Cidofovir
Cidofovir Anhydrous · Injection, Solution · Intravenous
Uses
Cidofovir 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.
Dosage and administration
DOSAGE AND ADMINISTRATION CIDOFOVIR INJECTION MUST NOT BE ADMINISTERED BY INTRAOCULAR INJECTION. Dosage THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATE MUST NOT BE EXCEEDED. CIDOFOVIR INJECTION 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 INJECTION 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 (Cr Cl ). As creatinine clearance is dependent on serum creatinine and patient weight, it is necessary to calculate clearance prior to initiation of cidofovir injection. Cr Cl (mL/min) should be calculated according to the following formula: Creatinine clearance for males = [140-age (years)] × [body wt (kg)] 72 × [serum creatinine (mg/dL)] Creatinine clearance for females = [140-age (years)] × [body wt (kg)]× 0.85 72 × [serum creatinine (mg/dL)] Maintenance Treatment The recommended maintenance dose of cidofovir injection is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over one hr), administered once every 2 weeks. Dose Adjustment Changes in Renal Function During Cidofovir Injection Therapy The maintenance dose of cidofovir injection must be reduced from 5 mg/kg to 3 mg/kg for an increase in serum creatinine of 0.3 to 0.4 mg/dL above baseline. Cidofovir injection therapy must be discontinued for an increase in serum creatinine of ≥ 0.5 mg/dL above baseline or development of ≥ 3+ proteinuria. Preexisting Renal Impairment Cidofovir injection is contraindicated in patients with a serum creatinine concentration > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria). Probenecid Probenecid must be administered orally with each cidofovir injection dose. Two grams must be administered 3 hr prior to the cidofovir injection dose and one gram administered at 2 and again at 8 hr after completion of the one hr cidofovir injection infusion (for a total of 4 grams). Ingestion of food prior to each dose of probenecid may reduce drug-related nausea and vomiting. Administration of an antiemetic may reduce the potential for nausea associated with probenecid ingestion. In patients who develop allergic or hypersensitivity symptoms to probenecid, the use of an appropriate prophylactic or therapeutic antihistamine and/or acetaminophen should be considered (see CONTRAINDICATIONS ). Hydration Patients must receive at least one liter of 0.9% (normal) saline solution intravenously with each infusion of cidofovir injection. The saline solution should be infused over a 1 to 2 hr period immediately before the cidofovir injection infusion. Patients who can tolerate the additional fluid load should receive a second liter. If administered, the second liter of saline should be initiated either at the start of the cidofovir injection infusion or immediately afterwards, and infused over a 1 to 3 hr period. Method of Preparation and Administration Inspect vials visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is observed, the vial should not be used. With a syringe, extract the appropriate volume of cidofovir injection from the vial and transfer the dose to an infusion bag containing 100 mL 0.9% (normal) saline solution. Infuse the entire volume intravenously into the patient at a constant rate over a one hr period. Use of a standard infusion pump for administration is recommended. It is recommended that cidofovir injection infusion admixtures be administered within 24 hr of preparation and that refrigerator or freezer storage not be used to extend this 24 hr limit. If admixtures are not intended for immediate use, they may be stored under refrigeration (2°C to 8°C) for no more than 24 hr. Refrigerated admixtures should be allowed to equilibrate to room temperature prior to use. The chemical stability of cidofovir injection admixtures was demonstrated in polyvinyl chloride composition and ethylene/propylene copolymer composition commercial infusion bags, and in glass bottles. No data are available to support the addition of other drugs or supplements to the cidofovir admixture for concurrent administration. Cidofovir injection is supplied in single-dose vials. Partially used vials should be discarded (see Handling and Disposal ). Compatibility with Ringer's solution, Lactated Ringer's solution or bacteriostatic infusion fluids has not been evaluated. Handling and Disposal Due to the mutagenic properties of cidofovir, adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration, and disposal of cidofovir injection. The National Institutes of Health presently recommends that such agents be prepared in a Class II laminar flow biological safety cabinet and that personnel preparing drugs of this class wear surgical gloves and a closed front surgical-type gown with knit cuffs. If cidofovir injection contacts the skin, wash membranes and flush thoroughly with water. Excess cidofovir injection and all other materials used in the admixture preparation and administration should be placed in a leak-proof, puncture-proof container. The recommended method of disposal is high temperature incineration.
Contraindications
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. Such agents must be discontinued at least seven days prior to starting therapy with cidofovir injection. Cidofovir injection is contraindicated in patients with hypersensitivity to cidofovir. Cidofovir injection is contraindicated in patients with a history of clinically severe hypersensitivity to probenecid or other sulfa-containing medications. Direct intraocular injection of cidofovir injection is contraindicated; direct injection of cidofovir has been associated with iritis, ocular hypotony, and permanent impairment of vision.
Warnings
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 injection infusion. Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (see PRECAUTIONS ). The safety of cidofovir injection has not been evaluated in patients receiving other known potentially nephrotoxic agents, such as intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and non-steroidal anti-inflammatory agents (see DOSAGE AND ADMINISTRATION ). Preexisting Renal Impairment Initiation of therapy with cidofovir injection is contraindicated in patients with a baseline serum creatinine > 1.5 mg/dL, a creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria). Hematological Toxicity Neutropenia may occur during cidofovir injection therapy. Neutrophil count should be monitored while receiving cidofovir injection therapy. Decreased Intraocular Pressure/Ocular Hypotony Decreased intraocular pressure may occur during cidofovir injection therapy, and in some instances has been associated with decreased visual acuity. Intraocular pressure should be monitored during cidofovir injection therapy. Metabolic Acidosis Decreased serum bicarbonate associated with proximal tubule injury and renal wasting syndrome (including Fanconi's syndrome) have been reported in patients receiving cidofovir injection (see ADVERSE REACTIONS ). Cases of metabolic acidosis in association with liver dysfunction and pancreatitis resulting in death have been reported in patients receiving cidofovir injection.
Precautions
General Due to the potential for increased nephrotoxicity, doses greater than the recommended dose must not be administered and the frequency or rate of administration must not be exceeded (see DOSAGE AND ADMINISTRATION ). Cidofovir injection is formulated for intravenous infusion only and must not be administered by intraocular injection. Administration of cidofovir injection by infusion must be accompanied by oral probenecid and intravenous saline prehydration (see DOSAGE AND ADMINISTRATION ). Uveitis/Iritis Uveitis or iritis was reported in clinical trials and during postmarketing in patients receiving cidofovir injection therapy. Treatment with topical corticosteroids with or without topical cycloplegic agents should be considered. Patients should be monitored for signs and symptoms of uveitis/iritis during cidofovir injection therapy. Information for Patients Patients should be advised that cidofovir injection is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during and following treatment. Patients receiving cidofovir injection should be advised to have regular follow-up ophthalmologic examinations. Patients may also experience other manifestations of CMV disease despite cidofovir injection therapy. HIV-infected patients may continue taking antiretroviral therapy, but those taking zidovudine should be advised to temporarily discontinue zidovudine administration or decrease their zidovudine dose by 50%, on days of cidofovir injection administration only, because probenecid reduces metabolic clearance of zidovudine. Patients should be informed of the major toxicity of cidofovir injection, namely renal impairment, and that dose modification, including reduction, interruption, and possibly discontinuation, may be required. Close monitoring of renal function (routine urinalysis and serum creatinine) while on therapy should be emphasized. The importance of completing a full course of probenecid with each cidofovir injection dose should be emphasized. Patients should be warned of potential adverse events caused by probenecid (e.g., headache, nausea, vomiting, and hypersensitivity reactions). Hypersensitivity/allergic reactions may include rash, fever, chills and anaphylaxis. Administration of probenecid after a meal or use of antiemetics may decrease the nausea. Prophylactic or therapeutic antihistamines and/or acetaminophen can be used to ameliorate hypersensitivity reactions. Patients should be advised that cidofovir causes tumors, primarily mammary adenocarcinomas, in rats. Cidofovir injection should be considered a potential carcinogen in humans (see Carcinogenesis, Mutagenesis and Impairment of Fertility ). Women should be advised of the limited enrollment of women in clinical trials of cidofovir injection. Patients should be advised that cidofovir injection caused reduced testes weight and hypospermia in animals. Such changes may occur in humans and cause infertility. Women of childbearing potential should be advised that cidofovir is embryotoxic in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for one month following treatment with cidofovir injection. Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir injection. Drug Interactions Probenecid Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine). Concomitant medications should be carefully assessed. Zidovudine should either be temporarily discontinued or decreased by 50% when coadministered with probenecid on the day of cidofovir injection infusion. Nephrotoxic Agents Concomitant administration of cidofovir injection and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated. Such agents must be discontinued at least 7 days prior to starting therapy with cidofovir injection. Carcinogenesis, Mutagenesis and Impairment of Fertility Chronic, 2-year carcinogenicity studies in rats and mice have not been carried out to evaluate the carcinogenic potential of cidofovir. However, a 26-week toxicology study evaluating once weekly subscapular subcutaneous injections of cidofovir in rats was terminated at 19 weeks because of the induction, in females, of palpable masses, the first of which was detected after six doses. The masses were diagnosed as mammary adenocarcinomas which developed at doses as low as 0.6 mg/kg/week, equivalent to 0.04 times the human systemic exposure at the recommended intravenous cidofovir injection dose based on AUC comparisons. In a 26-week intravenous toxicology study in which rats received 0.6, 3, or 15 mg/kg cidofovir once weekly, a significant increase in mammary adenocarcinomas in female rats as well as a significant incidence of Zymbal's gland carcinomas in male and female rats were seen at the high dose but not at the lower two doses. The high dose was equivalent to 1.1 times the human systemic exposure at the recommended dose of cidofovir injection, based on comparisons of AUC measurements. In light of the results of these studies, cidofovir should be considered to be a carcinogen in rats as well as a potential carcinogen in humans. Cynomolgus monkeys received intravenous cidofovir, alone and in conjunction with concomitant oral probenecid, intravenously once weekly for 52 weeks at doses resulting in exposures of approximately 0.7 times the human systemic exposure at the recommended dose of cidofovir injection.
Side effects
1. 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 ). 2. 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. 3. 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 three patients. Risk of ocular hypotony may be increased in patients with preexisting diabetes mellitus. 4. Anterior Uveitis/Iritis: Uveitis or iritis has been reported in clinical trials and during post-marketing in patients receiving cidofovir injection therapy. Uveitis or iritis was reported in 15 of 135 (11%) patients receiving 5 mg/kg maintenance dosing. Treatment with topical corticosteroids with or without topical cycloplegic agents may be considered. Patients should be monitored for signs and symptoms of uveitis/iritis during cidofovir injection therapy. 5. Metabolic Acidosis: A diagnosis of Fanconi's syndrome, as manifested by multiple abnormalities of proximal renal tubular function, was reported in 1% of patients. Decreases in serum bicarbonate to ≤ 16 mEq/L occurred in 16% of cidofovir-treated patients. Cases of metabolic acidosis in association with liver dysfunction and pancreatitis resulting in death have been reported in patients receiving cidofovir injection. In clinical trials, cidofovir injection was withdrawn due to adverse events in 39% of patients treated with 5 mg/kg every other week as maintenance therapy. The incidence of adverse reactions reported as serious in three controlled clinical studies in patients with CMV retinitis, regardless of presumed relationship to drug, is listed in Table 4. Table 4: Serious Clinical Adverse Events or Laboratory Abnormalities Occurring in > 5% of Patients N = 135 Patients receiving 5 mg/kg maintenance regimen in Studies 105, 106 and 107. # patients (%) Proteinuria (≥ 100 mg/dL) 68 (50) Neutropenia (≤ 500 cells/mm 3 ) 33 (24) Decreased Intraocular Pressure Defined as decreased intraocular pressure (IOP) to ≤ 50% that at baseline. Based on 70 patients receiving 5 mg/kg maintenance dosing (Studies 105, 106 and 107), for whom baseline and follow-up IOP determinations were recorded. 17 (24) Decreased Serum Bicarbonate (≤ 16 mEq/L) 21 (16) Fever 19 (14) Infection 16 (12) Creatinine Elevation (≥ 2.0 mg/dL) 16 (12) Pneumonia 12 (9) Dyspnea 11 (8) Nausea with Vomiting 10 (7) The most frequently reported adverse events regardless of relationship to study drugs (cidofovir or probenecid) or severity are shown in Table 5. The following additional list of adverse events/intercurrent illnesses have been observed in clinical studies of cidofovir injection and are listed below regardless of causal relationship to cidofovir injection. Evaluation of these reports was difficult because of the diverse manifestations of the underlying disease and because most patients received numerous concomitant medicines.
Drug interactions
Drug Interactions Probenecid Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine). Concomitant medications should be carefully assessed. Zidovudine should either be temporarily discontinued or decreased by 50% when coadministered with probenecid on the day of cidofovir injection infusion. Nephrotoxic Agents Concomitant administration of cidofovir injection and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated. Such agents must be discontinued at least 7 days prior to starting therapy with cidofovir injection.
Pregnancy
Pregnancy Teratogenic Effects Cidofovir was embryotoxic (reduced fetal body weights) in rats at 1.5 mg/kg/day and in rabbits at 1.0 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.
Pediatric use
Pediatric Use Safety and effectiveness in children have not been studied. The use of cidofovir injection in children with AIDS warrants extreme caution due to the risk of long-term carcinogenicity and reproductive toxicity. Administration of cidofovir injection to children should be undertaken only after careful evaluation and only if the potential benefits of treatment outweigh the risks.
Geriatric use
Geriatric Use No studies of the safety or efficacy of cidofovir injection in patients over the age of 60 have been conducted. Since elderly individuals frequently have reduced glomerular filtration, particular attention should be paid to assessing renal function before and during cidofovir injection administration (see DOSAGE AND ADMINISTRATION ).
Overdosage
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 3 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.
Description
The chemical name of cidofovir is 1-[( S )-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C 8 H 14 N 3 O 6 P
• 2H 2 O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is: Cidofovir, USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of cidofovir injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION ). Cidofovir Structural Formula
Mechanism of action
Mechanism of Action Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma 1, 2, 3 . Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis.
How supplied
Cidofovir Injection USP, 75 mg per mL, for intravenous infusion, is available in: NDC 67457-210-05 5 mL (375 mg) single-dose vial, packaged individually. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free Sterile, Nonpyrogenic Discard unused portion.
Patient information
Information for Patients Patients should be advised that cidofovir injection is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during and following treatment. Patients receiving cidofovir injection should be advised to have regular follow-up ophthalmologic examinations. Patients may also experience other manifestations of CMV disease despite cidofovir injection therapy. HIV-infected patients may continue taking antiretroviral therapy, but those taking zidovudine should be advised to temporarily discontinue zidovudine administration or decrease their zidovudine dose by 50%, on days of cidofovir injection administration only, because probenecid reduces metabolic clearance of zidovudine. Patients should be informed of the major toxicity of cidofovir injection, namely renal impairment, and that dose modification, including reduction, interruption, and possibly discontinuation, may be required. Close monitoring of renal function (routine urinalysis and serum creatinine) while on therapy should be emphasized. The importance of completing a full course of probenecid with each cidofovir injection dose should be emphasized. Patients should be warned of potential adverse events caused by probenecid (e.g., headache, nausea, vomiting, and hypersensitivity reactions). Hypersensitivity/allergic reactions may include rash, fever, chills and anaphylaxis. Administration of probenecid after a meal or use of antiemetics may decrease the nausea. Prophylactic or therapeutic antihistamines and/or acetaminophen can be used to ameliorate hypersensitivity reactions. Patients should be advised that cidofovir causes tumors, primarily mammary adenocarcinomas, in rats. Cidofovir injection should be considered a potential carcinogen in humans (see Carcinogenesis, Mutagenesis and Impairment of Fertility ). Women should be advised of the limited enrollment of women in clinical trials of cidofovir injection. Patients should be advised that cidofovir injection caused reduced testes weight and hypospermia in animals. Such changes may occur in humans and cause infertility. Women of childbearing potential should be advised that cidofovir is embryotoxic in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for one month following treatment with cidofovir injection. Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir injection.
Label text from the FDA structured product label by Mylan Institutional LLC (revised Apr 15, 2021). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Cidofovir in 1 product
Cidofovir NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 67457-210 | Cidofovir 75 mg/mL Injection, Solution | Mylan Institutional LLC | ANDA |
Frequently asked questions
What is Cidofovir used for?
Cidofovir 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.
What are the side effects of Cidofovir?
1. 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… See the full label for the complete list.
Who makes Cidofovir?
Cidofovir is listed by 1 labeler in the FDA NDC directory, including Mylan Institutional LLC.