Medication info

Herceptin Injection 440 mg (Trastuzumab)

Prescription medicationInjections정맥 · 피하Expired
Ingredient · strength
Trastuzumab›440mg / 1 vial
Manufacturer / importer
(주)한국로슈
Appearance
A colorless injectable solution with a white to light yellow freeze-dried substance filled in a vial, which, when reconstituted with the solvent, appears as a colorless to pale yellow clear or slightly cloudy liquid.
Packaging
1 vial/box
Approval status
Expired

MFDS item code 201400490 · Approved 2014.02.04

This product's status changed to Expired on 2024.02.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment effect for HER2-positive metastatic and early-stage breast cancer (including metastatic gastric cancer).
Who receives it
Adults
Adult administration
Breast Cancer Metastatic Breast Cancer 1-Week Schedule: Initial loading dose: 4 mg/kg. Maintenance dose: 2 mg/kg weekly (to be started one week after the initial loading dose). Breast Cancer Metastatic Breast Cancer 3-Week Schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg every three weeks (to be started three weeks after the initial loading dose). Early Breast Cancer 3-Week Schedule: Initial loading dose: 8 mg/kg. Then, maintain with doses every three weeks.

Ingredients

Importer
(주)한국로슈

Efficacy & effects

Treatment effect for HER2-positive metastatic and early-stage breast cancer (including metastatic gastric cancer).

  • Metastatic breast cancer
  • postmenopausal patients with hormone receptor-positive cancer
  • early-stage breast cancer
  • locally advanced (including inflammatory) disease
  • tumors with a diameter > 2 cm
  • metastatic gastric cancer
  • HER2-positive metastatic gastric adenocarcinoma
  • gastroesophageal junction adenocarcinoma.
View approved original text

This drug is used for the treatment of patients with HER2-positive metastatic and early-stage breast cancer. For patients with metastatic breast cancer, it is administered alone if they have received prior chemotherapy; otherwise, it is combined with paclitaxel or docetaxel. Additionally, in postmenopausal patients with hormone receptor-positive cancer, it is used in conjunction with aromatase inhibitors. For early-stage breast cancer patients, it is used in combination with preoperative and postoperative chemotherapy, and for locally advanced or large tumors, it is combined with chemotherapy before being administered alone. Furthermore, for HER2-positive gastric adenocarcinoma or gastroesophageal junction adenocarcinoma patients with no prior experience in anticancer treatment, it is used with platinum-based drugs and capecitabine or 5-FU. Therefore, this drug is effectively used for the treatment of HER2-positive breast cancer and gastric cancer.

How it is given

Adult administration

Breast Cancer Metastatic Breast Cancer 1-Week Schedule: Initial loading dose: 4 mg/kg. Maintenance dose: 2 mg/kg weekly (to be started one week after the initial loading dose). Breast Cancer Metastatic Breast Cancer 3-Week Schedule: Initial loading dose: 8 mg/kg. Maintenance dose: 6 mg/kg every three weeks (to be started three weeks after the initial loading dose). Early Breast Cancer 3-Week Schedule: Initial loading dose: 8 mg/kg. Then, maintain with doses every three weeks.

Precautions

This drug may affect cardiac function, so caution is especially required for patients with heart failure or cardiac dysfunction. Patients at high risk of cardiac disease should undergo cardiac function tests before treatment and also have their heart condition monitored regularly during treatment. If cardiac function continues to decline during the administration of this drug, consideration should be given to discontinuing it. Allergic reactions or infusion-related side effects may occur during administration, so the patient's condition should be closely monitored during infusion. If serious reactions such as difficulty breathing or hypotension occur, administration should be stopped immediately and appropriate treatment should be provided. Pulmonary-related side effects may also occur rarely, so patients with respiratory symptoms should be particularly cautious. This drug should not be administered to patients with hypersensitivity to certain components, severe difficulty in breathing, neonates, or premature infants. The risk of cardiac toxicity increases when used in combination with anthracycline-based drugs, so cardiac function should be closely monitored during combination therapy. This drug may pose risks to the fetus in pregnant or potentially pregnant women, so effective contraception is necessary during and for a period after treatment. Use in breastfeeding is not recommended, and special care is required when administering to children or the elderly. Dizziness or drowsiness can occur during driving or operating machinery, so caution should be exercised when symptoms are present. This drug should be prepared in a sterile state, and during reconstitution and dilution, the specified solution and method must be strictly adhered to. No drug interactions have been reported between this drug and others, but consulting with a specialist is recommended for concurrent use. Adverse reactions reported after administration include infections, blood abnormalities, gastrointestinal symptoms, skin reactions, and neurological symptoms; if symptoms are severe or persistent, consult medical personnel.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • difficulty breathing
  • severe swelling (edema)
  • hypertension
  • hypotension
  • wheezing
  • bronchospasm
  • ventricular tachycardia
  • decreased oxygen saturation
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  • anaphylaxis
  • respiratory distress syndrome
  • heart failure
  • cardiac dysfunction
  • pulmonary infiltration
  • interstitial lung disease
  • acute respiratory distress syndrome
  • pneumonia
  • interstitial pneumonia
  • pleural effusion
  • shortness of breath
  • pulmonary edema
  • respiratory failure
  • jaundice
  • cardiopalmus
  • cardiomyopathy
  • cardiogenic shock
  • cardiac symptoms
  • acute pulmonary edema.

Mild side effects

  • Nausea
  • muscle pain
  • anemia
  • neutropenia
  • leukopenia
  • thrombocytopenia
  • insomnia
  • anxiety
  • depression
  • dizziness
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  • headache
  • altered taste
  • peripheral neuropathy
  • conjunctivitis
  • increased tearing
  • dry eyes
  • hearing loss
  • decreased ejection fraction
  • palpitations
  • decreased blood pressure
  • increased blood pressure
  • irregular heartbeat
  • shortness of breath
  • cough
  • nosebleed
  • runny nose
  • lung abnormalities
  • diarrhea
  • vomiting
  • nausea
  • lip swelling
  • abdominal pain
  • indigestion
  • constipation
  • stomatitis
  • alopecia
  • rash.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to avoid contact with air. Additionally, it is important to store it at a refrigerator temperature between 2°C to 8°C to maintain the drug's effectiveness.

Appearance and packaging

Appearance

A colorless injectable solution with a white to light yellow freeze-dried substance filled in a vial, which, when reconstituted with the solvent, appears as a colorless to pale yellow clear or slightly cloudy liquid.

Package unit

1 vial/box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.