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Brigatinib

Precautions

Before taking brigatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, other lung/breathing problems, heart disease (such as slow heartbeat), disease of the pancreas (pancreatitis), liver disease, diabetes, vision problems.

This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun during treatment and for at least 5 days after stopping treatment. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using brigatinib. Brigatinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Side Effects

Nausea/vomiting, diarrhea, decreased appetite, abdominal pain, constipation, tiredness, dizziness, fever, headache, trouble sleeping, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: slow heartbeat, unusual tiredness, vision changes (such as blurred vision, double vision), increased thirst/urination, unusual muscle pain/tenderness/weakness, numbness/tingling of arms/legs, signs of pancreatitis or liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin).

Get medical help right away if you have any very serious side effects, including: symptoms of new or worsening lung problems (such as cough, shortness of breath, chest pain).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.