What Is ALUNBRIG? ALUNBRIG is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC):

that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body, and who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib.

It is not known if ALUNBRIG is safe and effective in children.

There is an ongoing study to learn how ALUNBRIG works over a longer period of time.

Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

Once-Daily ALUNBRIG® (brigatinib)

Because Your Next Step Matters

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Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

How Does ALUNBRIG Work? ALUNBRIG works by blocking the abnormal ALK protein responsible for growth and spread of ALK+ NSCLC

Definitions Metastasis—The spread of cancer from the original site to another part of the body.

Resistance—When cancer cells fail to respond to a drug used to destroy or weaken them. Drug resistance may happen at the beginning of a treatment, or may happen over time.

What Is ALUNBRIG® (brigatinib)? ALUNBRIG is a prescription medicine used to treat people with NSCLC:

that has a certain type of abnormal ALK gene, and

that has spread to other parts of your body, and

who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib.

It is not known if ALUNBRIG is safe and effective in children.

There is an ongoing study to learn how ALUNBRIG works over a longer period of time.

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You’re Starting a New Treatment, and We Realize You May Have Questions

This brochure is intended to help you understand your new therapy and what you may expect.

Why Do I Need to Start a New Treatment?ALK+ NSCLC (anaplastic lymphoma kinase-positive non-small cell lung cancer) is a form of lung cancer that is caused by defects in the ALK gene and can be treated with drugs that target this gene. Even with targeted treatments, ALK+ NSCLC can progress (worsen). Progression is when tumors grow, spread to other parts of the body (called metastasis), or when new tumors develop while on treatment.

Alternatively, some patients may not be able to tolerate treatments and your healthcare provider may recommend a new medication.

What Causes ALK+ NSCLC Progression?While ALK-inhibitor treatment may initially work, eventually patients may experience disease progression. This progression may happen when the disease develops resistance, which can be caused by a number of different factors. One such factor is mutations in the ALK gene, which prevent the treatment from blocking the growth of cancer cells. This can cause the drug to stop working.

What Are Common Sites of ALK+ NSCLC Progression?Patients with ALK+ NSCLC may have their cancer spread to other parts of the body, including the liver, bone, and the brain.

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Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

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What Is the Most Important Information I Should Know About ALUNBRIG® (brigatinib)?

ALUNBRIG can cause serious side effects, including:Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment, and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of trouble breathing or shortness of breath, chest pain, cough (with or without mucus), or fever.

High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain, or shortness of breath.

Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you start to take or have any changes in heart or blood pressure medicines.

Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including double vision, seeing flashes of light, blurry vision, light hurting your eyes, or new or increased floaters.

Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Serious Side Effects (Continued) Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.

High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including needing to urinate more than usual, or feeling very thirsty, very hungry, sick to your stomach, weak, tired, or confused.

Common Side EffectsThe most common side effects of ALUNBRIG include:

nausea cough diarrhea headache fatigue

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ALUNBRIG. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

REMEMBER: Be sure to tell your healthcare provider about any side effects you have while taking ALUNBRIG

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALUNBRIG if you have certain side effects

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ALUNBRIG® (brigatinib) Was Shown to Shrink Tumors After Crizotinib Treatment

ALUNBRIG Also Showed Results in the Brain

Study Results for the Recommended Dosing Regimen Group In the same study, 18 patients in the 90 180-mg group had measurable tumors that had spread to the brain.

Brain tumors shrank in two-thirds of patients (12 out of 18)

Zero patients had a complete response in the brain

12 out of 18 (67%) patients had a partial response in the brain

Of the 12 patients who responded to treatment with ALUNBRIG, 6 patients responded for 6 months or longer and 3 patients responded for 12 months or longer

Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

Additional Study Results In the same study, 112 patients received 90 mg of ALUNBRIG orally once daily (90-mg group) without having their dose increased.

54 out of 112 (48%) patients achieved a response

— 4 out of 112 (3.6%) patients achieved a complete response

— 50 out of 112 (45%) patients achieved a partial response

Responses lasted a median of 13.8 months in both dosing groups.

Definitions Median—A median is the middle number in a set of data. In other words, half of the numbers in the group are more than the median and half of the numbers in the group are less than the median. Complete response—The disappearance of tumors in response to a given treatment. This is not the same as a cure.Partial response—The decrease in the size and spread of tumors in response to a given treatment.

The ALUNBRIG study included 222 people with ALK+ NSCLC whose cancer had spread to other parts of the body and who had taken the medicine crizotinib and their disease worsened. One hundred ten patients received the recommended dosing regimen of 90 mg of ALUNBRIG orally once daily for 7 days, followed by an increase to 180 mg orally once daily (90 180-mg group).

Study Results for the Recommended Dosing Regimen Group

53% (58 out of 110) of patients achieved a response, meaning their tumors either shrank or disappeared while taking ALUNBRIG.

PATIENTS ACHIEVING A RESPONSE PATIENTS NOT ACHIEVING A RESPONSE53%OF PATIENTS

5 out of 110 (4.5%) patients achieved a complete response

53 out of 110 (48%) patients achieved a partial response

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Additional Study Results In 26 patients with ALK+ NSCLC in the 90-mg group who had measurable tumors that had spread to the brain:

Brain tumors shrank in 11 out of 26 (42%) patients

— 2 out of 26 (7.7%) patients had a complete response in the brain

— 9 out of 26 (35%) patients had a partial response in the brain

Of the 11 patients who responded to treatment with ALUNBRIG, 7 patients responded for 6 months or longer and 4 patients responded for 12 months or longer Actor portrayal

Once-Daily Dosing Regimen

DAYS 1-790 MG ONCE DAILY

One 90-mg Tablet

One 180-mg Tablet

180 MG ONCE DAILYWEEK 2+

WEEK 1

DAY 8 AND BEYOND

AS DIRECTED BY YOUR HEALTHCARE PROVIDER

Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

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Before You Take ALUNBRIG® (brigatinib)

Before you take ALUNBRIG, tell your healthcare provider about all your medical conditions, including if you: have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have diabetes mellitus or glucose intolerance, have liver problems, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.

— Females who are able to become pregnant should use effective non-hormonal birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.

— Males who have female partners that are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.

It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Some of your other medicines may affect the way ALUNBRIG works. Certain medications may increase your risk of side effects such as slow heart rate (bradycardia) when taken with ALUNBRIG.

Recommended Dosing Regimen for ALUNBRIG

Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Store ALUNBRIG at room temperature of 68°F to 77°F (20°C to 25°C). Do not store above 86°F (30°C).

For more information, go to www.ALUNBRIG.com or call 1-844-T1Point (1-844-817-6468).

Can be taken with or without food

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Your healthcare provider will start you on a 90-mg dose of ALUNBRIG for the first 7 days of treatment. If you tolerate this dose of ALUNBRIG well, your healthcare provider may increase your dose to 180 mg after the first 7 days of treatment.

Always follow your healthcare provider’s dosing instructions.

Please read the Important Safety Information throughout and the Patient Information in the accompanying full Prescribing Information.

Taking ALUNBRIG® (brigatinib)

How Should I Take ALUNBRIG? Take ALUNBRIG exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ALUNBRIG unless your healthcare provider tells you to

Your healthcare provider will start you on a 90-mg dose of ALUNBRIG for the first 7 days of treatment. If you tolerate this dose of ALUNBRIG well, your healthcare provider may increase your dose after the first 7 days of treatment

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALUNBRIG if you develop side effects

Take ALUNBRIG 1 time each day

Take ALUNBRIG with or without food

Swallow ALUNBRIG tablets whole. Do not crush or chew tablets

If you miss a dose of ALUNBRIG, do not take the missed dose. Take your next dose at your regular time

If you vomit after taking a dose of ALUNBRIG, do not take an extra dose. Take your next dose at your regular time

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American Cancer Society | 1-800-227-2345 | www.cancer.org

Bonnie Addario Lung Cancer Foundation | 1-650-598-2857 | www.lungcancerfoundation.org

Cancer Care | 1-800-813-HOPE (4673) | www.cancercare.org

Cancer Support Community | 1-888-793-9355 | www.cancersupportcommunity.org

Free to Breathe | 1-844-835-4325 | www.freetobreathe.org

Lungevity | 1-312-407-6100 | www.lungevity.org

Lung Cancer Alliance | 1-800-298-2436 | www.lungcanceralliance.org

Lung Cancer Foundation of America | 1-507-354-1361 | www.lcfamerica.org

National Cancer Institute | 1-800-422-6237 | www.cancer.gov

We hope you will use the resources above to find the people, tools, and education that will enable you to become an active participant in your care. Takeda Oncology is not affiliated with these organizations. By listing these resources, Takeda Oncology is not endorsing any particular service or group and we are not responsible for the content of these sites or services. They are provided here for informational purposes and are not meant to replace your healthcare provider’s medical advice.

Additional Resources That May Be Useful

To learn more about ALUNBRIG, speak to your healthcare provider or visit ALUNBRIG.com.

For information about a financial assistance and support program, visit ALUNBRIG.com/1Point.

Visit ALUNBRIG.com to learn more.

Please read the Patient Information in the accompanying full Prescribing Information.

All trademarks are the property of their respective owners. ©2019 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved. 01/19 MAT-US-BRG-18-00100

Once-Daily ALUNBRIG® (brigatinib)

Because Your Next Step Matters

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