Augtyro (Repotrectinib) – NSCLC | HongKong DengYue Medicine

Augtyro Application Scope

Augtyro (repotrectinib) is a next-generation oral tyrosine kinase inhibitor used to treat certain ROS1-positive and NTRK-fusion tumors.

Characteristics

• Ingredients: Repotrectinib

• Properties:

  • Tyrosine kinase inhibitor targeting ROS1 and TRK A/B/C

  • Capsules in 40 mg and 160 mg strengths

• Packaging Specification: Bottles of 60 capsules for 40 mg or 120 capsules for 40 mg

• Storage: Store at room temperature (20–25 °C / 68–77 °F)

• Expiry Date: See individual bottle label (typical shelf‑life 2+ years)

• Executive Standard: Meets USP/NF and FDA–required standards (see prescribing info)

• Approval Number: FDA approved Nov 15, 2023 (NDA 218213)

• Date of Revision: Prescribing info updated June 2024

• Manufacturer: Bristol-Myers Squibb Company

Guidelines for the Use of Augtyro

• Dosage and Administration:

  • Starting dose:

    • 160 mg orally once daily for 14 days

    • Then 160 mg twice daily, with or without food

  • Swallow capsules whole; don’t crush or chew

  • If a dose is missed or the patient vomits, skip and continue at the next scheduled time

• Adverse Reactions:

  • Common (≥20%):

    • dizziness, altered taste (dysgeusia), peripheral neuropathy, constipation

    • dyspnea, ataxia, fatigue, cognitive impairment, muscle weakness, nausea

  • Serious:

    • CNS effects, interstitial lung disease/pneumonitis, hepatotoxicity

    • elevated CPK, hyperuricemia, fractures, embryo-fetal toxicity

• Contraindications: None listed in prescribing information

• Precautions:

  • Monitor for CNS toxicity:

    • dizziness, ataxia, cognitive effects; withhold/reduce dose if needed

  • Monitor for ILD/pneumonitis; discontinue permanently if confirmed

  • Check liver function every 2 weeks in the first month, then as needed

  • Monitor muscle enzymes and uric acid

  • Advise against breastfeeding during treatment and for 10 days after the last dose

Augtyro Interactions

• Drug Interactions: Avoid coadministration with strong/moderate CYP3A or P-gp inducers/inhibitors

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.