Frequently Asked Questions about Alunbrig® (brigatinib)

Class: Biological Therapy

Generic Name: brigatinib

Trade Name: Alunbrig®

For which conditions is Alunbrig approved for? Alunbrig is approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase) whose disease has worsened after taking Xalkori® (crizotinib) or cannot tolerate Xalkori.

What is the mechanism of action? Alunbrig is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, Alunbrig targets ALK.

How is Alunbrig typically given (administered)? Alunbrig is given orally (capsule) once daily until disease progression or unacceptable side effects. A lower dose is given for the first 7 days of treatment and if well tolerated, then a higher dose is prescribed.

How are patients typically monitored? Alunbrig can cause complications involving the lungs, heart, eyes, pancreas, blood sugar and muscles. Respiratory symptoms, blood pressure, heart rate, CPK levels, pancreatic enzyme levels, and blood sugar are checked regularly.

What are the common (occur in 25% or more of patients) side effects of treatment with Alunbrig?

  • Diarrhea
  • Nausea
  • Fatigue
  • Cough
  • Headache

What are the less common side effects of treatment with Alunbrig?

  • Lung problems
  • High blood pressure
  • Slow heart rate
  • Vision problems
  • Muscle pain, tenderness and weakness
  • Inflammation of the pancreas
  • High blood sugar

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your medical conditions and about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements.
  • Take Alunbrig exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.
  • Take Alunbrig one time each day and swallow whole.
  • Take Alunbrig with or without food.
  • If you miss a dose of Alunbrig, do not take the missed dose. Take your next dose at your regular time.
  • Talk to your doctor if you are taking CYP3A inhibitors or inducers.
  • Avoid eating grapefruit or drinking grapefruit juice during treatment.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your healthcare provider if you have any of the following:
    • Lung or breathing problems
    • High blood pressure
    • Slow heartbeat
    • Vision problems
    • History of pancreatitis
    • Diabetes mellitus or glucose intolerance
    • Liver problems
    • Kidney problems or are on dialysis.
  • Tell your doctor if you’re pregnant or plan to become pregnant. Alunbrig may harm your unborn baby. Women who are able to become pregnant should use an effective method of birth control during treatment with Alunbrig and for at least four months after stopping Alunbrig. Talk to your healthcare provider about birth control methods that may be right for you. Men should also use effective birth control while on treatment with Alunbrig and for at least 3 months after completing treatment.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Alunbrig.

When should patients notify their physician? Tell your doctor if you have signs of lung problems including trouble breathing, shortness of breath, any cough, chest pain or fever. Also tell your doctor if you have any signs of high blood pressure such as headaches, blurred vision, chest pain or shortness of breath. Any signs of slow heart rate should also be reported to you doctor right away including feeling dizzy, lightheaded or faint. If you start to take or have any changes in heart or blood pressure medicines, notify your doctor. In addition, let your doctor know right away if you get new or worsening symptoms of pancreatitis which includes weight loss, nausea or upper abdominal pain that may spread to the back that worsens with eating.

Tell your doctor if you have signs of vision problems. These include:

  • Double vision
  • Seeing flashes of light
  • Blurry vision
  • Light sensitivity
  • New or increased floaters

Tell your doctor if you have signs of myalgia including muscle pain, muscle tenderness or weakness.

Tell your doctor if you have signs of high blood sugar. These include:

  • Feeling very thirsty
  • Needing to urinate more than usual
  • Feeling very hungry
  • Feeling sick to your stomach
  • Feeling weak or tired
  • Feeling confused

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONNECT SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECTDISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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