Ganciclovir (oral)

Ganciclovir (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Ganciclovir (oral) is an antiviral that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include pruritus, sweating, diarrhea, loss of appetite, vomiting, anemia, neutropenia, thrombocytopenia, neuropathy, blurred vision,punctate keratitis, vitreous hemorrhage.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS).

• SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS.

Dosage

• THE RECOMMENDED DOSE FOR GANCICLOVIR CAPSULES SHOULD NOT BE EXCEEDED.

• For Treatment of CMV Retinitis in Patients WithNormal Renal Function:

• Induction Treatment

• Ganciclovir capsules should not be used for induction treatment.

• Maintenance Treatment

• Following induction treatment, the recommended maintenance dosage of ganciclovir capsules is 1000 mg tid with food. Alternatively, the dosing regimen of 500 mg 6 times daily every 3 hours with food, during waking hours, may be used.

• For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

• For the Prevention of CMV Disease in Patients With Advanced HIV Infection andNormalRenal Function:

• The recommended prophylactic dose of ganciclovir capsules is 1000 mg tid with food.

• For the Prevention of CMV Disease in Transplant Recipients With Normal Renal Function:

• The recommended prophylactic dosage of ganciclovir capsules is 1000 mg tid with food.

• The duration of treatment with ganciclovir capsules in transplant recipients is dependent upon the duration and degree of immunosuppression. In a controlled clinical trial of liver allograft recipients, treatment with ganciclovir capsules was continued through week 14 posttransplantation (see INDICATIONS AND USAGE section for a more detailed discussion).

• Renal Impairment:

• In patients with renal impairment, the dose of ganciclovir capsules should be modified as shown below:

table08

• Creatinine clearance for females = 0.85 x male value

• Patient Monitoring: Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment. Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

• Reduction of Dose: Dosage reductions in renally impaired patients should be considered for ganciclovir capsules (see Renal Impairment). Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS). Ganciclovir should not be administered in patients with severe neutropenia (ANC less than 500/µL) or severe thrombocytopenia (platelets less than 25,000/µL).

• Handling and Disposal: Caution should be exercised in the handling of ganciclovir capsules. Avoid direct contact with the skin or mucous membranes of the powder contained in ganciclovir capsules. If such contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Ganciclovir capsules should not be opened or crushed.

• Because ganciclovir shares some of the properties of antitumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. Several guidelines on this subject have been published.

• There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ganciclovir (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ganciclovir (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ganciclovir (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ganciclovir (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ganciclovir (oral) in pediatric patients.

Contraindications

• Ganciclovir is contraindicated in patients with hypersensitivity to ganciclovir or acyclovir.

Warnings

• Hematologic: Ganciclovir should not be administered if the absolute neutrophil count is less than 500 cells/µL or the platelet count is less than 25,000 cells/µL. Granulocytopenia (neutropenia), anemia and thrombocytopenia have been observed in patients treated with ganciclovir. The frequency and severity of these events vary widely in different patient populations (see ADVERSE EVENTS).

• Ganciclovir should, therefore, be used with caution in patients with pre-existing cytopenias or with a history of cytopenic reactions to other drugs, chemicals or irradiation. Granulocytopenia usually occurs during the first or second week of treatment but may occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days of discontinuing drug.

• Impairment of Fertility: Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility. These effects were reversible at lower doses and irreversible at higher doses (seePRECAUTIONS: Carcinogenesis, Mutagenesis and Impairment of Fertility). Although data in humans have not been obtained regarding this effect, it is considered probable that ganciclovir at the recommended doses causes temporary or permanent inhibition of spermatogenesis. Animal data also indicate that suppression of fertility in females may occur.

• Teratogenesis: Because of the mutagenic and teratogenic potential of ganciclovir, women of childbearing potential should be advised to use effective contraception during treatment. Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir (see Pregnancy; Teratogenic Effects: Category C).

Precautions

• General

• Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal function. IF RENAL FUNCTION IS IMPAIRED, DOSAGE ADJUSTMENTS SHOULD BE CONSIDERED FOR GANCICLOVIR CAPSULES. Such adjustments should be based on measured or estimated creatinine clearance values

Adverse Reactions

Clinical Trials Experience

• Adverse events that occurred during clinical trials of ganciclovir capsules are summarized below, according to the participating study subject population.

• • Subjects With AIDS

• Three controlled, randomized, phase 3 trials comparing ganciclovir-IV and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, ganciclovir-IV or ganciclovir capsules were prematurely discontinued in 9% of subjects because of adverse events. In a placebo-controlled, randomized, phase 3 trial of ganciclovir capsules for prevention of CMV disease in AIDS, treatment was prematurely discontinued because of adverse events, new or worsening intercurrent illness, or laboratory abnormalities in 19.5% of subjects treated with ganciclovir capsules and 16% of subjects receiving placebo. Laboratory data and adverse events reported during the conduct of these controlled trials are summarized below.

table05

• Adverse events: The following table shows selected adverse events reported in 5% or more of the subjects in three controlled clinical trials during treatment with ganciclovir capsules (3000 mg/day) and in one controlled clinical trial in which ganciclovir capsules (3000 mg/day) were compared to placebo for the prevention of CMV disease.

table06

• The following events were frequently observed in clinical trials but occurred with equal or greater frequency in placebo-treated subjects: abdominal pain, nausea, flatulence, pneumonia, paresthesia, rash.

• Retinal Detachment: Retinal detachment has been observed in subjects with CMV retinitis both before and after initiation of therapy with ganciclovir. Its relationship to therapy with ganciclovir is unknown. Retinal detachment occurred in 8% of patients treated with ganciclovir capsules. Patients with CMV retinitis should have frequent ophthalmologic evaluations to monitor the status of their retinitis and to detect any other retinal pathology.

• Transplant RecipientsThere has been one controlled clinical trial of ganciclovir capsules for the prevention of CMV disease in transplant recipients. Laboratory data and adverse events reported during these trials are summarized below.

• Laboratory Data: The following table shows the frequency of granulocytopenia (neutropenia) and thrombocytopenia observed:

table07

• In 3 out of 4 trials, patients receiving either ganciclovir-IV solution or ganciclovir capsules had elevated serum creatinine levels when compared to those receiving placebo. Most patients in these studies also received cyclosporine. The mechanism of impairment of renal function is not known. However, careful monitoring of renal function during therapy with ganciclovir capsules is essential, especially for those patients receiving concomitant agents that may cause nephrotoxicity.

• General

• Other adverse events that were thought to be “probably” or “possibly” related to ganciclovir capsules in controlled clinical studies in either subjects with AIDS or transplant recipients are listed below. These events all occurred in at least 3 subjects.

• Body as a Whole: abdomen enlarged, asthenia, chest pain, edema, headache, injection site inflammation, malaise, pain

• Digestive System: abnormal liver function test, aphthous stomatitis, constipation, dyspepsia, eructation

• Hemic and Lymphatic System: pancytopenia

• Respiratory System: cough increased, dyspnea

• Nervous System: abnormal dreams, anxiety, confusion, depression, dizziness, dry mouth, insomnia, seizures, somnolence, thinking abnormal, tremor

• Skin and Appendages: alopecia, dry skin

• Special Senses: abnormal vision, taste perversion, tinnitus, vitreous disorder

• Metabolic and Nutritional Disorders: creatinine increased, SGOT increased, SGPT increased, weight loss

• Cardiovascular System: hypertension, phlebitis, vasodilatation

• Urogenital System: creatinine clearance decreased, kidney failure, kidney function abnormal, urinary frequency

• Musculoskeletal System: arthralgia, leg cramps, myalgia, myasthenia

• The following adverse events reported in patients receiving ganciclovir may be potentially fatal: gastrointestinal perforation, multiple organ failure, pancreatitis and sepsis.

Postmarketing Experience

• The following events have been identified during postapproval use of the drug. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either the seriousness, frequency of reporting, the apparent causal connection or a combination of these factors:

• acidosis, allergic reaction, anaphylactic reaction, arthritis, bronchospasm, cardiac arrest, cardiac conduction abnormality, cataracts, cholelithiasis, cholestasis, congenital anomaly, dry eyes, dysesthesia, dysphasia, elevated triglyceride levels, encephalopathy, exfoliative dermatitis, extrapyramidal reaction, facial palsy, hallucinations, hemolytic anemia, hemolytic uremic syndrome, hepatic failure, hepatitis, hypercalcemia, hyponatremia, inappropriate serum ADH, infertility, intestinal ulceration, intracranial hypertension, irritability, loss of memory, loss of sense of smell, myelopathy, oculomotor nerve paralysis, peripheral ischemia, pulmonary fibrosis, renal tubular disorder, rhabdomyolysis, Stevens-Johnson syndrome, stroke, testicular hypotrophy, Torsades de Pointes, vasculitis, ventricular tachycardia

Drug Interactions

• Didanosine: At an oral dose of 1000 mg of ganciclovir every 8 hours and didanosine, 200 mg every 12 hours, the steady-state didanosine AUC0-12 increased 111 ± 114% (range: 10% to 493%) when didanosine was administered either 2 hours prior to or concurrent with administration of ganciclovir (n = 12 patients, 23 observations). A decrease in steady-state ganciclovir AUC of 21 ± 17% (range: -44% to 5%) was observed when didanosine was administered 2 hours prior to administration of ganciclovir, but ganciclovir AUC was not affected by the presence of didanosine when the two drugs were administered simultaneously (n = 12). There were no significant changes in renal clearance for either drug.

• Zidovudine: At an oral dose of 1000 mg of ganciclovir every 8 hours, mean steady-state ganciclovir AUC0-8 decreased 17 ± 25% (range: -52% to 23%) in the presence of zidovudine, 100 mg every 4 hours (n = 12). Steady-state zidovudine AUC0-4 increased 19 ± 27% (range: -11% to 74%) in the presence of ganciclovir.

• Since both zidovudine and ganciclovir have the potential to cause neutropenia and anemia, some patients may not tolerate concomitant therapy with these drugs at full dosage.

• Probenecid: At an oral dose of 1000 mg of ganciclovir every 8 hours (n = 10), ganciclovir AUC0-8 increased 53 ± 91% (range: -14% to 299%) in the presence of probenecid, 500 mg every 6 hours. Renal clearance of ganciclovir decreased 22 ± 20% (range: -54% to -4%), which is consistent with an interaction involving competition for renal tubular secretion.

• Imipenem-cilastatin: Generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.

• Other Medications: It is possible that drugs that inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa may have additive toxicity when administered concomitantly with ganciclovir. Therefore, drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues, should be considered for concomitant use with ganciclovir only if the potential benefits are judged to outweigh the risks.

• No formal drug interaction studies of ganciclovir and drugs commonly used in transplant recipients have been conducted.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Teratogenic Effects: Pregnancy Category CT

• Ganciclovir has been shown to be embryotoxic in rabbits, mice and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (2 x the human exposure based on AUC comparisons), respectively.

• Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality.

• Ganciclovir may be teratogenic or embryotoxic at dose levels recommended for human use. There are no adequate and well-controlled studies in pregnant women. Ganciclovir should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

• TFootnote: Compared with the single 5 mg/kg intravenous infusion, human exposure is doubled during the intravenous induction phase (5 mg/kg bid) and approximately halved during maintenance treatment with ganciclovir capsules (1000 mg tid). The cross-species dosage treatment should be multiplied by 2 for ganciclovir capsules.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ganciclovir (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ganciclovir (oral) during labor and delivery.

Nursing Mothers

• It is not known whether ganciclovir is excreted in human milk. However, many drugs are excreted in human milk and, because carcinogenic and teratogenic effects occurred in animals treated with ganciclovir, the possibility of serious adverse reactions from ganciclovir in nursing infants is considered likely (see Pregnancy: Teratogenic Effects: Pregnancy Category C). Mothers should be instructed to discontinue nursing if they are receiving ganciclovir. The minimum interval before nursing can safely be resumed after the last dose of ganciclovir is unknown.

Pediatric Use

• SAFETY AND EFFICACY OF GANCICLOVIR IN PEDIATRIC PATIENTS HAVE NOT BEEN ESTABLISHED. THE USE OF GANCICLOVIR IN THE PEDIATRIC POPULATION WARRANTS EXTREME CAUTION DUE TO THE PROBABILITY OF LONG-TERM CARCINOGENICITY AND REPRODUCTIVE TOXICITY. ADMINISTRATION TO PEDIATRIC PATIENTS SHOULD BE UNDERTAKEN ONLY AFTER CAREFUL EVALUATION AND ONLY IF THE POTENTIAL BENEFITS OF TREATMENT OUTWEIGH THE RISKS.

• Ganciclovir capsules have not been studied in pediatric patients under age 13.

Geriatic Use

• The pharmacokinetic profiles of ganciclovir in elderly patients have not been established. Since elderly individuals frequently have a reduced glomerular filtration rate, particular attention should be paid to assessing renal function before and during administration of ganciclovir

• Clinical studies of ganciclovir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Ganciclovir is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly

Gender

There is no FDA guidance on the use of Ganciclovir (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ganciclovir (oral) with respect to specific racial populations.

Renal Impairment

• Ganciclovir should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of ganciclovir will be increased due to reduced renal clearance

• Hemodialysis has been shown to reduce plasma levels of ganciclovir by approximately 50%.

Hepatic Impairment

There is no FDA guidance on the use of Ganciclovir (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ganciclovir (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ganciclovir (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

• Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment. Increased serum creatinine levels have been observed in trials evaluating ganciclovir. Patients should have serum creatinine or creatinine clearance values monitored carefully to allow for dosage adjustments in renally impaired patients

IV Compatibility

There is limited information regarding IV Compatibility of Ganciclovir (oral) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Ganciclovir (oral) in the drug label.

Pharmacology

Ganciclovir (oral)
Systematic (IUPAC) name
2-amino-9-{[(1,3-dihydroxypropan-2-yl)oxy]methyl}-6,9-dihydro-3H-purin-6-one
Identifiers
CAS number	82410-32-0
ATC code	J05AB06 S01AD09 (WHO)
PubChem	3454
DrugBank	DB01004
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	255.23 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	5% (oral)
Metabolism	guanylate kinase (CMV UL97 gene product)
Half life	2.5–5 hours
Excretion	Renal
Therapeutic considerations
Pregnancy cat.	D(AU) C(US)
Legal status	Prescription Only (S4)(AU) POM(UK) [[Prescription drug|Template:Unicode-only]](US)
Routes	IV, oral, intravitreal

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ganciclovir (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ganciclovir (oral) in the drug label.

Nonclinical Toxicology

• • Carcinogenesis, MutagenesisT

• Ganciclovir was carcinogenic in the mouse at oral doses of 20 and 1000 mg/kg/day (approximately 0.1x and 1.4x, respectively, the mean drug exposure in humans following the recommended intravenous dose of 5 mg/kg, based on area under the plasma concentration curve [AUC] comparisons). At the dose of 1000 mg/kg/day there was a significant increase in the incidence of tumors of the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland and vagina) and liver in females. At the dose of 20 mg/kg/day, a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, forestomach in males and females, and liver in females. No carcinogenic effect was observed in mice administered ganciclovir at 1 mg/kg/day (estimated as 0.01x the human dose based on AUC comparison). Except for histiocytic sarcoma of the liver, ganciclovir- induced tumors were generally of epithelial or vascular origin. Although the preputial and clitoral glands, forestomach and harderian glands of mice do not have human counterparts, ganciclovir should be considered a potential carcinogen in humans.

• Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes in vitro at concentrations between 50 to 500 and 250 to 2000 mcg/mL, respectively. Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5000 mcg/mL.

Clinical Studies

Treatment of CMV Retinitis

• The diagnosis of CMV retinitis should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis include candidiasis, toxoplasmosis, histoplasmosis, retinal scars and cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason it is essential that the diagnosis of CMV be established by an ophthalmologist familiar with the retinal presentation of these conditions. The diagnosis of CMV retinitis may be supported by culture of CMV from urine, blood, throat or other sites, but a negative CMV culture does not rule out CMV retinitis.

table02

• Prevention of CMV Disease in Subjects With AIDS

• ICM 1654: In a double-blind study conducted between November 1992 and July 1994, 725 subjects with AIDS, who were CMV seropositive and/or culture positive, were randomized to receive ganciclovir capsules, 1000 mg, every 8 hours, or placebo.3 The study population had a median age of 38 years (range: 21 to 69); were 99% male; were 82% Caucasian, 10% Hispanic, 7% African-American and 1% Asian; and had a median CD4 count of 21 (range: 0 to 100). The mean observation time was 351 days (range: 5 to 621). As shown in the following table, significantly more placebo recipients developed CMV disease

Studies Comparing Ganciclovir-Capsules to Ganciclovir-IV:

table03

• CMV syndrome: CMV viremia and unexplained fever, accompanied by malaise and/or neutropenia.
• Ganciclovir capsules significantly reduced the 6-month incidence of CMV disease in patients at increased risk of CMV disease, including seronegative recipients of organs from seropositive donors (15% [3/21] with ganciclovir capsules vs 44% [11/25] with placebo), and patients receiving antilymphocyte antibodies (5% [2/44] with ganciclovir capsules vs 33% [12/37] with placebo). The incidence of HSV infection at 6 months was 4% (5/150) in ganciclovir vs 24% (36/154) in placebo recipients (relative risk: 0.13; 95% CI: 0.05, 0.32).

How Supplied

• Ganciclovir 250 mg capsules are opaque green cap/opaque green body; size ‘1’ hard gelatin capsules, printed “RX636” on cap and body in black ink, containing white to off-white granular powder. They are supplied as follows:

• NDC 63304-636-60 Bottles of 60

• NDC 63304-636-90 Bottles of 90

• NDC 63304-636-28 Bottles of 180

• NDC 63304-636-10 Bottles of 1000

• Ganciclovir 500 mg capsules are opaque ivory yellow cap/opaque green body, size ‘0’ elongated hard gelatin capsules, printed “RX637” on cap and body in black ink, containing white to off-white granular powder. They are supplied as follows:

• NDC 63304-637-60 Bottles of 60

• NDC 63304-637-90 Bottles of 90

• NDC 63304-637-28 Bottles of 180

• NDC 63304-637-05 Bottles of 500

• Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].

Storage

There is limited information regarding Ganciclovir (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ganciclovir (oral) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ganciclovir (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

• All patients should be informed that the major toxicities of ganciclovir are granulocytopenia (neutropenia), anemia and thrombocytopenia and that dose modifications may be required, including discontinuation. The importance of close monitoring of blood counts while on therapy should be emphasized. Patients should be informed that ganciclovir has been associated with elevations in serum creatinine.

• Patients should be instructed to take ganciclovir capsules with food to maximize bioavailability.

• Patients should be advised that ganciclovir has caused decreased sperm production in animals and may cause infertility in humans. Women of childbearing potential should be advised that ganciclovir causes birth defects in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment with ganciclovir. Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir.

• Patients should be advised that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen.

• All HIV+ Patients: These patients may be receiving zidovudine (Retrovir®*). Patients should be counseled that treatment with both ganciclovir and zidovudine simultaneously may not be tolerated by some patients and may result in severe granulocytopenia (neutropenia). Patients with AIDS may be receiving didanosine (Videx®#). Patients should be counseled that concomitant treatment with both ganciclovir and didanosine can cause didanosine serum concentrations to be significantly increased.

• HIV+ Patients With CMV Retinitis: Ganciclovir is not a cure for CMV retinitis, and immunocompromised patients may continue to experience progression of retinitis during or following treatment. Patients should be advised to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with ganciclovir. Some patients will require more frequent follow-up.

Precautions with Alcohol

• Alcohol-Ganciclovir (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Label Page=Ganciclovir (oral)
 |Label Name=Ganciclovir (oral)11.png

}}

{{#subobject:

 |Label Page=Ganciclovir (oral)
 |Label Name=Ganciclovir (oral)11.png

}}