Valcyte

Drug overview for VALCYTE (valganciclovir hcl):

Generic name: VALGANCICLOVIR HCL (val-gan-SIGH-klow-veer)
Drug class: Antiviral - CMV Infection
Therapeutic class: Anti-Infective Agents

Valganciclovir, a prodrug of ganciclovir, is an antiviral agent; after in vivo conversion to an active metabolite, the drug is active against herpes viruses.

No enhanced Uses information available for this drug.

DRUG IMAGES

VALCYTE 450 MG TABLET
VALCYTE 50 MG/ML SOLUTION

The following indications for VALCYTE (valganciclovir hcl) have been approved by the FDA:

Indications:
CMV retinitis in AIDS patient
Prevention of CMV disease after cardiac transplantation
Prevention of CMV disease after kidney transplantation
Prevention of cytomegalovirus disease after kidney-pancreas transplantation

Professional Synonyms:
Cytomegalovirus prophylaxis after cardiac transplantation
Cytomegalovirus prophylaxis after kidney transplantation
Cytomegalovirus prophylaxis after kidney-pancreas transplantation
Cytomegalovirus retinitis in AIDS
Prevention of CMV disease after renal transplantation

The following dosing information is available for VALCYTE (valganciclovir hcl):

Dosing
Administration
VALCYTE
VALGANCICLOVIR HCL

Dosage of valganciclovir hydrochloride is expressed in terms of valganciclovir.

Valganciclovir hydrochloride is administered orally as tablets or an oral solution and should be given with food. Adults should receive valganciclovir tablets (not the oral solution). Valganciclovir tablets should not be broken or crushed.

Valganciclovir oral solution is the preferred dosage form for pediatric patients. Valganciclovir tablets should be used in pediatric patients only if the calculated dose is within 10% of the tablet strength (i.e., a single 450-mg tablet may be used if the calculated dose is 405-495 mg). (See Pediatric Dosage under Dosage and Administration: Dosage.) Patients receiving valganciclovir should be adequately hydrated.

Females of childbearing potential should be tested for pregnancy prior to initiation of valganciclovir. (See Pregnancy under Warnings/Precautions: Specific Populations, in Cautions.) Because of the mutagenic and/or carcinogenic potential of valganciclovir, the tablets, powder for oral solution, and reconstituted oral solutions of the drug should be handled carefully according to guidelines issued for cytotoxic drugs. (See Handling and Disposal under Warnings/Precautions: Other Warnings/Precautions, in Cautions.)

Dosing information for VALCYTE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VALCYTE 450 MG TABLET	Maintenance	Adults take 2 tablets (900 mg) by oral route once daily with food

Generic dosing information for VALGANCICLOVIR HCL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VALGANCICLOVIR 450 MG TABLET	Maintenance	Adults take 2 tablets (900 mg) by oral route once daily with food

The following drug interaction information is available for VALCYTE (valganciclovir hcl):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 6 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Zidovudine/Ganciclovir, Valganciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The magnitude of the toxic effects of both drugs are increased. CLINICAL EFFECTS: Increased side effects, including hematologic and gastrointestinal toxicity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid this combination. Coadministration should be considered only if the potential benefits are judged to outweigh the risks. Dose reduction or interruption may be needed. Monitor with frequent complete blood counts with differential and platelet counts. DISCUSSION: Patients receiving zidovudine and ganciclovir concurrently developed hematologic toxicity, including neutropenia and anemia, and gastrointestinal toxicity. Both ganciclovir and zidovudine have box warnings regarding hematologic toxicity. Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported. In a study in 12 patients, an oral dose of ganciclovir (1000 mg every 8 hours) administered concurrently with zidovudine (100 mg every 4 hours) decreased the mean steady state area-under-the-curve (AUC) of ganciclovir 17% and increased the zidovudine AUC 19%.	LAMIVUDINE-ZIDOVUDINE, RETROVIR, ZIDOVUDINE
Imipenem-Cilastatin/Ganciclovir,Valganciclovir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown, but may involve additive or synergistic effects on the seizure threshold. CLINICAL EFFECTS: Concurrent use of imipenem-cilastatin with ganciclovir may result in generalized seizures.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of imipenem-cilastatin states that imipenem-cilastatin and ganciclovir should not be coadministered unless the potential benefits outweigh the risks of seizures.(1) DISCUSSION: Generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin.(1)	IMIPENEM-CILASTATIN SODIUM, PRIMAXIN, RECARBRIO
Deferiprone/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis may increase the frequency or risk for severe toxicity.(1) CLINICAL EFFECTS: Concurrent use of deferiprone and myelosuppressive agents may result in severe neutropenia or agranulocytosis, which may be fatal. PREDISPOSING FACTORS: Agranulocytosis may be less common in patients receiving deferiprone for thalassemia, and more common in patients treated for other systemic iron overload conditions (e.g. myelodysplastic syndromes, sickle cell disease).(2,3) Inadequate monitoring appears to increase the risk for severe outcomes. Manufacturer post market surveillance found that in all fatal cases of agranulocytosis reported between 1999 and 2005, data on weekly white blood count (WBC) monitoring was missing. In three fatal cases, deferiprone was continued for two to seven days after the detection of neutropenia or agranulocytosis.(2) PATIENT MANAGEMENT: If possible, discontinue one of the drugs associated with risk for neutropenia or agranulocytosis. If alternative therapy is not available, documentation and adherence to the deferiprone monitoring protocol is essential. Baseline absolute neutrophil count (ANC) must be at least 1,500/uL prior to starting deferiprone. Monitor ANC weekly during therapy. If infection develops, interrupt deferiprone therapy and monitor ANC more frequently. If ANC is less than 1,500/uL but greater than 500/uL, discontinue deferiprone and any other drugs possibly associated with neutropenia. Initiate ANC and platelet counts daily until recovery (i.e. ANC at least 1,500/uL). If ANC is less than 500/uL, discontinue deferiprone, evaluate patient and hospitalize if appropriate. Do not resume deferiprone unless potential benefits outweigh potential risks.(1) DISCUSSION: Drugs linked to this monograph have an FDA Boxed Warning for risk of neutropenia, agranulocytosis, or pancytopenia, or have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(1-25) In pooled clinical studies submitted to the FDA, 6.1% of deferiprone patients met criteria for neutropenia and 1.7% of patients developed agranulocytosis.(1) The time to onset of agranulocytosis was highly variable with a range of 65 days to 9.2 years (median, 161 days).(3)	DEFERIPRONE, DEFERIPRONE (3 TIMES A DAY), FERRIPROX, FERRIPROX (2 TIMES A DAY), FERRIPROX (3 TIMES A DAY)
Clozapine/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine and other myelosuppressive agents may be associated with neutropenia or agranulocytosis.(2) CLINICAL EFFECTS: Moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). The disease treated by the myelosuppressive agent may be compromised if myelosuppression requires dose reduction, delay, or discontinuation of the myelosuppressive agent. Undetected severe neutropenia or agranulocytosis may be fatal. PREDISPOSING FACTORS: Low white blood counts prior to initiation of the myelosuppressive agent may increase risk for clinically significant neutropenia. PATIENT MANAGEMENT: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(2) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(1-2) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(2) DISCUSSION: Clozapine is only available through a restricted distribution system which requires documentation of the ANC prior to dispensing.(1) Agents linked to this interaction generally have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(3-26)	CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ
Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)	HICON, SODIUM IODIDE I-131
Ganciclovir; Valganciclovir/Maribavir SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Maribavir may inhibit pUL97 protein kinase which catalyzes the phosphorylation step required for activation of ganciclovir or valganciclovir.(1) CLINICAL EFFECTS: Concurrent administration of maribavir with ganciclovir or valganciclovir may antagonize the antiviral activity of ganciclovir or valganciclovir, resulting in decreased clinical efficacy and/or virological failure of ganciclovir and valganciclovir.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of maribavir states that the concurrent use of maribavir with ganciclovir or valganciclovir is not recommended.(1) DISCUSSION: Ganciclovir and valganciclovir require activation via phosphorylation to the active form by human CMV pUL97 protein kinase.(2,3) The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of pUL97 and may antagonize the antiviral activity of ganciclovir or valganciclovir.(1) In the setting of combination therapy, in vitro data suggests antagonistic activity when maribavir is coadministered with ganciclovir or valganciclovir.(4-7)	LIVTENCITY

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Tenofovir/Selected Nephrotoxic Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tenofovir and other nephrotoxic agents may result in additive or synergistic effects on renal function and increase nephrotoxicity risk.(1) CLINICAL EFFECTS: Concurrent use of tenofovir and other nephrotoxic agents may result in renal toxicity and acute renal failure.(1) Reports of acute renal failure and Fanconi syndrome have been reported with tenofovir use.(2,3) However, this has been reported in 3 case reports and the renal failure may have been complicated by other pre-existing conditions.(2) PREDISPOSING FACTORS: Pre-existing renal dysfunction, long duration of use, low body weight, concomitant use of drugs that may increase tenofovir levels may increase the risk of nephrotoxicity.(1) PATIENT MANAGEMENT: The US prescribing information for tenofovir recommends avoiding concurrent or recent use of a nephrotoxic agent.(3) Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function. Tenofovir should be avoided with high-dose or multiple NSAIDs. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.(3) Patients receiving concurrent NSAIDs with tenofovir should be monitored for possible renal toxicity.(1,2) The dosing interval should be adjusted in patients with a baseline creatinine clearance of less than 50 ml/min.(1-3) DISCUSSION: From March 18, 2003 to December 1, 2005, Health Canada received 10 reports of nephrotoxic reactions with tenofovir. Three of these occurred following the addition of a NSAID to tenofovir therapy. In the first report, a patient maintained on tenofovir for 29 months developed acute renal failure and acute tubular necrosis requiring dialysis 5 days after beginning indomethacin (100 mg rectally twice daily). In the second report, a patient maintained on tenofovir for 7 months developed acute renal failure and acute tubular necrosis after taking 90 tablets of naproxen (375 mg) over 2 months. The patient died. In the third report, a patient maintained on tenofovir for over a year developed acute renal failure and nephrotic syndrome after 2 months of valdecoxib (20 mg daily) therapy. Symptoms subsided following discontinuation of valdecoxib.(1)	BIKTARVY, CIMDUO, COMPLERA, DELSTRIGO, DESCOVY, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EMTRICITABINE-TENOFOVIR DISOP, GENVOYA, ODEFSEY, STRIBILD, SYMFI, SYMFI LO, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TRUVADA, VEMLIDY, VIREAD

Drug Interaction

Drug Names

Tenofovir/Selected Nephrotoxic Agents

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Tenofovir and other nephrotoxic agents may result in additive or synergistic effects on renal function and increase nephrotoxicity risk.(1)

CLINICAL EFFECTS: Concurrent use of tenofovir and other nephrotoxic agents may result in renal toxicity and acute renal failure.(1) Reports of acute renal failure and Fanconi syndrome have been reported with tenofovir use.(2,3) However, this has been reported in 3 case reports and the renal failure may have been complicated by other pre-existing conditions.(2)

PREDISPOSING FACTORS: Pre-existing renal dysfunction, long duration of use, low body weight, concomitant use of drugs that may increase tenofovir levels may increase the risk of nephrotoxicity.(1)

PATIENT MANAGEMENT: The US prescribing information for tenofovir recommends avoiding concurrent or recent use of a nephrotoxic agent.(3) Evaluate renal function prior to initiation of concurrent therapy and continue renal function monitoring during therapy. Dose adjustments may be required for impaired renal function.

Tenofovir should be avoided with high-dose or multiple NSAIDs. Alternatives to NSAIDs should be considered in patients at risk for renal dysfunction.(3) Patients receiving concurrent NSAIDs with tenofovir should be monitored for possible renal toxicity.(1,2) The dosing interval should be adjusted in patients with a baseline creatinine clearance of less than 50 ml/min.(1-3)

DISCUSSION: From March 18, 2003 to December 1, 2005, Health Canada received 10 reports of nephrotoxic reactions with tenofovir. Three of these occurred following the addition of a NSAID to tenofovir therapy. In the first report, a patient maintained on tenofovir for 29 months developed acute renal failure and acute tubular necrosis requiring dialysis 5 days after beginning indomethacin (100 mg rectally twice daily).

In the second report, a patient maintained on tenofovir for 7 months developed acute renal failure and acute tubular necrosis after taking 90 tablets of naproxen (375 mg) over 2 months. The patient died. In the third report, a patient maintained on tenofovir for over a year developed acute renal failure and nephrotic syndrome after 2 months of valdecoxib (20 mg daily) therapy. Symptoms subsided following discontinuation of valdecoxib.(1)

BIKTARVY, CIMDUO, COMPLERA, DELSTRIGO, DESCOVY, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EMTRICITABINE-TENOFOVIR DISOP, GENVOYA, ODEFSEY, STRIBILD, SYMFI, SYMFI LO, SYMTUZA, TENOFOVIR DISOPROXIL FUMARATE, TRUVADA, VEMLIDY, VIREAD

The following contraindication information is available for VALCYTE (valganciclovir hcl):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

Valganciclovir is contraindicated in patients who have had a clinically important hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any ingredient in the formulation.

There are 2 contraindications. Absolute contraindication.

Contraindication List
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Severe bone marrow depression

There are 11 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute renal failure
Anemia
Aplastic anemia
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Dehydration
Granulocytopenic disorder
Neutropenic disorder
Pregnancy
Thrombocytopenic disorder

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Kidney disease with likely reduction in glomerular filtration rate (GFr)

The following adverse reaction information is available for VALCYTE (valganciclovir hcl):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects occurring in 20% or more of adults receiving valganciclovir include diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. Adverse effects occurring in 20% or more of pediatric patients receiving valganciclovir include diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.

There are 25 severe adverse reactions.

More Frequent	Less Frequent
Anemia Fever Neutropenic disorder Retinal detachment Thrombocytopenic disorder	Hallucinations Hemorrhage Hyperkalemia Hypersensitivity drug reaction Hypophosphatemia Kidney disease with reduction in glomerular filtration rate (GFr) Pancytopenia Seizure disorder

Rare/Very Rare
Abnormal hepatic function tests Acute renal failure Agranulocytosis Anaphylaxis Aplastic anemia Ascites Drug-induced psychosis Dyspnea Granulocytopenic disorder Hypertension Leukopenia Pleural effusions

There are 41 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Diarrhea Headache disorder Insomnia Nausea Paresthesia Peripheral neuropathy Tremor Urinary tract infection Vomiting	Acute cognitive impairment Agitation Candidiasis Hematuria Night sweats Ocular pain Peripheral edema Symptoms of anxiety Weight loss

Rare/Very Rare
Abdominal distension Acne vulgaris Anorexia Arthralgia Back pain Constipation Cough Cramps Depression Dizziness Dyspepsia Dysuria Edema Fatigue Female infertility General weakness Oligospermia Pain Pharyngitis Pruritus of skin Skin inflammation Upper respiratory infection

The following precautions are available for VALCYTE (valganciclovir hcl):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of valganciclovir have not been established in pediatric patients younger than 1 month of age. Use of valganciclovir for the prevention of CMV disease in pediatric heart transplant recipients 1 month to 16 years of age is based on safety and pharmacokinetic data from 2 studies in pediatric solid organ transplant recipients and is supported by efficacy data from studies in adult solid organ transplant recipients. Use of valganciclovir for the prevention of CMV disease in pediatric kidney transplant recipients 4 months to 16 years of age is based on safety, tolerability, and pharmacokinetic data from 2 open-label studies in solid organ transplant recipients in this age group and is supported by efficacy data from studies in adult solid organ transplant recipients.

Safety and efficacy of valganciclovir have not been established for prevention of CMV disease in pediatric heart transplant recipients younger than 1 month of age, pediatric kidney transplant recipients younger than 4 months of age, or pediatric liver transplant recipients of any age. The safety profile of valganciclovir in pediatric patients generally is similar to that observed in adults. However, upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, abdominal pain, and neutropenia have been reported more frequently in pediatric patients than in adults.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

In animal studies, ganciclovir caused maternal and fetal toxicity, embryofetal mortality, and teratogenicity. Valganciclovir is expected to have reproductive toxicity similar to ganciclovir. (See Teratogenesis under Warnings/Precautions: Warnings, in Cautions.) Data are not available regarding use of valganciclovir in pregnant women to establish the presence or absence of drug-associated risk.

An ex vivo placental model indicates that ganciclovir crosses the human placenta by passive diffusion and is not saturable over a concentration range of 1-10 mg/mL. Although most maternal CMV infections are asymptomatic or may be associated with a self-limited mononucleosis-like syndrome, CMV infections in pregnant immunocompromised patients (e.g., those with human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS), transplant recipients) may be symptomatic and result in substantial maternal morbidity and mortality. Perinatal transmission of CMV from infected mothers to their neonates can occur resulting in congenital CMV infection and disease.

(See Congenital Cytomegalovirus Disease under Uses: Treatment of Cytomegalovirus Infection and Disease.) Females of childbearing potential should undergo pregnancy testing before initiation of valganciclovir. In addition, pregnancy should be avoided in female patients receiving valganciclovir and in females with male partners receiving valganciclovir. Females of childbearing potential should be advised to use an effective method of contraception during and for at least 30 days after valganciclovir therapy and male patients should be advised to use a reliable method of barrier contraception during and for at least 90 days after valganciclovir therapy.

It is not known whether valganciclovir or ganciclovir is distributed into human milk, affects the breast-fed infant, or affects milk production. Animal data from studies using ganciclovir indicate that the drug is distributed into milk of lactating rats. Because of the potential for serious adverse effects in nursing infants, valganciclovir is not recommended in breast-feeding women. HIV-infected mothers should be instructed not to breast-feed their infants because of the risk of transmission of HIV.

Safety and efficacy of valganciclovir have not been specifically evaluated in geriatric patients 65 years of age or older and there were insufficient numbers of individuals in this age group in clinical studies to determine whether they respond differently than younger adults. Pharmacokinetics of the drug have been not studied in geriatric patients. Because geriatric individuals frequently have decreased renal function and because valganciclovir is substantially excreted by the kidneys, particular attention should be paid to assessing renal function before and during valganciclovir therapy in this age group.

If evidence of renal impairment exists or develops, appropriate dosage adjustments should be made. In general, dosage should be selected carefully, usually starting at the low end of the dosage range, taking into account the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.

CMV retinitis in AIDS patient
B25.9	Cytomegaloviral disease, unspecified
H32	Chorioretinal disorders in diseases classified elsewhere
Prevention of CMV disease after cardiac transplantation
Z94.1	Heart transplant status
Z94.3	Heart and lungs transplant status
Prevention of CMV disease after kidney transplantation
Z94.0	Kidney transplant status
Prevention of CMV disease in kidney-pancreas transplant
Z94.0	Kidney transplant status
Z94.83	Pancreas transplant status