Brigatinib tablets

What is this medicine?

BRIGATINIB (brig A ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. If you vomit after taking your medicine, take your next dose at the regular time and do not take an extra dose. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• chest pain or chest tightness

• cough

• fever

• headache

• nausea

• sensitivity to light

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• signs and symptoms of muscle injury like dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain or side or back pain

• stomach pain

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

• tiredness

• vomiting

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS

• boceprevir

• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• clarithromycin

• conivaptan

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• grapefruit juice

• rifampin

• St. John's Wort

What if I miss a dose?

If you miss a dose or if you vomit after taking your medicine, do not take another dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at controlled room temperature between 20 and 25 degrees C (68 and 67 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• diabetes

• eye disease, vision problems

• high blood pressure

• history of irregular heartbeat

• history of pancreatitis

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• muscle aches or weakness

• scarring or thickening of the lungs

• an unusual or allergic reaction to brigatinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or health care professional right away if you have any change in your eyesight.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 4 months after the last dose. Men should use effective contraception during treatment and for 3 months after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 1 week after the last dose.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This drug 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 doctor tells you to stop.