Denavir (Penciclovir) Adverse Reactions
- dysgeusia
- edema
- erythema
- headache
- hypoesthesia
- maculopapular rash
- paresthesias
- parosmia
- pruritus
- skin discoloration
- skin irritation
- urticaria
Denavir (Penciclovir) Adverse Reactions
In two double-blind, placebo-controlled trials, 1516 patients were treated with penciclovir cream and 1541 with placebo vehicle. The incidence of adverse events was similar for both treatment groups and there were no adverse reactions reported more frequently with penciclovir than with placebo. Headache was the most frequently reported adverse event, which occurred in 5.3% of patients treated with penciclovir and 5.8% of patients treated with placebo. Local adverse reactions were reported by 2.7% of the patients treated with penciclovir and 3.9% of placebo-treated patients. The following local adverse reactions were reported in penciclovir-treated and vehicle only-treated patients, respectively, and thus, it is not clear if these adverse events were due to active drug or to the cream base: skin irritation (1.3% vs 1.8%), hypoesthesia (0.9% vs 1.4%), dysgeusia (0.2% vs 0.3%), pruritus (0% vs 0.3%), pain (0% vs 0.1%), maculopapular rash (0.1% vs 0.1%) and allergic reaction (0% vs 0.1%). In two studies which evaluated the dermal tolerance of 5% penciclovir cream (not currently available in the US) using occluded patch testing methodology, penciclovir cream induced mild erythema in about 50% of subjects. The irritancy profile was similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.
Systemic drug exposure following topical administration of penciclovir is negligible (i.e., below the limit of assay detection). However, to compare data from carcinogenicity studies, an assumption of 100% absorption of penciclovir from the topically applied product was used. In two-year carcinogenicity studies with famciclovir (the oral prodrug of penciclovir), an increase in the incidence of mammary adenocarcinoma (a common tumor in female rats of the strain used) was seen in female rats receiving 600 mg/kg/day (about 395 times the maximum theoretical human exposure to penciclovir). No increase in tumor incidence was seen among male rats treated with famciclovir doses up to 240 mg/kg/day (approximately 190 times the maximum theoretical human AUC for penciclovir).
Testicular toxicity was observed in multiple animal species following repeated IV administration of penciclovir at doses of at least 1155 times the maximum theoretical human AUC. No adverse testicular or reproductive effects were observed in rats or dogs when lower IV dosages were used (up to 845 times the maximum theoretical human dose). In controlled clinical trials of famciclovir (the oral prodrug of penciclovir), there was no evidence of clinically significant effects on sperm count, motility, or morphology.
Adverse events reported with post-marketing use of penciclovir in adults include: headache, oral/pharyngeal edema, parosmia, application site reactions, aggravated condition, decreased therapeutic response, erythematous rash, pain, paresthesias, pruritus, skin discoloration and urticaria.
[ Last revised: 10/29/2003 4:06:00 PM ]
Related entries
Monthly Archives
Syndicate
Allergies
