| 英文药名：VECTIBIX（Panitumumab[Genetical/Recombination]）
中文药名：维克替比（帕尼单抗点滴静注）
生产厂家：武田药品
药品介绍
帕尼单抗治疗结肠直肠癌具独特优势帕尼单抗(Panitumumab)是第一个靶向表皮生长因子受体(EGFR)的全人源化单克隆抗体，而表皮生长因子受体则是一种在肿瘤细胞信号传导过程中扮演着重要角色的蛋白。帕尼单抗即将成为表皮生长因子受体抑制剂中的又一新成员，后者开发的第一适应证为经过标准化疗治疗失败的转移性结肠直肠癌。
ベクティビックス点滴静注100mg／ベクティビックス点滴静注400mg
商標名
Vectibix
一般名
パニツムマブ（遺伝子組換え）
（Panitumumab（Genetical Recombination））〔JAN〕
効能・効果
KRAS遺伝子野生型の治癒切除不能な進行結腸癌・KRAS遺伝子野生型の治癒切除不能な再発結腸癌・KRAS遺伝子野生型の治癒切除不能な進行直腸癌・KRAS遺伝子野生型の治癒切除不能な再発直腸癌。
<効能・効果に関連する使用上の注意>
1.術後補助化学療法として本剤を使用した場合の有効性及び安全性は確立… 続きを見る...用法・容量
2週間に1回、パニツムマブ(遺伝子組換え)として1回6mg/kg(体重)を60分以上かけて点滴静注する。なお、患者の状態に応じて適宜減量する。
<用法・用量に関連する使用上の注意>
1.本剤と併用する他の抗悪性腫瘍剤は、添付文書の【臨床成績】及び「その他の注意」の項の内容を熟知し、選択する。
2.重… 続きを見る...副作用
<国内使用成績調査(全例調査)>
市販後の一定期間に投与症例の全例を登録して実施した調査において、安全性評価対象3,085例中2,595例(84%)に副作用が認められ、その主なものは、ざ瘡様皮膚炎1,591例(52%)、爪囲炎731例(24%)、皮膚乾燥605例(20%)、低マグネシウム血症520例… 続きを見る...使用上の注意
(警告)
1.本剤を投与する場合は、緊急時に十分対応できる医療施設において、がん化学療法に十分な知識と経験を持つ医師のもとで、本剤が適切と判断される症例についてのみ投与する。また、治療開始に先立ち、患者又はその家族に有効性及び危険性を十分説明し、同意を得てから投与する。
2.間質性肺疾患が現れるこ… 続きを見る...
包装规格
点滴静注100mg：1バイアル
点滴静注400mg：1バイアル
製造販売元
武田薬品工業株式会社
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 SAFETY INFORMATION
WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
Dermatologic Toxicity: Dermatologic toxicities occurred in 89% of patients and were severe (NCI-CTC grade 3 or higher) in 12% of patients receiving Vectibix® monotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
Infusion Reactions: Severe infusion reactions occurred in approximately 1% of patients. Fatal infusion reactions occurred in postmarketing experience.
[See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].
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, necrotizing fasciitis 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.
Vectibixis not indicated for use in combination with chemotherapy.
In an interim analysis of a randomized clinical trial, the addition of Vectibixto 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.
Patients with a history or evidence of interstitial pneumonitis, pulmonary fibrosis, were excluded from most clinical trials.
Therefore, the estimated risk in a general population that includes such patients is uncertain.
Cases of interstitial lung disease (ILD), including fatalities, have been reported in patients treated with Vectibix. Interrupt Vectibix therapy for the acute onset or worsening of pulmonary symptoms. Discontinue Vectibix therapy if ILD is confirmed.
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.
Keratitis and ulcerative keratitis, known risk factors for corneal perforation, have been reported with Vectibix.
Monitor for evidence of keratitis or ulcerative keratitis. Interrupt or discontinue
Vectibix for acute or worsening keratitis.
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.
完整资料附件：http://www.info.pmda.go.jp/go/pack/4291417A1020_1_07/
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产地国家： 日本
原产地英文商品名:
VECTIBIX（ベクティビックス点滴静注）100mg Infusion 1vial
原产地英文药品名:
Panitumumab（Genetical/Recombination）
中文参考商品译名:
VECTIBIX（ベクティビックス点滴静注）100毫克/瓶 1瓶
中文参考药品译名:
帕尼单抗
生产厂家中文参考译名:
武田药品
生产厂家英文名:
Takeda Pharmaceutical
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产地国家： 日本
原产地英文商品名:
VECTIBIX（ベクティビックス点滴静注）400mg Infusion 1vial
原产地英文药品名:
Panitumumab（Genetical/Recombination）
中文参考商品译名:
VECTIBIX（ベクティビックス点滴静注）400毫克/瓶 1瓶
中文参考药品译名:
帕尼单抗
生产厂家中文参考译名:
武田药品
生产厂家英文名:
Takeda Pharmaceutical
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