Aidsinfo provides the following drug label solely as an example of the labels available for ganciclovir. 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. Interactions between ganciclovir intravenous and selected. The clinical formulation is supplied in a sterile form for intravenous use only. These highlights do not include all the information needed to use actemra safely and effectively. Pediatric dosing of ganciclovir and valganciclovir. 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. 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 fda prescribing information, side effects and uses. 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. Valcyte valganciclovir hydrochloride tablets, valcyte valganciclovir hydrochloride for oral solution. It is used to prevent disease caused by a virus called cytomegalovirus cmv in people who have received organ or. Jun 01, 2019 ganciclovir is a white to offwhite crystalline powder.
To date, all clinical isolates which exhibit high level resistance to. Cytovene ganciclovir is an antiviral drug used to treat and prevent infections caused by cytomegalovirus. Cytomegalovirus disease in the highly active antiretroviral therapy era. Highlights of prescribing information these highlights do not include all the information needed to use recarbrio safely and effectively. 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. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Zirgan is used to treat eye ulcers caused by a herpes virus important safety information. 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. 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. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol.
Highlights of prescribing information use recarbrio safely. Cytoveneiv ganciclovir sodium for injection, for intravenous use initial u. Do not take valcyte if you have ever had a serious reaction to valganciclovir, ganciclovir as valcyte or. Highlights of prescribing information these highlights. The lyophilized powder has an aqueous solubility of greater than 50 mgml at 25c. The capsule form of ganciclovir should be taken by mouth with food. Ganciclovir for injection, usp is supplied in cartons of 25 singledose vials ndc 4202317325. Thus, it is used judiciously and handled as a cytotoxic. Investigational entry inhibitors these entry inhibitors have not been approved by the fda. Ganciclovir is a polar hydrophilic compound with a solubility. The chemical name for ganciclovir sodium is 92hydroxy1hydroxymethylethoxymethylguanine. The current pi format contains two main components. Cytoveneiv is the brand name for ganciclovir sodium for injection. These highlights do not include all the information needed.
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. It is widely used for the treatment of cmv infections among patients with impaired cellmediated. Ganciclovir prescribing information from the fda web site. These highlights do not include all the information needed to use valtrex safely and effectively. Actemra subcutaneous formulation is not intended for intravenous. Refer to the policy on cytotoxicbiotherapy agents administration within the clinical practice manual for further information. Please see safety information below and additional important safety information in the full prescribing information by clicking here. Recent studies of combined prophylaxis with cmvigiv and ganciclovir have shown reductions in the incidence of. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus cmv. The product information may be subsequently updated by the member state.
Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or. These highlights do not include all the information needed to. Reduced susceptibility to cidofovir, however, has been reported for dna polymerase mutants of cmv which are resistant to ganciclovir69. Draft guidance on ganciclovir this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. May 15, 2015 the current pi format contains two main components. Highlights of prescribing information valcytefor oral. Such adjustments should be based on measured or estimated creatinine clearance values see dosage and administration.
Tell your doctor if you have or have ever had anemia red blood cells do not bring enough. See full prescribing information for complete boxed warning. Several fdaapproved drug labels may be available for ganciclovir. Ganciclovir is the active part of the drug that actually slows the growth of cmv virus. Vials of vinblastine sulfate for injection usp contain 10 mg. Ganciclovir is considered a potential human carcinogen, teratogen, and mutagen. Do not wear contact lenses while using zirgan or anytime you have signs or symptoms of an eye infection. In this study, patients received ganciclovir iv at 5 mgkg twice a day for the initial 14 days posttransplant, then at 6 mgkg each day for 5 days per week through day 28. 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. It is also considered likely to cause inhibition of spermatogenesis. This infection usually occurs in patients who have suppressed immune systems such as patients with aids and organ transplant patients. Cytoveneiv ganciclovir sodium for injection, for intravenous use. Highlights of prescribing information adult patients.
Risk of serious infections see full prescribing information for complete boxed warning. Myfortic mycophenolic acid delayedrelease tablets, for oral use initial u. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Valtrex valacyclovir, valcyte valganciclovir, cytovene. Side effects of cytovene ganciclovir, warnings, uses. Highlights of prescribing information these highlights do not.
Highlights of prescribing information adult patients should. Highlights of prescribing information these highlights do not include all the information needed to use cytovene iv safely and effectively. Ganciclovir side effects, dosage, interactions drugs. Actemra subcutaneous formulation is not intended for. Ganciclovir is used to treat cmv retinitis in people with immunosuppression caused by hiv or. Highlights of prescribing information these highlights do not include all the information needed to use cytoveneiv safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use myfortic safely and effectively.
Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been. Highlights of prescribing information these highlights do not include all of the information needed to use zirgantm safely and effectively. Ganciclovir, when formulated as monosodium salt in the intravenous iv. Cytomegalovirus immune globulin csl behring warnings cytogam. Ganciclovir was the first antiviral agent approved for the treatment of cytomegalovirus cmv infection. Ganciclovir capsules fda prescribing information, side.
Ancef prescribing information pdf ancef official prescribing information for healthcare professionals. Dosing algorithms valganciclovir dose according to the prescribing information 7. Sections or subsections omitted from the full prescribing information. Ganciclovir cytovene treatment national hiv curriculum. More current versions may be available on the manufacturers web site. Ganciclovir for injection usp is indicated for the treatment of cytomegalovirus cmv retinitis in. Highlights of prescribing information these highlights do not include all the information needed to. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u. Dosage information ganciclovir comes in capsule, injectable. Survival was 60% in the ganciclovir group and 80% in patients receiving cmvigiv and ganciclovir p. Highlights of prescribing information these highlights do not include all the information needed to use valcyte safely and effectively. Zirgan is indicated for topical ophthalmic use only. Thus, it is used judiciously and handled as a cytotoxic drug in the clinical setting. This means it is changed to ganciclovir once it is absorbed into the body.
This infection usually occurs in patients who have suppressed immune systems such. Accidental release measures contain spill and collect, as appropriate. Dosage information ganciclovir comes in capsule, injectable liquid, and eye implant forms. Refer to the respective prescribing information of the coadministered drugs to confirm compatibilityof. The chemical name for ganciclovir sodium is 92hydroxy1hydroxymethylethoxymethylguanine, monosodium salt.
This information is generalized and not intended as specific medical advice. Ganciclovir fda label aidsinfo information on hivaids. Ganciclovir is an antiviral drug that slows the growth and spread of the cytomegalovirus cmv. Highlights of prescribing information valacyclovir. Ganciclovir is available as 250 mg and 500 mg capsules. Cytoveneiv ganciclovir, formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to offwhite lyophilized powder. Zirgan should only be used in the eye do not wear contact lenses while using. Ganciclovir is a polar hydrophilic compound with a solubility of 2.