ケピバンス 化学特性,用途語,生産方法
説明
Mucositis, an inflammation of the oral and gastrointestinal mucosa, is often induced
in patients receiving high-dose chemotherapy and radiotherapy for hematological
malignancies. Patients with head and neck cancer, as well as, patients
receiving stem cell transplants are particularly at risk for developing this debilitating side effect that can lead to swallowing difficulty, thereby, necessitating total parenteral
nutrition in severe cases. Other complications include potential infections,
overuse of opioid analgesics to treat the pain, and extended hospitalization. Palifermin,
a recombinant human keratinocyte growth factor (KGF), has been approved as
a novel agent to treat this condition. As a member of the heparin-family of fibroblast
growth factors, palifermin provides protection from the damaging effects of chemotherapy
and radiation by selectively promoting epithelial cell proliferation, leading to
an increased rate of healing. Palifermin is produced by recombinant DNA technology
utilizing an expression vector encoding KGF
des-23. As an N-terminal, truncated
version of endogenous KGF having amino acids 1–23 deleted, palifermin has greater
stability while retaining biological activity.Serious adverse events were similar to those
observed with placebo and were typically attributed to the underlying malignant
disease. Minor side effects were skin rash (＜1%), dysesthesia, pruritis, tongue
thickening, and transient taste changes. While keratinocyte growth-factor receptor is
not expressed in hematological cancers, it is possible that secondary tumors that
express this receptor could be advanced by palifermin treatment. Long-term evaluation
of this risk is ongoing; however, at 12 months, the progression-free survival
rates were similar for palifermin and placebo. The recommended dosage of palifermin
is 60 Mg/kg/day, delivered by i.v. bolus injection, for 3 consecutive days before
and three consecutive days following myelotoxic therapy, insuring that the third dose
is delivered greater than 24 h before the commencement of the myelotoxic therapy.
No formal drug–drug interaction studies have been conducted with palifermin.
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Originator
Amgen (US)
brand name
Kepivance
ケピバンス 上流と下流の製品情報
原材料
準備製品