医薬品リファレンス
Sapropterin
Sapropterin is a medicine in the class miscellaneous.
- 薬効分類: Miscellaneous
最終更新日 出典: US FDA label
医療従事者向け・参照専用。このページは簡潔な要約であり、医学的助言ではなく、公式の添付文書や臨床判断に代わるものではありません。処方・調剤の前に必ず確認してください。
このページの臨床コンテンツは英語でのみ提供されています。
要点
- 薬効分類
- Miscellaneous
- ATCコード
- A16AX07
- 一般的な剤形
- 溶液, 錠剤
- 既知の相互作用
- 11 (中等度: 9 · 軽度: 2)
- 商品名
- 5
- 国・市場
- 2
作用のしくみ
Sapropterin is a synthetic form of BH4, the cofactor for phenylalanine hydroxylase (PAH). It can activate residual PAH activity, improve oxidative metabolism of Phe and lower Phe levels in some PKU patients.
成人の通常用量（添付文書の要約）
BH4-responsive PKU (patients 7 years and older): starting dose 10 to 20 mg/kg (actual body weight), orally once daily, with a meal, with Phe-restricted diet; after response is established adjust within 5 to 20 mg/kg per day by blood Phe
妊娠と授乳
- 妊娠
- Unknown Available data have not identified a drug-associated risk of major birth defects or miscarriage; uncontrolled maternal Phe is harmful, so keep blood Phe between 120 and 360 micromol/L. Rabbit study showed holoprosencephaly at 10 times the MRHD.
- 授乳
- Unknown Insufficient data on presence in human milk; no lactation-related safety concerns reported in 13 breastfed infants. Weigh benefits of breastfeeding against maternal need.
報告されている副作用
- Headache
- Rhinorrhea
- Pharyngolaryngeal pain
- Diarrhea
- Vomiting
- Cough
注意が必要な方
- Hypersensitivity including anaphylaxis: not recommended with history of anaphylaxis; discontinue and treat if anaphylaxis occurs, continue Phe restriction.
- Upper GI mucosal inflammation (esophagitis, gastritis) can occur; monitor for signs and symptoms.
- Hypophenylalaninemia: higher risk in pediatric patients younger than 7 years at 20 mg/kg per day.
妊娠中または授乳中であること、腎臓や肝臓の病気、アレルギー、ほかに使用しているすべての薬やサプリメントについて、薬剤師または医師にお伝えください。
主な相互作用 (11)
- Avanafil + Sapropterin Moderate
- Carbidopa-entacapone-levodopa + Sapropterin Moderate
- Carbidopa-levodopa + Sapropterin Moderate
- Levodopa + Sapropterin Moderate
- Methotrexate + Sapropterin Moderate
- Phenobarbitone + Sapropterin Moderate
- Pyrimethamine + Sapropterin Moderate
- Sapropterin + Sodium valproate Moderate
- Sapropterin + Tadalafil Moderate
- Sapropterin + Sildenafil Minor
Pro+会員向け
ページ全体を見る
アカウントを作成してPro+トライアルを始めると、Sapropterinの完全なモノグラフ（用量、妊娠・授乳、副作用、警告、すべての相互作用）を表示できます。
- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
- IV preparation and dilution
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よくある質問
What is Sapropterin used for?
Sapropterin is a medicine in the class miscellaneous.
What side effects have been reported with Sapropterin?
Headache, Rhinorrhea, Pharyngolaryngeal pain, Diarrhea, Vomiting, Cough.
Can Sapropterin be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Available data have not identified a drug-associated risk of major birth defects or miscarriage; uncontrolled maternal Phe is harmful, so keep blood Phe between 120 and 360 micromol/L. Rabbit study showed holoprosencephaly at 10 times the MRHD. Breastfeeding: Unknown. Insufficient data on presence in human milk; no lactation-related safety concerns reported in 13 breastfed infants. Weigh benefits of breastfeeding against maternal need.
What does Sapropterin interact with?
MediHelp lists 11 known interactions for Sapropterin. Moderate: 9 · Minor: 2. The most serious include Avanafil, Carbidopa-entacapone-levodopa, Carbidopa-levodopa.
完全なモノグラフ、用量、相互作用チェッカーはMediHelpアプリで
MediHelpアプリで、完全なリファレンスを開き、複数薬剤の相互作用をチェックし、用量ツールを利用できます。
