What is ALUNBRIG?
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,
- that has spread to other parts of your body
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What is the most important information I should know about ALUNBRIG ?
ALUNBRIG can cause serious side effects. These serious side effects include:
- 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
- Cough with or without mucus
- Chest pain
- 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 rate 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:
- seeing flashes of light
- light hurting your eyes
- new or increased floaters
- bluryr vision
- double 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 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.
- 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
- feeling sick to your stomach
- feeling very hungry
- needing to urinate more than usual
- feeling confused
- feeling weak or tired
- The most common side effects of ALUNBRIG include:
- diarrhea
- fatigue
- nausea
- rash
- cough
- muscle pain
- high blood pressure
- vomiting
- 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 of the possible side effects of ALUNBRIG.
Call your doctor for medical advice about side effects.
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 low dose (90 mg) 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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Important Safety Information
- 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.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking ALUNBRIG?
Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you:
- have lung or breathing problemstext here
- have high blood pressure
- have a slow heartbeat
- have 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. 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.
- are breastfeeding or plan to breastfeed. 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.
It is not known if ALUNBRIG is safe and effective in children
General information about ALUNBRIG
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ALUNBRIG for a condition for which it was not prescribed. Do not give ALUNBRIG to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in ALUNBRIG ?
Active ingredient: Brigatinib
Other ingredient: 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.