Herceptin 440 mg (Trastuzumab) (Monoclonal Antibody, Recombinant)

Adult administration

Trastuzumab is administered intravenously. For the treatment of metastatic breast cancer: 1-week regimen: initial loading dose of 4 mg/kg, maintenance dose of 2 mg/kg weekly starting one week after the initial loading dose. 3-week regimen: initial loading dose of 8 mg/kg, maintenance dose of 6 mg/kg every 3 weeks starting three weeks after the initial loading dose. For early-stage breast cancer treatment: 3-week regimen: initial loading dose of 8 mg/kg.

This drug may affect heart function, so patients with heart disease or those who have previously taken heart-related medications should have their cardiac status thoroughly evaluated before administration. In particular, patients with a history of heart conditions such as heart failure, angina, or hypertension should be careful as they are at risk for exacerbating heart function. During administration of this drug, regular cardiac function tests should be conducted, and administration may be discontinued if there is a significant decline in heart function. Additionally, allergic reactions or infusion-related side effects may occur during infusion, so the patient's condition should be closely monitored during administration. If serious allergic symptoms such as difficulty breathing, hypotension, or rash occur, administration must be stopped immediately, and appropriate treatment is necessary. This drug can also affect lung function, hence special caution is required for patients with lung diseases or respiratory symptoms during administration. The drug contains a component called benzyl alcohol, so it should not be administered to neonates or premature infants, and patients with hypersensitivity to benzyl alcohol should avoid its use. Women who are pregnant or may become pregnant should maintain effective contraception during and for a certain period after treatment, as administration during pregnancy can affect the fetus, thus careful consideration is essential. This drug is not recommended for use in children (under age 18) as safety and efficacy have not been established. Although it can be used without special dose adjustment in the elderly or patients with impaired kidney or liver function, consultation with healthcare professionals is advisable based on their condition. This drug may cause dizziness or drowsiness when driving or operating machinery, thus caution should be exercised if such symptoms occur. It is important to consult with healthcare professionals prior to medication administration to inform them of one's health status and history and to undergo regular check-ups and monitoring.

Serious side effects

• Urticaria
• angioedema
• dyspnea
• wheezing
• bronchospasm
• anaphylaxis
• decreased oxygen saturation
• hypotension
• heart failure (congestive)
• reduced ejection fraction

Mild side effects

• Nausea
• myalgia
• neutropenia
• neuropathy
• fever
• sensory disturbances
• chills
• anorexia
• peripheral neuropathy
• vomiting

This drug should be stored in a sealed container to avoid contact with air, and it is advisable to keep it at refrigerated temperatures between 2 to 8 degrees Celsius. This way of storage helps maintain the drug's efficacy and prevents deterioration.

Appearance

A white to pale yellow freeze-dried powder in a colorless, transparent glass vial that becomes a clear to pale opalescent colorless to yellow solution upon reconstitution.

Package unit

1 vial/box [vial (440 mg)]