JP6279905B2 - 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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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
-
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/215—IFN-beta
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61P25/00—Drugs for disorders of the nervous system
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- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/555—Interferons [IFN]
- C07K14/565—IFN-beta
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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 (20)
- 多発性硬化症の処置として8週間にわたるインターフェロンβ1aの筋肉内投与に起因するインフルエンザ様症状を軽減するために使用される用量調節パッケージであって、
前記用量調節パッケージは、
インターフェロンβ1aと、
多発性硬化症の患者に対して、1週目に7.5μgのインターフェロンβ1aを患者に対して筋肉内投与するための第1の送達装置、2週目に15μgのインターフェロンβ1aを患者に対して筋肉内投与するための第2の送達装置、3週目に22.5μgのインターフェロンβ1aを患者に対して筋肉内投与するための第3の送達装置、を備え、第1のスケジュールに従って週に一度の筋肉内投与を行う送達装置と、
を含み、
4週目から8週目にかけて週に一度ずつ、30μgのインターフェロンβ1aを患者に対して筋肉内投与した場合に、
(1)8週間にわたって週に一度ずつ、30μgのインターフェロンβ1aが筋肉内投与される第2のスケジュールに従ってインターフェロンβ1aが筋肉内投与された多発性硬化症の患者において、インターフェロンβ1aを筋肉内投与した4〜6時間後に、および、12〜15時間後におけるインフルエンザ様症状、
および、
(2)1週目および2週目に、7.5μgのインターフェロンβ1aを患者に対して筋肉内投与し、3週目および4週目に、15μgのインターフェロンβ1aを患者に対して筋肉内投与し、5週目および6週目に、22.5μgのインターフェロンβ1aを患者に対して筋肉内投与し、7週目および8週目に、30μgのインターフェロンβ1aを患者に筋肉内投与する第3のスケジュールに従ってインターフェロンβ1aが筋肉内投与された多発性硬化症の患者において、インターフェロンβ1aを筋肉内投与した4〜6時間後に、および、12〜15時間後におけるインフルエンザ様症状、
と比較して、8週間にわたって、インターフェロンβ1aの筋肉内投与から4〜6時間後または12〜15時間後に現れるインフルエンザ様症状の発症率および重篤度を軽減させる用の用量調節パッケージ。 - 凍結乾燥状態のインターフェロンβ1aを内容するバイアルを含む、請求項1に記載の用量調節パッケージ。
- バイアルアダプタを備え、
前記送達装置は、凍結乾燥されたインターフェロンβ1aを希釈する希釈剤で予め充填されたシリンジである請求項2に記載の用量調節パッケージ。 - 前記送達装置は、あらかじめ正確な薬用量のインターフェロンβ1aが液体の状態で充填されたシリンジである請求項1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1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1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1に記載の用量調節パッケージ。
- 針さし予防装置を備える請求項1に記載の用量調節パッケージ。
- 前記針さし予防装置は、針シールドを含む請求項8に記載の用量調節パッケージ。
- 前記針シールドは患者による手作業で作動される請求項9に記載の用量調節パッケージ。
- 前記針シールドは自動化されている請求項9に記載の用量調節パッケージ。
- 自動化された前記針シールドは患者によって作動される請求項11に記載の用量調節パッケージ。
- 針が患者による一切の操作なしに自動的に遮蔽される請求項11に記載の用量調節パッケージ。
- 針が患者による一切の操作なしに遮蔽される請求項11に記載の用量調節パッケージ。
- 用量制限用量調節装置を含む請求項1に記載の用量調節パッケージ。
- 鎮痛薬もしくは抗炎症薬またこれらの混合物を含む請求項1から請求項15のいずれか1項に記載の用量調節パッケージ。
- 前記鎮痛薬もしくは前記抗炎症薬は、ステロイドである請求項16に記載の用量調節パッケージ。
- 前記鎮痛薬もしくは前記抗炎症薬は、非ステロイド系抗炎症薬である請求項16に記載の用量調節パッケージ。
- 前記鎮痛薬もしくは前記抗炎症薬は、アセトアミノフェンである請求項16に記載の用量調節パッケージ。
- 前記鎮痛薬もしくは前記抗炎症薬は、イブプロフェンである請求項16に記載の用量調節パッケージ。
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