Riferimento farmaci
Sapropterin
Sapropterin is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- A16AX07
- Forme farmaceutiche comuni
- soluzione, compressa
- Interazioni note
- 11 (Moderata: 9 · Minore: 2)
- Nomi commerciali
- 5
- Paesi e mercati
- 2
Come agisce
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.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
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
Gravidanza e allattamento
- Gravidanza
- 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.
- Allattamento
- 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.
Effetti indesiderati segnalati
- Headache
- Rhinorrhea
- Pharyngolaryngeal pain
- Diarrhea
- Vomiting
- Cough
Chi deve prestare attenzione
- 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.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (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
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- 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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Domande frequenti
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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