Tuzepat Injection 150 mg (Trastuzumab)

Adult administration

Metastatic Breast Cancer 1-week regimen: Initial loading dose 4 mg/kg, maintenance dose 2 mg/kg weekly. Metastatic Breast Cancer 3-week regimen: Initial loading dose 8 mg/kg, maintenance dose 6 mg/kg every 3 weeks. Early-stage Breast Cancer 3-week regimen: Initial loading dose 8 mg/kg, maintenance dose 6 mg/kg every 3 weeks. Early-stage Breast Cancer 1-week regimen: Initial loading dose 4 mg/kg, maintenance dose 2 mg/kg weekly. Metastatic Gastric Cancer 3-week regimen:

This drug may affect cardiac function; therefore, cardiac health should be thoroughly assessed before administration. Special caution is required for patients with a history of heart disease or for the elderly. Regular cardiac function tests must be conducted during treatment, and administration may be stopped if cardiac function worsens. Allergic reactions or infusion-related side effects may occur during infusion, so patient observation by healthcare professionals is required during administration. If symptoms such as breathing difficulties, rash, or hypotension occur, immediate notification is necessary. It is advisable not to administer this drug to patients with pulmonary issues. Women who are pregnant or may become pregnant should use effective contraception during and for a certain period after drug administration due to potential effects on the fetus, and its use should be approached with caution. It is also recommended to avoid administration while breastfeeding. The safety and efficacy of this drug have not been established for children; therefore, it should not be used in patients under 18 years of age. Elderly patients or those with impaired kidney or liver function may use this drug without special dosage adjustment, but their condition should be closely monitored. Cases of overdose are rare, but patients should consult healthcare professionals immediately in such instances. Proper preparation of the drug before administration is essential; the diluent specified should be used, and rapid administration after reconstitution is important. This drug has low potential for interactions with other medications, but healthcare professionals should be consulted regarding concomitant medications. Patients may experience dizziness or drowsiness during treatment, so driving or operating machinery should be avoided until symptoms are alleviated.

Serious side effects

Hives, angioedema, shortness of breath, wheezing, chest tightness, severe swelling (edema), anaphylaxis, anaphylactic shock, heart failure, pulmonary infiltration, acute respiratory distress syndrome, pneumonia, interstitial pneumonia, pleural effusion, acute pulmonary edema, respiratory failure, decreased left ventricular ejection fraction, heart palpitations, tachycardia, cardiomyopathy, pericardial effusion, cardiogenic shock, hypoxia, decreased oxygen saturation, cardiac symptoms, heart failure, cardiac dysfunction, febrile neutropenia

Mild side effects

• Anemia
• leukopenia
• thrombocytopenia
• weight loss
• loss of appetite
• insomnia
• anxiety
• depression
• tremors
• dizziness

This drug should be stored in a sealed container to prevent exposure to air and should be kept refrigerated between 2°C to 8°C to maintain its freshness and efficacy.

Appearance

A colorless injectable solution filled in a vial containing a white to light yellow lyophilized powder, which upon adding the solvent becomes a clear or slightly turbid solution that is colorless to pale yellow.

Package unit

1 vial/box [vial (304.32 mg)]