What is ALUNBRIG^® (brigatinib)?

[Larissa]
I think when you get a cancer diagnosis, it really does settle upon you, that life really isn't gonna be the same anymore.

I was 37 years old when I was diagnosed with lung cancer.

I had the C-section, this beautiful baby girl. And the pain just didn't go away. 

It took just a couple of weeks to go from oh my goodness, like, you have a collapsed lung and all this fluid, then it moved to there's something wrong with your lung. We're gonna try to re-inflate it and figure out what it was. And then pretty soon they're like, "How 'bout a CT scan?" And then words started coming up. Things like maybe we need to biopsy. Maybe we need to do a PET scan. And once those words hit, it was just that trigger that, no, this is really serious. And we are gonna probably start hearing that big C word that no one wants to hear.  

When they said lung cancer, I was like, "I don't really get that. I don't understand how I could have lung cancer. I haven't smoked. How could I have lung cancer?" And that was, you know, before I finally learned that anyone with lungs can get lung cancer. 

I fully expected to have to go through chemotherapy, lose my hair, get really weak and sick and then do some radiation. That was my picture of what it meant to fight cancer.

Initially, my treatment started with, targeted therapy. So I started on a TKI, right away, and that treatment worked very well for my body, for my cancer, it held the cancer under control for about two years.

I first learned about ALUNBRIG when my first TKI was starting to fade. It was starting to not be as effective. And so I knew we were gonna have to move onto something else. 

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 that has spread to other parts of your body. It is not known if ALUNBRIG is safe and effective in children.
My expectations of starting ALUNBRIG were very hopeful. I really did expect it to work well for me.

My dosage for ALUNBRIG started out as 90 mg tablets after a week, I started taking 180 mg tablets. And that's the dosage I've been on for the last 5 years.

Having ALUNBRIG as a once daily medication has meant it's been very convenient. It can fit right into my regular schedule. It can be part of my morning routine. And then I'm done, and I don't have to think about cancer anymore, for the rest of the day.

I have experienced some high blood pressure while taking ALUNBRIG, but this is just one of the possible side effects, and everyone is different. Speak to your healthcare provider about all the potential side effects with ALUNBRIG.

It's always really positive to me when I go to a doctor's appointment and my oncologist comes in and says like, “Everything is just boring.” That's kind of how he describes it. And really what he's saying is, “Your cancer is under control.”

The fact that it's under control, that there's no progression, is the best possible scenario for me.
Today, I feel great. Yesterday I was able to work from home.  I was able to take my kids to all of the things I needed to take them to.

To me, cancer is really a journey.

What helps me to fight is thinking about my four kids and thinking about what kind of mom I want to be, in the now, and thinking about the fact that I want to be, you know, the mom that's there for them through all of the stages of life that I can be. 

[Female VO]
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: trouble breathing or shortness of breath, chest pain, cough with or without mucus, 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: double vision, seeing flashes of light, blurry vision, light hurting your eyes, 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: yellowing of your skin or the white part of your eyes, dark or brown (tea color) urine, nausea or vomiting, pain on the right side of your stomach area, bleed or bruise more, itchy skin, decreased appetite, 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: feeling very thirsty, needing to urinate more than usual, feeling very hungry, feeling sick to your stomach, feeling weak or tired, 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.

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.

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.