Discover the power of Sapropterin
We are here to provide you with valuable information on our effective treatment option for patients with Hyperphenylalaninaemia (HPA) in patients with Phenylketonuria (PKU). Our mission is to improve the lives of those affected by this condition and help them lead healthier, happier lives. Feel free to explore our site and learn more about the benefits of Sapropterin dihydrochloride.
Extremely high purity of the active substance
sapropterin dihydrochloride made by Dipharma S.A.¹
Sapropterin LogixX is available in
100 mg and 500 mg powder for oral solution sachets,
and 100 mg soluble tablets.
Active substances:
One soluble tablet contains 100 mg of sapropterin dihydrochloride (corresponding to 77 mg of sapropterin).
Each sachet of “100 mg” powder contains 100 mg of sapropterin dihydrochloride (corresponding to 77 mg sapropterin).
Each sachet of “500 mg” powder contains 500 mg of sapropterin dihydrochloride (corresponding to 384 mg of sapropterin).
Areas of application:
Sapropterin is a synthetic formulation of an endogenous substance called tetrahydrobiopterin (BH4). The body needs BH4 to be able to use an amino acid called phenylalanine to then produce another amino acid called tyrosine.
Sapropterin LogixX is used to treat phenylalaninemia (HPA) or phenylketonuria (PKU) in adults and children. HPA and PKU lead to abnormally high levels of phenylalanine in the blood, which can be harmful.
Sapropterin LogixX lowers these levels in some BH4-responsive patients, and it can increase the amount of phenylalanine that can be obtained from food. Sapropterin LogixX is also used to treat a congenital condition called BH4 deficiency in which the body is unable to produce enough BH4.
Due to very low BH4 levels, phenylalanine cannot be properly utilised and its concentration increases, resulting in harmful effects. By replacing BH4, which the body cannot produce, Sapropterin LogixX reduces the harmful excess of phenylalanine in the blood and increases tolerance to dietary phenylalanine.
Dosage:
PKU - The usual starting dose in adults and children with PKU is 10 mg/kg body weight/day once a day, preferably at the same time each day and in the morning with food.
BH4 deficiency - The usual starting dose in adults and children with BH4 deficiency is 2 to 5 mg/kg body weight/day. The daily dose is divided into 2 or 3 doses throughout the day.
Sapropterin LogixX should be taken with food to increase absorption.
Contraindications:
Sapropterin LogixX must not be used in the event of hypersensitivity (allergy) to the active substance sapropterin or any of the excipients contained in Sapropterin LogixX.
Interactions:
Caution is recommended in the event of the concomitant use of methotrexate, trimethoprim, vasodilators, products for the treatment of male impotence (e.g. sildenafil, tadalafil, vardenafil), minoxidil or levodopa:
Side effects:
very common: Headaches and runny nose (rhinorrhoea).
Common: Hyperphenylalaninemia, laryngopharyngeal pain, nasal congestion, cough, diarrhoea, vomiting, abdominal pain, dyspepsia, nausea.
Occasional: Gastritis, oesophagitis and oesophageal pain.
For further information, see the SmPC by clicking on the link to the eMC
Sapropterin Dihydrochloride 100 mg soluble tablets
Sapropterin Dihydrochloride 100 mg powder for oral solution
Sapropterin Dihydrochloride 500 mg powder for oral solution
Marketing Authorisation Holder : LogixX Pharma Limited, Merlin House, Reading, RG7 4AB
Reporting of side effects - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the Package Leaflet. Side effects can be reported to LogixX Pharma Limited using the Contact Us Form or email mi@logixxpharma.com or also directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.