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Tolerability and Safety

 

ACTIKERALL has a good tolerability profile and is well accepted by patients1,3-6,8

ACTIKERALL showed a good tolerability profile in both settings, lesion (up to 10 simultaneously) and field3-6#
During treatment, mild to moderate irritation and inflammation at the application site can occur and is expected1

Efficacy table 5 -png

#< 25cm2
ACTIKERALL showed high levels of patient satisfaction5,6  
     
  94.7% (n=161/170) treated with ACTIKERALL in the lesion-directed study would recommend the treatment6
  Treatment discontinuation rates due to treatment-emergent adverse effects were low (1.9%) in the field-directed study5#
 
#<25cm2
*AEs were more common in patients receivingACTIKERALL(95.2%) compared to diclofenac HA◊– diclofenac 3% in hyaluronic acid (76.8%) or vehicle (84.7%). Most AEs for 5-FU/SA patients were mild-to-moderate application-site reactions (92%), with irritation and inflammation the most common. Treatment was well tolerated; only seven patients (3.7%) discontinued treatment due to AEs in the 5-FU/SA group versus nine patients (4.9%) receiving diclofenac Hyaluronic Acid (HA).4
◊Diclofenac 3% in hyaluronic acid.

Safety

Drug-related treatment-emergent adverse events occurring at a frequency ≥ 1% were mainly comprised of application site disorders and skin disorders1(see Table)

System organ class Frequency Adverse reaction
General disorders and administration site conditions Very common  At application site: erythema, inflammation, irritation (including burning), pain, pruritus
Common At application site: bleeding, erosion, scab
Uncommon At application site: oedema, ulcer, dermatitis
Skin and subcutaneous tissue disorder Common Skin exfoliation
Nervous system disorders  Common Headache
Eye disorders Uncommon Dry eye, eye pruritus, increased lacrimation

 

  Application site reactions mostly mild to moderate1,5
  ACTIKERALL was rated by physicians to have very good/good tolerability in 77.2% of patients at 8 weeks after the end of treatment6

 
PBS
Please review the Product Information before prescribing.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at   www.tga.gov.au/reporting-problems.
WARNING - Actikerall® should only be used on a total area no greater than 25 cm2 at a time. Use should be limited to certain body sites and skin types. See PI section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
AK = Actinic Keratosis, DMSO = Dimethyl Sulfoxide, RCM = Reflectance Confocal Microscopy, TSQM = Treatment Satisfaction Questionnaire for Medication, AEs = Adverse Events.
 
References
1. ACTIKERALL Product Information. 2. Rajkumar JR, et al. INDIVIDUAL ARTICLE: Safety and Tolerability of Topical Agents for Actinic Keratosis: A Systematic Review of Phase 3 Clinical Trials. J Drugs Dermatol. 2021;20;10(Suppl):s4-14. 3. Simon JC, et al. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015;29(5):881-9. 4. Stockfleth E, et al. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol. 2011;165(5):1101-8. 5. Stockfleth E, et al. Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-directed Treatment of Actinic Keratosis: a Phase III, Randomized, Double-blind, Vehicle-controlled Trial. Dermatol Ther (Heidelb). 2017;7(1):81-96. 6. Stockfleth E, et al. Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. Eur J Dermatol. 2012;22(3):370-374. 7. Martínez N, et al. Alternative lacquer removal techniques to remove 0.5% 5-fluorouracil/10% salicylic acid topical solutions for actinic keratosis. Presented at 14th EADO Congress; 6-9 November; Barcelona, Spain. 2018. 8. Szeimies RM, et al. Efficacy of low-dose 5-fluorouracil/salicylic acid in actinic keratoses in relation to treatment duration. J Dtsch Dermatol Ges. 2015;13(5):430-8. 9. Ulrich M, et al. Use of reflectance confocal microscopy to evaluate 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of subclinical lesions of actinic keratosis: subanalysis of a Phase III, randomized, double-blind, vehicle-controlled trial. J Eur Acad Dermatol Venereol. 2018;32(3):390-396. 10. Garofalo V, et al. Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: an observational study. J Dermatolog Treat. 2022;33(5):2664-2669.