Sampenet Injection 150 mg (Trastuzumab)

Adult administration

For the treatment of breast cancer and gastric cancer, there are 1-week and 3-week treatment regimens, administered as follows: 1-week regimen: - Initial loading dose: 4 mg/kg - Maintenance dose: 2 mg/kg administered weekly starting one week after the initial loading dose. 3-week regimen: - Initial loading dose: 8 mg/kg - Maintenance dose: 6 mg/kg administered every 3 weeks starting three weeks after the initial loading dose. For metastatic gastric cancer, the maintenance dose is administered as follows.

This medication may affect heart function, so patients with heart failure or heart disease, or those who have previously taken medications that stress the heart, must undergo a thorough evaluation of their heart condition before administration. During the administration of this drug, cardiac function should be monitored regularly, and treatment plans should be adjusted immediately if any abnormal signs are detected. During infusion, allergic reactions or infusion-related side effects may occur, so the patient's condition must be closely observed during administration. Patients with respiratory problems or lung diseases may be at risk when administered this drug, necessitating special precautions. Pregnant women or women who may become pregnant must ensure effective contraception during and for a period after the administration of this medication, and breastfeeding should be avoided during this period. The safety and efficacy of this drug have not been established in children, so it should not be administered to patients under 18 years of age. Elderly patients or those with impaired kidney and liver function can receive this drug without special dosage adjustments; however, they should be closely monitored. There is no specific antidote for overdose, so the dosage must be strictly adhered to. This drug must be prepared and diluted under aseptic conditions and must not be mixed with other medications; before administration, the product must be checked for particulate matter or discoloration. It must be stored in a sealed container to prevent exposure to air or moisture, and should be refrigerated at a temperature between 2°C and 8°C for optimal safety. If stored at room temperature, care must be taken as there are time limitations on usage.

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, asthma attacks, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis, significantly decreased urine output, severe generalized edema with elevated blood pressure, severe cardiac events.

Mild side effects

• Fatigue
• nausea
• vomiting
• headache
• dizziness
• insomnia
• anxiety
• depression
• drowsiness
• decreased blood pressure

This drug must be stored in a sealed container to prevent exposure to air and moisture, preferably at refrigerator temperatures between 2°C and 8°C. This method preserves the drug's efficacy and prevents degradation.

Appearance

A colorless and transparent vial containing a white to pale yellow freeze-dried powder. After reconstitution, the turbidity should be no more than slightly turbid, and the color should be from colorless to bright yellow.

Package unit

1 vial per packaging unit (carton)