Medication info

Tuzepat 440 mg (Trastuzumab)

Prescription medicationInjections정맥
Ingredient · strength
Trastuzumab›440mg / 1 vial
Manufacturer / importer
(주)삼오제약
Appearance
A colorless injectable solution in a vial filled with a freeze-dried white to pale yellow substance, which becomes a clear or slightly cloudy liquid that is colorless to light yellow when a solvent is added.
Packaging
1 vial/box [vial (892.7 mg)]
Approval status
Active

MFDS item code 202302083 · Approved 2023.07.10

Summary

Main use
Efficacy in treating HER2 positive metastatic and early-stage breast cancer (including metastatic gastric cancer)
Who receives it
Adults
Adult administration
For the treatment of metastatic breast cancer, it can be divided into weekly and tri-weekly regimens. Weekly regimen: Initial loading dose 4 mg/kg, followed by a maintenance dose of 2 mg/kg every week (starting one week after the initial loading dose). Tri-weekly regimen: Initial loading dose 8 mg/kg, followed by a maintenance dose of 6 mg/kg every 3 weeks (starting three weeks after the initial loading dose). When combined with docetaxel or paclitaxel, initial administration.

Ingredients

Importer
(주)삼오제약

Efficacy & effects

Efficacy in treating HER2 positive metastatic and early-stage breast cancer (including metastatic gastric cancer)

  • Breast cancer
  • metastatic breast cancer
  • early-stage breast cancer
  • locally advanced disease
  • inflammatory disease
  • tumors
  • metastatic gastric cancer
  • metastatic gastric adenocarcinoma
  • gastroesophageal junction adenocarcinoma
View approved original text

This medication is used to treat patients with HER2 positive metastatic breast cancer and early-stage breast cancer. For metastatic breast cancer patients who have previously received chemotherapy, it is administered as a monotherapy, while it is given in combination with paclitaxel or docetaxel for patients who have not undergone chemotherapy. Additionally, for hormone receptor positive postmenopausal patients, it is used in conjunction with aromatase inhibitors. In early-stage breast cancer patients, it is combined with preoperative and postoperative chemotherapy or administered alone to enhance efficacy. This drug is also used in conjunction with platinum-based drugs in metastatic gastric cancer patients. In summary, this drug is effectively used to treat HER2 positive breast cancer and gastric cancer.

How it is given

Adult administration

For the treatment of metastatic breast cancer, it can be divided into weekly and tri-weekly regimens. Weekly regimen: Initial loading dose 4 mg/kg, followed by a maintenance dose of 2 mg/kg every week (starting one week after the initial loading dose). Tri-weekly regimen: Initial loading dose 8 mg/kg, followed by a maintenance dose of 6 mg/kg every 3 weeks (starting three weeks after the initial loading dose). When combined with docetaxel or paclitaxel, initial administration.

Precautions

This medication may affect heart function, so patients with heart disease or those who have received heart treatment in the past must undergo cardiac examination before administration. Careful attention is especially required for patients at high risk of heart failure or the elderly. Furthermore, allergic reactions or infusion-related side effects may occur during administration, so the patient's condition should be closely monitored during administration. It is safe not to administer this medication to patients who have severe respiratory symptoms or significant pulmonary abnormalities. This medication should not be used in newborns or premature infants as the preservative ingredients in this formulation may pose a risk. Women who are pregnant or of childbearing potential should ensure effective contraception during and after the use of this medication, considering its potential impact on the fetus. The safety and efficacy of this medication in children have not been established; therefore, it is not recommended for patients under 18 years of age. Dizziness or drowsiness may occur during administration, so driving or operating machinery should be avoided. The dosing solution should be prepared under sterile conditions, and the specified storage and usage conditions must be strictly adhered to. There have been no significant reports of drug interactions when this medication is combined with other drugs; however, monitoring of cardiac function is necessary during combination therapy with chemotherapeutics.

Side effects and when to seek care immediately

Serious side effects

  • Rash
  • angioedema
  • breathing difficulty
  • wheezing
  • anaphylaxis
  • hypotension
  • bronchospasm
  • ventricular tachycardia
  • decreased oxygen saturation
  • respiratory distress syndrome
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  • anaphylactic reactions
  • anaphylactic shock
  • cardiac dysfunction
  • congestive heart failure
  • heart failure
  • cardiomyopathy
  • pericardial effusion
  • cardiogenic shock
  • decreased ejection fraction
  • cardiac symptoms
  • heart flickering
  • palpitations
  • heart abnormalities
  • pulmonary infiltrates
  • interstitial lung disease
  • acute respiratory distress syndrome
  • pneumonia

Mild side effects

  • Fever
  • nausea
  • vomiting
  • headache
  • chills
  • loss of appetite
  • insomnia
  • anxiety
  • depression
  • dizziness
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  • sensory disturbances
  • taste disturbances
  • peripheral neuropathy
  • muscle rigidity
  • drowsiness
  • conjunctivitis
  • increased tearing
  • dry eyes
  • hearing loss
  • decreased blood pressure
  • increased blood pressure
  • irregular heartbeat
  • palpitations
  • heart flickering
  • upper respiratory infections
  • rhinitis
  • pharyngitis
  • runny nose
  • nosebleeds
  • cough
  • asthma
  • diarrhea
  • abdominal pain
  • dyspepsia
  • constipation
  • stomatitis
  • hemorrhoids
  • dry mouth
  • erythema
  • rash

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

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering, and to maintain freshness and effectiveness, it should be kept at a refrigerated temperature between 2 to 8 degrees Celsius. Therefore, always keep the lid tightly closed until it is used, and avoid extremely hot or cold environments.

Appearance and packaging

Appearance

A colorless injectable solution in a vial filled with a freeze-dried white to pale yellow substance, which becomes a clear or slightly cloudy liquid that is colorless to light yellow when a solvent is added.

Package unit

1 vial/box [vial (892.7 mg)]

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.

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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.