エタネルセプト（遺伝子組換え）

危険有害性情報のコード(GHS)

• 絵表示(GHS)

  

• 注意喚起語

  Warning

• 危険有害性情報

  H351：発がんのおそれの疑い

• 注意書き

  P201：使用前に取扱説明書を入手すること。

  P202：全ての安全注意を読み理解するまで取り扱わないこ と。

  P281：指定された個人用保護具を使用すること。

  P308+P313：暴露または暴露の懸念がある場合：医師の診断/手当てを 受けること。

  P405：施錠して保管すること。

  P501：内容物/容器を．．．に廃棄すること。

エタネルセプト（遺伝子組換え） 化学特性,用途語,生産方法

• 用途

  生物学的製剤免疫抑制薬

• 説明

  Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell line and is the first biotechnology-derived drug to be introduced for the reduction of the signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have not adequately responded to one or more of the synthetic DMARDs. It is a dimeric soluble form of the p75 TNFR capable of binding to two TNF molecules in the circulation. It consists of the extracellular ligand binding portion of the 75-kDa human TNFR fused to the Fc portion of human IgG1.
  
  The Fc component of etanercept contains the CH2 domain, the CH3 domain, and the hinge region, but not the CH1 domain of IgG1. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kDa. Two TNFRs have been identified, a 75-kDa protein and a 55-kDa protein, that occur as monomeric molecules on cell surfaces and soluble forms in the blood. The biological activity of TNF requires its binding to either of the two cell surface TNFRs. Etanercept can bind specifically to two molecules of TNFα in the circulation, preventing its interaction with cell surface TNFRs.

• 使用

  To decrease signs and symptoms of rheumatoid arthritis.
  
  Etanercept (Enbrel) is a soluble TNF receptor fusion protein. It is FDA approved for moderate to severe psoriasis at a dose of 50 mg twice weekly by subcutaneous injection for the initial 12 weeks, followed by a stepdown to 50 mg weekly for maintenance. The most common side effect is injection site reactions. Rare cases of serious infection, demyelinating disease, and congestive heart failure have been reported by postmarketing surveillance.

• 適応症

  Etanercept (Enbrel) is a recombinant fusion protein designed to block the action of TNF-α. The drug is composed of the extracellular ligand-binding portion of the 75-kilodalton human TNF receptor linked to the Fc portion of human IgG1. TNF-α is a cytokine thought to play a major role in the pathogenesis of a number of inflammatory skin diseases, including psoriasis. Etanercept binds soluble TNF-α, preventing it from binding to and activating receptors for TNF that are present on cell membranes.

• 薬理学

  Etanercept (Enbrel) is a soluble TNF receptor fusion protein. It is FDA approved for moderate to severe psoriasis at a dose of 50 mg twice weekly by subcutaneous injection for the initial 12 weeks, followed by a stepdown to 50 mg weekly for maintenance.

• 臨床応用

  Etanercept is approved in the United States for the treatment of psoriatic arthritis and rheumatoid arthritis. Although etanercept has not been specifically approved for the treatment of the cutaneous manifestations of psoriasis, it significantly improves the skin lesions of patients with moderate to severe cutaneous psoriasis who have used it for psoriatic joint disease.

• 副作用

  The most common adverse reaction to etanercept is mild to moderate erythema, pain, or pruritus at the injection site (37%). Headaches and abdominal pain can also occur. New positive autoantibodies, such as antinuclear antibodies (ANA), anti-dsDNA antibodies, and anticardiolipin antibodies, can develop in patients treated with etanercept. Although there is so far no association between this and the development of autoimmune diseases or malignancies, long-term studies have yet to be done. Rare cases of pancytopenia may be associated with this drug. Although clinical trials showed no increased risk of infection with etanercept treatment, postmarketing reports of serious infections, sepsis, and associated fatalities exist.

• 予防処置

  Etanercept therapy should not be initiated in patientswith active infection. If an infection develops in a persontaking etanercept, he or she should be closely monitored.If a serious infection or sepsis occurs, the drugshould be discontinued. Etanercept should be usedwith caution in individuals who have conditions predisposingthem to serious infection (e.g., uncontrolleddiabetes, hematological abnormalities). Data on druginteractions are limited. Live virus vaccines are contraindicatedbecause of the potential for secondarytransmission of the infection by the vaccine. Myelosuppressiveantirheumatic agents have been associatedwith pancytopenia in some patients treated with etanercept.

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