Tagrisso Tablets (Osimertinib)

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Tagrisso Tablets (Osimertinib)

Osimertinib


Product information

Tagrisso (osimertinib) is a medication for treating advanced non-small cell lung cancer (NSCLC) with EGFR T790M mutations. It is taken once daily as a tablet. Key side effects include diarrhea, rash, and potential serious lung and heart issues. It is not recommended for pregnant or breastfeeding women and should be used with caution in the elderly. Regular monitoring is necessary during treatment.

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TAGRISSO (Osimertinib) - Canada Product Information



What is Tagrisso?

Tagrisso (osimertinib) is a medication used to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC). It works by targeting and blocking a protein called EGFR that helps cancer cells grow


Who can take Tagrisso?

Tagrisso is prescribed for adults with locally advanced or metastatic NSCLC that has tested positive for the EGFR T790M mutation and has progressed after previous EGFR-targeted therapy. A test will be done to confirm the presence of this mutation before starting treatment.


How to take Tagrisso?

  • Dosage: The usual dose is one 80 mg tablet taken once a day.
  • How to take: Swallow the tablet whole with water. You can take it with or without food, at the same time each day.
  • If you can't swallow the tablet: Dissolve it in 50 mL of non-carbonated water, stir until dispersed, and drink immediately. Rinse the glass with another 50 mL of water and drink to ensure you take the full dose.
  • Missed dose: If you miss a dose, take it as soon as you remember unless the next dose is due within 12 hours. Do not double up on doses.

Important safety information


Do not take Tagrisso if you:

Are allergic to osimertinib or any of its ingredients.


Special Populations:

  • Pregnancy: Tagrisso can harm an unborn baby. Women of childbearing potential should use effective contraception during treatment and for 2 months after the last dose. Men with partners of childbearing potential should use contraception during treatment and for 4 months after the last dose.
  • Breastfeeding: Do not breastfeed while taking Tagrisso.
  • Children: Safety and effectiveness in children under 18 have not been established.
  • Elderly: No dose adjustments are needed for elderly patients.

Possible side effects

Common side effects (may affect more than 1 in 10 people):

  • Diarrhea
  • Rash
  • Dry skin
  • Nail problems
  • Stomatitis (mouth sores)
  • Pruritus (itching)

Serious side effects:

  • Interstitial lung disease (ILD)
  • Heart rhythm problems
  • Severe skin reactions
  • Eye problems like keratitis

If you experience any serious side effects or signs of an allergic reaction (swelling of the face, lips, tongue, or throat; difficulty breathing), seek medical help immediately.


Drug interactions

  • Avoid: Strong CYP3A4 inducers (e.g., rifampicin, St. John's Wort) as they can reduce Tagrisso’s effectiveness.
  • Caution: Tagrisso may interact with other medications. Inform your doctor about all the medications you are taking, including over-the-counter drugs and supplements.

Storage

  • Keep out of reach of children.
  • Store at room temperature: 59°F to 86°F.
  • Do not use: After the expiration date printed on the package.

For more information

If you have any questions or concerns about taking Tagrisso, please talk to your doctor or pharmacist. This provides a summary of key information about Tagrisso. Always follow the advice of your healthcare provider for the best results with your treatment.



Reference: Tagrisso Canada product monograph