pharmacopeia
GET
/api/v1/drug/valganciclovir

Boxed warning

HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir for oral solution [see Warnings and Precautions ( 5.1 )]. Impairment of Fertility: Based on animal data and limited human data, valganciclovir for oral solution may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )]. Fetal Toxicity: Based on animal data, valganciclovir for oral solution has the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )]. Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir for oral solution has the potential to cause cancers in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning. Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir.

2D structure
[2-[(2-amino-6-oxo-1H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate
SMILES CC(C)[C@@H](C(=O)OCC(CO)OCN1C=NC2=C1N=C(NC2=O)N)N
InChIKey WPVFJKSGQUFQAP-GKAPJAKFSA-N

Mechanism of action

Sourced from openFDA

Valganciclovir is an antiviral drug with activity against CMV [see Microbiology ( 12.4 )] .

DNA PolymeraseNucleic Acid Synthesis

Indications

Sourced from openFDA
  • Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2 )] .

Contraindications

Sourced from openFDA
  • Valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions ( 6.1 )]. Hypersensitivity to valganciclovir or ganciclovir.contraindicated

Dosage & administration

Sourced from openFDA

Pediatric Dosage ( 2.3 ) Prevention of CMV disease in kidney transplant patients 4 months to 16 years of age Dose once a day within 10 days of transplantation until 200 days post-transplantation according to dosage algorithm (note the calculation of creatinine clearance using a modified Schwartz formula in children) Prevention of CMV disease in heart transplant patients 1 month to 16 years of age Dose once a day within 10 days of transplantation until 100 days post-transplantation according to dosage algorithm (note the calculation of creatinine clearance using a modified Schwartz formula in children) Valganciclovir for oral solution should be taken with food. ( 2.1 , 12.3 ) 2.1 General Dosing Information Valganciclovir for oral solution should be taken with food [see Clinical Pharmacology ( 12.3 )] . Valganciclovir for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient [see Dosage and Administration ( 2.4 )] . 2.3 Recommended Dosage in Pediatric Patients Prevention of CMV Disease in Pediatric Kidney Transplant Patients : For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of post-transplantation until 200 days post-transplantation. Prevention of CMV Disease in Pediatric Heart Transplant Patients : For pediatric heart transplant patients 1 month to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of transplantation until 100 days post-transplantation.

Warnings & precautions

Sourced from openFDA

Acute renal failure: Acute renal failure may occur in elderly patients (with or without reduced renal function), patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients or those taking nephrotoxic drugs, reduce dosage in patients with renal impairment, and monitor renal function. ( 5.2 , 8.5 , 8.6 ) 5.1 Hematologic Toxicity Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir or ganciclovir. Valganciclovir for oral solution should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dL. Valganciclovir should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions ( 5.1 ) ]. Acute Renal Failure [see Warnings and Precautions ( 5.2 ) ]. Impairment of Fertility [see Warnings and Precautions ( 5.3 )] . Fetal Toxicity [see Warnings and Precautions ( 5.4 )] . Mutagenesis and Carcinogenesis [see Warnings and Precautions ( 5.5 )] . The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with valganciclovir tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with valganciclovir for oral solution or tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache. Adult patients: Most common adverse reactions and laboratory abnormalities (reported in at least one indication by greater than or equal to 20% of patients) are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting.

Use in specific populations

Sourced from openFDA

Lactation: Breastfeeding is not recommended with use of valganciclovir. ( 8.2 ) 8.1 Pregnancy Risk Summary After oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir. In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. There are no available human data on use of valganciclovir or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. The background risk of major birth defects and miscarriage for the indicated populations is unknown. However, the background risk in the U.S. general population of major birth defects is 2% to 4% and the risk of miscarriage is 15% to 20% of clinically recognized pregnancies. Advise pregnant women of the potential risk to the fetus [see Warnings and Precautions (5.3), Use in Specific Populations ( 8.3 )]. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome.

Pharmacokinetics

Sourced from openFDA
Metabolism
Valganciclovir is a prodrug of ganciclovir. Valganciclovir C max and AUC are approximately 1% and 3% of those of ganciclovir, respectively.

Overdosage

Sourced from openFDA

Experience with Valganciclovir Tablets: An overdose of valganciclovir could possibly result in increased renal toxicity [see Use in Specific Populations ( 8.6 )] . Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of valganciclovir [see Clinical Pharmacology ( 12.3 )] . Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . Reports of adverse reactions after overdoses with valganciclovir, some with fatal outcomes, have been received from clinical trials and during postmarketing experience. The majority of patients experienced one or more of the following adverse events: Hematological toxicity: myelosuppression including pancytopenia, bone marrow failure, leukopenia, neutropenia, granulocytopenia Hepatotoxicity: hepatitis, liver function disorder Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute kidney injury, elevated creatinine Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting Neurotoxicity: generalized tremor, seizure

Approval history

Sourced from openFDA
  • Mar 29, 2001NDANDA021304Cheplapharm
  • Aug 28, 2009NDANDA022257Cheplapharm
  • Nov 4, 2014ANDAANDA203511Dr Reddys
  • Nov 4, 2014ANDAANDA200790Strides Pharma Intl
  • Mar 18, 2016ANDAANDA205166Hetero Labs Ltd V
  • Mar 31, 2016ANDAANDA204750Aurobindo Pharma Ltd
  • Jul 18, 2016ANDAANDA205220Actavis Labs Fl Inc
  • Dec 12, 2017ANDAANDA206876Dr Reddys

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
18,445 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use2,93716%
  2. 2Cytomegalovirus Infection1,7959.7%
  3. 3Drug Ineffective1,4758.0%
  4. 4Neutropenia1,1146.0%
  5. 5Pyrexia9485.1%
  6. 6Leukopenia9335.1%
  7. 7Diarrhoea9275.0%
  8. 8Acute Kidney Injury8194.4%
  9. 9Death7584.1%
  10. 10Cytomegalovirus Viraemia7344.0%
  11. 11Pancytopenia6893.7%
  12. 12Drug Resistance6583.6%
  13. 13Anaemia6473.5%
  14. 14Transplant Rejection6353.4%
  15. 15Thrombocytopenia6203.4%

Literature

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Recent PubMed references pinned to Valganciclovir as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 139 ClinicalTrials.gov registrations naming Valganciclovir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Valganciclovir work?
Valganciclovir is an antiviral drug with activity against CMV [see Microbiology ( 12.4 )] .
What is Valganciclovir used for?
According to FDA labeling, Valganciclovir carries indications including: Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies ( 14.2 )] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Valganciclovir?
Valganciclovir is classified as Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, DNA Polymerase Inhibitors, Nucleic Acid Synthesis Inhibitors, Decreased DNA Integrity, Decreased DNA Replication.
What are the brand names for Valganciclovir?
Valganciclovir is marketed under brand names including Valcyte.
What are the contraindications for Valganciclovir?
Valganciclovir labeling lists contraindications including: Valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions ( 6.1 )]. Hypersensitivity to valganciclovir or ganciclovir.. Always consult the full prescribing information and a clinician.
Note. Data for valganciclovir is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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