CIDOFOVIR PACKAGE INSERT PDF

If you are a consumer or patient please visit this version. The chemical structure is:. Cidofovir injection is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. The formulation is pH-adjusted to 7. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir.

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Due to dose-dependent nephrotoxicity, renal function, including serum creatinine and urine protein, must be monitored within 48 hours of each dose of cidofovir and the dose of cidofovir modified for changes in renal function as appropriate. Proteinuria may be an early indication of nephrotoxicity. Intravenous normal saline and probenecid therapy must be given concurrently with cidofovir. In clinical trials, very high concentrations of cidofovir were found in the kidneys, and the transport into proximal tubular cells was faster than efflux into the urine, suggesting active tubular secretion.

A high concentration of cidofovir in the kidney is believed to be directly related to renal toxicity, but the actual mechanism is unknown. Probenecid is used to antagonize the active tubular secretion of cidofovir in the proximal tubules. Prior foscarnet therapy has been associated with an increased risk of nephrotoxicity; these patients should be closely monitored. Cidofovir use is contraindicated in patients who are receiving agents with nephrotoxic potential.

At least seven days should pass following the administration of agents with nephrotoxic potential prior to the initiation of therapy with cidofovir. Cidofovir therapy has been associated with neutropenia. Therefore, neutrophil counts should be monitored during cidofovir therapy. Although no adequate studies have been performed in humans, cidofovir was embryotoxic and teratogenic in preclinical animal studies.

Cidofovir is classified as pregnancy category C, and should be used in pregnancy only if the benefit clearly outweighs the potential risk. Women of childbearing potential should use effective contraception during and for one month following treatment with cidofovir. Men should practice barrier contraceptive methods during and for 3 months following treatment with cidofovir. The manufacturer warns of potential male-mediated teratogenicity as cidofovir causes reduced testes weight and hypospermia in animals.

These effects may also occur in humans. Men should also be warned about the potential for infertility. Men should practice barrier contraceptive methods during and for 3 months after treatment with cidofovir. The manufacturer considers cidofovir to be a potential carcinogen in humans and may cause a new primary malignancy.

In animal studies, mammary adenocarcinomas in rats was noted. Women should be warned about the carcinogenic potential of cidofovir and of the limited study of cidofovir in females. Women of childbearing potential should use effective contraception during and for 1 month after treatment with cidofovir. Cidofovir should be used cautiously in children in light of the risk of long-term carcinogenesis and reproductive toxicity. Antiviral; acyclic phosphonate nucleotide analog; structurally similar to acyclovir; not dependent upon intracellular activation.

Used for cyomegalovirus CMV infection; investigational uses include activity against poxviruses. Associated with renal toxicity. Hydration and concomitant administration of probenecid must accompany systemic cidofovir therapy.

Treatment duration depends on the immune status of the patient. For HIV-infected patients who have had a sustained immune response to highly active antiretroviral therapy i.

However, because relapses may occur at any CD4 count, all patients who have had maintenance CMV therapy discontinued should continue to undergo regular ophthalmologic monitoring every 3 months for early detection of CMV relapse as well as for immune reconstitution uveitis.

Various degrees of renal toxicity occurred, from transient increases in serum creatinine to hemodialysis. Symptoms of adenovirus infection cleared in 1 to 4 weeks median 2. Six of 7 patients became culture-negative after the first dose, but 2 had recurrent positive cultures on treatment.

No renal toxicity was reported. Overall 16 of 19 patients had a complete or partial response to cidofovir 9 complete responses versus only 2 patients in the placebo group after a median of 43 days of treatment. The CDC suggests cidofovir as an alternative regimen, but provides no further recommendations.

A small series of 17 patients with severe, recurrent laryngeal papillomatosis were treated with cidofovir 2. Of the 17 patients treated, 14 patients showed complete remission. Four of these patients required relapsed and responded to repeated cidofovir therapy. Duration of therapy was 1 to 13 months. In addition, patients treated with cidofovir for CMV retinitis have reported resolution of molluscum contagiosum. A second dose 1 week later may be considered if clinically indicated.

Preparation and administration of cidofovir solutions should follow guidelines established for other potentially mutagenic agents, such as chemotherapy agents, including preparation in a Class II laminar flow biological safety cabinet.

Personnel preparing and administering this agent should wear protective gloves and gowns. To minimize the potential for renal toxicity, patients must receive oral probenecid and hydration with normal saline concurrently with cidofovir.

Probenecid 2 g PO is administered 3 hours prior to cidofovir and 1 g PO at 2 and 8 hours following the completion of the cidofovir infusion. Hydration with 1 liter NS should be infused over 1—2 hours immediately prior to cidofovir infusion. Patients who can tolerate the fluid load should receive a second liter over 1—3 hours starting with or after the completion of the cidofovir infusion.

Cidofovir is administered via intravenous infusion. Do not administer intraocularly. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous infusion: Dilute in mL 0. Use diluted solutions of cidofovir within 24 hours of preparation. These solutions may be stored at room temperature or under refrigeration. Generic: - Discard product if it contains particulate matter, is cloudy, or discolored - Discard unused portion.

Do not store for later use. The safe and effective use of cidofovir for treatment of other CMV infections e. According to the manufacturer, cidofovir is contraindicated in patients with a known, severe probenecid hypersensitivity, sulfonamide hypersensitivity, or hypersensitivity to other sulfa-containing medications.

Probenecid contains a sulfonamide side chain but does not contain the N4 aromatic amine or the N1-substituent present in sulfonamide antibiotics and thought to be responsible for hypersensitivity-type adverse reactions. The risk of cross-sensitivity in patients taking a nonantibiotic sulfonamide that have a history of sulfonamide hypersensitivity is low and has been confirmed by recent observational studies.

In general, patients with a history of hypersensitivity to any drug are predisposed to subsequent hypersensitivity reactions to other drugs. Because of this, patients with a history of sulfonamide hypersensitivity should be monitored for hypersensitivity reactions to other drugs, including cidofovir; however, treatment with a nonantibiotic sulfonamide may not need to be withheld in patients with a sulfonamide allergy as long as patients are monitored appropriately, especially if alternative therapies are not available.

Dehydration should be avoided prior to and during cidofovir therapy. Adequate hydration is necessary in patients receiving cidofovir in order to prevent potential nephrotoxicity.

Intravenous prehydration with at least one liter of normal saline should be administered prior to each infusion of cidofovir, with additional IV normal saline administered during or after each infusion when tolerated. Special attention should be given to repletion of fluids in patients with chronic diarrhea or AIDS-related wasting because they may have intravascular volume depletion. Direct ocular exposure of cidofovir should be avoided and intraocular administration is contraindicated.

Direct injection has been associated with iritis, ocular hypotony and permanent vision impairment. Iritis is more likely to occur in patients previously treated for CMV retinitis, those having diabetes mellitus, or receiving protease inhibitors.

Patients should be monitored for the development of iritis and uveitis during cidofovir therapy. In addition, intraocular pressures should be monitored during cidofovir therapy as decreases in intraocular pressure associated with decreases in visual acuity have been reported. It is not known if cidofovir is excreted in human milk; however, use during breast-feeding is not recommended because of its potential for carcinogenic and other adverse effects in the infant.

Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a drug administered to the mother, health care providers are encouraged to report the adverse effect to the FDA. Since geriatric patients commonly have reduced glomerular filtration, attention should be paid to renal function before and during therapy. Due to the mutagenic properties of cidofovir, health care personnel should take precautions to avoid accidental exposure to cidofovir.

The National Institutes of Health recommends cidofovir be prepared in a Class II laminar flow biologic safety cabinet and that personnel preparing the drug wear protective gloves and gowns.

If cutaneous exposure occurs, wash and flush thoroughly with water. Excess cidofovir solution and all other materials used in the preparation and administration of this agent should be placed in a leak-proof, puncture-proof container. Aspirin should be discontinued 7 days prior to beginning cidofovir. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Major Since salicylates cause nephrotoxicity, concurrent use of salicylates and cidofovir should be done with caution.

Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Major Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents may lead to additive nephrotoxicity. Salicylates should be given with caution to patients taking cidofovir. Acyclovir: Severe The administration of cidofovir with another potentially nephrotoxic agent, such as acyclovir, is contraindicated.

Acyclovir should be discontinued at least 7 days prior to beginning cidofovir. Adefovir: Severe The administration of cidofovir with another potentially nephrotoxic agent, such as adefovir, is contraindicated. Adefovir should be discontinued at least 7 days prior to beginning cidofovir. Aldesleukin, IL Moderate Aldesleukin may cause nephrotoxicity. Concurrent administration of drugs possessing nephrotoxic effects with Aldesleukin, such as cidofovir, may increase the risk of kidney dysfunction.

In addition, reduced kidney function secondary to Aldesleukin treatment may delay elimination of concomitant medications and increase the risk of adverse events from those drugs.

Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: Severe The administration of cidofovir with another potentially nephrotoxic agent, such as diuretics, is contraindicated. Diuretics should be discontinued at least 7 days prior to beginning cidofovir.

Aliskiren; Hydrochlorothiazide, HCTZ: Severe The administration of cidofovir with another potentially nephrotoxic agent, such as diuretics, is contraindicated. Amikacin: Severe The administration of cidofovir with other potentially nephrotoxic agents, such as aminoglycosides, is contraindicated.

These agents should be discontinued at least 7 days prior to beginning cidofovir. Amiloride: Severe The administration of cidofovir with another potentially nephrotoxic agent, such as diuretics, is contraindicated.

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