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Valcyte (Valganciclovir Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for Valcyte. Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 8.

Table 8 Established and Other Potentially Significant Drug Interactions With Ganciclovir
Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment
Zidovudine ↓ Ganciclovir
↑ Zidovudine
Zidovudine and Valcyte each have the potential to cause neutropenia and anemia
Probenecid ↑ Ganciclovir Patients taking probenecid and Valcyte should be monitored for evidence of ganciclovir toxicity
Mycophenolate Mofetil (MMF) ↔ Ganciclovir (in patients with normal renal function)
↔ MMF (in patients with normal renal function)
Patients with renal impairment should be monitored carefully as levels of MMF metabolites and ganciclovir may increase
Didanosine ↓ Ganciclovir
↑ Didanosine
Patients should be closely monitored for didanosine toxicity

OVERDOSAGE

Experience With Valcyte Tablets: One adult developed fatal bone marrow depression (medullary aplasia) after several days of dosing that was at least 10-fold greater than recommended for the patient's estimated degree of renal impairment.

An overdose of Valcyte could also possibly result in increased renal toxicity [see Dosage and Administration, Use in Specific Populations].

Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of Valcyte [see Clinical Pharmacology]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [see Clinical Pharmacology].

Experience With Intravenous Ganciclovir: Reports of overdoses with intravenous ganciclovir 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: pancytopenia, bone marrow depression, medullary aplasia, leukopenia, neutropenia, granulocytopenia

Hepatotoxicity: hepatitis, liver function disorder

Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine

Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting

Neurotoxicity: generalized tremor, convulsion

CONTRAINDICATIONS

Valcyte 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].

REFERENCES

  • NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  • OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  • American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
  • Polovich, M., White, J. M., & Kelleher, L.O. (eds.). 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.). Pittsburgh, PA: Oncology Nursing Society.
  • Drew A.L., Miner R., Saleh E. 1993. Antiviral Susceptibility Testing of Cytomegalovirus Criteria for Detecting Resistance to Antivirals. Clinical Diagnostic Virology 1:179-185.
  • Hakki M., Chou, S. The biology of cytomegalovirus drug resistance. Curr Opinion in Infectious Dis. 2011; 24:605-611.
  • Lurain, N.S., Chou, S. Antiviral drug resistance of humancytomegalovirus. Clin Microbiol Rev. 2010; 23(4):689-712.

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