Cytovene capsules approved. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Cytovene capsules approved. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

J Physicians Assoc AIDS Care. 1995 Jan;2(1):15. Unique Identifier : AIDSLINE AIDS/95700122

Abstract: Cytovene (ganciclovir) capsules were approved by the Food and Drug Administration (FDA) on December 22, 1994 as an alternative to the intravenous formulation for maintenance therapy of CMV retinitis in patients with HIV disease. This treatment is limited to those whose retinitis is stable following appropriate IV induction therapy, and where the risk of more rapid disease progression is balanced by the benefit of avoidance of daily infusion. FDA approval also allows physicians to prescribe the capsules off-label as a prophylaxis against CMV retinitis. Clinical studies have shown that in patients taking the Cytovene capsules, the mean time to CMV retinitis progression was 5-12 days less than in those patients on the IV formulation. The major side effects of the Cytovene capsules were the same as those associated with IV formulation: granulocytopenia, anemia, and thrombocytopenia. Side effects unique to the oral treatment include diarrhea, fever, leukopenia and nausea. The benefits of Cytovene capsules are fewer serious incidents of sepsis, fewer catheter-related infections, and a lower incidence of both anemia and leukopenia.

Keywords: Administration, Oral Cytomegalovirus Infections/COMPLICATIONS/*DRUG THERAPY Drug Approval/LEGISLATION & JURISPRUD Ganciclovir/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/THERAPEUTIC USE HIV Infections/*COMPLICATIONS Infusions, Intravenous Retinitis/COMPLICATIONS/*DRUG THERAPY United States United States Food and Drug Administration NEWSLETTER ARTICLE
950530
M9551017

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