Brigatinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic) after other treatments have failed.

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

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

Brigatinib can cause serious side effects such as lung problems, vision problems, high blood pressure, high blood sugar, very slow heartbeats, muscle damage, or pancreatitis.

Call your doctor at once if you have side effects, such as: severe headache, confusion, feeling light-headed, blurred vision, seeing flashes of light or "floaters" in your vision, increased thirst or urination, hunger, nausea, upper stomach pain spreading to your back, unexplained muscle pain or weakness, fever, cough, chest pain, trouble breathing, very slow heartbeats, or feeling like you might pass out.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Brigatinib is usually taken once per day, with or without food.

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

If you vomit shortly after taking brigatinib, do not take another dose. Stay on your regular schedule.

Your blood pressure will need to be checked often.

You should not stop using brigatinib unless your doctor tells you to.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

Initial dose: 90 mg orally once a day for the first 7 days
Maintenance dose: 180 mg orally once a day

Comments:
-Patients should be selected for the treatment of metastatic NSCLC based on the presence of ALK positivity in tumor specimens.
-FDA-approved test for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/CompanionDiagnostic
-Treatment should be continued until disease progression or unacceptable toxicity.

Use: For treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test

You should not use brigatinib if you are allergic to it.

Tell your doctor if you have ever had:

• lung disease or breathing problems;

• slow heartbeats;

• high blood pressure;

• vision problems;

• diabetes or glucose intolerance;

• pancreas problems;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may need to have a negative pregnancy test before starting this treatment.

Brigatinib can harm an unborn baby if the mother or the father is using brigatinib.

• If you are a woman, do not use this medicine if you are pregnant. Brigatinib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use an effective non-hormonal form of birth control such as an intrauterine device (IUD). Avoid getting pregnant for at least 4 months after your last dose.

• If you are a man, use condoms or other barrier birth control if your sex partner is able to get pregnant. Keep using condoms 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 brigatinib.

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

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Skip the missed dose and use your next dose at the regular time. 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.

Avoid eating grapefruit and drinking grapefruit juice while taking brigatinib.

Grapefruit may interact with brigatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

brigatinib may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

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

Brigatinib may cause serious side effects. Call your doctor at once if you have:

• lung problems--cough, trouble breathing, chest pain, fever;

• vision problems--blurred vision, double vision, increased sensitivity to light, seeing flashes of light or "floaters" in your vision;

• high blood pressure--severe headache, pounding in your neck or ears, dizziness;

• high blood sugar--increased thirst, increased urination, hunger, nausea, fruity breath odor, weakness, confusion;

• heart problems--very slow heartbeats, feeling like you might pass out;

• muscle problems--unexplained muscle pain or weakness; or

• pancreatitis--upper stomach pain (worse with eating and may spread to your back), nausea, weight loss.

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

Common side effects of brigatinib may include:

• nausea, vomiting, diarrhea;

• increased blood pressure;

• trouble breathing;

• cough;

• rash;

• muscle pain;

• headache; or

• feeling tired.

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 affect brigatinib. 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 a lab test before you begin your treatment to see whether your cancer can be treated with brigatinib. Your doctor also will order certain lab tests and check your blood pressure before and during your treatment to check your body's response to brigatinib.

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.