CIDOFOVIR PACKAGE INSERT PDF

CIDOFOVIR PACKAGE INSERT PDF

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August 7, 2020

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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It is currently available only for intravenous infusion.

Cidofovir – Wikipedia

Several small studies and case reports describe the successful use of cidofovir applied either topically or by intralesional injection in several virally induced cutaneous diseases.

Available information demonstrates that cidofovir is a potent antiviral agent with activity against several DNA viruses that cause cutaneous disease when applied topically or administered by intralesional injection. No significant systemic side effects have been noted, although application site reactions are common and can occasionally be severe. The effective use of topical and intralesional cidofovir for the treatment of diseases of the skin caused by DNA viruses has been demonstrated in animals and a limited number of patients including those infected with human immunodeficiency virus HIV.

This article reviews the pharmacology of cidofovir and the utility of topical and intralesional cidofovir for the treatment of viral infections caused by human papillomavirus, herpesviruses including acyclovir resistant strainsKaposi’s sarcoma-associated herpesvirus, molluscum contagiosum and monkeypox.

Cidofovir is a nucleoside analog of deoxycytidine monophosphate figure 1 that has antiviral activity against a broad range of DNA viruses. Upon incorporation into the host cell, cidofovir CDV undergoes 2 stages of phosphorylation, via monophosphate kinase and pyruvate kinase, respectively, to form an active metabolite, cidofovir diphosphate CDVpp figure 2.

Cidofovir | DermNet NZ

Unlike acyclovir and gancyclovir, CDV is not dependent upon virally encoded thymidine kinase for activation. Mendel et al determined that the antiviral activity of CDV against herpes simplex virus with mutant thymidine kinase is not only maintained but appears to be enhanced in tissue culture.

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The pharmacokinetic properties of CDV in humans have only been reported for the intravenous administration of this drug. CDV exhibits dose-independent pharmacokinetic parameters i. In another study, Cundy et al observed the pharmacokinetic properties of CDV in African green monkeys by cidofkvir, oral and subcutaneous routes of administration. Van Cutsem et al described the successful treatment of a large HPV-induced squamous papilloma of the hypopharynx and esophagus with intralesional cidofovir [.

Petersen and colleagues report the case of a year old immunocompetent male with a history of laryngeal papillomas who had over 80 surgeries in 30 years [.

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Snoeck et al treated knsert females and ten males with severe, recurrent laryngeal papillomatosis with intralesional cidofovir as a 2. We reported 2 cases of verrucae vulgares refractory to conventional therapy that responded to treatment with topical CDV. I have treated other pediatric patients with topical cidofovir in whom more conventional therapies were unsuccessful, contraindicated or declined unpublished data.

Even large lesions respond with significant clearing. In a case involving an 8-year-old boy, a large verruca affecting the dorsal surface of the thumb was present, as well as smaller lesions affecting the lateral nail folds figure 3.

The tumor jnsert large enough to encroach on the underlying nail matrix, causing nail dystrophy.

In an in vitro study Kedes and Ganem evaluated the activity of various antiviral agents against Kaposi’s sarcoma-associated herpesvirus KSHVnow referred to more commonly as herpesvirus type 8. Cidofovir was found to be the most potent inhibitor of KSHV of the 4 agents tested acyclovir, cidofovir, foscarnet, gancyclovir.

Davies et al reported the successful treatment of a child with severe molluscum contagiosum infection and Wiskot-Aldrich syndrome. Zabawski and Cockerell reported the successful treatment of two immunocompetent children with molluscum contagiosum with topical cidofovir. Although no human trials have been performed, cidofovir was found to decrease morbidity and cudofovir associated with monkeypox orthopoxvirus infections in 2 animal models. De Clercq and Cidoovir demonstrated that topical cidofovir was effective cidogovir human herpesvirus types 1 and 2 and thymidine kinase deficient herpesvirus type 1 in mice.

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They demonstrated that its efficacy was superior to acyclovir [.

Snoeck et al reported the use of topical cidofovir in 2 patients with resistant herpesvirus infections. Finally, Sacks et al described the successful use of cidofovir topical gel in otherwise healthy patients with recurrent genital herpes infection.

An cirofovir to approve the use of topical cidofovir for acyclovir-resistant herpesvirus infections was denied by the United States Food and Drug Administration, citing the need for phase three data. Cidofovir is an antiviral drug that has a broad spectrum of activity against a number of different DNA viruses.

Continued investigations into its potential to treat malignant neoplasms and life threatening viral infections such as monekypox in addition to merely symptomatic viral maladies is to be encouraged. Its routine use in dermatology is hampered by its high cost, lack of continued interest by the manufacturer, and nagging concerns regarding carcinogenicity. The appearance of tumors in humans or animals other than rats has not been described, so that the true role of CDV as a carcinogen remains unclear.

In contrast, its activity as a potent antiviral drug and, more importantly, as an antitumor drug is well established. Figures 3 and 4. The lesion had been refractory to several treatments with liquid nitrogen, and destruction was relatively contraindicated because of concerns over hypertrophic scarring.

The parent called after 3 days to report a decrease in size. No irritation was reported and no systemic side effects were seen. At 8 weeks, the thumb was clinically clear of verruca and treatment was discontinued figure 4. At 4 months, no signs of recurrence are seen.

Growth of normal nail plate proximally was clearly evident.