Rezivertinib – NSCLC | HongKong DengYue Medicine

Rezivertinib Application Scope

Rezivertinib is a third-generation, irreversible EGFR tyrosine kinase inhibitor used to treat EGFR-mutated non-small cell lung cancer (NSCLC), particularly in patients with the T790M resistance mutation.

Characteristics

• Ingredients: Rezivertinib

• Properties:

  • Orally active, selective, irreversible third-generation EGFR TKI

  • Potent against EGFR sensitizing mutations (exon 19 del, L858R)

  • T790M resistance mutants

  • Good central nervous system (CNS) penetration and antitumor activity

• Packaging Specification: Available as 30 mg capsules, typically in blister packs

• Storage: Store in a cool, dry place, away from light and moisture

• Expiry Date: As stated on the packaging, follow specific lot labeling

• Executive Standard: Complies with National Medical Products Administration standards (China)

• Approval Number:  Refer to the official NMPA; for example, approval May 15, 2024

• Date of Revision: Based on the newest prescribing info updates (e.g., mid‑2025)

• Manufacturer: Beta Pharma (Shanghai) Co., Ltd.

Guidelines for the Use of Rezivertinib

• Dosage and Administration:

  • Common Phase II/I dosing:

    • 180 mg once daily, oral, until disease progression or unacceptable toxicity

  • Phase IIa (first-line) used 180 mg QD with ORR ~84%, median PFS ~21 months

• Adverse Reactions:

  • Treatment-related AEs in ~93%, grade ≥3 in ~9%

  • Common AEs:

    • rash, paronychia, musculoskeletal pain, nausea, fatigue, edema

    • stomatitis, cough, diarrhea, vomiting, decreased appetite, dry skin, dyspnea

  • Lab abnormalities:

    • lymphopenia, albumin/phosphate/potassium decrease; GGT/ALT/AST increase

• Contraindications:

  • None specifically documented, but avoid use in pregnant/lactating women due to embryo-fetal toxicity

  • Generally contraindicated for those with known hypersensitivity to EGFR TKIs

• Precautions:

  • Monitor for interstitial lung disease/pneumonitis

  • Watch for dermatologic, ocular, and hepatic adverse events

  • Advise contraception during

  • 3 months after therapy in women of reproductive potential

Rezivertinib Interactions

• Drug Interactions:

  • No strong inducers/inhibitors highlighted

  • Review concurrent medications metabolized by CYP450 enzymes

  • Clinical data limited; monitor when co-administered with CYP modulators

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.