- May 11, 2022
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Brand Name :
Kuvan
Synonyms :
sapropterin
Class :
Enzyme Cofactors
Dosage Forms & Strengths
Tablet
100mg
Powder
100mg/packet
10-20 mg/kg orally daily
The levels of Blood phenylalanine (Phe) evaluated after 1 week, if Phe levels in the blood have not decreased next periodically increase dose to 20 mg/kg/day
Maintenance dose: After determining responsiveness, the dose is adjusted b/w 5 and 20 mg/kg/day according to the biochemical response.
Non-Responders:
If Phe levels would not decrease after 1 month of treatment at 20 mg/kg/day must be considered non-responders and treatment should be stopped.
Dosage Forms & Strengths
Tablet
100mg
Powder
100mg/packet
10-20 mg/kg orally daily
The levels of Blood phenylalanine (Phe) evaluated after 1 week, if Phe levels in the blood have not decreased next periodically increase dose to 20 mg/kg/day
Maintenance dose: After determining responsiveness, the dose is adjusted b/w 5 and 20 mg/kg/day according to the biochemical response.
Non-Responders:
If Phe levels would not decrease after 1 month of treatment at 20 mg/kg/day must be considered non-responders and treatment should be stopped.
sapropterin may increase the hypotensive effect of phosphodiesterase 5 inhibitors
sapropterin may increase the hypotensive effect of phosphodiesterase 5 inhibitors
sapropterin may increase the hypotensive effect of phosphodiesterase 5 inhibitors
sapropterin may increase the risk of adverse/toxic effect of levodopa-containing products
It may enhance the risk of adverse reactions when combined with Enzymes
It may enhance the risk of adverse reactions when combined with Enzymes
It may enhance the risk of adverse reactions when combined with Enzymes
It may enhance the risk of adverse reactions when combined with Enzymes
It may enhance the risk of adverse reactions when combined with Enzymes
may decrease serum concentration of sapropterin
trimethoprim: they may diminish the serum concentration of sapropterin
choline magnesium trisalicylate
It may enhance the risk of adverse reactions when combined with Salicylates
Adverse drug reactions
Frequency Defined
>10%
Headache (15%)
Rhinorrhea (11%)
1-10%
Cough (7%)
Nasal congestion (4%)
Vomiting (8%)
Nausea (8%)
Diarrhea (8%)
Pharyngolaryngeal pain (10%)
<1%
Thrombocytopenia
Gastrointestinal bleeding
Spinal cord injury
Pregnancy warnings:
AU TGA pregnancy category: B1
US FDA pregnancy category: C
Lactation:
The drug excretion in breast milk is unknown.
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient Information Leaflet
Generic Name: sapropterin
Why do we use sapropterin?
sapropterin is an Enzyme Cofactors used to treat Hyperphenylketonuria.
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