tocofersolan: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
tocofersolan: clinical details
Prescribing considerations
- Initiation and supervision should be by a physician experienced in congenital or hereditary chronic cholestasis.
- Bioavailability differs from other vitamin E preparations; do not assume interchangeability.
- Use cautiously in renal impairment, dehydration or underlying liver impairment.
- Consider sodium content for patients following a controlled-sodium diet.
- Parahydroxybenzoate excipients may cause allergic reactions, including delayed reactions.
Contraindications and cautions
- Hypersensitivity to tocofersolan, d-alpha-tocopherol or any excipient.
- Preterm newborn infants.
Monitoring
- Plasma vitamin E, particularly during early treatment and regularly thereafter.
- Renal function in renal impairment or dehydration.
- Liver function in underlying hepatic impairment.
- Prothrombin time and INR with vitamin K antagonists.
- Effects or concentrations of fat-soluble vitamins and highly lipophilic medicines where clinically relevant.
Clinical pharmacology
Tocofersolan is d-alpha-tocopherol polyethylene glycol succinate. It forms micelles that aid absorption of non-polar lipids and is hydrolysed in the gut to active d-alpha-tocopherol. It may inhibit intestinal P-glycoprotein and increase absorption of susceptible substances.
Formulation and product differences
- The product is a pale-yellow oral solution supplied with a measuring syringe.
- Its water-miscible formulation has different bioavailability from other vitamin E products.
- It contains sodium methyl and ethyl parahydroxybenzoates and sodium.
- Compatibility with other medicines has not been established; do not mix them.
tocofersolan preparations and strengths
Oral solution
Route: Oral
Strengths: 50 mg/mL
tocofersolan interactions
Formal interaction studies have not been performed. Important potential interactions include:
Vitamin K antagonists, including warfarin
Vitamin E may increase bleeding tendency. Coagulation testing and anticoagulant review may be required during and after treatment.
Fat-soluble vitamins A, D, E and K
Their intestinal absorption may increase, so clinical or laboratory monitoring may be needed.
Highly lipophilic medicines
Absorption of medicines such as steroids, some antibiotics, antihistamines, ciclosporin and tacrolimus may increase. Monitor effects and concentrations where appropriate.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.