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藥品參考

Sapropterin

Sapropterin is a medicine in the class miscellaneous.

  • 藥物類別: Miscellaneous

最後更新 來源: US FDA label

僅供醫療專業人員參考。本頁為簡要摘要,並非醫療建議,亦不能取代官方仿單或臨床判斷。開立處方或調劑前請務必核實。

本頁的臨床內容僅提供英文版。

重點資訊

藥物類別
Miscellaneous
ATC 代碼
A16AX07
常見劑型
溶液, 錠劑
已知交互作用
11 (中度: 9 · 輕微: 2)
商品名
5
國家與市場
2

劑型、規格與商品名稱會因國家而異。請核對您手上的產品。

作用方式

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.

成人常用劑量(仿單摘要)

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

僅摘錄仿單中第一行劑量說明;完整的劑量內容請見 App。

懷孕與哺乳

懷孕
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.
哺乳
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.

已通報的副作用

  • Headache
  • Rhinorrhea
  • Pharyngolaryngeal pain
  • Diarrhea
  • Vomiting
  • Cough

哪些人需要特別留意

  • 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.

請告知藥師或醫師您是否懷孕或哺乳、是否患有腎臟或肝臟疾病、是否有過敏,以及您正在使用的所有其他藥物或保健品。

重要交互作用 (11)

All 11 interactions, with severity and what to do

Pro+ 會員專屬

解鎖完整頁面

建立帳號並開始 Pro+ 試用,即可開啟 Sapropterin 的完整藥品專論:劑量、懷孕與哺乳、副作用、警示及所有交互作用。

  • 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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常見問題

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.

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