Ttarisso (Osimertinib) – NSCLC | HongKong DengYue Medicine

Osimertinib Application Scope

• First-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.

• Treatment of locally advanced or metastatic NSCLC with EGFR T790M mutation after progression on EGFR-TKI therapy.

Osimertinib Characteristics

• Ingredients: Osimertinib

• Properties:​ Third-generation EGFR tyrosine kinase inhibitor (TKI); targeted therapy

• Packaging Specification:​ 40 mg & 80 mg film-coated tablets × 30 tablets/box

• Storage:​ Store at 20–25°C; protect from moisture and light

• Expiry Date: As per package label

• Executive Standard: ​FDA / EMA approval standard

• Approval Number: FDA NDA 208065

• Date of Revision: Latest EMA SmPC: March 2023

• Manufacturer: AstraZeneca

Guidelines for the Use of Ttarisso

• Dosage and Administration:

  • Recommended Dose: 80 mg orally once daily (continuous dosing)

  • Administration: Take orally, with or without food; swallow tablets whole

  • Missed Dose:​ Take as soon as remembered; do not double dose

• Adverse Reactions:

  • Common Adverse Reactions:

    • Diarrhea

    • Rash, dry skin

    • Fatigue

    • Nail toxicity

  • Serious Adverse Reactions:

    • Interstitial lung disease / pneumonitis

    • QT prolongation

    • Severe skin reactions (e.g., Stevens-Johnson syndrome)

• Contraindications: Hypersensitivity to excipients

• Precautions:

  • Monitor for ILD/pneumonitis, cardiac effects (QT prolongation), and dermatologic toxicity

  • Dose adjustment for severe adverse events or hepatic impairment

Osimertinib Interactions

• Strong CYP3A inducers may reduce its exposure

• Strong CYP3A inhibitors may increase its exposure

• Avoid co-administration with medications that prolong QT interval

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.