Brigatinib

Brigatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the bodys. Brigatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Brigatinib comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take brigatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take brigatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not chew or crush them.

If you vomit after taking brigatinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may start you on a low dose of brigatinib and increase your dose once after 7 days of treatment.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of brigatinib or other medications that you are taking, depending on the side effects that you experience during your treatment. Talk to your doctor about how you are feeling during your treatment. Do not stop taking brigatinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking brigatinib,

• tell your doctor and pharmacist if you are allergic to brigatinib, any other medications, or any of the ingredients in brigatinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox, Tolsura), ketoconazole, buprenorphine and naloxone (Suboxone), carbamazepine (Equetro, Tegretol, Teril, others), clarithromycin, cyclosporine (Gengraf, Neoral, Sandimmune), diltiazem (Cardizem, Cartia, Diltzac, others), efavirenz (Sustiva, in Atripla, Symfi), erythromycin (E.E.S., Eryc, Erythrocin), indinavir (Crixivan), nefazodone, nelfinavir (Viracept), nevirapine (Viramune), phenobarbital; phenytoin (Dilantin, Phenytek), pioglitazone (Actos, in Actoplus Met, Duetact, Oseni), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), ritonavir (Norvir, in Kaletra, Technivie, Viekira), sirolimus (Rapamune), tacrolimus (Astagraf, Envarsus, Prograf), or verapamil (Calan, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with brigatinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had high blood pressure; a slow heartbeat; diabetes or other blood sugar problems; or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. Brigatinib may interfere with the action of hormonal contraceptives (birth control pills, patches, rings, implants, or injections), so you should not use these as your only method of birth control during your treatment. You must use a non-hormonal birth control such as a barrier method (device that blocks sperm from entering the uterus such as a condom or a diaphragm). Ask your doctor to help you choose a method of birth control that will work for you. If you are female, you will need to use non-hormonal birth control during your treatment and for 4 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and continue to use birth control for 3 months after your final dose. Brigatinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with brigatinib and for up to 1 week after your final dose.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking brigatinib.

Avoid eating grapefruit and drinking grapefruit juice while taking brigatinib.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you miss taking brigatinib for 14 days or longer, talk to your doctor before starting to take it again. You will probably have to restart taking it at a lower dose.

Brigatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• diarrhea
• vomiting
• constipation
• tiredness
• rash
• headache
• numbness, pain, tingling, or burning feeling in the feet or hands
• back or joint pain
• loss of appetite
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath or difficulty breathing
• chest pain
• cough with or without mucus
• fever
• headache, dizziness, lightheadedness, or feeling faint
• blurred or double vision
• seeing flashes of light
• light hurting your eyes
• seeing ''floaters'' or small specks
• extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness
• upper stomach pain that may spread to the back or get worse with eating; weight loss; or nausea
• slow or irregular heartbeat
• muscle pain, spasms, tenderness, or weakness

Brigatinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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