Brigatinib tablets

What is this medication?

BRIGATINIB (brig A ti nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats non-small cell lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Alunbrig

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes
• eye disease
• high blood pressure
• history of pancreatitis
• kidney disease
• liver disease
• lung disease
• slow heartbeat
• vision problems
• an unusual or allergic reaction to brigatinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

This medicine may interact with the following medications:

• certain antibiotics like erythromycin and clarithromycin
• certain antivirals for HIV or AIDS
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• grapefruit juice
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

Do not become pregnant while taking this medicine or for 4 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Tell your health care provider right away if you have any change in your eyesight.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Your health care provider may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care provider.

This medicine may increase blood sugar. Ask your health care provider if changes in diet or medicines are needed if you have diabetes.

This medicine can cause a serious condition in which there is too much acid in your blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or trouble breathing, stop taking this medicine and call your health care provider right away. If possible, use a ketone dipstick to check for ketones in your urine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• cough
• fruity breath
• high blood sugar (increased hunger, thirst, or urination; unusually weak or tired; blurry vision)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes and skin)
• muscle injury (dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain; back pain)
• pancreatitis (stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting, fast heartbeat)
• slow heartbeat (trouble breathing; chest pain; dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• trouble breathing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• nausea
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.