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【商品名】： 维克替比 Vectibix 研究还进一步揭示，帕尼单抗较西妥单抗的具有更多特性，包括更长的半衰期、更高的受体亲和性和更好的免疫耐受性等。帕尼单抗的药动学性质也提示，其用药不必要像西妥单抗那样，必须首先给予负荷剂量。帕尼单抗和西妥单抗分属全人源化和嵌合型鼠-人抗体，故帕尼单抗的耐受性亦应优于西妥单抗。 【原产地英文商品名】VECTIBIX 400mg/20ml/Vial
VECTIBIX - panitumumab治疗注射液 肺纤维化：中止开发间质性肺疾病，肺炎，或肺浸润患者Vectibix. Indication
Vectibix® (panitumumab) is indicated as a single agent for the treatment of epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix® as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix®. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix® in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix® is not recommended for the treatment of colorectal cancer with these mutations. Important Product Safety Information, including Boxed WARNINGS.
In Study 1, dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 16% of patients with mCRC receiving Vectibix®. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported. Withhold or discontinue Vectibix® for severe or life-threatening dermatologic toxicity and monitor for inflammatory or infectious sequelae. Terminate the infusion for severe infusion reactions Vectibix® is not indicated for use in combination with chemotherapy. In an interim analysis of a randomized clinical trial, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased overall survival and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in patients treated with Vectibix® included rash/dermatitis/acneiform (26% vs 1%); diarrhea (23% vs 12%); dehydration (16% vs 5%), primarily occurring in patients with diarrhea; hypokalemia (10% vs 4%); stomatitis/mucositis (4% vs < 1%); and hypomagnesemia (4% vs 0%). NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in patients treated with Vectibix® (7% vs 4%) and included fatal events in 3 (< 1%) patients treated with Vectibix®. In a single-arm study of 19 patients receiving Vectibix® in combination with IFL, the incidence of NCI-CTC grade 3-4 diarrhea was 58%; in addition, grade 5 diarrhea occurred in 1 patient. In a single-arm study of 24 patients receiving Vectibix® plus FOLFIRI, the incidence of NCI-CTC grade 3 diarrhea was 25%. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix®. Of the 2 cases, 1 involved a patient with underlying idiopathic pulmonary fibrosis and resulted in death. The second patient had symptoms of pulmonary fibrosis, which was confirmed by CT. Additionally, a third patient died with bilateral pulmonary infiltrates of uncertain etiology with hypoxia. Permanently discontinue Vectibix® therapy in patients developing interstitial lung disease, pneumonitis, or lung infiltrates. In a randomized, controlled clinical trial, median magnesium levels decreased by 0.1 mmol/L in the Vectibix® arm; hypomagnesemia (NCI-CTC grade 3 or 4) requiring oral or IV electrolyte repletion occurred in 2% of patients. Hypomagnesemia occurred 6 weeks or longer after the initiation of Vectibix®. In some patients, both hypomagnesemia and hypocalcemia occurred. Patients' electrolytes should be periodically monitored during and for 8 weeks after the completion of Vectibix® therapy. Institute appropriate treatment (eg, oral or intravenous electrolyte repletion) as needed. Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats, and limit sun exposure while receiving Vectibix® and for 2 months after the last dose. Adequate contraception in both males and females must be used while receiving Vectibix® and for 6 months after the last dose of Vectibix® therapy. Vectibix® may be transmitted from the mother to the developing fetus and has the potential to cause fetal harm when administered to pregnant women. Discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother. If nursing is interrupted, it should not be resumed earlier than 2 months following the last dose of Vectibix®. The most common adverse events of Vectibix® are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration. The most serious adverse events of Vectibix® are pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation. [next] 医薬品名:ベクティビックス点滴静注100mg 5mL 一般名:パニツムマブ(遺伝子組換え) 商品名 ベクティビックス点滴静注１００ｍｇ 禁忌病名 注意レベル： 禁止 注意レベル： 慎重投与 注意レベル： 注意 注意レベル： 注意 頻度： 頻度不明 頻度： ５％以上 頻度： 頻度不明 記載場所： 重大な副作用 頻度： ５％未満 頻度： ５％以上 頻度： ５％以上 記載場所： その他の副作用 頻度： ５％以上 頻度： 頻度不明 頻度： ５％未満 頻度： ５％未満 記載場所： その他の副作用 頻度： ５％未満 頻度： 頻度不明 頻度： 頻度不明 記載場所： 使用上の注意 頻度： 頻度不明
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维克替比(帕尼单抗注射剂)|Vectibix(Panitumumab）简介：
—— Vectibix(panitumumab)药品介绍：结直肠癌治疗药Vectibix(panitumumab、帕尼单抗)是第一个完全人源化单克隆抗体，其靶向作用于表皮生长因子受体（EGFR）。2005年7月，Panitumumab获得FDA快速通道 ... 责任编辑：admin |
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