Medication info

Herceptin Subcutaneous Injection 600 mg (Trastuzumab)

Prescription medicationInjections정맥 · 피하
Ingredient · strength
Trastuzumab›120mg / 1mL
Manufacturer / importer
(주)한국로슈
Appearance
A colorless to yellow clear or opaque liquid filled in a colorless transparent vial injection
Packaging
1 vial/box [vial (5 mL)]
Approval status
Active

MFDS item code 201402190 · Approved 2014.05.09 · Insurance code 645001361

Summary

Main use
Efficacy for treatment of HER2 positive metastatic and early breast cancer
Who receives it
Adults
Adult administration
Administer this medication 600mg every 3 weeks. No loading dose is required, and the recommended dose should be subcutaneously injected over 2-5 minutes every 3 weeks. Alternate the injections between the left and right thighs. The new injection site must be more than 2.5cm away from the site of the previous injection, and injection should not be done on skin that is red, bruised, painful, or hard. After the first injection, monitor the patient for 30 minutes, and for subsequent injections, for 15 minutes.

Ingredients

Importer
(주)한국로슈

Efficacy & effects

Efficacy for treatment of HER2 positive metastatic and early breast cancer

  • Breast cancer
  • metastatic breast cancer
  • early breast cancer
  • locally advanced disease
  • inflammatory disease
  • tumors
View approved original text

This medication is used for the treatment of patients with HER2 positive breast cancer. In cases of metastatic breast cancer, it is administered alone to patients who have previously received chemotherapy, and is used in combination with paclitaxel or docetaxel for first-time patients. Additionally, it is administered together with aromatase inhibitors to postmenopausal hormone receptor-positive patients who have not received trastuzumab. For early breast cancer, this medication is given in conjunction with neoadjuvant or adjuvant chemotherapy to enhance therapeutic efficacy. This treatment process plays a crucial role in improving the treatment of HER2 positive breast cancer.

How it is given

Adult administration

Administer this medication 600mg every 3 weeks. No loading dose is required, and the recommended dose should be subcutaneously injected over 2-5 minutes every 3 weeks. Alternate the injections between the left and right thighs. The new injection site must be more than 2.5cm away from the site of the previous injection, and injection should not be done on skin that is red, bruised, painful, or hard. After the first injection, monitor the patient for 30 minutes, and for subsequent injections, for 15 minutes.

Precautions

This medication can affect cardiac function, so caution is especially necessary for patients with heart disease or weakened heart function. It is crucial to evaluate heart status through cardiac function tests before administering this medication. During administration, regular cardiac function tests should also be conducted, and treatment may be discontinued if heart function worsens. Allergic reactions or infusion-related reactions may occur during the infusion of this medication, so patients should be monitored for a certain period after the injection. If symptoms such as difficulty breathing, hypotension, or rash occur, medical personnel should be notified immediately, and the infusion should be stopped or treatment received if necessary. Severe pulmonary adverse reactions have been reported rarely, so patients with pulmonary issues should consult a specialist before administration. Patients with hypersensitivity to this medication or severe dyspnea at rest should not receive it. Caution is required for patients who are currently using or have previously used anthracycline drugs, those with heart failure symptoms, hypertension, or coronary artery disease. During the administration of this medication, blood abnormalities such as reduced white blood cell count may frequently occur, therefore regular blood tests are necessary. Pregnant women or those who may become pregnant should use effective contraception during and for a certain period after administering this medication, and nursing mothers are advised to avoid breastfeeding. The safety and efficacy of this medication have not been established in children. Before administration, visually check whether the medication has deteriorated, store it in a refrigerator, and properly dispose of it if not used. This medication may affect the ability to drive or operate machinery, so caution is necessary if experiencing dizziness or drowsiness.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • difficulty breathing
  • respiratory distress
  • wheezing
  • pulmonary edema
  • acute respiratory distress syndrome
  • bronchospasm
  • pneumonia
  • pleural effusion
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  • increased blood pressure
  • severe allergic reactions
  • cardiac dysfunction
  • heart failure
  • cardiomyopathy
  • confusion
  • paralysis
  • severe headache
  • jaundice
  • hepatocellular damage
  • hepatitis
  • hepatic pain
  • acute pulmonary edema
  • cardiac arrhythmia
  • cardiac shock
  • heart failure
  • cardiac abnormalities
  • anaphylactic reactions
  • anaphylaxis

Mild side effects

  • Skin rash
  • urticaria
  • fever
  • increased blood pressure
  • dizziness
  • headache
  • vomiting
  • diarrhea
  • loss of appetite
  • weight loss
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  • insomnia
  • anxiety
  • drowsiness
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • conjunctivitis
  • increased tearing
  • dry eyes
  • hearing loss
  • cough
  • nosebleeds
  • runny nose
  • wheezing
  • pneumonia
  • pleural effusion
  • diarrhea
  • stomatitis
  • abdominal pain
  • indigestion
  • constipation
  • dry mouth
  • mastitis
  • weakness
  • chest pain
  • fatigue
  • influenza-like symptoms
  • pain
  • mucositis

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

Storage

This medication should be stored in a tightly sealed container that does not allow air in and kept in a dark place that does not allow direct light. Additionally, do not freeze the medication; keep it refrigerated at temperatures between 2 and 8 degrees Celsius.

Appearance and packaging

Appearance

A colorless to yellow clear or opaque liquid filled in a colorless transparent vial injection

Package unit

1 vial/box [vial (5 mL)]

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.