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Active Pharma Ingredients / 30 Aug 2026

ASANDEUTERTINIB

Generic Name: ASANDEUTERTINIB

ABSTRACT -

Asandeutertinib, also known as TY-9591, is an investigational deuterated epidermal growth factor receptor tyrosine kinase inhibitor with antineoplastic potential. It is being evaluated mainly for EGFR-mutated non-small cell lung cancer, including patients with central nervous system involvement. It is not a routine globally approved EGFR inhibitor at this time.

DOSAGE -

  • No approved universal dosage regimen is established.
  • Clinical studies have evaluated oral once-daily dosing, including 160 mg once daily in some advanced NSCLC studies, but dosing remains protocol-defined.
  • Dose interruption, reduction, or discontinuation should follow trial criteria for rash, diarrhea, pneumonitis, QT prolongation, cardiac dysfunction, or laboratory toxicity.
  • Do not substitute for osimertinib or other EGFR TKIs without oncology direction.

SIDE EFFECTS–

  • Rash, acneiform dermatitis, dry skin, pruritus, paronychia, or stomatitis
  • Diarrhea, nausea, reduced appetite, weight loss, or fatigue
  • Interstitial lung disease/pneumonitis, cough, dyspnea, or fever
  • QT prolongation, cardiomyopathy, or decreased ejection fraction by EGFR-TKI class concern
  • Ocular symptoms, liver enzyme changes, cytopenias, or infection risk

ALLERGIC REACTIONS -

  • Allergy may include rash, urticaria, angioedema, dyspnea, severe dizziness, or anaphylaxis.
  • Severe cutaneous adverse reaction, blistering, mucosal lesions, or systemic symptoms require urgent care.

DRUG INTERACTIONS-

  • Other EGFR TKIs, QT-prolonging drugs, CYP3A inhibitors/inducers, antiarrhythmics, macrolides, fluoroquinolones, azoles, antipsychotics, and antidepressants require review.
  • Anticoagulants, antiplatelets, and cancer therapies with overlapping pulmonary, cardiac, hepatic, or skin toxicity require monitoring.
  • Avoid unapproved investigational combinations unless protocol-defined.

PREAUTIONS–

  • Confirm EGFR mutation profile and disease setting before treatment.
  • Assess baseline ECG, electrolytes, cardiac function if indicated, pulmonary history, liver function, ocular symptoms, pregnancy status, and co-medications.
  • Monitor skin, diarrhea, lung symptoms, ECG/QT risk, liver enzymes, and blood counts.
  • Use effective contraception according to protocol.

WARNINGS –

  • New or worsening dyspnea, cough, fever, chest pain, syncope, severe diarrhea, or serious rash requires urgent oncology review.
  • Investigational status means long-term safety and comparative efficacy are still being defined.
  • Do not use outside a clinical trial or specialist oncology direction.
  • Keep out of reach of children.

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