JP2014508174A - 速い用量調節の漸増投与レジメンを用いた、インターフェロンの筋肉内投与に伴うインフルエンザ様症状を軽減するための方法 - Google Patents
速い用量調節の漸増投与レジメンを用いた、インターフェロンの筋肉内投与に伴うインフルエンザ様症状を軽減するための方法 Download PDFInfo
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Abstract
Description
1〜2週目−用量の1/4(0.0625mg/0.25ml)
3〜4週目−用量の1/2(0.125mg/0.5ml)
5〜6週目−用量の3/4(0.1875mg/0.75ml)
7週目−規定用量(0.25mg/1ml)
Betaseron(登録商標)のラベルには、用量漸増法がインフルエンザ様症状を軽減する場合があることが表示されている。欧州のBetaferon(登録商標)のラベル(1−8−24)には、下記のような3週間の期間にわたる皮下投与の用量調節の指示があり、4週目から規定用量になる:
1週目−用量の1/4(0.0625mg/0.25ml)
2週目−用量の1/2(0.125mg/0.5ml)
3週目−用量の3/4(0.1875mg/0.75ml)
4週目−規定用量(0.25mg/1ml)
欧州のBetaferon(登録商標)のラベルには、用量を1/4ずつ増量する3週間の用量調節期間を設けてあるが、一般に治療の開始時のみに忍容性を高め、副作用を軽減するため、処置の開始時の用量漸増が推奨されている。6週間の用量調節期間とインフルエンザ様症状の軽減の可能性とが表示されている米国のBetaseron(登録商標)のラベルと異なり、欧州のBetaferon(登録商標)のラベルには、3週間の用量調節期間におけるインフルエンザ様症状の処置に関する記載がない。2つの臨床試験から、3週間の期間にわたり用量を1/4ずつ増量しても、緩徐な用量調節レジメンと比較してインフルエンザ様症状があまり軽減されないことが明らかにされる。
1〜2週目−用量の1/5−皮下注射3×/週
(33μgの用量調節用量=4.4μg)
(44μgの用量調節用量=8.8μg)
3〜4週目−用量の1/2−皮下注射3×/週
(33μgの用量調節用量=11μg)
(44μgの用量調節用量=22μg)
5週目−規定用量−皮下注射3×/週
欧州のRebif(登録商標)のラベルには、4週間の期間に徐々に増量して有害反応を低下させることが推奨されている。最初の2週間に1/5用量にすると、タキフィラキシーが発現し、したがって副作用を軽減できるという目的が満たされる。米国および欧州のラベルにはどちらも、インターフェロンβの投与に伴うインフルエンザ様症状の処置に関する記載がない。これまで考察した製品および臨床試験はすべて、IFN−β1aまたはIFN−β1bの皮下投与に関するものである。
(a)1〜3週目に漸増投与レジメンに従い患者にインターフェロンを筋肉内投与すること;および
(b)4週目にインターフェロンの規定の治療有効用量を筋肉内投与すること
を含む方法。
Claims (31)
- 多発性硬化症を処置する方法であって、インターフェロンを患者に週1回筋肉内投与することを含み、処置は、前記インターフェロンが1週目に4分の1用量、2週目に2分の1用量、3週目に4分の3用量、および4週目以降に規定の治療有効用量で投与される用量調節期間から開始する方法。
- 前記1週目の用量は約7.5マイクログラム、前記2週目の用量は約15マイクログラム、前記3週目の用量は約22.5マイクログラム、および前記4週目の用量は約30マイクログラムである、請求項1に記載の方法。
- 前記インターフェロンはインターフェロンβ1aである、請求項1に記載の方法。
- 多発性硬化症の患者へのインターフェロンの投与に伴うインフルエンザ様症状を軽減する方法であって、
(a)1〜3週目に漸増投与レジメンに従い前記患者に前記インターフェロンを筋肉内投与すること;および
(b)4週目にインターフェロンの規定の治療有効用量を筋肉内投与すること
を含む方法。 - 前記漸増投与レジメンは1週目に前記治療有効用量の4分の1、2週目に前記治療有効用量の半分、および3週目に前記治療有効用量の4分の3を投与することを含む、請求項4に記載の方法。
- 前記インターフェロンはインターフェロンβ1aである、請求項4に記載の方法。
- 前記規定の治療有効用量は30マイクログラムである、請求項4に記載の方法。
- 前記インフルエンザ様症状は、発熱、筋痛、悪寒、発汗、疲労、頭痛および倦怠感を含む、請求項4に記載の方法。
- 一定の期間にわたりインターフェロンの薬用量を変化させるレジメンのコンプライアンスを可能にするための用量調節パッケージであって、前記パッケージはインターフェロン、前記インターフェロンの送達装置、および用量調節期間中に患者が前記インターフェロンを筋肉内投与するための指示書を含み、前記インターフェロンは1週目に4分の1用量、2週目に2分の1用量、3週目に4分の3用量、および4週目に規定の治療有効用量で投与される、用量調節パッケージ。
- 前記指示書は約7.5マイクログラムの1週目の薬用量、約15マイクログラムの2週目の用量、約22.5マイクログラムの3週目の薬用量、および約30マイクログラムの4週目の薬用量を記載する、請求項9に記載の用量調節パッケージ。
- 前記インターフェロンはバイアル中に凍結乾燥形態で提供される、請求項9に記載の用量調節パッケージ。
- バイアルアダプターと、前記凍結乾燥インターフェロンの希釈液を予め充填したシリンジとをさらに含む、請求項11に記載の用量調節パッケージ。
- 前記インターフェロンは液体製剤で提供される、請求項9に記載の用量調節パッケージ。
- 前記インターフェロン液体製剤はプレフィルドシリンジで提供される、請求項13に記載の用量調節パッケージ。
- 前記プレフィルドシリンジは1〜4週目の正確な薬用量が充填されている、請求項14に記載の用量調節パッケージ。
- 前記送達装置は自動注射器を含む、請求項9に記載の用量調節パッケージ。
- 前記送達装置は針を含まない、請求項9に記載の用量調節パッケージ。
- 前記送達装置はペンである、請求項9に記載の用量調節パッケージ。
- 針刺し予防装置をさらに含む、請求項9に記載の用量調節パッケージ。
- 前記針刺し予防装置は針シールドを含む、請求項19に記載の用量調節パッケージ。
- 前記シールドは前記患者による手作業で作動される、請求項20に記載の用量調節パッケージ。
- 前記シールドは自動化されている、請求項20に記載の用量調節パッケージ。
- 前記自動シールドは前記患者により作動される、請求項22に記載の用量調節パッケージ。
- 前記針は前記患者による一切の行為なしに自動的に遮蔽される、請求項22に記載の用量調節パッケージ。
- 前記針は前記患者による一切の行為なしに遮蔽される、請求項22に記載の用量調節パッケージ。
- 前記パッケージは用量制限用量調節装置をさらに含む、請求項9に記載の用量調節パッケージ。
- 鎮痛薬もしくは抗炎症剤またはこれらの混合物の投与をさらに含む、請求項1〜8のいずれかに記載の方法。
- 前記薬剤はステロイドである、請求項27に記載の方法。
- 前記薬剤は非ステロイド系抗炎症薬である、請求項27に記載の方法。
- 前記薬剤はアセトアミノフェンである、請求項27に記載の方法。
- 前記薬剤はイブプロフェンである、請求項27に記載の方法。
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