HERZUMA 150mg (Trastuzumab) (Monoclonal Antibody, Recombinant DNA)

Adult administration

Metastatic breast cancer weekly regimen: initial loading dose of 4 mg/kg, maintenance dose of 2 mg/kg administered weekly starting one week after the initial loading dose.\n3-week regimen: initial loading dose of 8 mg/kg, maintenance dose of 6 mg/kg administered every 3 weeks starting three weeks after the initial loading dose.\nEarly-stage breast cancer 3-week regimen: initial loading dose of 8 mg/kg, followed by maintenance dose of 6 mg/kg every 3 weeks.\nEarly breast cancer.

This medication may affect heart function, so caution should be exercised for patients with heart disease or previous heart issues. In particular, patients with heart failure or reduced heart function should undergo heart examinations before treatment and have their heart function monitored regularly during treatment. Allergic reactions or infusion-related adverse effects may occur during infusion, so the patients' condition should be closely monitored. Serious reactions such as difficulty breathing or hypotension may occur, and if such symptoms arise, immediate medical attention should be sought. Rare side effects affecting the lungs have also been reported; therefore, caution is advised for patients with pulmonary disease or symptoms of dyspnea. This medication should not be administered to patients with hypersensitivity reactions or severe dyspnea. Furthermore, patients with a history of using certain chemotherapeutic agents or receiving radiation therapy should use this medication with caution due to increased risk of cardiac-related side effects. Various side effects including blood cell count reductions, infections, gastrointestinal symptoms, skin reactions, etc., may occur; therefore, medical consultation should be sought immediately if any abnormal symptoms appear. Women who are pregnant or may become pregnant should ensure effective contraception during and for a period after taking this medication, and use should be avoided while breastfeeding. Dizziness or drowsiness may occur, so driving or operating hazardous machinery should be avoided during treatment. This medication must be prepared in a sterile environment, and the solution should be checked for abnormalities before administration. Although drug interactions are not widely reported, it is advisable to consult with healthcare professionals regarding concomitant medications.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

• Nausea
• muscle pain
• neutropenia
• neuropathy
• fever
• chills
• appetite loss
• peripheral neuropathy
• vomiting
• weakness

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

Appearance

The white to pale yellow freeze-dried powder, which forms a colorless to pale yellow solution ranging from clear to slightly opalescent after reconstitution, is contained in a colorless transparent glass vial.

Package unit

1 vial/box [vial (150 milligrams)]