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

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

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.

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.

Before taking this medicine

To make sure Lorbrena is safe for you, 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).

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

• If you are a woman, do not use Lorbrena 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 Lorbrena.

Lorbrena 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.

Lorbrena 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 Lorbrena, and for at least 7 days after your last dose.

Take Lorbrena 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 Lorbrena, 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 Lorbrena 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

Comments:
-If a dose is missed, take the missed dose unless the next dose is due within 4 hours; do not take 2 doses at the same time to make up for a missed dose.
-Do not take an additional dose if vomiting occurs but continue with the next scheduled dose.

Use: For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).

To make sure Lorbrena is safe for you, 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).

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

• If you are a woman, do not use Lorbrena 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 Lorbrena.

Lorbrena 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.

Lorbrena 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 Lorbrena, 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.

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

Get emergency medical help if you have signs of an allergic reaction to Lorbrena: 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 Lorbrena 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.