Sampenet Injection 440 mg (Trastuzumab)

Adult dosage

For the treatment of metastatic breast cancer, the 1-week regimen involves an initial loading dose of 4 mg/kg, followed by a maintenance dose of 2 mg/kg every week starting 1 week after the initial dose. The 3-week regimen involves an initial loading dose of 8 mg/kg, followed by a maintenance dose of 6 mg/kg every 3 weeks starting 3 weeks after the initial dose. When used in combination with docetaxel and paclitaxel, the concomitant drug should be administered the day after the initial dose, and immediate administration is possible if there is good tolerance.

This drug may affect heart function, so special caution should be exercised for patients with heart disease or a history of heart problems. Heart function tests should be done before administration, and the heart condition should be regularly monitored during treatment. If symptoms of heart failure or heart function impairment occur, medical personnel should be notified immediately, and the medication may be discontinued if necessary. Allergic reactions or infusion-related side effects may occur during infusion, so swift action should be taken if symptoms arise. Symptoms such as shortness of breath, rash, and hypotension should be reported to medical personnel immediately. There is also a risk of lung issues, so patients with respiratory symptoms or lung disease need to be cautious. This medication contains benzyl alcohol and should not be administered to newborns or premature infants. Women who are pregnant or may become pregnant should use effective contraception during treatment and for 7 months after treatment while discussing potential effects on the fetus. It is safest to avoid breastfeeding during treatment and for 7 months after treatment. The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established, so caution is warranted. Elderly patients and those with impaired kidney or liver function can use it without special dosage adjustments, but their condition should be closely monitored. Dizziness or drowsiness may occur while driving or operating machinery, so caution is advised. This drug has low potential for interactions when used with other medications, but healthcare providers should be consulted about other drugs being taken. When preparing the medication, an aseptic environment should be maintained, and proper solvents should be used, and storage conditions should be adhered to after preparation. This medication should be stored in a refrigerator while avoiding freezing.

Serious side effects

Hives, angioedema, shortness of breath, wheezing, anaphylaxis, severe swelling (edema), heart failure, heart tremors, palpitations, cardiomyopathy, pericardial effusion, cardiogenic shock, heart failure (congestive), decreased left ventricular ejection fraction, heart disease, acute pulmonary edema, pulmonary edema, acute respiratory distress syndrome, pneumonia, interstitial lung disease, interstitial pneumonia, pleural effusion, respiratory failure, respiratory function loss, pulmonary fibrosis, pulmonary infiltrates, bronchospasm, hypoxemia, oxygen saturation

Mild side effects

• Skin rash
• nausea
• vomiting
• headache
• insomnia
• anxiety
• depression
• dizziness
• taste disturbances
• peripheral neuropathy

This medication should be stored in a sealed container to prevent contact with air and kept at a refrigerated temperature between 2 degrees and 8 degrees. This will maintain the drug's effectiveness and prevent deterioration.

Appearance

A colorless, transparent vial containing a white to pale yellow lyophilized powder. After reconstitution, the turbidity should be slightly below cloudy, and the color should range from colorless to bright yellow.

Package unit

1 vial/box [vial (440 mg)]