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ALUNBRIG- brigatinib tablet, coated


  1. Patient Information
  2. Inform Patients Of The Following:
  3. Before You Take Alunbrig, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Should I Take Alunbrig?
  5. What Should I Avoid While Taking Alunbrig?
  6. Alunbrig May Cause Serious Side Effects, Including:
  7. Active Ingredient:
  8. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform Patients Of The Following: 

Interstitial Lung Disease (ILD)/Pneumonitis

Inform patients of the symptoms and risks of serious pulmonary adverse reactions such as ILD/pneumonitis. Advise patients to immediately report any new or worsening respiratory symptoms[
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 ALUNBRIG is safe and effective in children.

Before You Take Alunbrig, 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 with ALUNBRIG or think you may be pregnant.
    • Femaleswho 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.
    • Maleswho 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.

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 have 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.

What Should I Avoid While Taking Alunbrig? 

  • Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.
What are the possible side effects of ALUNBRIG?

Alunbrig May Cause Serious Side Effects, Including: 

    • Store ALUNBRIG at room temperature 20 C to 25 C (68 F to 77 F).
    Keep ALUNBRIG and all medicines out of the reach of children.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 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.
    You can ask your healthcare provider or pharmacist for information about ALUNBRIG that is written for health professionals.

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.
Manufactured for: ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA
For more information, go to www.alunbrig.com or call 1-844-217-6468.



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