CIDOFOVIR PACKAGE INSERT PDF
Suspension of maintenance treatment with cidofovir should be considered in accordance with local .. See the package leaflet for further information. 4. What you need to know before you use Cidofovir Cidofovir must be administered by a healthcare professional . Package leaflet: Information for the user. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Vistide (cidofovir).
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Copyright American Medical Association. Two children with human immunodeficiency virus 1 HIV-1 presented to the dermatology clinic for treatment of disseminated molluscum contagiosum MC.
Both children suffered from severe social isolation because of their facial disfigurement. Their MC lesions were refractory to numerous therapeutic modalities, including liquid nitrogen, cantharidin, and 0. Both patients exhibited hundreds of umbilicated pearly and skin-colored papules disseminated over the entire body, including the face and perineal area Nisert 1A and C. Eighteen months after cessation of therapy, the lesions had healed with postinflammatory hyperpigmentation and superficial scars B and D.
Our goal was to develop a minimally scarring, effective nonsurgical method of treating recalcitrant and disfiguring MC in patients with severe immunosuppression and high HIV-1 levels despite HAART. Nonfacial lesions were treated similarly, but they were also occluded with adhesive tape Scotch 3M for at least 12 hours. All lesions were treated except those near ibsert edge of the upper and lower eyelids, because the patients refused treatment of this area and to avoid irritation of the conjunctiva.
Both patients exhibited redness and painful erosions at the sites of previous lesions 5 to 15 days after the initial application of the drug.
Most redness and erosion resolved during the 2-day restperiod. The surrounding perilesional skin appeared to be unaffected by treatment.
The lesions healed with superficial scars, postinflammatory hypopigmentation, and hyperpigmentation. Large lesions healed with varioliform scars Figure 1B and D. No systemic adverse effects were noted.
During therapy, neither patient developed neutropenia, and their serum urea nitrogen and creatinine levels were within the normal range. After 2 months of treatment, all the lesions that were treated showed complete clinical resolution.
There was no evidence of recurrence at the 3- 6- and month follow-up visits. There was no statistical difference between the absolute CD4 T-cell counts and viral loads before and at 18 months after cessation of therapy. Also, patient 1 remained clear of MC lesions at 21 months after cessation of therapy. At the end of the study, both patients showed significant improvement in their self-image and resumed their social activities. Molloscum contagiosum commonly affects children and immunocompromised individuals.
Children with acquired immunodeficiency syndrome AIDS who exhibit extensive and recalcitrant MC suffer from increased morbidity and disfigurement. Recalcitrant MC in these children represents a therapeutic challenge. Cidofovir therapy has also been reported to induce clearing of MC lesions in 3 adults with AIDS, 2 of whom were receiving the drug intravenously for cytomegalovirus retinitis, and 1 of whom was being treated topically.
Within 2 to 3 weeks, the lesions treated with cidofovir showed acute inflammation followed by resolution. Cidofovir is a nucleotide analog of deoxycytidine monophosphate that has cidofoir antiviral activity against DNA viruses, including cytomegalovirus, 3 herpes simplex virus, 4 human papillomavirus, 56 and MC.
Cidofovir ibsert, cidofovir’s active metabolite, acts as a competitive inhibitor of, and an alternate substrate for, DNA polymerase. In fact, it has been shown that strains of herpes simplex virus that were resistant to acyclovir, ganciclovir, or foscarnet remained sensitive to cidofovir. Packagw animal studies regarding topical administration of cidofovir are available.
Recently, Cundy et al 11 investigated the availability of topical cidofovir on abraded and intact skin of rabbits. The bioavailability of topical cidofovir was 0.
Furthermore, they found that the bioavailability of cidofovir was enhanced in vehicles containing propylene glycol. In this study, we used Dermovan, a vehicle that contains propylene glycol. We believe that the combination of a vehicle such as Dermovan and occlusion enhanced the optimal delivery of the drug. Most likely, occlusion increased the efficacy and absorption of the drug by increasing cidofovjr skin surface area, hydration, and temperature and by maintaining a reservoir of the drug in the stratum corneum.
The inflammation and erosions produced by this formulation may have further increased the absorption. We decided not to occlude facial skin and mucous membranes, because there is increased absorption of topical formulations in these areas. Topical application of cidofovir on intact rabbit skin led to negligible systemic exposure apckage the drug.
The pharmacokinetics of 0. Most nucleoside analogs are relatively specific for HIV, except lamivudine, which also has shown ihsert against hepadnaviruses. It is unlikely that HAART was responsible for the resolution of the MC lesions, since there were no significant differences in absolute CD4 T-cell counts and viral loads before or after treatment with topical cidofovir.
To our knowledge, we report for the first time the use of topical cidofovir for generalized and facial MC in children with AIDS. This cidofovjr method avoids the potential significant renal toxicity associated with systemic therapy. Double-blind control trials of topical cidofovir in Dermovan for MC in HIV-infected children will confirm our preliminary results.
Dermatology Online Journal
Patel, RPh ; et al Maria L. Intravenous cidofovir for peripheral cytomegalovirus retinitis in patients with AIDS: A randomized, double-blind, placebo-controlled trial of cidofovir gel for the treatment of acyclovir-unresponsive mucocutaneous herpes cidofofir virus infection in patients with AIDS. Treatment of anogenital papillomavirus infections with an acyclic nucleoside phosphonate analogue.
N Engl J Med. Effects of lamivudine on replication of hepatitis B virus in HIV-infected men. Sign in to access your subscriptions Sign in to your personal account.
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