Herceptin (Trastuzumab) – Breast Cancer | HongKong DengYue Medicine

Herceptin Trastuzumab Application Scope

• Adjuvant Breast Cancer: Treatment of HER2-overexpressing node-positive or node-negative (ER/PR negative or with one high-risk feature) breast cancer as part of a treatment regimen with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline-based therapy.

• Metastatic Breast Cancer: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

• Metastatic Gastric Cancer: In combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Trastuzumab Characteristics

• Ingredients: Active ingredient: Trastuzumab (recombinant DNA-derived humanized monoclonal antibody).

• Properties: Trastuzumab binds to the extracellular domain of the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumor cells that overexpress HER2.

• Packaging Specification: For injection: 150 mg lyophilized powder in a single-dose vial for reconstitution.

• Storage: Store vials of Herceptin at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the vial.

• Expiry Date: Refer to the packaging for the specific expiry date.

• Executive Standard: Complies with applicable national and international standards.

• Approval Number: BLA 103792.

• Date of Revision: Refer to the packaging for the specific date.

• Manufacturer: Genentech, Inc.

Guidelines for the Use of Trastuzumab

• Dosage and Administration:

  • Adjuvant Breast Cancer:

    • Initial dose: 8 mg/kg as an intravenous infusion over 90 minutes.

    • Subsequent doses: 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks for 52 weeks.

  • Metastatic Breast Cancer:

    • Initial dose: 4 mg/kg as an intravenous infusion over 90 minutes.

    • Subsequent doses: 2 mg/kg as an intravenous infusion over 30 minutes weekly.

  • Metastatic Gastric Cancer:

    • Initial dose: 8 mg/kg as an intravenous infusion over 90 minutes.

    • Subsequent doses: 6 mg/kg as an intravenous infusion over 30 to 90 minutes every three weeks.

  • Recommended Dose: As specified above, depending on the indication.

  • Administration: Administer as an intravenous infusion.

  • Missed Dose:​ If a dose is missed, administer as soon as possible and resume the regular dosing schedule.

• Adverse Reactions:

  • Common Adverse Reactions: Fever, chills, nausea, vomiting, diarrhea, headache, fatigue, rash, and pain.

  • Serious Adverse Reactions: Cardiac dysfunction, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

• Contraindications: None known.

• Precautions:

  • Monitor left ventricular ejection fraction (LVEF) during treatment.

  • Discontinue Herceptin for a persistent (>8 weeks) LVEF decline or for suspension of Herceptin dosing on more than 3 occasions for cardiomyopathy.

  • Assess pregnancy status prior to initiation.

Trastuzumab Interactions

• No formal drug interaction studies have been conducted.

• Administering paclitaxel in combination with Herceptin resulted in a two-fold decrease in paclitaxel clearance.

 

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.