Therapeutic drug monitoring of ganciclovir treatment for cytomegalovirus infections among immunocompromised children article in journal of the pediatric. The length of treatment depends on your general health, the type of infection you have, and how well you respond to the medication. Ganciclovir is a polar hydrophilic compound with a solubility of 2. Zirgan ganciclovir dose, indications, adverse effects, interactions. Ganciclovir fda prescribing information, side effects and uses. More frequent monitoring is recommended for patients who have previously experienced leukopenia with ganciclovir or another nucleoside analog or in whom neutrophil counts are less than cu mm prior to initiating therapy with the drug. Ganciclovir resistance should be suspected in the presence of rising or persistently elevated viral loads despite treatment with appropriately dosed ganciclovir for more. A case of severe ganciclovirinduced encephalopathy fulltext.
The manufacturer warns that ganciclovir injection should only be used for treatment and prevention of cytomegalovirus cmv in people with certain diseases because the medication may cause severe side effects and there is currently not enough information to support safety and effectiveness in other groups of people. Monitor anc at least twice weekly during ganciclovir therapy. It is used to treat and prevent a viral eye infection called cytomegalovirus cmv retinitis. Ganciclovir was the first antiviral agent approved for the treatment of cytomegalovirus cmv infection. Therapeutic drug monitoring of ganciclovir treatment for. Monitoring of renal function is recommended as serum creatinine levels may rise during ganciclovir therapy. Side effects of cytovene ganciclovir, warnings, uses. Consumer information about the medication ganciclovir injection cytovene, includes side effects, drug interactions, recommended dosages, and storage information. The first patient is diagnosed with thymoma a, the second is a heart transplant recipient, and the third is an hivpositive patient.
Ganciclovir 500 mg 500mg 10 capsules capsule ganciclovir drug information. Follow facility policy for handling and disposing of antineoplastic drugs. It is used to prevent disease caused by a virus called cytomegalovirus cmv in people who have received organ or bone marrow transplants. This includes patients with acquired immune deficiency syndrome aids. Ganciclovir 91,3,dihydroxy2propoxymethyl guanine, or dhpg is an acyclic analog of the nucleoside guanosine. 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. Read more about the prescription drug ganciclovir injection. Chqgdl01005 treatment guideline for infants with congenital cmv disease ccmv 4 side effects ganciclovir gcv, and less frequently valganciclovir, use is associated with bone marrow suppression. Cytovene, ganciclovir dosing, indications, interactions. Ganciclovir side effects, dosage, interactions drugs. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda.
Therapeutic drug monitoring of ganciclovir treatment for cytomegalovirus infections among immunocompromised children article in journal of the pediatric infectious diseases society 52. Ganciclovir drug information indications, dosage, side. Ganciclovir capsules are used to treat cmv retinitis after the condition has been controlled by intravenous injected into a vein ganciclovir. Nov 09, 2018 ganciclovir is an antiviral drug that slows the growth and spread of the cytomegalovirus cmv. Ganciclovir is an antiviral drug that slows the growth and spread of the cytomegalovirus cmv. Va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Patients with cmv retinitis should have frequent ophthalmological examinations during treatment with ganciclovir for injection solution to monitor disease status and for other retinal abnormalities see adverse reactions 6.
It is used to prevent disease caused by a virus called cytomegalovirus cmv in. 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. Our case studies illustrate how therapeutic drug monitoring. It slows the growth and spread of the cytomegalovirus. Jun 01, 2019 table 8 and table 9 provide a listing of established drug interaction studies with ganciclovir. Treatment guideline for infants with congenital cmv disease. Feb 03, 2020 very bad and sometimes lifethreatening blood and bone marrow problems like anemia, low platelet counts, or low white blood cell counts have happened with ganciclovir systemic. Dec 21, 2018 ganciclovir is a prescription medicine approved by the u. Ganciclovir is considered a potential human carcinogen, teratogen, and mutagen. The drug is converted intracellularly to ganciclovir 5monophosphate by a viral kinase, which is encoded by the cytomegalovirus cmv gene ul97 during infection. Aug 28, 2019 table 8 and table 9 provide a listing of established drug interaction studies with ganciclovir. It is commonly used to treat and prevent cytomegalovirus infections of the eye or body. Ganciclovir is a deoxyguanosine analog that exhibits potent inhibition of cytomegalovirus cmv replication and is used intravenously. Ganciclovir ophthalmic drug monograph pediatric care.
Ganciclovir ophthalmic side effects, dosage, interactions. Dosing of ganciclovir for the prophylaxis and treatment of. Ganciclovir is used to treat cmv retinitis in people with immunosuppression caused by. Monitoring of trough plasma ganciclovir levels and. This infection usually occurs for people with weakened immune systems, such as people who have had transplants or chemotherapy, and people who have aids. This article presents 3 cases of immunocompromised patients for whom therapeutic drug monitoring of ganciclovir in combination with cytomegalovirus viral load. Food and drug administration fda for the treatment of cytomegalovirus retinitis cmv retinitis in individuals with aids. Oral ganciclovir fda approved, 1994 can be used for maintenance therapy of cmv retinitis after it has been healed with intravenous ganciclovir therapy. Ganciclovir injection food and drug administration. Ganciclovir ophthalmic for the eyes is used to treat certain viral infections affecting the eyes. Ganciclovir injection should only be infused into veins with adequate blood flow to permit rapid dilution and distribution. Recommended dosage for treatment of cmv retinitis in adult patients with normal renal function. However, a clinically feasible tool for valganciclovir dosage adjustment based on individual auc is not available.
Either ganciclovir or foscarnet can be injected directly into the eye to achieve high drug levels. The objective of this study was to develop and validate a reliable and clinically applicable limited sampling strategy using bayesian estimation for individualizing valganciclovir dose in pediatric kidney transplant patients. An update of its therapeutic use in cytomegalovirus infection. In addition, ganciclovir prophylaxis appears more cost effective than the majority of other currently available therapies for cmv with oral ganciclovir more cost effective than intravenous ganciclovir. Three days of oral ganciclovir results in therapeutically useful plasma drug levels in the cf. In addition, ganciclovir prophylaxis appears more cost effective than the majority of other currently available therapies for cmv with oral ganciclovir. Aug 22, 2016 we have recently experienced a case of an extremely premature infant with severe postnatal cmv infection. Variations, taking into account individual circumstances, may be appropriate. Variations, taking into account individual circumstances, may. Therapeutic drug monitoring of ganciclovir for postnatal. May be harmful by inhalation, ingestion, or skin absorption. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Table 8 provides the effects of coadministered drug on ganciclovir plasma pharmacokinetic parameters, whereas table 9 provides the effects of ganciclovir on plasma pharmacokinetic parameters of coadministered drug.
Ganciclovir drug information, uses, side effects, chemistry. Ganciclovir is also used to prevent cmv disease in people with immunosuppression due to an organ transplant. Ganciclovir injection comes as a powder to be mixed with liquid and injected intravenously into a vein. Ganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to. We administer intravitreal injections of ganciclovir 2. Only select registry of toxic effects of chemical substances rtecs data is presented here.
Ganciclovir, a drug against cytomegalovirus cmv infection, is generally well. Ganciclovir will not cure this eye infection, but it may help to keep the symptoms. It works by preventing the virus cmv that causes the. Population pharmacokinetics of ganciclovir after intravenous. Patient counselling this drug may cause convulsion, sedation, ataxia andor confusion, if affected, do not drive or operate machinery. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. The recommendations in this online publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Very bad and sometimes lifethreatening blood and bone marrow problems like anemia, low platelet counts, or low white blood cell counts have happened with ganciclovir systemic. The drug is converted intracellularly to ganciclovir 5monophosphate by a. This article presents 3 cases of immunocompromised patients for whom therapeutic drug monitoring of ganciclovir in combination with cytomegalovirus viral load measurement was used to guide treatment. Ganciclovir ophthalmic gel is an fdadesignated orphan drug for this indication.
Ganciclovir injection cytovene side effects, medical. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Individualization of valganciclovir prophylaxis for. Pharmacokinetic assessment of oral ganciclovir in lung transplant. 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. Levels may be useful in certain situations such as. Dailymed ganciclovir ganciclovir sodium injection, solution. It is changed in the body to the active form of the drug called ganciclovir. Change in dose or even stopping the drug may be needed if any of these side effects happen.
Ganciclovir is a prescription medicine approved by the u. Gancyclovir definition of gancyclovir by medical dictionary. Although ganciclovirinduced encephalopathy has been described in several reports. It is used to treat or prevent infections caused by certain kinds of viruses. Valganciclovir is one of its forms, and it is rapidly converted to ganciclovir after oral administration.
Learn how to pronounce the drugs name, its indications, dosage, how to take, when. During the treatment with ganciclovir, we performed therapeutic drug monitoring tdm and measurement of cmv load in the peripheral blood that were useful to obtain a proper therapeutic effect and avoid overdosage. Ganciclovir is also fdaapproved for the prevention of cmv disease in recipients of organ transplants who are at risk for cmv diseases. We have recently experienced a case of an extremely premature infant with severe postnatal cmv infection. Ganciclovir is used to treat cmv retinitis in people with immunosuppression caused by hiv or aids.
See actual entry in rtecs for complete information. Ganciclovir injection cytovene side effects, medical uses. Thus, it is used judiciously and handled as a cytotoxic drug in the clinical setting. Several fdaapproved drug labels may be available for ganciclovir. Therapeutic drug monitoring of ganciclovir after valganci clovir administration is not. Dosing of ganciclovir for the prophylaxis and treatment of cmv disease in solid organ transplant recipients article in transplantation 693. Table 8 and table 9 provide a listing of established drug interaction studies with ganciclovir. Ganciclovir implant vitrasert is used to treat cytomegalovirus cmv infection of the eye. Ganciclovir get uptodate information on ganciclovir side effects, uses, dosage, overdose, pregnancy, alcohol and more. Look up information on diseases, tests, and procedures. These patients were all diagnosed with cytomegalovirus and treated with ganciclovir. The results of therapeutic drug monitoring in adult solid organ transplant recipients receiving prophylaxis indicated that a 24hour ganciclovir area under the curve auc 24 of 4050 ghr per ml was associated with delayed development of cmv viremia 2. Cytovene ganciclovir is an antiviral drug used to treat and prevent infections caused by cytomegalovirus.
Studies using this drug regimen have shown efficacy, but it is clear that oral ganciclovir is less effective than intravenous ganciclovir for many patients. However, the optimal exposure for the treatment of cmv disease is unknown. Aidsinfo provides the following drug label solely as an example of the labels available for ganciclovir. Ganciclovir belongs to a group of medications known as antivirals. Monitor serum creatinine or creatinine clearance at least q2wk. Neutrophil and platelet counts at least every other day during twicedaily dosing and weekly thereafter.
Learn how to pronounce the drug s name, its indications, dosage, how to take, when. Ganciclovir investigated as a drug, mutagen and tumorigen. Ganciclovir capsules are used to treat cytomegalovirus cmv retinitis eye infection that can cause blindness in people whose immune system is not working normally. Ganciclovir is used to treat the symptoms of cytomegalovirus infection of the eyes in people whose immune system is not working fully.
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