Alunbrig (brigatinib)

What is Alunbrig?

Alunbrig is a brand-name prescription drug.

It’s FDA-approved to treat a type of lung cancer called anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). It’s used in people whose cancer has spread from their lungs to other parts of their body (called metastatic cancer).

Drug details

Alunbrig contains the active drug brigatinib. It belongs to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. These drugs are used to treat specific types of cancer.

Alunbrig comes as tablets that are taken by mouth each day. It’s available in three strengths: 30 milligrams (mg), 90 mg, and 180 mg.

FDA approval

In 2017, the Food and Drug Administration (FDA) approved Alunbrig for use through an accelerated approval program.

These programs are for drugs that show promising results in early clinical studies when they’re used by people who don’t have other treatment options for their condition.

Alunbrig has received full approval from the FDA now that additional clinical studies have been completed.

Effectiveness

In clinical studies, Alunbrig was effective in treating the type of lung cancer described above. To learn more, see the “Alunbrig uses” section below.

Alunbrig generic

Alunbrig contains the active drug brigatinib.

Alunbrig is available only as a brand-name medication. It’s not currently available in generic form.

Alternatives to Alunbrig

Other drugs are available that can treat non-small cell lung cancer (NSCLC). Some may be better suited for you than others. If you’re interested in finding an alternative to Alunbrig, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of drugs that may be used to treat NSCLC include:

• alectinib (Alecensa)
• ceritinib (Zykadia)
• crizotinib (Xalkori)
• erlotinib (Tarceva)
• afatinib (Gilotrif)
• bevacizumab (Avastin)

Alunbrig (brigatinib) vs. Alecensa (alectinib)

You may wonder how Alunbrig compares to other medications that are prescribed for similar uses. Here we look at how Alunbrig and Alecensa are alike and different.

Ingredients

Alunbrig contains the drug brigatinib, while Alecensa contains the drug alectinib. Both of these drugs belong to the same class of medications called kinase inhibitors.

Uses

Both Alunbrig and Alecensa are approved by the Food and Drug Administration (FDA) to treat anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic. (Metastatic means the cancer has spread to other parts of your body.)

Drug forms and administration

Alunbrig comes as tablets that are taken by mouth each day. It’s available in three strengths: 30 mg, 90 mg, and 180 mg.

The typical starting dosage of Alunbrig is 90 mg once daily for the first 7 days of treatment. Then if you’re feeling well on the drug, your doctor will increase your dosage to 180 mg each day. Alunbrig can be taken with or without food.

Alecensa comes as capsules that are taken by mouth each day. It’s available in one strength: 150 mg. The typical dosage of Alecensa is 600 mg (four capsules) taken twice each day. Alecensa should be taken with food.

The dosage of either medication can be adjusted by your doctor if you’re having bothersome side effects.

Side effects and risks

Alunbrig and Alecensa both belong to the same class of medications. Therefore, both drugs can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Alunbrig, with Alecensa, or with both drugs (when taken individually).

• Can occur with Alunbrig:
  • belly pain
  • fever
  • tingling in your hands or feet
  • reduced appetite
  • insomnia (trouble sleeping)
  • increased blood sugar level
• Can occur with Alecensa:
  • edema (swelling in your hands, legs, or feet)
  • being unable to taste certain foods
  • weight gain
• Can occur with both Alunbrig and Alecensa:
  • headache
  • nausea or vomiting
  • diarrhea
  • constipation
  • fatigue (lack of energy)
  • muscle spasms or pain
  • rash
  • cough
  • trouble breathing

Serious side effects

These lists contain examples of serious side effects that can occur with Alunbrig, with Alecensa, or with both drugs (when taken individually).

• Can occur with Alunbrig:
  • high blood pressure
• Can occur with Alecensa:
  • neutropenia (low level of neutrophils, which are a type of white blood cell)
  • liver toxicity
  • kidney problems, which may lead to kidney failure
• Can occur with both Alunbrig and Alecensa:
  • inflammation or swelling in your lungs
  • vision problems, such as blurry vision, seeing “floaters,” or having reduced ability to see
  • bradycardia (slow heart rate)
  • anemia (low red blood cell level)
  • lymphopenia (low level of lymphocytes, which are a type of white blood cell)
  • severe muscle pain

Effectiveness

Both Alunbrig and Alecensa are used to treat anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic.

These drugs haven’t been directly compared in clinical studies. But separate studies have shown that Alecensa and Alunbrig are each effective to treat ALK+ metastatic NSCLC in people who:

• haven’t yet received treatment for their cancer, or
• have taken a drug called crizotinib, but either their cancer worsened with the treatment or they couldn’t tolerate the side effects of crizotinib

Costs

Alunbrig and Alecensa are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Alunbrig (brigatinib) vs. Xalkori (crizotinib)

You may wonder how Alunbrig compares to Xalkori.

Ingredients

Alunbrig contains the drug brigatinib, while Xalkori contains the drug crizotinib. These medications both belong to a class of drugs called kinase inhibitors.

Uses

Both Alunbrig and Xalkori are approved by the Food and Drug Administration (FDA) to treat anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic. (Metastatic means the cancer has spread to other parts of your body.)

Xalkori is also used to treat NSCLC that’s receptor tyrosine kinase (ROS1) positive.

Additionally, Xalkori is used in certain children and young adults with a specific type of large cell lymphoma. (This is a type of blood cell cancer.)

Effectiveness

These drugs haven’t been directly compared in clinical studies. But separate studies have shown that Xalkori and Alunbrig are each effective as the first drug a person receives to treat ALK+ metastatic NSCLC.

Also, Alunbrig is effective for this use in people who’ve already received Xalkori. In order for them to use Alunbrig, either:

• their cancer worsened with Xalkori treatment, or
• they couldn’t tolerate the side effects of Xalkori

Costs

Alunbrig and Xalkori are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Alunbrig (brigatinib) vs. Zykadia (ceritinib)

You may wonder how Alunbrig compares to other medications that are prescribed for similar uses. Here we look at how Alunbrig and Zykadia are alike and different.

Ingredients

Alunbrig contains the drug brigatinib, while Zykadia contains the drug ceritinib. Both of these medications belong to the same class of drugs called kinase inhibitors.

Uses

Both Alunbrig and Zykadia are approved by the Food and Drug Administration (FDA) to treat anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic. (Metastatic means the cancer has spread to other parts of your body.)

Drug forms and administration

Alunbrig comes as tablets that are taken by mouth each day. It’s available in three strengths: 30 mg, 90 mg, and 180 mg.

The typical starting dosage of Alunbrig is 90 mg once daily for the first 7 days of treatment. Then if you’re feeling well on the drug, your doctor will increase your dosage to 180 mg each day. Alunbrig can be taken with or without food.

Zykadia also comes as tablets. It’s available in one strength: 150 mg. You’ll usually take 450 mg of Zykadia (three tablets) by mouth once daily with food.

If you have bothersome side effects from either drug, your doctor may lower your dosage.

Side effects and risks

Alunbrig and Zykadia both belong to the same class of drugs. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Alunbrig, with Zykadia, or with both drugs (when taken individually).

• Can occur with Alunbrig:
  • mouth sores
  • tingling in your hands or feet
  • muscle spasms
  • insomnia (trouble sleeping)
  • high blood pressure
• Can occur with Zykadia:
  • weight loss
• Can occur with both Alunbrig and Zykadia:
  • nausea or vomiting
  • pain or discomfort in your esophagus (the tube that connects your throat to your stomach)
  • high blood sugar level
  • constipation
  • muscle or back pain
  • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Alunbrig, with Zykadia, or with both drugs (when taken individually).

• Can occur with Alunbrig:
  • vision problems, such as blurry vision, seeing “floaters,” and having reduced ability to see
  • lymphopenia (low level of lymphocytes, which are a type of white blood cell)
  • severe muscle pain
  • high blood pressure
• Can occur with Zykadia:
  • pericarditis (inflammation of the lining around your heart)
  • long QT interval (a type of heart rhythm disorder)
  • neutropenia (low level of neutrophils, which are a type of white blood cell)
  • liver toxicity
  • pancreatitis (inflammation in your pancreas)
• Can occur with both Alunbrig and Zykadia:
  • anemia (low red blood cell level)
  • inflammation or swelling in your lungs
  • bradycardia (slow heart rate)

Effectiveness

Both Alunbrig and Zykadia are used to treat anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic (has spread to other parts of your body).

These drugs haven’t been directly compared in clinical studies. But separate studies have shown that Zykadia and Alunbrig are each effective to treat ALK+ metastatic NSCLC in people who:

• haven’t yet received treatment for their cancer, or
• have taken a drug called crizotinib, but either their cancer worsened with the treatment or they couldn’t tolerate the side effects of crizotinib

Costs

Alunbrig and Zykadia are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Alunbrig side effects

Alunbrig can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Alunbrig. This list does not include all possible side effects.

For more information on the possible side effects of Alunbrig, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Alunbrig, you can do so through MedWatch.

More common side effects

The more common side effects of Alunbrig can include:

• nausea or vomiting
• diarrhea
• constipation
• belly pain
• fatigue (lack of energy)
• fever
• cough
• trouble breathing
• headache
• tingling in your hands or feet
• rash
• muscle spasms or pain
• reduced appetite
• insomnia (trouble sleeping)
• increased blood sugar level

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Alunbrig aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

• Anemia (low red blood cell level). Symptoms can include:
  • fatigue (lack of energy)
  • fast heart beat
  • shortness of breath
• Lymphopenia (low level of lymphocytes, which are a certain type of white blood cell). Symptoms can include:
  • frequent infections
  • swollen lymph nodes
• Sensitivity to sunlight. Symptoms may include:
  • sunburn
  • rash

Other serious side effects, which are discussed in the section below called “Side effect details,” include:

• lung inflammation or infection
• vision changes
• high blood pressure
• bradycardia (slow heart rate)
• severe muscle pain
• severe allergic reaction

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Alunbrig. It’s not known how many people have allergic reactions to Alunbrig.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Alunbrig. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Lung inflammation and infection

Alunbrig may cause inflammation or infection in your lungs when you’re taking the drug. In clinical studies, 3.7% to 9.1% of people taking Alunbrig had inflamed or swollen lungs.

Inflammation in your lungs (called pneumonitis) happens when the walls of the alveoli (small air-filled sacs in your lungs) become swollen. This can make it hard for you to breathe and can cause a cough. If your lungs become scarred or damaged inside from inflammation, you may develop interstitial lung disease. This condition also makes it hard for you to breathe.

During your treatment with Alunbrig, your doctor will monitor you for symptoms of lung inflammation or infection. If you’re having any problems with your lungs, your doctor may adjust your dosage of Alunbrig. They may also have you stop taking the drug for a while.

High blood pressure

It’s possible that you’ll have new or worsening high blood pressure (hypertension) when you’re taking Alunbrig. In clinical studies, 11% to 32% of people taking Alunbrig had high blood pressure.

Symptoms of high blood pressure can include severe headache and chest pain.

Your doctor may check your blood pressure about a week after you start taking Alunbrig. They’ll continue to monitor your blood pressure during treatment and make changes to your dosage if needed. If your blood pressure becomes too high, your doctor may recommend that you stop taking Alunbrig.

Slow heart rate

Slow heart rate (bradycardia) is a possible side effect of Alunbrig. With this condition, your heart beats less than 50 times each minute. In clinical studies, 5.7% to 8.1% of people taking Alunbrig had bradycardia.

Symptoms of bradycardia can include:

• fatigue (lack of energy)
• dizziness or lightheadedness
• shortness of breath
• chest pain

Your doctor may monitor your heart rate during Alunbrig treatment to make sure that your heart rate is within a safe range. If your heart rate is too low, or you’re having symptoms of bradycardia, your doctor may adjust your dosage of Alunbrig. They may also recommend that you stop taking Alunbrig for a while.

Vision problems

It’s possible to have problems with your vision when you’re taking Alunbrig. In clinical studies, 7.3% to 10% of people taking Alunbrig reported changes in their ability to see.

Changes in vision may include:

• blurry vision
• reduced ability to see clearly
• seeing double
• seeing “floaters”

If you have any changes in your vision while you’re taking Alunbrig, call your doctor right away. They may check your eyes using certain tests. This will help your doctor make sure if it’s safe for you to continue taking Alunbrig.

During treatment, your doctor also will monitor you for vision problems. If you develop problems with your vision, your doctor may adjust your dosage of the drug. They may also recommend that you stop using Alunbrig for a while.

Muscle pain

You may have muscle pain when you’re taking Alunbrig. In clinical studies, 9.2% to 28% of people taking the drug had muscle pain.

Alunbrig may increase the level of an enzyme (protein) in your blood called creatine phosphokinase (CPK). This enzyme is usually released when you have muscle damage or injury. While it’s not known why Alunbrig causes increased CPK levels, it can be a sign that muscle damage has occurred.

Your doctor may check your CPK levels during Alunbrig treatment. This helps your doctor to make sure that it’s safe for you to continue taking the drug. If you develop muscle pain during treatment, talk with your doctor. They can recommend ways to improve your discomfort.

Nausea

Nausea is a common side effect of Alunbrig. In clinical studies, 30% to 58% of people had nausea while taking Alunbrig. For most people, this side effect gets better over time. But for other people, nausea occurs more often and lasts for a longer time during treatment.

Let your doctor know if you have vomiting while you’re taking Alunbrig. Call you doctor right away if you feel dizzy or lightheaded, which may mean that you’re dehydrated (low fluid level in your body). Also, let your doctor know if your vomit looks red or black in color.

Diarrhea

You may have diarrhea when you’re taking Alunbrig. In clinical studies, 19% to 57% of people taking the drug had diarrhea. For most people, this side effect gets better over time. But for other people, it happens more often and lasts for a longer time during treatment.

Let your doctor know if you have diarrhea while you’re taking Alunbrig. Call you doctor right away if you feel dizzy or lightheaded, which may mean that you’re dehydrated (low fluid level in your body). Also, let your doctor know if your stool looks red or black in color. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Fatigue

Fatigue (lack of energy) is a common side effect of Alunbrig. In clinical studies, 29% to 40% of people taking the drug felt fatigued. For most people, this side effect gets better over time. But for other people, it happens more often and lasts for a longer time during treatment.

Fatigue can sometimes be a symptom of other side effects of Alunbrig, such as:

• anemia (low red blood cell level)
• bradycardia (slow heart rate)
• high blood pressure

If you feel fatigued while you’re taking Alunbrig, talk with your doctor. They can recommend ways to help improve your energy levels.

Increased blood sugar level

It’s possible to have increased blood sugar levels (hyperglycemia) while you’re taking Alunbrig. In a clinical studies, 43% to 56% of people taking the drug had a new or worsened high blood sugar level. Of people who had a history of diabetes when they started taking Alunbrig, 10% had to use insulin to control their blood sugar level.

Symptoms of an increased blood sugar level can include:

• increased thirst
• increased urination
• fatigue (lack of energy)

Your doctor may check your blood sugar level before you start Alunbrig. And they may continue to monitor your blood sugars while you’re taking the drug.

If you have a history of diabetes or prediabetes, your doctor may monitor your blood sugar level very closely when you’re taking Alunbrig. If your blood sugar level is not well managed while you’re using Alunbrig, your doctor may recommend that you stop using the drug until your blood sugar level returns to a safe range. They may also prescribe medication to help control your blood sugar levels.

Alunbrig dosage

The Alunbrig dosage your doctor prescribes will depend on several factors. These include:

• how you’re feeling while using Alunbrig
• any changes on certain lab tests that may occur with Alunbrig use
• other medical conditions you may have
• other medications you may be taking

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Alunbrig comes as tablets that are taken by mouth, with or without food. It’s available in three strengths:

• 30 milligrams (mg)
• 90 mg
• 180 mg

Dosage for non-small cell lung cancer

The typical starting dosage of Alunbrig is 90 mg taken by mouth once daily for the first 7 days of treatment. After that, your doctor will increase your dosage to 180 mg each day.

Depending on side effects that you have while you’re taking Alunbrig, your doctor may adjust your dosage. In some cases, they may recommend that you stop taking Alunbrig for a while.

What if I miss a dose?

If you miss a dose of Alunbrig, or you vomit after taking the medication, don’t take an extra dose. Instead, just wait and take your next dose of Alunbrig at the regular time.

Will I need to use this drug long term?

Yes, Alunbrig is meant to be taken as long as the drug is working to keep your cancer from getting worse. Your doctor will recommend that you stop using Alunbrig if your cancer becomes worse during treatment, or if you have complications from the drug. The length of time that Alunbrig is used varies for each person taking it.

Alunbrig cost

As with all medications, the cost of Alunbrig can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Alunbrig, or if you need help understanding your insurance coverage, help is available.

Takeda Pharmaceutical Company, the manufacturer of Alunbrig, offers a program called Takeda Oncology 1Point. For more information and to find out if you’re eligible for support, call 844-817-6468 (844-T1POINT) or visit the program website.

Alunbrig uses

The Food and Drug Administration (FDA) approves prescription drugs such as Alunbrig to treat certain conditions.

Alunbrig for non-small cell lung cancer

Alunbrig is used to treat a type of lung cancer called anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). It’s used in people whose cancer has spread from their lungs to other parts of their body (called metastatic cancer).

ALK+ NSCLC is a type of lung cancer that commonly occurs in people who’ve never smoked, but who have the ALK mutation. (A mutation is an abnormal change in one of your genes.)

The ALK gene mutation causes cells in your lungs to be abnormal and multiply (make more cells) very quickly. These abnormal cells, which are cancerous, can spread to other parts of your body.

Effectiveness for non-small cell lung cancer

In clinical studies, Alunbrig was effective in treating the type of NSCLC described above. To learn how the drug performed in studies, see Alunbrig’s prescribing information.

Based on the National Comprehensive Care Network’s guidelines, Alunbrig is recommended:

• as the first drug treatment in people with metastatic ALK+ NSCLC who haven’t yet received treatment for their cancer, or
• as treatment in people who’ve taken a drug called crizotinib, but either their cancer worsened with crizotinib or they couldn’t tolerate the side effects of crizotinib

Alunbrig and alcohol

It’s not known if Alunbrig is safe to use if you consume alcohol. Alcohol can affect how well your liver works. If you take Alunbrig while having impaired liver function, certain side effects of Alunbrig may be worse and more dangerous for you.

If you drink alcohol often, talk with your doctor about whether it’s safe for you to take Alunbrig.

Alunbrig interactions

Alunbrig can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Alunbrig and other medications

Below is a list of medications that can interact with Alunbrig. This list does not contain all of the drugs that may interact with Alunbrig.

Before taking Alunbrig, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that can change the metabolism of Alunbrig

Alunbrig interacts with drugs that are metabolized (broken down) in your body by an enzyme (protein) called CYP3A. This includes many different drugs. Taking these drugs with Alunbrig can either increase or decrease the level of Alunbrig or the other drug in your body.

If the level of a certain drug is increased, you could have increased side effects from that drug. If the level of a certain drug is decreased, that drug may be less effective to treat your condition.

Examples of drugs that increase the level of Alunbrig in your body include:

• certain antifungals, such as:
  • ketoconazole (Nizoral)
  • itraconazole
  • fluconazole (Diflucan)
• certain antivirals, such as:
  • cobicistat (Tybost)
  • indinavir
  • nelfinavir (Viracept)
  • ritonavir (Norvir)
  • saquinavir (Invirase)

Examples of drugs that decrease the level of Alunbrig in your body include:

• antibiotics, such as rifampin (Rimactane)
• seizure medications, such as:
  • carbamazepine (Carbatrol, Tegretol)
  • phenytoin (Dilantin, Phenytek)
  • phenobarbital

Examples of drugs that may be less effective if they’re taken with Alunbrig include:

• hormonal birth control drugs (such as birth control pills)
• certain pain medications, such as alfentanil (Alfenta)
• certain anxiety medications, such as buspirone
• conivaptan (Vaprisol), an antidiuretic hormone
• certain chemotherapy drugs, such as everolimus (Afinitor)
• certain sedatives, such as midazolam (Nayzilam)

There are many drugs other than those listed here that are also metabolized by CYP3A4 and can interact with Alunbrig. Talk with your doctor or pharmacist about all of the medications you’re taking to make sure that your risk of drug interactions is low.

Alunbrig and herbs and supplements

Alunbrig interacts with certain herbs and supplements that are metabolized (broken down) in your body by an enzyme (protein) called CYP3A.

St. John’s wort

One example of an herb that interacts with Alunbrig is St. John’s wort. This herbal supplement is often used to improve moods. If you use St. John’s wort with Alunbrig, the level of Alunbrig in your body may be increased. This can increase your risks of side effects from the drug.

Talk with your doctor or pharmacist about all of the herbs and supplements you’re taking to make sure that your risk of drug interactions is low.

Alunbrig and foods

Alunbrig may interact with certain foods, such as grapefruit and grapefruit juice. Consuming Alunbrig and grapefruit together may increase the level of Alunbrig in your body. This may increase your risk of side effects from the drug.

Talk with your doctor if you regularly drink grapefruit juice or eat grapefruit. Your doctor can recommend whether it’s safe for you to continue doing this while you’re using Alunbrig.

How to take Alunbrig

You should take Alunbrig according to your doctor or another healthcare professional’s instructions.

When to take

Alunbrig should be taken once each day, at any time of the day. It’s best to take Alunbrig at the same time each day.

Taking Alunbrig with food

Alunbrig can be taken with or without food.

Can Alunbrig be crushed, split, or chewed?

No, Alunbrig tablets should be swallowed whole. They shouldn’t be crushed, split, or chewed.

If you have trouble swallowing pills, talk with your doctor or pharmacist about other treatment options.

How Alunbrig works

Alunbrig is used to treat a type of lung cancer called anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) that’s metastatic (has spread to other parts of your body).

What is ALK+ NSCLC?

ALK+ NSCLC is a type of lung cancer that commonly occurs in people who’ve never smoked, but who have the ALK mutation. (A mutation is an abnormal change in one of your genes.)

The ALK gene mutation causes cells in your lungs to be abnormal and multiply (make more cells) very quickly. These abnormal cells, which are cancerous, can spread to other parts of your body.

What does Alunbrig do?

Alunbrig contains the drug brigatinib. It belongs to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. These drugs are used to treat specific types of cancer.

Alunbrig works by attaching to and inhibiting (blocking the action of) the ALK protein. This protein usually tells certain cancer cells in your body to multiply (make more cells).

With Alunbrig treatment, this action is blocked, which stops the cancer cells from multiplying. This leads to smaller and fewer cancer tumors in your body.

How long does it take to work?

Alunbrig can take different lengths of time to work in different people. In clinical studies, people using Alunbrig were followed for several months to over a year.

About 53% to 78% of the people had a reduction in the size and spread of their tumors while taking Alunbrig. However, 22% to 47% of people using Alunbrig didn’t see any response to treatment during the study.

Each person’s cancer will respond differently to Alunbrig. Your doctor will monitor your cancer to see if Alunbrig is working to treat it.

Alunbrig and pregnancy

Animal studies have shown that Alunbrig may affect fertility and cause problems if it’s used during pregnancy. These studies are described below.

Alunbrig’s effect on pregnancy

Alunbrig shouldn’t be used by pregnant people. In animal studies, this drug did cause birth defects in fetuses exposed to the drug. Although animal studies don’t always predict what will happen in humans, it’s thought that Alunbrig could possibly cause harm in human fetuses as well.

Before starting Alunbrig, you’ll take a pregnancy test to make sure that you aren’t pregnant. If you are pregnant, or you’re considering becoming pregnant, talk with your doctor about the safety of using Alunbrig.

Alunbrig’s effect on fertility

Some animal studies have suggested that Alunbrig reduces fertility (ability to reproduce) in males exposed to the drug. It’s not known if this also happens in humans using the drug.

If you have questions about the effect of Alunbrig on your fertility, talk with your doctor.

Alunbrig and birth control

Alunbrig shouldn’t be used in people who are pregnant. It should also be avoided by people who may become pregnant or have a partner who can become pregnant. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you’re using Alunbrig.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” below refers to sex assigned at birth.

For females using Alunbrig

If you’re a female who could become pregnant while taking Alunbrig, it’s recommended that you use a nonhormonal method of birth control during treatment. You should continue to use this form of birth control for at least 4 months after you’ve stopped Alunbrig treatment.

It’s important to use a nonhormonal form of birth control because Alunbrig can decrease the effectiveness of hormonal birth control drugs. You may have a greater risk of becoming pregnant if you’re using Alunbrig with birth control that contains hormones.

Examples of nonhormonal birth control options include:

• condoms
• diaphragms
• copper intrauterine devices (Paragard)

For males using Alunbrig

If you’re a male using Alunbrig, and you have a partner who can possibly get pregnant, it’s recommended that you use effective nonhormonal birth control (such as condoms) during Alunbrig treatment. You should continue to use birth control for at least 3 months after your final dose of Alunbrig.

Alunbrig and breastfeeding

Alunbrig shouldn’t be used by people who are breastfeeding. It’s not known if Alunbrig passes into human breast milk. However, if the drug does pass into human breast milk, it can cause severe side effects to a child who is breastfed.

You shouldn’t breastfeed while taking Alunbrig for 1 weekafter your last dose of the drug. If you have questions about breastfeeding while using Alunbrig, talk with your doctor.

Common questions about Alunbrig

Here are answers to some frequently asked questions about Alunbrig.

Has Alunbrig been proven safe and effective for long-term use?

When it first became available, Alunbrig hadn’t been studied for long-term use. It had been approved through an accelerated approval program by the Food and Drug Administration.

These programs are for drugs that show promising results in early clinical studies when they’re used by people who don’t have other treatment options for their condition.

Since Alunbrug’s approval, an additional study has been completed. In this study, Alunbrig was compared with another approved treatment called crizotinib. The results showed that Alunbrig was at least as effective or more effective than crizotinib. This was for people with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who hadn’t received treatment in the past.*

If you have questions about the risks and benefits of using Alunbrig over a long period, talk with your doctor.

* This is the type of cancer Alunbrig is used to treat. “Metastatic” means that the cancer has spread to other parts of your body. To learn more about this condition, see the “Alunbrig uses” section above.

Is Alunbrig chemotherapy?

No, Alunbrig isn’t a chemotherapy drug. In some definitions, chemotherapy is considered to be any drug that treats cancer. However, a more precise definition of traditional chemotherapy classifies it as a systemic treatment for cancer. “Systemic treatment” means a treatment that can affect your whole body.

Chemotherapy affects all cells in your body that are quickly multiplying (making more cells). This includes cancer cells, but also other cells. Chemotherapy can affect healthy cells in your body that are multiplying quickly.

Certain newer drugs called targeted therapies work only on specific cells or parts of cells inside your body. Alunbrig is a type of targeted therapy. It targets and attacks only a specific type of cancer cell, instead of attacking all the cells in your body that are multiplying quickly.

Because targeted therapies affect fewer cells in the body, these drugs can cause fewer side effects than systemic drugs such as chemotherapy.

Can I take Alunbrig if I have diabetes?

You may be able to if your doctor advises you to. However, Alunbrig may increase your blood sugar level, which might make the drug unsafe for you to take if you have diabetes.

In clinical studies, 43% to 56% of people taking Alunbrig had new or worsening high blood sugar. During the study, 20 people with diabetes were included and were given Alunbrig. Of these people, only 2 had to start taking insulin to treat the elevated blood sugar levels caused by Alunbrig.

If you have diabetes, and you’re interested in taking Alunbrig, talk with your doctor. They can recommend whether this drug is a safe option for your treatment.

Alunbrig precautions

Before taking Alunbrig, talk with your doctor about your health history. Alunbrig may not be right for you if you have certain medical conditions. These include:

• Diabetes. Alunbrig may increase your blood sugar level, which might make the drug unsafe for use by people with diabetes. If you have a history of diabetes or elevated blood sugar levels, talk with your doctor before starting Alunbrig.
• High blood pressure or slow heart rate. If you have high blood pressure or slow heart rate, Alunbrig could worsen your condition. Your doctor may monitor your blood pressure and heart rate after you start taking Alunbrig. They may recommend that you stop using the drug if your blood pressure gets too high or heart rate gets too slow during treatment. Talk with your doctor about any history of blood pressure problems before starting Alunbrig.
• Severe kidney problems. It’s not known for sure if Alunbrig is safe for use by people with severe kidney problems. Talk with your doctor about any history of kidney problems before starting Alunbrig.
• Severe liver problems. It’s not known if Alunbrig is safe for use by people with severe liver problems. Talk with your doctor about any history of liver problems before starting Alunbrig.
• Pregnancy & breastfeeding. Alunbrig shouldn’t be used by women who are pregnant or breastfeeding. See the sections above called “Alunbrig and pregnancy” and “Alunbrig and breastfeeding” for more information.

Note: For more information about the potential negative effects of Alunbrig, see the “Alunbrig side effects” section above.

Alunbrig overdose

Using more than the recommended dosage of Alunbrig can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

• nausea
• vomiting
• diarrhea
• high blood pressure
• bradycardia (slow heart rate)
• coughing or trouble breathing

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Alunbrig expiration, storage, and disposal

When you get Alunbrig from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Alunbrig tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container.

Disposal

If you no longer need to take Alunbrig and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

You can find useful tips on medication disposal here. You can also ask your pharmacist for tips on how to dispose of your medication.