Valganciclovir

What is Valganciclovir

Valganciclovir is the L-valyl ester of ganciclovir (i.e., a prodrug), which exists as a mixture of two diastereomers.

After oral administration, both diastereomers are rapidly converted to ganciclovir. Ganciclovir is a synthetic analog of guanine and is effective against human cytomegalovirus (CMV) infections. The advantage of valganciclovir is the ability to attain in vivo exposure similar to IV ganciclovir and higher than oral ganciclovir capsules.

During induction therapy of CMV retinitis, similar outcomes were noted in patients treated with valganciclovir or IV ganciclovir. Valganciclovir is approved for use as induction treatment of CMV retinitis in patients with AIDS, as maintenance therapy after induction, or in patients with inactive CMV retinitis.

Valganciclovir is also approved for prophylaxis against CMV after heart, kidney, or kidney-pancreas transplantation.

Valganciclovir received initial FDA-approval for use in adults in March 2001.

Approval was extended to children 4 months and older for the prevention of CMV disease in kidney and heart transplant patients in August 2009, and in April 2015, valganciclovir was approved for use in infants as young as 1 month of age after heart transplant.

Brand Name

Valcyte

Indications

  1. congenital cytomegalovirus (CMV) disease
  2. cytomegalovirus (CMV)
  3. cytomegalovirus (CMV) disease prophylaxis
  4. cytomegalovirus (CMV) retinitis
  5. cytomegalovirus (CMV) retinitis prophylaxis
  6. cytomegalovirus (CMV)-associated gastrointestinal disease
  7. encephalitis
  8. Epstein-Barr virus
  9. herpes simplex virus type 1
  10. herpes simplex virus type 2
  11. human herpesvirus 6 (HHV-6)
  12. human herpesvirus 6 (HHV-6) infection
  13. human herpesvirus 8 (HHV-8)
  14. human herpesvirus 8 (HHV-8) infection
  15. multicentric Castleman disease
  16. varicella-zoster virus

Side Effects

  1. abdominal pain
  2. agitation
  3. agranulocytosis
  4. anaphylactic shock
  5. anemia
  6. anxiety
  7. aplastic anemia
  8. arthralgia
  9. asthenia
  10. back pain
  11. bleeding
  12. bone marrow suppression
  13. candidiasis
  14. chills
  15. clastogenesis
  16. confusion
  17. constipation
  18. cough
  19. depression
  20. diarrhea
  21. dizziness
  22. dysgeusia
  23. dyspepsia
  24. dyspnea
  25. elevated hepatic enzymes
  26. fatigue
  27. fever
  28. hallucinations
  29. headache
  30. hearing loss
  31. hematuria
  32. hyperkalemia
  33. hypophosphatemia
  34. hypotension
  35. infection
  36. infertility
  37. influenza
  38. insomnia
  39. leukopenia
  40. macular edema
  41. malaise
  42. muscle cramps
  43. myalgia
  44. nausea
  45. neutropenia
  46. new primary malignancy
  47. night sweats
  48. ocular pain
  49. oral ulceration
  50. pancreatitis
  51. pancytopenia
  52. paresthesias
  53. peripheral edema
  54. peripheral neuropathy
  55. pharyngitis
  56. pruritus
  57. psychosis
  58. renal failure (unspecified)
  59. retinal detachment
  60. seizures
  61. spermatogenesis inhibition
  62. teratogenesis
  63. thrombocytopenia
  64. tremor
  65. vomiting
  66. weight loss
  67. wound dehiscence

Monitoring Parameters

  • CBC with differential
  • ophthalmologic exam
  • pregnancy testing
  • serum creatinine/BUN

Contraindications

  • accidental exposure
  • acyclovir hypersensitivity
  • anemia
  • antimicrobial resistance
  • aplastic anemia
  • bone marrow suppression
  • breast-feeding
  • children
  • contraception requirements
  • dehydration
  • dialysis
  • famciclovir hypersensitivity
  • ganciclovir hypersensitivity
  • geriatric
  • infants
  • infertility
  • male-mediated teratogenicity
  • neonates
  • neutropenia
  • new primary malignancy
  • ocular exposure
  • penciclovir hypersensitivity
  • pregnancy
  • pregnancy testing
  • radiation therapy
  • renal failure
  • renal impairment
  • reproductive risk
  • thrombocytopenia
  • valacyclovir hypersensitivity
  • valganciclovir hypersensitivity

Interactions

  • Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
  • Amikacin
  • Aminoglycosides
  • Amphotericin B
  • Amphotericin B cholesteryl sulfate complex (ABCD)
  • Amphotericin B lipid complex (ABLC)
  • Amphotericin B liposomal (LAmB)
  • Aprotinin
  • Bacitracin
  • Bictegravir; Emtricitabine; Tenofovir Alafenamide
  • Cisplatin
  • Colchicine; Probenecid
  • Cyclosporine
  • Dapsone
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Didanosine, ddI
  • Doravirine; Lamivudine; Tenofovir disoproxil fumarate
  • Doxorubicin
  • Efavirenz; Emtricitabine; Tenofovir
  • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Emtricitabine
  • Emtricitabine; Rilpivirine; Tenofovir alafenamide
  • Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
  • Emtricitabine; Tenofovir alafenamide
  • Emtricitabine; Tenofovir disoproxil fumarate
  • Entecavir
  • Flucytosine
  • Gentamicin
  • Hyaluronidase, Recombinant; Immune Globulin
  • Hydroxyurea
  • Imipenem; Cilastatin
  • Imipenem; Cilastatin; Relebactam
  • Immune Globulin IV, IVIG, IGIV
  • Kanamycin
  • Lamivudine, 3TC; Zidovudine, ZDV
  • Lamivudine; Tenofovir Disoproxil Fumarate
  • Mycophenolate
  • Nonsteroidal antiinflammatory drugs
  • Paromomycin
  • Pentamidine
  • Plazomicin
  • Polymyxin B
  • Probenecid
  • Streptomycin
  • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
  • Tacrolimus
  • Talimogene Laherparepvec
  • Telbivudine
  • Tenofovir Alafenamide
  • Tenofovir, PMPA
  • Tobramycin
  • Trimethoprim
  • Vancomycin
  • Vinblastine
  • Vinca alkaloids
  • Vincristine
  • Vincristine Liposomal
  • Vinorelbine
  • Zidovudine, ZDV
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