Vedrop (Tocofersolan)
Water-soluble vitamin E for treating vitamin E deficiency in chronic cholestasis
Vedrop (tocofersolan) is a prescription medicine containing a water-soluble form of vitamin E. It is specifically designed to treat vitamin E deficiency caused by impaired fat absorption (malabsorption) in patients from birth (full-term neonates) to 18 years of age who have chronic cholestasis — a condition in which bile cannot flow properly from the liver to the intestine. Because standard vitamin E is fat-soluble and requires bile for absorption, children with cholestasis need this specialized formulation to prevent the neurological damage that vitamin E deficiency can cause.
Quick Facts
Key Takeaways
- Vedrop is a water-soluble form of vitamin E designed for children who cannot absorb standard fat-soluble vitamin E due to chronic cholestasis.
- It is approved for patients from birth (full-term neonates) to 18 years of age and must not be used in premature infants.
- The standard dose is 0.34 ml/kg/day, adjusted by a physician based on blood vitamin E levels.
- Vedrop can increase the absorption of other fat-soluble medications and vitamins, requiring careful monitoring.
- The most common side effect is diarrhea; the bottle must be discarded one month after first opening.
What Is Vedrop and What Is It Used For?
Vedrop is a specialized pharmaceutical preparation that contains vitamin E in the form of tocofersolan (also known as d-alpha-tocopheryl polyethylene glycol 1000 succinate, or TPGS). Unlike conventional vitamin E supplements, which are fat-soluble and depend on bile salts for intestinal absorption, tocofersolan has been chemically modified to be water-soluble. This critical property enables it to form micelles in the gastrointestinal tract and be absorbed even when bile flow is severely impaired or absent.
The primary indication for Vedrop is the treatment of vitamin E deficiency resulting from digestive malabsorption in pediatric patients with chronic cholestasis. Cholestasis refers to any condition in which the flow of bile from the liver to the duodenum is reduced or blocked. This may be caused by inherited conditions such as biliary atresia, Alagille syndrome, progressive familial intrahepatic cholestasis (PFIC), or other congenital liver diseases. Without adequate bile, the intestine cannot properly absorb fat-soluble vitamins (A, D, E, and K), leading to deficiency states that can have serious clinical consequences.
Vitamin E (alpha-tocopherol) is an essential lipid-soluble antioxidant that protects cell membranes from oxidative damage. In children, vitamin E deficiency can lead to progressive and potentially irreversible neurological damage, including peripheral neuropathy, spinocerebellar ataxia (loss of coordination), skeletal myopathy (muscle weakness), and pigmented retinopathy (vision problems). Early and adequate supplementation with a bioavailable form of vitamin E is therefore crucial to prevent these complications.
Vedrop was approved by the European Medicines Agency (EMA) under exceptional circumstances, recognizing that the rarity of chronic cholestasis in children makes it difficult to obtain complete clinical data. The EMA reviews new information about this medicine annually and updates recommendations as needed. It remains a critical therapeutic option for this vulnerable pediatric population, filling an important gap where standard vitamin E supplements fail.
Each milliliter of Vedrop oral solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, equivalent to approximately 74.5 IU of tocopherol. The solution is administered orally, either directly or diluted in water, using the graduated oral syringe provided in the packaging.
What Should You Know Before Taking Vedrop?
Contraindications
Vedrop should not be taken if the patient has a known allergy (hypersensitivity) to vitamin E (d-alpha-tocopherol) or to any of the other ingredients in the formulation. These excipients include potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, and purified water. The preservatives E219 and E215 may cause allergic reactions, which may in some cases be delayed.
Vedrop must not be used in premature (preterm) newborns. The polyethylene glycol component of tocofersolan may pose safety risks to premature infants, whose renal and hepatic systems are still immature. This is an absolute contraindication.
Warnings and Precautions
Before starting Vedrop, patients or caregivers should inform the prescribing physician about any existing medical conditions, particularly kidney problems or liver impairment. Careful monitoring is essential in the following situations:
- Kidney impairment or dehydration: Vedrop should be used with caution, and renal function should be closely monitored. The polyethylene glycol (PEG) component of tocofersolan has been associated with potential nephrotoxicity. Patients who are dehydrated are at increased risk of kidney damage and should be adequately hydrated before and during treatment.
- Liver impairment: Since Vedrop is specifically indicated for patients with cholestatic liver disease, hepatic function should be regularly assessed. The physician will monitor liver enzymes and overall liver function throughout treatment to ensure the medicine is not exacerbating the underlying condition.
Regular blood tests to monitor vitamin E levels, kidney function, liver function, and electrolytes (particularly sodium and potassium) are recommended during treatment. The physician will use these results to adjust the dose as needed and to detect any adverse effects early.
Pregnancy and Breastfeeding
Although Vedrop is indicated for pediatric patients, it is important to note the limited data regarding its use during pregnancy and breastfeeding. No clinical data are available on exposure to tocofersolan during pregnancy. It is not known whether tocofersolan or its metabolites are excreted in human breast milk. Women who are pregnant, breastfeeding, think they may be pregnant, or are planning to become pregnant should consult their physician before using this medicine.
Driving and Operating Machinery
Vedrop is unlikely to affect the ability to drive or use machines. No studies on this effect have been performed, but given the pharmacological profile of the active substance, no impairment is expected.
Vedrop contains 0.18 mmol (4.1 mg) of sodium per ml. Patients on a controlled sodium diet should discuss this with their physician, especially at higher doses where sodium intake from the medicine may become clinically relevant.
How Does Vedrop Interact with Other Drugs?
Tocofersolan, as a water-soluble vitamin E derivative that forms micelles, has the unique property of enhancing the gastrointestinal absorption of other lipophilic (fat-soluble) substances. This surfactant-like behavior means that when Vedrop is co-administered with certain medications, their bioavailability may be significantly increased. This can lead to higher-than-expected blood levels and potentially enhanced therapeutic or adverse effects. It is therefore essential that the prescribing physician is informed of all medications the patient is taking, including over-the-counter products.
Major Interactions
The most clinically significant interaction is with oral anticoagulants, particularly warfarin and similar vitamin K antagonists. Vitamin E is known to have mild anticoagulant properties of its own, and at pharmacological doses it can potentiate the effect of these blood-thinning medications. This increases the risk of bleeding events. Patients receiving both Vedrop and oral anticoagulants require regular monitoring of their international normalized ratio (INR) and prothrombin time, with anticoagulant dose adjustments as needed.
Absorption Enhancement
Because tocofersolan acts as a solubilizing agent in the gut, it can enhance the absorption of other fat-soluble vitamins (A, D, E, K) and highly lipophilic medications. The following drug classes are particularly affected:
| Interacting Drug/Class | Type of Interaction | Clinical Significance | Recommended Action |
|---|---|---|---|
| Warfarin / Oral anticoagulants | Enhanced anticoagulant effect | High — increased bleeding risk | Regular INR monitoring; dose adjustment |
| Fat-soluble vitamins (A, D, E, K) | Increased absorption | Moderate — risk of hypervitaminosis | Monitor vitamin levels; adjust doses |
| Ciclosporin | Increased bioavailability | High — narrow therapeutic index | Therapeutic drug monitoring |
| Tacrolimus | Increased bioavailability | High — narrow therapeutic index | Therapeutic drug monitoring |
| Corticosteroids | Increased absorption | Moderate | Monitor for corticosteroid side effects |
| Antihistamines (lipophilic) | Increased absorption | Low to moderate | Monitor for enhanced sedation |
The physician should monitor the treatment effect of all co-administered lipophilic medications and adjust doses as necessary. This is particularly important for drugs with narrow therapeutic indices, where small increases in blood levels can lead to toxicity. Patients or caregivers should always inform every healthcare provider about all medications currently being used, including vitamin supplements.
What Is the Correct Dosage of Vedrop?
Vedrop should always be taken exactly as prescribed by the physician. The dosing is weight-based and individualized according to the patient's vitamin E blood levels. Treatment should be initiated and supervised by a physician experienced in managing chronic cholestasis and fat-soluble vitamin deficiencies in children.
Children (Birth to 18 Years)
Standard Dosing
The recommended starting dose is 0.34 ml/kg/day of the oral solution (equivalent to 17 mg d-alpha-tocopherol/kg/day). The physician will prescribe the exact dose in milliliters based on the patient's body weight. Regular blood tests to measure serum vitamin E (alpha-tocopherol) levels will be performed, and the dose will be adjusted accordingly to achieve and maintain adequate vitamin E status.
| Body Weight | Daily Dose (ml) | Vitamin E (mg/day) | Syringe Size |
|---|---|---|---|
| 3 kg (neonate) | 1.0 ml | 51 mg | 1 ml syringe |
| 5 kg | 1.7 ml | 85 mg | 2 ml syringe |
| 10 kg | 3.4 ml | 170 mg | 2 ml syringe |
| 20 kg | 6.8 ml | 340 mg | 2 ml syringe |
| 30 kg | 10.2 ml | 510 mg | 2 ml syringe |
How to Administer
Vedrop oral solution should be swallowed using the oral dosing syringe provided in the package. It can be taken before or after meals, with or without water. The steps for measuring and administering the dose are as follows:
- Open the bottle by pressing down and twisting the child-resistant cap.
- Insert the oral syringe (provided in the pack) into the bottle opening.
- Draw up the solution by pulling the plunger to the graduation mark corresponding to the prescribed dose in milliliters (ml).
- Remove the syringe from the bottle.
- Administer the dose by pressing the plunger to empty the contents either directly into the mouth or into a glass of water (then drink the entire contents of the glass).
- Close the bottle securely after use.
- Wash the syringe thoroughly with water after each use.
A 1 ml oral syringe is provided with the 10 ml and 20 ml bottles, and a 2 ml syringe with the 60 ml bottle. For doses larger than the syringe capacity, multiple syringe-loads will be needed.
Missed Dose
If a dose is missed, skip the missed dose and return to the normal dosing schedule. Do not take a double dose to compensate for a forgotten one. Consistent daily dosing is important for maintaining adequate vitamin E levels, but a single missed dose is unlikely to have immediate clinical consequences. If doses are frequently missed, consult the prescribing physician.
Overdose
Taking large doses of vitamin E may cause transient diarrhea and abdominal pain. If symptoms persist for more than two days, contact a physician or pharmacist. There is no specific antidote; treatment is supportive and symptomatic. In cases of significant overdose, seek immediate medical advice.
Stopping Treatment
Do not discontinue Vedrop without consulting the prescribing physician. Vitamin E deficiency may recur if treatment is stopped, potentially leading to progressive neurological damage. If discontinuation is being considered (for example, after successful liver transplantation or resolution of cholestasis), the physician will guide a gradual transition to standard vitamin E supplements while monitoring serum levels.
What Are the Side Effects of Vedrop?
Like all medicines, Vedrop can cause side effects, although not everybody gets them. The side effects reported with Vedrop are generally mild to moderate in severity and are often related to the gastrointestinal system. The polyethylene glycol component of tocofersolan can have osmotic effects in the gut, which may contribute to gastrointestinal symptoms.
It is important to report any suspected side effects to a healthcare professional. Post-marketing surveillance helps to continuously monitor the benefit-risk balance of the medicine, which is particularly important for products approved under exceptional circumstances like Vedrop.
Common Side Effects
May affect up to 1 in 10 patients
- Diarrhea
Uncommon Side Effects
May affect up to 1 in 100 patients
- Asthenia (feeling of weakness or fatigue)
- Headache
- Alopecia (hair loss)
- Pruritus (itching)
- Skin rash
- Abnormal blood sodium levels (hyponatremia or hypernatremia)
- Abnormal blood potassium levels (hypokalemia or hyperkalemia)
- Elevated transaminases (liver enzymes ALT and AST)
Frequency Not Known
Cannot be estimated from available data
- Abdominal pain (stomach ache)
Patients with pre-existing kidney impairment should be particularly monitored, as the polyethylene glycol component may affect renal function. Electrolyte disturbances (sodium and potassium abnormalities) may also be related to this mechanism. Elevated liver enzymes should be interpreted in the context of the underlying cholestatic disease, as these patients typically already have abnormal hepatic parameters.
The preservatives sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) may cause allergic reactions, which may in some cases be delayed. If an allergic reaction occurs (such as skin rash, itching, swelling, or difficulty breathing), discontinue the medicine and seek medical attention promptly.
If any of these side effects become severe, or if you notice any effects not listed here, contact a physician or pharmacist. Reporting side effects helps regulatory authorities monitor the safety profile of the medicine and update prescribing information when necessary.
How Should You Store Vedrop?
Vedrop does not require any special storage conditions, meaning it can be stored at room temperature. However, proper storage and handling practices are essential to maintain the quality and safety of the medicine:
- Keep out of sight and reach of children. The child-resistant cap provides additional protection, but the bottle should be stored in a safe location.
- Check the expiry date printed on the carton and bottle (after "EXP"). The expiry date refers to the last day of the stated month. Do not use the medicine after this date.
- Discard after one month: Once the bottle has been opened for the first time, it must be used within one month. After one month, discard the bottle and any remaining solution, even if the medicine appears unchanged. This is because the preservative system may not maintain sterility indefinitely after the seal is broken.
- Proper disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired medicines to a pharmacy for safe disposal. This helps protect the environment from pharmaceutical contamination.
Vedrop oral solution is a slightly viscous, pale yellow liquid supplied in an amber glass bottle with a child-resistant screw cap. The brown glass protects the solution from light degradation. Available bottle sizes are 10 ml, 20 ml, and 60 ml. Each carton contains one bottle and one oral syringe for accurate dose measurement.
What Does Vedrop Contain?
Active Ingredient
The active substance is tocofersolan. Each milliliter of Vedrop oral solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, which corresponds to approximately 74.5 IU (International Units) of tocopherol. Tocofersolan is the International Nonproprietary Name (INN) for d-alpha-tocopheryl polyethylene glycol 1000 succinate (also abbreviated as vitamin E TPGS). It is a water-soluble derivative created by esterifying d-alpha-tocopherol succinate with polyethylene glycol 1000, resulting in an amphiphilic molecule that can self-assemble into micelles in aqueous solution.
Inactive Ingredients (Excipients)
The other ingredients in Vedrop are:
- Potassium sorbate — a preservative that prevents microbial growth.
- Sodium methyl parahydroxybenzoate (E219) — a preservative (paraben). May cause allergic reactions, sometimes delayed.
- Sodium ethyl parahydroxybenzoate (E215) — a preservative (paraben). May cause allergic reactions, sometimes delayed.
- Glycerol — used as a humectant and solvent to maintain solution stability.
- Disodium phosphate dodecahydrate — a buffering agent to maintain optimal pH.
- Concentrated hydrochloric acid — used for pH adjustment during manufacturing.
- Purified water — the vehicle for the oral solution.
Patients with known sensitivity to parabens should discuss this with their physician before starting treatment. The sodium content (0.18 mmol or 4.1 mg per ml) should also be considered in patients on sodium-restricted diets, particularly those receiving higher doses based on their body weight.
Frequently Asked Questions About Vedrop
Vedrop is used to treat vitamin E deficiency caused by malabsorption due to chronic cholestasis in children from birth (full-term neonates) to 18 years of age. Cholestasis is a condition in which bile cannot flow properly from the liver to the intestine, preventing the normal absorption of fat-soluble vitamins including vitamin E. Without treatment, vitamin E deficiency can lead to progressive neurological damage.
Standard vitamin E is fat-soluble and requires bile salts for absorption in the intestine. Children with chronic cholestasis have impaired bile flow, making them unable to absorb regular vitamin E. Vedrop contains tocofersolan, a chemically modified water-soluble form of vitamin E that can be absorbed without bile salts. This makes it the only effective oral vitamin E supplement for these patients.
No. Vedrop must not be used in premature (preterm) newborns. It is approved only for full-term neonates and older children up to 18 years. The polyethylene glycol component poses potential safety risks to premature infants whose organ systems, particularly kidneys and liver, are not yet fully developed. If a premature infant requires vitamin E supplementation, alternative routes or formulations should be discussed with a neonatologist.
Once opened, a bottle of Vedrop must be used within one month. After one month, the bottle and any remaining solution should be discarded, even if it appears unchanged. This precaution ensures the sterility and potency of the medicine. Write the date of first opening on the bottle label to help track this. Unopened bottles can be kept until the expiry date printed on the packaging.
Yes, Vedrop can interact with oral anticoagulants such as warfarin. Vitamin E has mild blood-thinning properties and can enhance the effect of anticoagulant medications, increasing the risk of bleeding. If your child is taking any blood-thinning medications, the physician will perform regular blood tests (INR/prothrombin time) and may need to adjust the anticoagulant dose. Always inform your healthcare team about all medications being taken.
Vedrop can be taken directly by mouth using the provided oral syringe, or the dose can be emptied into a glass of water and then consumed. It can be taken before or after meals. The solution should not be mixed with other liquids or foods beyond water, as this has not been studied and may affect the stability or absorption of the medicine. Always use the oral syringe provided in the package to ensure accurate dosing.
References
- European Medicines Agency (EMA). Vedrop — Summary of Product Characteristics. Last updated November 2024. Available at: EMA EPAR — Vedrop.
- Thebaut A, Nemeth A, Le Garrec J, et al. Oral Tocofersolan Corrects or Prevents Vitamin E Deficiency in Children With Chronic Cholestasis. Journal of Pediatric Gastroenterology and Nutrition. 2016;63(6):610–615. doi:10.1097/MPG.0000000000001264.
- Sokol RJ. Fat-Soluble Vitamins and Their Importance in Patients With Cholestatic Liver Diseases. Gastroenterology Clinics of North America. 1994;23(3):673–705.
- European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Guidelines on Management of Cholestatic Liver Disease in Children. JPGN. 2021.
- World Health Organization (WHO). WHO Model List of Essential Medicines for Children. 9th List, 2023. Available at: WHO Essential Medicines for Children.
- Brigelius-Flohé R, Traber MG. Vitamin E: Function and Metabolism. FASEB Journal. 1999;13(10):1145–1155.
- Sokol RJ, Butler-Simon N, Conner C, et al. Multicenter Trial of d-Alpha-Tocopheryl Polyethylene Glycol 1000 Succinate for Treatment of Vitamin E Deficiency in Children with Chronic Cholestasis. Gastroenterology. 1993;104(6):1727–1735.
- British National Formulary for Children (BNFC). Tocofersolan Monograph. National Institute for Health and Care Excellence (NICE). Updated 2024.
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specializing in pediatric gastroenterology, hepatology, and clinical pharmacology. Our content follows international evidence-based guidelines from the European Medicines Agency (EMA), the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the World Health Organization (WHO).
All information is derived from the EMA-approved Summary of Product Characteristics, peer-reviewed clinical studies, and international guidelines. Evidence level: Grade 1A where available.
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