Generic Name: brigatinib
Dosage Form: Tablets
Date of Approval: April 28, 2017
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer
FDA Approves Alunbrig
The U.S. Food and Drug Administration (FDA) has granted Accelerated Approval to Alunbrig (brigatinib), a once-daily oral kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
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. 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
- cough with or without mucous
- chest pain
- High blood pressure (hypertension). Alunbrig may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment. 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. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment. 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 treatment and refer you to an eye specialist if you develop severe vision problems. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
- double vision
- light hurting your eyes
- seeing flashes of light
- new or increased floaters
- blurry vision
- 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. 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. 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. 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
See Alunbrig side effects for more information about side effects.
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 this medicine is safe and effective in children.
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have lung or breathing problems
- have high blood pressure
- have a slow heartbeat
- have any vision problems
- have or have had pancreatitis
- have diabetes mellitus or glucose intolerance
- are pregnant or plan to become pregnant. Alunbrig can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment or think you may be pregnant.
- Females who are able to become pregnant should use effective non-hormonal birth control during treatment and for at least four months after the final dose. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment. Talk to your healthcare provider about birth control choices that are right for you during treatment.
- Males who have female partners that are able to become pregnant should use effective birth control during treatment and for at least three months after the final dose.
- are breastfeeding or plan to breastfeed. It is not known if Alunbrig passes into your breast milk. Do not breastfeed during treatment and for one week after the final dose.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.
How should I take Alunbrig?
- Take this medicine exactly as your healthcare provider tells you to take it. Do not change your dose or stop treatment unless your healthcare provider tells you to.
- Your healthcare provider will start you on a low dose (90 mg) for the first seven days of treatment. If you tolerate this dose well, your healthcare provider may increase your dose after the first seven days of treatment.
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have side effects.
- Take Alunbrig one time each day, with or without food.
- Swallow the tablets whole. Do not crush or chew the tablets.
- If you miss a dose, do not take the missed dose. Take your next dose at your regular time.
- If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
What should I avoid while taking Alunbrig?
- Avoid eating grapefruit or drinking grapefruit juice during treatment. Grapefruit may increase the amount of Alunbrig in your blood.
Alunbrig side effects
Alunbrig may cause serious side effects, including:
- See Important information
The most common side effects of Alunbrig include:
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 of the possible side effects. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Alunbrig?
- Store the tablets at room temperature 20°C to 25°C (68°F to 77°F). Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Alunbrig.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in Alunbrig?
Active ingredient: brigatinib
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, and hydrophobic colloidal silica. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.