Chemical formula: C₃₅H₅₈O₆ Molecular mass: 574.8 g/mol
Tocofersolan interacts in the following cases:
Tocofersolan should be administered with caution in patients with underlying liver impairment and under close monitoring of the hepatic functions in such patients.
As data on patients with renal impairment are limited, tocofersolan should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients.
Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as steroids, antibiotics, antihistamines, cyclosporine, tacrolimus). Therefore, monitoring should be performed and, when necessary, doses should be adjusted.
As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR). A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary.
For tocofersolan no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development. Caution should be exercised when prescribing to pregnant women.
It is unknown whether tocofersolan is excreted in human breast milk. The excretion of tocofersolan in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with tocofersolan should be made taking into account the benefit of breast-feeding to the child and the benefit of tocofersolan therapy to the woman.
No data is available.
Tocofersolan has no or negligible influence on the ability to drive and use machines.
The most commonly reported adverse reaction during treatment is diarrhoea.
Reported adverse reactions are listed below, by system organ class and by frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System organ class | Adverse reactions |
|---|---|
| Gastrointestinal disorders | Common: diarrhoea Not known: abdominal pain |
| Skin and subcutaneous tissue disorders | Uncommon: alopecia, pruritus, rash |
| General disorders and administration site conditions | Uncommon: asthenia, headache |
| Investigations | Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
