Ganciclovir is a synthetic guanine derivative active against cytomegalovirus cmv. Zirgan is indicated for topical ophthalmic use only. Zirgan is used to treat eye ulcers caused by a herpes virus important safety information. Myfortic mycophenolic acid delayedrelease tablets, for oral use initial u. The product information may be subsequently updated by the member state.
Cytoveneiv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Highlights of prescribing information these highlights do not include all the information needed to use cytoveneiv safely and effectively. It is widely used for the treatment of cmv infections among patients with impaired cellmediated immunity, particularly persons with poorly controlled and advanced hivaids, and recipients of solid organ and bone marrow transplantation, who. Ganciclovir is a polar hydrophilic compound with a solubility. See full prescribing information for complete boxed warning. The chemical name for ganciclovir sodium is 92hydroxy1hydroxymethylethoxymethylguanine. Ganciclovir is an antiviral drug that slows the growth and spread of the cytomegalovirus cmv. Highlights of prescribing information these highlights do not include all the information needed to. These highlights do not include all the information needed. These highlights do not include all the information needed to use valtrex safely and effectively. Refer to the respective prescribing information of the coadministered drugs to confirm compatibilityof. Ganciclovir was the first antiviral agent approved for the treatment of cytomegalovirus cmv infection. Ganciclovir for injection, usp ganciclovir sodium is supplied in 10 ml sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir as a white lyophilized cake or powder. Ganciclovir may lower the number of all types of cells in your blood, causing serious and lifethreatening problems.
Ganciclovir is a white to offwhite crystalline powder with a molecular formula of c 9 h n 5 0 4 and a molecular weight of 255. Accidental release measures contain spill and collect, as appropriate. This information is generalized and not intended as specific medical advice. Pediatric dosing of ganciclovir and valganciclovir. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. This infection usually occurs in patients who have suppressed immune systems such. Ganciclovir fda label aidsinfo information on hivaids. Several fdaapproved drug labels may be available for ganciclovir. Cytovene ganciclovir is an antiviral drug used to treat and prevent infections caused by cytomegalovirus. Draft guidance on ganciclovir this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Istodax is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg singledose vial containing 11 mg of romid epsin and 22 mg of the bulking agent, povidone, usp.
Investigational entry inhibitors these entry inhibitors have not been approved by the fda. Highlights of prescribing information these highlights do not. The most common side effects reported in patients were blurred vision, eye irritation, eye redness and punctate keratitis a specific type of eye surface irritation. Ganciclovir, when formulated as monosodium salt in the intravenous iv. Sections or subsections omitted from the full prescribing information. Ancef prescribing information pdf ancef official prescribing information for healthcare professionals. Zirgan should only be used in the eye do not wear contact lenses while using. Reduced susceptibility to cidofovir, however, has been reported for dna polymerase mutants of cmv which are resistant to ganciclovir69. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Highlights of prescribing information these highlights. Highlights of prescribing information adult patients should. Valcyte valganciclovir hydrochloride tablets, valcyte valganciclovir hydrochloride for oral solution.
As ganciclovir is mainly renally excreted and since renal clearance decreases with age, a decrease in ganciclovir total body clearance and a prolongation of ganciclovir halflife can be anticipated in patients 65 years of age and older see dosage and administration 2. Dosing algorithms valganciclovir dose according to the prescribing information 7. Thus, it is used judiciously and handled as a cytotoxic. Ganciclovir is available as 250 mg and 500 mg capsules. The current pi format contains two main components. Side effects of cytovene ganciclovir, warnings, uses. Ganciclovir is a polar hydrophilic compound with a solubility of 2. Do not take valcyte if you have ever had a serious reaction to valganciclovir, ganciclovir as valcyte or. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u. Highlights of prescribing information these highlights do not include all the information needed to use recarbrio safely and effectively. The lyophilized powder has an aqueous solubility of greater than 50 mgml at 25c. Ganciclovir is used to treat cmv retinitis in people with immunosuppression caused by hiv or. These highlights do not include all the information needed to.
Recarbrio imipenem, cilastatin, and relebactamfor injection, for intravenous use initial u. This means it is changed to ganciclovir once it is absorbed into the body. Recent studies of combined prophylaxis with cmvigiv and ganciclovir have shown reductions in the incidence of. The capsule form of ganciclovir should be taken by mouth with food. Cytoveneiv ganciclovir sodium for injection, for intravenous use.
Ganciclovir fda prescribing information, side effects and uses. Ganciclovir is considered a potential human carcinogen, teratogen, and mutagen. Vials of vinblastine sulfate for injection usp contain 10 mg. Ganciclovir side effects, dosage, interactions drugs. It is used to prevent disease caused by a virus called cytomegalovirus cmv in people who have received organ or. Oct 06, 2017 ganciclovir is a white to offwhite crystalline powder with a molecular formula of c 9 h n 5 0 4 and a molecular weight of 255. Ganciclovir for injection usp is indicated for the treatment of cytomegalovirus cmv retinitis in. Interactions between ganciclovir intravenous and selected. Highlights of prescribing information these highlights do not include all the information needed to use myfortic safely and effectively.
Jun 01, 2019 ganciclovir is a white to offwhite crystalline powder. Highlights of prescribing information these highlights do not include all of the information needed to use zirgantm safely and effectively. Actemra subcutaneous formulation is not intended for intravenous. Cytoveneiv ganciclovir sodium for injection, for intravenous use initial u. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the dna polymerase and ul97 genes, have been shown to be cross resistant to cidofovir. Tell your doctor if you have or have ever had anemia red blood cells do not bring enough. Survival was 60% in the ganciclovir group and 80% in patients receiving cmvigiv and ganciclovir p. Do not wear contact lenses while using zirgan or anytime you have signs or symptoms of an eye infection. The chemical name for ganciclovir sodium is 92hydroxy1hydroxymethylethoxymethylguanine, monosodium salt.
Cytoveneiv is the brand name for ganciclovir sodium for injection. Dosage information ganciclovir comes in capsule, injectable liquid, and eye implant forms. Risk of serious infections see full prescribing information for complete boxed warning. Ganciclovir prescribing information from the fda web site. Highlights of prescribing information valacyclovir. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or. Ganciclovir capsules fda prescribing information, side. More current versions may be available on the manufacturers web site. Such adjustments should be based on measured or estimated creatinine clearance values see dosage and administration. The clinical formulation is supplied in a sterile form for intravenous use only. Highlights of prescribing information use recarbrio safely.
Highlights of prescribing information adult patients. It is also considered likely to cause inhibition of spermatogenesis. Ganciclovir cytovene treatment national hiv curriculum. Cytomegalovirus disease in the highly active antiretroviral therapy era. Highlights of prescribing information these highlights do not include all the information needed to use valcyte safely and effectively. To date, all clinical isolates which exhibit high level resistance to. Highlights of prescribing information valcytefor oral.
Dosage information ganciclovir comes in capsule, injectable. Highlights of prescribing information these highlights do not include all the information needed to use cytovene iv safely and effectively. Valtrex valacyclovir, valcyte valganciclovir, cytovene ganciclovir, zovirax acyclovir click on the journals name and link will take you to the pubmed abstract and publisher website, respectively. Please see safety information below and additional important safety information in the full prescribing information by clicking here. Ganciclovir for injection, usp is supplied in cartons of 25 singledose vials ndc 4202317325. Cytomegalovirus immune globulin csl behring warnings cytogam. Refer to the policy on cytotoxicbiotherapy agents administration within the clinical practice manual for further information. May 15, 2015 the current pi format contains two main components. This infection usually occurs in patients who have suppressed immune systems such as patients with aids and organ transplant patients. Ganciclovir is the active part of the drug that actually slows the growth of cmv virus.