Victoza (liraglutide，利拉鲁肽注射剂) - 新药热点

17PATIENT COUNSELING INFORMATION17.1 Risk of Thyroid C-cell TumorsPatients should be informed that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that the human relevance of this finding is unknown. Patients should be counseled to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician.
17.2 PancreatitisPatients should be informed that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to discontinue Victoza promptly, and to contact their physician, if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].
17.3 Never Share a Victoza Pen Between PatientsCounsel patients that they should never share a Victoza pen with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection.
17.4 InstructionsPatients should be informed of the potential risks and benefits of Victoza and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.
Patients should be advised that the most common side effects of Victoza are headache, nausea and diarrhea. Nausea is most common when first starting Victoza, but decreases over time in the majority of patients and does not typically require discontinuation of Victoza.
Physicians should instruct their patients to read the Patient Medication Guide before starting Victoza therapy and to reread each time the prescription is renewed. Patients should be instructed to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.
17.5 Laboratory TestsPatients should be informed that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1c levels, with a goal of decreasing these levels towards the normal range. A1c is especially useful for eva luating long-term glycemic control.

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