatinib. Your doctor will also check your blood pressure before and during your treatment. Your doctor will also order a lab test before you begin your treatment to see whether your cancer can be treated with lorlatinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.