Cidofovir

• INDICATION AND USAGE Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.ICD-10: B20

• Initiation of therapy with cidofovir injection is contraindicated in patients with a serum creatinine >1.5 mg/dL, a calculated creatinine clearance ≤55 mL/min, or a urine protein ≥100 mg/dL (equivalent to ≥2+ proteinuria). Cidofovir injection is contraindicated in patients receiving agents with nephrotoxic potential.contraindicated

CIDOFOVIR INJECTION, USP MUST NOT BE ADMINISTERED BY INTRAOCULAR INJECTION. Dosage THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATE MUST NOT BE EXCEEDED. CIDOFOVIR INJECTION, USP MUST BE DILUTED IN 100 MILLILITERS 0.9% (NORMAL) SALINE PRIOR TO ADMINISTRATION. TO MINIMIZE POTENTIAL NEPHROTOXICITY, PROBENECID AND INTRAVENOUS SALINE PREHYDRATION MUST BE ADMINISTERED WITH EACH CIDOFOVIR INFUSION. Induction Treatment The recommended induction dose of cidofovir injection for patients with a serum creatinine of ≤1.5 mg/dL, a calculated creatinine clearance > 55 mL/min, and a urine protein <100 mg/dL (equivalent to < 2+ proteinuria) is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. Because serum creatinine in patients with advanced AIDS and CMV retinitis may not provide a complete picture of the patient's underlying renal status, it is important to utilize the Cockcroft-Gault formula to more precisely estimate creatinine clearance (CrCl). As creatinine clearance is dependent on serum creatinine and patient weight, it is necessary to calculate clearance prior to initiation of cidofovir injection.

Nephrotoxicity Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to cidofovir injection administration. Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of cidofovir injection. Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of cidofovir injection. Dose adjustment or discontinuation is required for changes in renal function (serum creatinine and/or urine protein) while on therapy. Proteinuria, as measured by urinalysis in a clinical laboratory, may be an early indicator of cidofovir injection -related nephrotoxicity. Continued administration of cidofovir injection may lead to additional proximal tubular cell injury, which may result in glycosuria, decreases in serum phosphate, uric acid, and bicarbonate, elevations in serum creatinine, and/or acute renal failure, in some cases, resulting in the need for dialysis. Patients with these adverse events occurring concurrently and meeting a criteria of Fanconi's syndrome have been reported. Renal function that did not return to baseline after drug discontinuation has been observed in clinical studies of cidofovir injection. Intravenous normal saline hydration and oral probenecid must accompany each cidofovir infusion. Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (see PRECAUTIONS ).

Nephrotoxicity: Renal toxicity, as manifested by ≥2+ proteinuria, serum creatinine elevations of ≥0.4 mg/dL, or decreased creatinine clearance ≤55 mL/min, occurred in 79 of 135 (59%) patients receiving cidofovir injection at a maintenance dose of 5 mg/kg every other week. Maintenance dose reductions from 5 mg/kg to 3 mg/kg due to proteinuria or serum creatinine elevations were made in 12 of 41 (29%) patients who had not received prior therapy for CMV retinitis (Study 106) and in 19 of 74 (26%) patients who had received prior therapy for CMV retinitis (Study 107). Prior foscarnet use has been associated with an increased risk of nephrotoxicity; therefore, such patients must be monitored closely (see CONTRAINDICATIONS , WARNINGS , DOSAGE AND ADMINISTRATION ). Neutropenia: In clinical trials, at the 5 mg/kg maintenance dose, a decrease in absolute neutrophil count to ≤500 cells/mm 3 occurred in 24% of patients. Granulocyte colony stimulating factor (GCSF) was used in 39% of patients. Decreased Intraocular Pressure/Ocular Hypotony : Among the subset of patients monitored for intraocular pressure changes, a ≥50% decrease from baseline intraocular pressure was reported in 17 of 70 (24%) patients at the 5 mg/kg maintenance dose. Severe hypotony (intraocular pressure of 0 to 1 mm Hg) has been reported in 3 patients. Risk of ocular hypotony may be increased in patients with preexisting diabetes mellitus. Anterior Uveitis/Iritis: Uveitis or iritis has been reported in clinical trials and during postmarketing in patients receiving cidofovir injection therapy.

Pregnancy Teratogenic Effects: Pregnancy Category C Cidofovir was embryotoxic (reduced fetal body weights) in rats at 1.5 mg/kg/day and in rabbits at 1 mg/kg/day, doses which were also maternally toxic, following daily intravenous dosing during the period of organogenesis. The no-observable-effect levels for embryotoxicity in rats (0.5 mg/kg/day) and in rabbits (0.25 mg/kg/day) were approximately 0.04 and 0.05 times the clinical dose (5 mg/kg every other week) based on AUC, respectively. An increased incidence of fetal external, soft tissue and skeletal anomalies (meningocele, short snout, and short maxillary bones) occurred in rabbits at the high dose (1 mg/kg/day) which was also maternally toxic. There are no adequate and well-controlled studies in pregnant women. Cidofovir injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Two cases of cidofovir overdose have been reported. These patients received single doses of cidofovir injection at 16.3 mg/kg and 17.4 mg/kg, respectively, with concomitant oral probenecid and intravenous hydration. In both cases, the patients were hospitalized and received oral probenecid (one gram three times daily) and vigorous intravenous hydration with normal saline for 3 to 5 days. Significant changes in renal function were not observed in either patient.

• Jun 27, 2012ANDAANDA201276Mylan Institutional
• Jul 26, 2012ANDAANDA202501Avet Lifesciences

1. 1Off Label Use32824%
2. 2Drug Ineffective25819%
3. 3Drug Resistance14811%
4. 4Adenovirus Infection1339.6%
5. 5Acute Kidney Injury1329.5%
6. 6Bk Virus Infection1128.1%
7. 7Product Use In Unapproved Indication946.8%
8. 8Renal Impairment936.7%
9. 9Cytomegalovirus Infection896.4%
10. 10Drug Ineffective For Unapproved Indication815.8%
11. 11Cystitis Haemorrhagic755.4%
12. 12Viral Haemorrhagic Cystitis715.1%
13. 13Renal Failure695.0%
14. 14Cytomegalovirus Infection Reactivation634.5%
15. 15Multiple Organ Dysfunction Syndrome624.5%

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

• Patient with longstanding mpox keratitis successfully treated with topical Cidofovir 0.5% eye drops: a case report.
  BMC ophthalmology · 2026 · Otiti-Sengeri J, Mugisha D, Ngoma DB, et al.
  PMID 42168928DOI 10.1186/s12886-026-04930-6
• Intravitreal Cidofovir Injection for Refractory End-Stage Glaucoma and Vision Loss in Silicone Oil-Filled Eyes Following Retinal Reattachment Surgery in Dogs: Four Cases.
  Veterinary ophthalmology · 2026 · Kim S, Shim J
  PMID 42046189DOI 10.1111/vop.70185
• Treatment of Severe Ocular Mpox with Cidofovir and Tecovirimat.
  Emerging infectious diseases · 2026 · Brousse X, Kreidie R, Mourgues E, et al.
  PMID 41986997DOI 10.3201/eid3204.250882
• Intervention timing and disease stage shape tecovirimat and cidofovir efficacy in male SCID mice.
  Nature communications · 2025 · Cao X, Shi N, Qiu X, et al.
  PMID 41413043DOI 10.1038/s41467-025-67548-0
• Cidofovir induces antiviral immunity against Bombyx mori nucleopolyhedrovirus by modulating multiple immune pathways in silkworm.
  Pesticide biochemistry and physiology · 2026 · Mehmood N, Awais MM, Ma G, et al.
  PMID 41326100DOI 10.1016/j.pestbp.2025.106738
• Lipid-Optimized Sulfone-Bridged Cidofovir Prodrugs as Potent Antivirals Against Orthopoxviruses.
  Journal of medicinal chemistry · 2025 · Wang B, Wei P, Shi S, et al.
  PMID 41255014DOI 10.1021/acs.jmedchem.5c00863
• Frequency and Characterization of Local Ocular Toxicity in Cats Treated With Topical Ophthalmic Cidofovir for Presumptive Feline Herpesvirus-1 Infection.
  Veterinary ophthalmology · 2026 · Ledbetter EC, Morgan AJ
  PMID 40635316DOI 10.1111/vop.70046
• Treating Adenovirus Infection in Transplant Populations: Therapeutic Options Beyond Cidofovir?
  Viruses · 2025 · Narsana N, Ha D, Ho DY, et al.
  PMID 40431613DOI 10.3390/v17050599

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Cidofovir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
  Completed · Phase 3 · Interventional · 158 enrolled · AiCuris Anti-infective Cures AG
  NCT03073967updated 2026-06-12
• A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
  Recruiting · Phase 3 · Interventional · 180 enrolled · SymBio Pharmaceuticals
  NCT07387367updated 2026-04-27
• Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
  Active not recruiting · Phase 2 · Interventional · 27 enrolled · M.D. Anderson Cancer Center
  NCT01295645updated 2026-03-06
• A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
  Recruiting · Phase 3 · Interventional · 20 enrolled · Takeda
  NCT06439342updated 2026-03-02
• A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
  Recruiting · Observational · 168 enrolled · Takeda
  NCT06555432updated 2025-11-18
• Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
  Completed · Phase 3 · Interventional · 108 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT04055142updated 2024-07-10
• A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
  Recruiting · Phase 2 · Interventional · 52 enrolled · SymBio Pharmaceuticals
  NCT04706923updated 2024-06-21
• Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
  Completed · Observational · 3,520 enrolled · Daniel Benjamin
  NCT01431326updated 2023-09-06
• Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)
  Unknown · Observational · 400 enrolled · Newcastle-upon-Tyne Hospitals NHS Trust
  NCT03465280updated 2022-01-11
• Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
  Completed · Phase 3 · Interventional · 352 enrolled · Shire
  NCT02931539updated 2021-11-03

Frequently asked questions

What is Cidofovir used for?

According to FDA labeling, Cidofovir carries indications including: INDICATION AND USAGE Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cidofovir?

Cidofovir is classified as Nucleosides and nucleotides excl. reverse transcriptase inhibitors, DNA Integrity Alteration.

What are the contraindications for Cidofovir?

Cidofovir labeling lists contraindications including: Initiation of therapy with cidofovir injection is contraindicated in patients with a serum creatinine >1.5 mg/dL, a calculated creatinine clearance ≤55 mL/min, or a urine protein ≥100 mg/dL (equivalent to ≥2+ proteinuria). Cidofovir injection is contraindicated in patients receiving agents with nephrotoxic potential.. Always consult the full prescribing information and a clinician.