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Once-daily dosing1

 

One tablet, orally, once a day1

  • The recommended dose of TAGRISSO is one 80 mg tablet once a day until disease progression or unacceptable toxicity
  • Tablet should be swallowed whole with water
  • If a dose is missed, do not make up the dose and take the next dose as scheduled
  • Confirm the presence of an EGFR T790M mutation in tumor or plasma specimens prior to initiation of treatment

Administration options1

  • TAGRISSO can be taken with or without food
  • If the patient has difficulty swallowing solids, disperse tablet in 2 ounces (approximately 60 mL) of non-carbonated water only. Stir until tablet is dispersed in small pieces (the tablet will not completely dissolve), and swallow immediately
  • Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 4 to 8 ounces (120 mL to 240 mL) of water and immediately drink
  • For administration via a nasogastric tube, please see the complete Prescribing Information

Some situations may require dose interruption, discontinuation, or adjustment

Dose interruption1

  • TAGRISSO therapy should be withheld for any of the following:
    • QTc interval greater than 500 msec on at least 2 separate ECGs
      • Withhold until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then resume at 40 mg dose
    • Grade 3 or higher adverse reaction
      • Withhold for up to 3 weeks. If Grade 3 or higher adverse reaction improves to Grade 2–0 within three weeks, resume at80 mg or 40 mg daily

Dose discontinuation1

  • Permanently discontinue TAGRISSO if patients have:
    • Interstitial Lung Disease (ILD)/pneumonitis
    • QTc interval prolongation in combination with signs/symptoms of life-threatening arrhythmia
    • Symptomatic congestive heart failure or asymptomatic left ventricular dysfunction that persists ≥4 weeks
    • No improvement in Grade 3 or higher adverse reactions within 3 weeks

Drug adjustment1

  • When coadministering with a strong CYP3A inducer (if unavoidable), increase TAGRISSO dosage to 160 mg daily. Resume TAGRISSO at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer