Fomivirsen

Fomivirsen Brand Name– Vitravene

What is Fomivirsen

NOTE: This drug is discontinued in the US.

Fomivirsen (also known as ISIS 2922) is an ophthalmic antiviral agent.

It is administered by intravitreal injection for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have failed therapy with other anti-CMV drugs or who are intolerant or have a contraindication to other therapies.

Fomivirsen is the first drug to be approved based on antisense technology.

It causes fewer side effects and is more selective in its actions than other CMV therapies. Because of its mechanism of action, fomivirsen is more potent against CMV than either ganciclovir or foscarnet.

Fomivirsen injection also appears to be associated with a lower incidence of retinal detachment than ganciclovir intravitreal implant.

Fomivirsen can be used in combination with either foscarnet or ganciclovir. Final FDA approval was granted August 27, 1998.

At the time of approval, the incidence of CMV retinitis had declined due to highly active antiretroviral therapies. As a result, full enrollment was not achieved in any of the clinical trials.

However, 330 patients did receive fomivirsen. If the incidence of CMV retinitis rises, the manufacturer has agreed to conduct phase IV study to further determine the role of fomivirsen.

Indications

  1. cytomegalovirus (CMV)
  2. cytomegalovirus (CMV) retinitis
  3. cytomegalovirus (CMV) retinitis prophylaxis

Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: cytomegalovirus (CMV)

NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.

For the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a contraindication to other treatment(s) or for those who did not respond sufficiently to other treatment(s) for CMV retinitis

Side Effects

  1. abdominal pain
  2. anemia
  3. anorexia
  4. asthenia
  5. back pain
  6. blurred vision
  7. candidiasis
  8. cataracts
  9. chest pain (unspecified)
  10. conjunctival hyperemia
  11. conjunctivitis
  12. corneal edema
  13. cough
  14. dehydration
  15. depression
  16. diaphoresis
  17. diarrhea
  18. dizziness
  19. dyspnea
  20. elevated hepatic enzymes
  21. fever
  22. headache
  23. hypotonia
  24. infection
  25. injection site reaction
  26. iritis
  27. nausea
  28. neutropenia
  29. ocular hemorrhage
  30. ocular hypertension
  31. ocular inflammation
  32. ocular irritation
  33. ocular pain
  34. optic neuritis
  35. pancreatitis
  36. peripheral neuropathy
  37. photophobia
  38. photopsia
  39. rash
  40. retinal detachment
  41. retinal edema
  42. retinal hemorrhage
  43. retinal pigment changes
  44. retinopathy
  45. sinusitis
  46. thrombocytopenia
  47. uveitis
  48. visual impairment
  49. vomiting
  50. weight loss

Monitoring Parameters

  • ophthalmologic exam

Contraindications

  • breast-feeding
  • children
  • glaucoma
  • increased intraocular pressure
  • pregnancy
  • retinal bleeding

Interactions

There are no drug interactions associated with Fomivirsen products.