Fucibet® (fusidic acid and betamethasone valerate) is indicated for the topical treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection caused by Staphylococcus aureus (S. aureus) is confirmed or suspected.

Fucibet® demonstrated efficacy in Eczematous Dermatoses with 2° bacterial infection caused by S. aureus

Results observed after 2 weeks of twice-daily treatment1*:

Visual with arrow shape orange and grey icons pointing down, A36:C37 83% reduction in TSS and 33% reduction with lipid cream

Visual with people outline orange and grey icons showing 8-10 Fucibet patients and 3-10 patients with lipid cream vehicle

Visual with people outline orange and grey icons showing more patients with superior bacteriological response for Fucibet and less patients for lipid cream vehicle

How was the primary endpoint defined?

The primary endpoint for overall clinical response was the percentage reduction/change in TSS from baseline to end of treatment. TSS was calculated based on the severity of erythema, edema, oozing/crusting and excoriation, each assessed at a 4-point scale. In addition, for overall treatment efficacy patients with marked improvement or complete clearance were defined as responders.

Study design

A randomized, double-blind, three-arm, comparative trial of 629 patients with clinically-infected atopic dermatitis. Patients were treated with either twice-daily Fucibet® (n=275), fusidic acid/betamethasone valerate cream (n=264), or lipid cream vehicle (n=90) for two weeks.

See Clinical Trial Cases

Swipe to reveal cases of patients with infected dermatitis at baseline who were treated with Fucibet®
twice-daily for two weeks. Please note these are real patient cases and individual results may vary.

Results observed at Week 2: 37-year-old female patient with infected dermatitis

Close up of the neck of a female with infected dermatitis at week 0Close up of the neck of a female with reduced dermatitis at week 4

Results observed at Week 2: 73-year-old female patient with infected dermatitis

Close up of a leg of a female infected with dermatitis at week 0Close up of a leg of a female infected with dermatitis at week 4

Dosage and Administration1

For both adults and children over 6 years of age, apply a thin layer to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not exceed 2 weeks.

For up to 2 weeks

Close up of Fucibet® tube

Fucibet® is available in 30 g tubes

Safety Profile

Rate of Adverse Events (AEs) observed in a clinical trial of Fucibet®:

Orange and grey box visuals showing 13.5% rate of AEs with Fucibet vs 21.6% with vehicle

Orange and grey box visuals showing 2.6% lesional/peri-lesional AEs with Fucibet vs 13.6% with vehicle

Most common AEs were pruritus and skin burning sensation

A low rate of S. aureus resistance to Fucibet® has been observed (less than 3%)1*

Fusidic acid is predominantly active against Gram-positive bacteria, and highly effective against Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) strains.

In a sensitivity study of 2,302
S. aureus strains isolated over a 6-year period:

Orange icon with arrows showing a bouncing effect on the skin

Orange boxes showing data from a sensitivity study of S. aureus

*Clinical significance has not been established.

Mechanism of Action*

Close up of Fucibet packshot with labels on the left side showing Fucibet's ingredients

Dual inhibition of inflammation + bacterial protein synthesis*

Cycle visual showing the mode of action of betamethasone valerate and fusidic acid

†Betamethasone valerate: The mechanism of anti-inflammatory activity of topical coricosteroids is unclear. It is thought to induce lipocortins, which are postulated to control the biosynthesis of potent mediators of inflammation.

‡Fusidic acid: Interferes with amino acid transfer to ribosomes and primarily active against Gram-positive bacteria, in particular S. aureus including MRSA, Streptococcus spp., C. minutissimum, some Neisseria spp., and certain Clostridium spp.; mainly bacteriostatic but may be bactericidal at higher concentrations.

The penetration of fusidic acid*

Pharmacokinetics: Absorption*
Please note the dermal absorption of fusidic acid and betamethasone is difficult to quantify.

Visual showing Fucibet's penetration in 30 minutes from Epidermis to Subcutaneous Tissue
The degree of penetration depends on factors such as the duration of exposure and the condition of the skin and the site of application.
In vitro studies demonstrated that up to:
  • 2.5% of topically applied fusidic acid could cross intact human skin within 30 minutes
  • Up to 10% of the applied dose could penetrate down into the stratum corneum of the skin, reaching levels well above the minimum inhibitory concentration required for sensitive S. aureus strains*
*Clinical significance has not been established.

Fucibet® Safety Information

Indication and Clinical Use:
Fucibet® (fusidic acid and betamethasone valerate) is indicated for the topical treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection caused by Staphylococcus aureus is confirmed or suspected.

Fucibet® is suitable in cases where treatment with a potent corticosteroid is appropriate to manage the pruritus and inflammation associated with eczematous dermatoses, and is intended for use during flare-ups for short-term (up to 2 weeks) treatment against bacteria susceptible to fusidic acid.

To reduce the development of drug-resistant bacteria, Fucibet® should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.

Safety and efficacy have been established in patients ≥6 years old. Use with caution in pediatric patients.

Contraindications:
● Systemic fungal infections
● Primary skin infections caused by fungi, virus or bacteria
● Skin eruptions associated with tuberculosis or syphilis
● Perioral dermatitis and rosacea
● Eruptions following vaccinations

Relevant warnings and precautions:
● Avoid long-term continuous use
● Risk of systemic absorption
● Should not be used under occlusive dressing, over extensive areas, or on the face, scalp, axillae or scrotum
● Risk of HPA-axis suppression; Cushing’s syndrome, hyperglycemia, and glycosuria
● Susceptibility to infections
● Use with care near eyes
● Risk of bacterial resistance or microbial overgrowth
● Skin atrophy
● Safety during pregnancy or lactation has not been established

For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling LEO Pharma Medical Information at 1-800-263-4218.

© 2020 LEO Pharma Inc. All rights reserved.
® Registered trademark of LEO Pharma A/S used under license
and distributed by LEO Pharma Inc.
www.leo-pharma.ca

Reference:

  1. Current Fucibet® Product Monograph, LEO Pharma Inc.