(si DOF o veer)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Vistide: 75 mg/mL (5 mL [DSC])
Solution, Intravenous [preservative free]:
Generic: 75 mg/mL (5 mL)
Brand Names: U.S.
- Vistide [DSC]
- Antiviral Agent
Cidofovir is converted to cidofovir diphosphate (the active intracellular metabolite); cidofovir diphosphate suppresses CMV replication by selective inhibition of viral DNA synthesis. Incorporation of cidofovir diphosphate into growing viral DNA chain results in viral DNA synthesis rate reduction.
Vd: 0.41 L/kg; does not cross significantly into CSF
Minimal; phosphorylation occurs intracellularly to the active metabolite cidofovir diphosphate
Urine (70% to 85% as unchanged drug)
Renal clearance without probenecid: 150 ± 26.9 mL/minute/1.73 m2
Renal clearance with probenecid: 98.6 ± 27.9 mL/minute/1.73 m2
Plasma: ~2.6 hours; intracellular elimination half-lives of metabolites are longer (range: 24 to 87 hours) (Lea, 1996)
Special Populations: Renal Function Impairment
Clearance decreases proportionally with CrCl.
Use: Labeled Indications
Cytomegalovirus retinitis: Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
Limitations of use: Safety and efficacy have not been established for treatment of other CMV infections (eg, pneumonitis, gastroenteritis), congenital or neonatal CMV disease, or CMV disease in non-HIV infected individuals.
Off Label Uses
Herpes simplex virus (HSV) infection, acyclovir-resistant:
Data from case reports in immunocompromised patients (stem cell transplant recipients) suggest that intravenous cidofovir may be effective for acyclovir-resistant HSV type 1 mucosal infections [Andrei 2007], [Chen 2000], [LoPresti 1998]. A review article suggested that intravenous cidofovir be reserved for use following treatment failure with intravenous foscarnet due to concerns of cidofovir-associated toxicity [Levin 2004]. Additional trials may be necessary to further define the role of cidofovir in acyclovir-resistant HSV infections.
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, intravenous cidofovir might be effective as an alternative agent to intravenous foscarnet for the treatment of acyclovir-resistant HSV infections, although limited evidence is available and more studies are needed.
Data from a small number of immunocompromised AIDS patients in a randomized, double-blind, placebo-controlled trial suggest that topical cidofovir gel (not commercially available in the US) may be beneficial for the treatment of acyclovir-resistant mucocutaneous HSV infections [Lalezari 1997]. Additional trials may be necessary to further define the role of topical cidofovir in this condition. Review articles suggested that for skin lesions, topical cidofovir may offer the advantage of limiting cidofovir exposure and reduce the potential for cidofovir-associated toxicity and resistance [Levin 2004], [Lingappa 2007].
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, topical cidofovir 1 % gel might be effective as an alternative agent for the treatment of acyclovir-resistant HSV infections, although limited evidence is available and more studies are needed.
Hypersensitivity to cidofovir or any component of the formulation; history of clinically-severe hypersensitivity to probenecid or other sulfa-containing medications; serum creatinine >1.5 mg/dL; CrCl ≤55 mL/minute; urine protein ≥100 mg/dL (≥2+ proteinuria); use with or within 7 days of nephrotoxic agents; direct intraocular injection
Cytomegalovirus (CMV) retinitis: IV:
Induction: 5 mg/kg/dose with concomitant probenecid once weekly for 2 consecutive weeks
Maintenance: 5 mg/kg/dose with concomitant probenecid once every 2 weeks
Probenecid: 2 g 3 hours prior to cidofovir dose, then 1 g at 2 hours and 8 hours after completion of the infusion.
Hydration: Patients should also receive 1 L of NS intravenously infused over 1 to 2 hours immediately prior to each cidofovir infusion. If tolerated, a second liter may be administered over 1 to 3 hours at the start of cidofovir infusion or immediately following infusion.
Herpes simplex virus (HSV) infection, acyclovir-resistant (off-label use):
IV: Mucosal infections: 5 mg/kg/dose once weekly for 3 weeks (Andrei 2007; Chen 2000; LoPresti, 1998), then 5 mg/kg/dose once every 2 weeks for 3 doses (Andrei 2007). Concomitant oral probenecid and hydration has been used to reduce the risk of cidofovir-associated nephrotoxicity (LoPresti 1998)
Topical (off-label route): Mucocutaneous infections: Apply cidofovir 1% gel (extemporaneously prepared by a compounding pharmacy) once daily for 5 days (CDC [Workowski 2015]; Lalezari 1997; Lingappa 2007). Observe for 10 days following treatment; therapy may be repeated if necessary for up to six repetitive cycles (Lalezari 1997)
Refer to adult dosing.
Dosing: Renal Impairment
Preexisting renal impairment: Serum creatinine >1.5 mg/dL, CrCl ≤55 mL/minute, or urine protein ≥100 mg/dL (≥2+ proteinuria): Use is contraindicated.
Changes in renal function during therapy:
Serum creatinine increases by 0.3 to 0.4 mg/dL: Reduce dose to 3 mg/kg.
Serum creatinine increases ≥0.5 mg/dL or development of ≥3+ proteinuria: Discontinue therapy.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Dilute dose in NS 100 mL prior to infusion.
A 1% topical cidofovir gel may be prepared by using 5 mL of the 75 mg/mL cidofovir injection and combining with 32.5 mL of a propylene glycol-based jelly. Of note, propylene glycol may increase the absorption and bioavailability of cidofovir when used on abraded skin (McElhiney 2006).
IV: For IV infusion only. Infuse over 1 hour. Administer with concomitant probenecid. Hydrate with 1 L of NS IV over 1 to 2 hours immediately prior to cidofovir infusion. If tolerated, a second liter may be administered over a 1- to 3-hour period at the start of or immediately following cidofovir infusion.
Topical: Off-label route: An extemporaneously prepared gel may be prepared by a compounding pharmacy and applied topically for mucocutaneous infections (McElhiney 2006).
Store intact vials at 20°C to 25°C (68°F to 77°F). Admixtures in D51/4NS, D5W, or NS may be stored for ≤24 hours under refrigeration; however, admixtures must be administered within 24 hours of preparation.
Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy
Tenofovir Products: Cidofovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. Monitor therapy
Frequency not defined. *Incidence not specifically defined, but reported in the range of >10%. **Incidence not specifically defined, but reported in the range of 1% to 10%.
Cardiovascular: Cardiac disease, cardiac failure, cardiomyopathy, edema, orthostatic hypotension, shock, syncope, tachycardia
Central nervous system: Chills,* headache,* pain,* agitation, amnesia, anxiety, confusion, convulsions, dizziness, hallucination, insomnia, malaise, vertigo
Dermatologic: Alopecia,* skin rash,* skin discoloration, skin photosensitivity, urticaria
Endocrine & metabolic: Decreased serum bicarbonate,* Fanconi’s syndrome,** adrenocortical insufficiency
Gastrointestinal: Anorexia,* diarrhea,* nausea,* oral candidiasis,* vomiting,* abdominal pain, aphthous stomatitis, colitis, constipation, dysphagia, fecal incontinence, gastritis, gastrointestinal hemorrhage, gingivitis, melena, proctitis, stomatitis, tongue discoloration
Genitourinary: Nephrotoxicity,* proteinuria,* urinary incontinence
Hematologic & oncologic: Anemia,* neutropenia,* hypochromic anemia, immune thrombocytopenia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, pseudolymphoma, splenomegaly, thrombocytopenia
Hepatic: Abnormal liver function tests, hepatic disease, hepatic necrosis, hepatomegaly, hepatosplenomegaly, jaundice
Hypersensitivity: Hypersensitivity reaction
Infection: Infection,* sepsis
Local: Injection site reaction
Neuromuscular & skeletal: Weakness,* tremor
Ophthalmic: Decreased intraocular pressure,* iritis,* uveitis,* amblyopia, blindness, cataract, conjunctivitis, corneal lesion, diplopia, visual disturbance
Otic: Hearing loss
Renal: Increased serum creatinine*
Respiratory: Cough,* dyspnea,* pneumonia**
<1%, postmarketing, and/or case reports: Hepatic failure, metabolic acidosis, pancreatitis
Concerns related to adverse effects:
• Carcinogenic/teratogenic: [US Boxed Warning]: Possibly carcinogenic and teratogenic based on animal data. May cause hypospermia.
• Metabolic acidosis: Monitor for signs of metabolic acidosis; decreased sodium bicarbonate with proximal tubule injury and renal wasting syndrome (including Fanconi syndrome), as well as metabolic acidosis with hepatic impairment and pancreatitis (including some fatal cases) have been reported.
• Nephrotoxicity: [US Boxed Warning]: Acute renal failure resulting in dialysis and/or contributing to death has occurred with as few as 1 or 2 doses of cidofovir. Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of cidofovir and the dose of cidofovir modified as appropriate. Administration must be accompanied by oral probenecid and intravenous saline prehydration.
• Neutropenia: [US Boxed Warning]: Neutropenia has been reported; monitor neutrophil counts during therapy.
• Ocular complications: Decreased intraocular pressure, sometimes associated with decreased visual acuity, uveitis, or iritis may occur; monitor intraocular pressure for and signs of iritis/uveitis during therapy. If uveitis or iritis occurs, consider treatment with topical corticosteroids with or without topical cycloplegic agents.
• Renal impairment: Contraindicated in patients with a baseline serum creatinine >1.5 mg/dL, CrCl ≤55 mL/minute, or urine protein ≥100 mg/dL (≥2+ proteinuria); dosage adjustment or discontinuation of therapy may be required for changes in renal function during treatment.
• Administration: For intravenous use only, not for direct intraocular injection; iritis, ocular hypotony, and permanent impairment of vision may occur.
• Appropriate use: [US Boxed Warning]: Indicated only for CMV retinitis treatment in patients with AIDS.
Serum creatinine and urine protein (at baseline and within 48 hours of each dose), WBC with differential (prior to each dose); intraocular pressure and visual acuity, signs and symptoms of uveitis/iritis; metabolic acidosis.
Pregnancy Risk Factor
[US Boxed Warning]: Possibly carcinogenic and teratogenic based on animal data. May cause hypospermia. Women of childbearing potential should use effective contraception during therapy and for 1 month following treatment. Males should use a barrier contraceptive during therapy and for 3 months following treatment.
The indications for treating CMV retinitis during pregnancy are the same as in nonpregnant HIV infected woman; however systemic therapy should be avoided during the first trimester when possible. When therapy is needed to treat maternal infection, agents other than cidofovir are recommended (DHHS [Adult OI 2014]).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, diarrhea, lack of appetite, hair loss, vomiting, or nausea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of infection, signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), vision changes, eye pain, severe eye irritation, shortness of breath, severe loss of strength and energy, or thrush (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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- Drug class: purine nucleosides
Other brands: Vistide