Fescopihajusa 600/600 mg (Pertuzumab/Trastuzumab)

Adult administration

This drug should only be administered subcutaneously into the thigh and must not be given intravenously. Initial dose: Administer 1200 mg of pertuzumab and 600 mg of trastuzumab over 8 minutes and observe for 30 minutes. Maintenance dose (every 3 weeks): Administer 600 mg of pertuzumab and 600 mg of trastuzumab over 5 minutes and observe for 15 minutes. Patients who received the last intravenous administration of pertuzumab and trastuzumab less than 6 weeks ago should receive the maintenance dose.

This medicine may affect cardiac left ventricular function; therefore, left ventricular ejection fraction must be checked before administration and monitored regularly during treatment. When administering this drug, infusion-related reactions may occur, so patients should be closely monitored during the first administration and at maintenance dose administrations, and if severe reactions occur, the infusion rate should be adjusted or stopped. White blood cell counts, which may decrease due to chemotherapy, may drop further, hence blood counts should be frequently monitored to reduce the risk of infection. Hypersensitivity reactions may occur, so patient status should be closely monitored during and after administration, and emergency preparedness is needed. Serious pulmonary adverse reactions may rarely occur, so particular caution is required for patients with dyspnea or pulmonary symptoms. Patients with allergies to any of the ingredients in this drug should not receive it, and it should be used cautiously in patients with a history of poor cardiac function, uncontrolled hypertension, or recent heart disease. Women who are pregnant or may become pregnant should use effective contraception during the period of administration of this drug and for a certain period after administration; this drug should not be administered during pregnancy. It is safest to avoid breastfeeding during and for a certain period after the administration of this drug. Safety in children and adolescents has not been established, and no special dosage adjustment is necessary for the elderly. There is no established safety and appropriate dosage for patients with severely impaired renal or hepatic function, so caution is needed. This drug is in a ready-to-inject form and should not be mixed or diluted with other medications; it should be checked for discoloration or foreign substances before use. Used syringes and needles must never be reused and should be disposed of safely in designated waste containers. This medicine should be stored in a sealed container to avoid exposure to air and light and should be kept at cool refrigeration temperatures between 2°C and 8°C. This way of storage helps to maintain the drug's effectiveness and prevent degradation.

Serious side effects

• Left ventricular dysfunction
• heart failure
• infusion-related reactions
• febrile neutropenia
• anaphylaxis
• pulmonary infiltration
• interstitial lung disease
• acute respiratory distress syndrome
• pneumonia
• interstitial pneumonia

Mild side effects

• Diarrhea
• injection site reactions
• asthenia
• fatigue
• rash
• dry skin
• myalgia
• arthralgia
• neutropenia
• anemia

This drug should be stored in a sealed container to avoid exposure to air and light and should be kept at cool refrigeration temperatures between 2℃ and 8℃. This storage method helps maintain the effectiveness of the drug and prevents degradation.

Appearance

A colorless to pale yellow liquid filled in a colorless transparent vial injection.

Package unit

1 vial/box [vial (10 mL)]