Brigatinib (bri-GA-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

Alunbrig, Alunbrig Initiation Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how brigatinib works. Tell your doctor if you are using itraconazole, midazolam, or rifampin.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 4 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, lung or breathing problems, diabetes, or high blood pressure.
• This medicine may cause the following problems:
  • Lung or breathing problems, including interstitial lung disease or pneumonitis
  • High blood pressure
  • Slow heartbeat
  • Eye or vision problems
  • Muscle problems
  • Pancreatitis (swelling of the pancreas)
  • Liver problems
  • High blood sugar
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Limit your time in the sun during treatment and for at least 5 days after the last dose.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other change in vision
• Chest pain, trouble breathing, fever, chills, cough
• Confusion, sweating, increased hunger, thirst, or urination
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fast, slow, pounding, or uneven heartbeat
• Muscle pain, tenderness, or weakness
• Redness or other discoloration of the skin, severe sunburn, skin rash
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain in the arms or legs
• Runny or stuffy nose, sore throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088