What Is ALUNBRIG^® (brigatinib)?

[Greg]

My name is Greg. My wife's name is Amy. We live in Boston, Massachusetts. We like to go out and experience different things and travel a lot together whenever we have time.

I was diagnosed with ALK Positive, metastatic, non-small cell lung cancer in September of 2021 at the age of 39.

Before I was diagnosed, I was very active, almost on a daily basis. I really didn't stop moving from the time I woke up between 4:45, and 5:15 until I went to bed.

Around Memorial Day in 2021, after I was doing workouts, it was taking me longer to recover. And steadily deteriorated, which gave me a rise to suspect something else was going on.

The journey to diagnosis was actually a very long and stressful one. I got a lymph node that bulged from my neck on the left side, and during that time, I developed a persistent cough. I couldn't even walk my dog around the apartment building without feeling like I had run 10 plus miles or even a full race.

That all led to this day when I got up and went to work and I couldn't speak, and that was kind of the beginning of what I'll call the diagnosis process that took 11 days of being hospitalized.

But it wasn’t until the neurologist came in and noticed I had lost the ability to speak. She said to the nurse you need to get him down to an MRI. That’s when the result came back that showed 13 lesions in my head.

That's where the confirmation came that it's cancer. What type we did not know at this point.

And during the course of radiation, after we got the biopsy that was sent off for next generation sequencing to see if there were any biomarkers, we got the panel report back that confirmed and diagnosed me with ALK Positive metastatic, non-small cell lung cancer.

It really didn't make any sense to me. It doesn't matter your fitness level. It doesn't matter your lifestyle. I mean, one of the things that I've learned over the past four years now, is that if you have lungs, you can get lung cancer.

The decision to choose an ALK TKI as our first treatment option was because it works directly on the ALK mutation.

My oncologist discussed the variety of options in terms of the ALK TKI’s. We went over, you know, the pros, the cons, the side effects, the potential for response versus nonresponse.

It was a collaborative conversation. But ultimately, the decision was mine to make.

I was only on that first line of treatment for about a month. I had a significant downturn in my health and was hospitalized.

Although this was my experience on that treatment, each patient will be different.

I first learned about ALUNBRIG during the selection process of the first TKI. It wasn't until we decided to switch one month later to a second TKI that I really dug into the efficacy and the safety profile of ALUNBRIG. Deciding on ALUNBRIG for the second treatment option was a very quick decision.

ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer, NSCLC that has a certain type of abnormal anaplastic lymphoma kinase ALK gene and is not spread to other parts of your body. It is not known if ALUNBRIG is safe and effective in children.

Before starting ALUNBRIG, my doctor explained that I may experience side effects. The ones that were pointed out were specifically fatigue in my situation. He also shared that these can sometimes be serious, so it's important for me to understand this before we began treatment. While I've not experienced side effects while being treated by ALUNBRIG, please remember that's my experience, and others may experience something different.
Please speak with your healthcare provider about possible side effects with ALUNBRIG.

I started ALUNBRIG at 90 milligrams once a day for seven days, and then moved to 180 milligrams once a day, which is the recommended dose, and I've been on that ever since.

I think treatment with ALUNBRIG has impacted my life in a very positive way. The doctors use the term N.E.D. or “no evidence of disease” to describe my current state from the neck down.

Even when you're in a place that seems completely hopeless, there is hope, there is a possibility for things to change and for you to fight for it.

I'm really enjoying just being in the moment. I've checked a lot of things off my bucket list that I would not have thought I was able to do four years ago. I plan to live life unapologetically and the fullest, every day for however long I can.

ALUNBRIG (brigatinib) is a prescription medicine used to treat adults 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

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

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, including:
   o trouble breathing or shortness of breath
   o chest pain
   o cough with or without mucus
   o 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 take any 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:
   o double vision
   o seeing flashes of light
   o blurry vision
   o light hurting your eyes
   o 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.
• 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.
• Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:
   o yellowing of your skin or the white part of your eyes
   o dark or brown (tea color) urine
   o nausea or vomiting
   o pain on the right side of your stomach area
   o bleed or bruise more
   o itchy skin
   o decreased appetite
   o feeling tired
• 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:
   o feeling very thirsty
   o needing to urinate more than usual
   o feeling very hungry
   o feeling sick to your stomach
   o feeling weak or tired
   o feeling confused
The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing. 
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 doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

While taking ALUNBRIG you should:
• Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.
• Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Before you take ALUNBRIG, tell your healthcare provider about all of 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 liver problems, have diabetes mellitus or glucose intolerance, 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.
o Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
o Males who have female partners who 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.

Talk to your healthcare provider about ALUNBRIG, a once-daily oral prescription medication that may help treat adults with ALK-positive metastatic non-small cell lung cancer.