Medication info

Herceptin Injection 150 Milligrams (Trastuzumab) (Monoclonal Antibody, Recombinant DNA)

Prescription medication주사
Ingredient · strength
Trastuzumab›150mg / 1 vial
Manufacturer / importer
(주)한국로슈
Appearance
A colorless, transparent vial containing a white to slightly yellow freeze-dried powder.
Packaging
1 vial/box
Approval status
Active

MFDS item code 200511046 · Approved 2005.07.19 · Insurance code 645000611

Summary

Main use
Efficacy for HER2-positive metastatic and early breast cancer (in combination with chemotherapy) and metastatic gastric cancer.
Who receives it
Adults
Adult administration
Used for the treatment of metastatic breast cancer and early breast cancer, as well as metastatic gastric cancer. 1-week regimen - Initial loading dose: 4 mg/kg administered - Maintenance dose: 2 mg/kg administered weekly 3-week regimen - Initial loading dose: 8 mg/kg administered - Maintenance dose: 6 mg/kg administered every 3 weeks Administration should be performed as an intravenous infusion over 90 minutes, and rapid intravenous administration is prohibited. For breast cancer treatment, administer in conjunction with docetaxel, paclitaxel, or aromatase inhibitors.

Ingredients

Importer
(주)한국로슈

Efficacy & effects

Efficacy for HER2-positive metastatic and early breast cancer (in combination with chemotherapy) and metastatic gastric cancer.

  • Metastatic breast cancer
  • early breast cancer
  • locally advanced disease
  • inflammatory disease
  • tumors
  • metastatic gastric cancer.
View approved original text

This medication is used for the treatment of patients with HER2-positive metastatic breast cancer. For patients who have previously received chemotherapy, it is administered alone, while for treatment-naive patients, it is used in combination with paclitaxel or docetaxel. Additionally, it is used with aromatase inhibitors in postmenopausal patients who have not previously received trastuzumab and are hormone receptor positive. For early-stage breast cancer patients, it is used in combination with preoperative and postoperative chemotherapy or with specific adjunctive chemotherapy to enhance therapeutic efficacy. In cases of locally advanced breast cancer, it is utilized as neoadjuvant therapy and adjuvant therapy. This drug is also used in combination with platinum-based drugs for chemotherapy in HER2-positive metastatic gastric cancer. Therefore, this medication is effectively used for the treatment of HER2-positive cancers such as breast cancer and gastric cancer.

How it is given

Adult administration

Used for the treatment of metastatic breast cancer and early breast cancer, as well as metastatic gastric cancer. 1-week regimen - Initial loading dose: 4 mg/kg administered - Maintenance dose: 2 mg/kg administered weekly 3-week regimen - Initial loading dose: 8 mg/kg administered - Maintenance dose: 6 mg/kg administered every 3 weeks Administration should be performed as an intravenous infusion over 90 minutes, and rapid intravenous administration is prohibited. For breast cancer treatment, administer in conjunction with docetaxel, paclitaxel, or aromatase inhibitors.

Precautions

This medication may affect heart function; therefore, patients with heart disease or a history of heart problems must have their cardiac status carefully evaluated prior to administration. Care should be taken when administering this drug to patients with symptoms of heart failure or low ejection fraction. The drug may cause allergic reactions or infusion-related side effects during administration, hence the patient's condition should be closely monitored during the infusion. If symptoms such as difficulty breathing, hypotension, or rash occur, administration must be halted immediately and appropriate treatment should be given. Patients with lung issues or a history of pulmonary disease should also exercise caution when receiving this drug. Women who are pregnant or may become pregnant should avoid pregnancy during treatment and for some time thereafter, and breastfeeding should be discontinued if currently nursing. The safety and efficacy of this drug in children have not been established, and its use is not recommended in this population. Elderly patients or those with impaired kidney and liver function can use the drug without special dose adjustments, but close monitoring is necessary based on their condition. The injection solution should be prepared under aseptic conditions and used as soon as possible after reconstitution. This drug should not be mixed with other medications, and only the specified diluent should be used. Dizziness or drowsiness may occur during administration; therefore, driving or operating machinery should be avoided until symptoms resolve.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema, facial swelling), chest tightness, difficulty breathing, anaphylaxis, hypotension, wheezing, bronchospasm, ventricular tachycardia, decreased oxygen saturation, anaphylactic shock, respiratory distress syndrome, pulmonary infiltrates including interstitial lung disease, acute respiratory distress syndrome, pneumonia, interstitial pneumonitis, pleural effusion, acute pulmonary edema, respiratory failure, cardiac dysfunction (congestive heart failure, decreased left ventricular ejection fraction, myocardial toxicity.

Mild side effects

  • Nausea
  • myalgia
  • neutropenia
  • neuropathy
  • fever
  • chills
  • anorexia
  • peripheral neuropathy
  • vomiting
  • weakness
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  • headache
  • arthralgia
  • alopecia
  • pruritus
  • leukopenia
  • dyspepsia
  • fatigue
  • constipation
  • pain
  • chest pain
  • rash
  • back pain
  • bone pain
  • peripheral edema
  • diarrhea
  • mucositis
  • generalized weakness
  • erythema
  • tachycardia
  • palpitations
  • facial edema
  • loose stools
  • flushing
  • insomnia
  • numbness
  • cold-like symptoms
  • increased ALP
  • hepatitis
  • detailed.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and should be kept refrigerated at a temperature between 2 degrees and 8 degrees Celsius. Storing the drug in this manner maintains its efficacy and prevents degradation.

Appearance and packaging

Appearance

A colorless, transparent vial containing a white to slightly yellow freeze-dried powder.

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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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.