ENHERTU (Trastuzumab Deruxtecan) – HER2-driven cancers | HongKong DengYue Medicine

ENHERTU Trastuzumab Deruxtecan Application Scope

Antibody–drug conjugate (ADC) for HER2-targeted oncology—approved for:

• Unresectable or metastatic HER2-positive breast cancer after prior anti-HER2 therapy.

• Unresectable or metastatic HER2-low breast cancer after prior chemotherapy.

• HER2-mutant NSCLC after prior systemic therapy (accelerated approval).

• HER2-positive gastric/GEJ adenocarcinoma after prior trastuzumab-based regimen.

• HER2-positive (IHC 3+) unresectable or metastatic solid tumors after prior systemic treatment with no satisfactory options (accelerated approval).

  

ENHERTU Trastuzumab Deruxtecan Characteristics

• Ingredients: Trastuzumab deruxtecan

• Properties:​ Lyophilized powder in a single-dose vial

• Packaging Specification:​ 100 mg/vial

• Storage:​ Store at 2°C–8°C (36°F–46°F). Do not freeze. Protect from light

• Expiry Date: 24 months from manufacture date (see vial label for exact date)

• Executive Standard: ​Manufactured under cGMP guidelines

• Approval Number: FDA BLA 761139

• Date of Revision: Label revised April 2024 (USPI)

• Manufacturer: Daiichi Sankyo, Inc. (co-developed with AstraZeneca)

Guidelines for the Use of ENHERTU Trastuzumab Deruxtecan

• Dosage and Administration:

  • Recommended Dose:

    • Breast cancer, gastric cancer, and solid tumors: 5.4 mg/kg every 3 weeks.

    • NSCLC: 6.4 mg/kg every 3 weeks (dose may vary based on clinical context).

  • Administration:

    • Administer as an intravenous infusion over 30–90 minutes.

    • Do not mix with other drugs or administer as a bolus.

  • Missed Dose:​ If a dose is missed, administer as soon as possible. Adjust the schedule to maintain the 3-week interval.

• Adverse Reactions:

  • Common Adverse Reactions: Nausea, vomiting, fatigue, alopecia, constipation, decreased appetite, anemia, neutropenia, thrombocytopenia.

  • Serious Adverse Reactions:

    • Interstitial lung disease (ILD)/pneumonitis (monitor symptoms; discontinue if confirmed).

    • Left ventricular dysfunction (check LVEF baseline and during treatment).

    • Severe myelosuppression (monitor blood counts).

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• Contraindications:

  • Hypersensitivity to trastuzumab deruxtecan or any excipient.

  • Pregnancy (may cause fetal harm).

• Precautions:

  • Pregnancy/Lactation: Contraindicated. Use effective contraception during and for at least 7 months after treatment.

  • Fertility: May impair fertility in males and females.

  • Hepatic/Renal Impairment: No dose adjustment for mild-to-moderate impairment. Use with caution in severe impairment.

  • Older Patients: Increased risk of adverse reactions.

ENHERTU Interactions

• No clinically significant interactions with CYP3A4 inducers/inhibitors.

• Avoid concomitant use with other myelosuppressive drugs.

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.