Tocofersolan 50mg/ml oral solution sugar free
Requires a prescription from a doctor or prescriber
D-Alpha-tocopheryl polyethylene glycol 1000 succinate (Tocofersolan, Vedrop), has been developed in Europe as an orally bioavailable source of vitamin E in children suffering from cholestasis [L2371].
Safety information for pregnancy and breastfeeding
Pregnancy
There is no current data on taking tocofersolan during pregnancy.
Breastfeeding
It is unknown whether tocofersolan is released into human breast milk.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Browse all Drug Analysis Profiles A–Z
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Tocofersolan
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Tocofersolan on the MHRA register
Vedrop 50mg/ml oral solution
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
200 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Tocofersolan
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
29.7 h
Mechanism
Vitamin E is a major lipo-soluble antioxidant in humans.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
6.0 h
[L2371]
Due…
Half-life
29.7 h
Protein binding
[L2371]
Volume of distribution
Metabolism
Elimination
75%
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Tocofersolan is a polyethylene glycol derivative of α-tocopherol and synthetic water-soluble version of DB11251. Tocofersolan is an oral treatment of vitamin E deficiency due to digestive malabsorption in pediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis. It was approved by the European Medicines Agency (EMA) in June 2009 under the market name Vedrop. Moreover, the agent is capable of demonstrating antioxidant effects that make it a popular component to include in cosmetics and pharmaceuticals as well.
In addition to the above, tocofersolan has been studied as a promising application as an absorption enhancer in drug delivery MSDS.
[L2371]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 109 interactions
Common adverse reactions
The most commonly reported adverse reaction during treatment is diarrhea .
[L2371]
High doses of Vitamin E may cause diarrhea, abdominal pain, and other gastrointestinal conditions. In the case of an overdose, symptomatic treatment should be provided .
[L2371]
High doses of vitamin E have been reported to increase bleeding tendency in patients with Vitamin K deficiency, or patients taking oral anti-vitamins K treatment .
[L2371]
Therefore, careful monitoring of the prothrombin time and international normalized ratio (INR) are advised. A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary .
[L2371]
Renal impairment
Data regarding patients with renal impairment are limited, this drug should be administered with caution and those with renal impairment or dehydration should be closely followed .
[L2371]
Hepatic impairment
This drug should be administered with caution in patients with liver impairment and under close monitoring of the liver function tests in such patients .
[L2371]
Hypersensitivity
Vedrop, the commercial form, contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions, which are sometimes delayed .
[L2371]
Pregnancy
There is no current data on taking tocofersolan during pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ fetal development, parturition or postnatal development. Caution should be taken when prescribing this medication to pregnant women .
[L2371]
Breast-feeding
It is unknown whether tocofersolan is released into human breast milk. The excretion of tocofersolan in milk has not been studied in animals .
[L2371]
Fertility
No data is available .
[L2371]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L2371]
Due to its amphipathic property in which it forms its own micelles, tocofersolan is readily taken up into enterocytes, even in the absence of bile salts; fat-soluble d-alpha-tocopherol is then released after hydrolysis. This formulation enhances the absorption of d-alpha-tocopherol compared to the administration of free d-alpha-tocopherol. Additionally, tocophersolan may enhance the absorption of water-insoluble agents and other fat-soluble vitamins .
[L2376]
Tocofersolan is a pro-drug; the active metabolite is the d-alpha-tocopherol.
At low concentrations, tocofersolan forms micelles which improve the absorption of non-polar lipids such as other fat-soluble vitamins. Its required micellar concentration is low (0.04 to 0.06 mmol/l) .
[L2371]
A pharmacokinetic study of 12 healthy subjects compared tocofersolan with a water-miscible reference vitamin E after one single oral loading dose of 1200 IU (international units). The relative bioavailability of tocofersolan was found to be (Frel of 1.01 ± 1.74) with AUC0-t of 0.383 ± 0.203μM.h/mg, Cmax of 0.013 ± 0.006, Tmax of 6.0 h (6.0 – 24.0) .
[L2371]
For more information about Vitamin E metabolism, please visit the drug entry DB11251.
[L2371]
[L2371]
Absorption of deuterated tocofersolan demonstrated a normal pattern in lipoproteins: alpha-tocopherol peaked first in chylomicrons, then peaked in very low- density lipoproteins (VLDL) and finally in low-density lipoproteins (LDL) and high-density lipoproteins (HDL).
[L2371]
[L2371]
Proteins and enzymes this drug interacts with in the body
PMID:2897240 PMID:35970996 PMID:8898203 PMID:9038218 PMID:35507548
Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins .
PMID:8898203
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells PMID:2897240 PMID:35970996 PMID:9038218
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:7887897
Binds both phosphatidylinositol 3,4-bisphosphate and phosphatidylinositol 4,5-bisphosphate; the resulting conformation change is important for the release of the bound alpha-tocopherol (By similarity)
PMID:12016218 PMID:12519372 PMID:21226579
Receptor for HDL, mediating selective uptake of cholesteryl ether and HDL-dependent cholesterol efflux .
PMID:26965621
Also facilitates the flux of free and esterified cholesterol between the cell surface and apoB-containing lipoproteins and modified lipoproteins, although less efficiently than HDL. May be involved in the phagocytosis of apoptotic cells, via its phosphatidylserine binding activity PMID:12016218
PMID:22095670
Critical for the uptake of cholesterol across the plasma membrane of the intestinal enterocyte .
PMID:22095670
Involved in plant sterol absorption, it transports sitosterol, although at lower rates than cholesterol (By similarity). Is the direct molecular target of ezetimibe, a drug that inhibits cholesterol absorption and is approved for the treatment of hypercholesterolemia .
PMID:15928087
May have a function in the transport of multiple lipids and their homeostasis, thereby influencing lipid metabolism regulation .
PMID:15671032
May be involved in caveolin trafficking from the plasma membrane (By similarity). In addition, acts as a negative regulator of NPC2 and down-regulates its expression and secretion by inhibiting its maturation and accelerating its degradation PMID:22095670
PMID:27144356
Plays an essential role in the selective transport of dietary plant sterols and cholesterol in and out of the enterocytes and in the selective sterol excretion by the liver into bile .
PMID:11099417 PMID:11138003 PMID:15054092 PMID:27144356
Required for normal sterol homeostasis .
PMID:11099417 PMID:11138003 PMID:15054092
The heterodimer with ABCG8 has ATPase activity PMID:16893193 PMID:20210363 PMID:27144356
PMID:11099417 PMID:11452359 PMID:15054092 PMID:27144356
Required for normal sterol homeostasis .
PMID:11099417 PMID:11452359 PMID:15054092
The heterodimer with ABCG5 has ATPase activity PMID:16893193 PMID:20210363 PMID:27144356
PMID:24097981 PMID:35974019
Thereby, participates in phospholipid transfer to apolipoproteins to form nascent high density lipoproteins/HDLs .
PMID:14754908
Transports preferentially phosphatidylcholine over phosphatidylserine .
PMID:24097981
May play a similar role in the efflux of intracellular cholesterol to apolipoproteins and the formation of nascent high density lipoproteins/HDLs .
PMID:10533863 PMID:14754908 PMID:24097981 PMID:35974019
Translocates phospholipids from the outer face of the plasma membrane and forces it through its gateway and annulus into an elongated hydrophobic tunnel in its extracellular domain PMID:35974019
Also binds with a weaker affinity to other tocopherols and to tocotrienols. May have a transcriptional activatory activity via its association with alpha-tocopherol. Probably recognizes and binds some squalene structure, suggesting that it may regulate cholesterol biosynthesis by increasing the transfer of squalene to a metabolic active pool in the cell
Could also be involved in foam cell formation with elevated TRL and remnant lipoprotein (RLP). Mediates the rapid high-affinity uptake of chylomicrons (CM), HTG-VLDL, and trypsinized (tryp) VLDL devoid of APOE in vitro in macrophages
ATC A11HA08
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Tocofersolan
Additional database identifiers
Drugs Product Database (DPD)
72
HUGO Gene Nomenclature Committee (HGNC)
HGNC:40
GenAtlas
ABCB1
GeneCards
ABCB1
GenBank Gene Database
M14758
GenBank Protein Database
307180
Guide to Pharmacology
768
UniProt Accession
MDR1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2645
GeneCards
CYP4F2
Guide to Pharmacology
1344
UniProt Accession
CP4F2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12404
GenAtlas
TTPA
GeneCards
TTPA
GenBank Gene Database
D49488
GenBank Protein Database
699601
UniProt Accession
TTPA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1664
GenAtlas
SCARB1
GeneCards
SCARB1
GenBank Gene Database
Z22555
GenBank Protein Database
397607
UniProt Accession
SCRB1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7898
GenAtlas
NPC1L1
GeneCards
NPC1L1
GenBank Gene Database
AF192522
GenBank Protein Database
6643036
Guide to Pharmacology
2629
UniProt Accession
NPCL1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:13886
GeneCards
ABCG5
UniProt Accession
ABCG5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:13887
GeneCards
ABCG8
UniProt Accession
ABCG8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:29
GenAtlas
ABCA1
GeneCards
ABCA1
GenBank Gene Database
AF275948
GenBank Protein Database
9247086
UniProt Accession
ABCA1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:20627
GenAtlas
SEC14L4
GeneCards
SEC14L4
GenBank Gene Database
AY158085
GenBank Protein Database
27803380
UniProt Accession
S14L4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:10699
GenAtlas
SEC14L2
GeneCards
SEC14L2
GenBank Gene Database
AL096881
GenBank Protein Database
5596693
UniProt Accession
S14L2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:18655
GenAtlas
SEC14L3
GeneCards
SEC14L3
GenBank Gene Database
AY158086
GenBank Protein Database
27803382
UniProt Accession
S14L3_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:24087
GeneCards
APOBR
UniProt Accession
APOBR_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: