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Atazanavir/cobicistat is a fixed-dos"...
VISTIDE (cidofovir) is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF VISTIDE (cidofovir) 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
VISTIDE (cidofovir) MUST NOT BE ADMINISTERED BY INTRAOCULAR INJECTION.
THE RECOMMENDED DOSAGE, FREQUENCY, OR INFUSION RATE MUST NOT BE EXCEEDED. VISTIDE (cidofovir) 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 VISTIDE (cidofovir) INFUSION.
The recommended induction dose of VISTIDE (cidofovir) 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 VISTIDE (cidofovir) . CrCl (mL/min) should be calculated according to the following formula:
|Creatinine clearance for males =||[140-age (years)] X [body wt (kg)]|
|72 X [serum creatinine (mg/dL)]|
|Creatinine clearance for females =||[140-age (years)] X [body wt (kg)] X 0.85|
|72 X [serum creatinine (mg/dL)]|
The recommended maintenance dose of VISTIDE (cidofovir) is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr), administered once every 2 weeks.
Changes in Renal Function During VISTIDE (cidofovir) Therapy: The maintenance dose of VIS-TIDE must be reduced from 5 mg/kg to 3 mg/kg for an increase in serum creatinine of 0.3 - 0.4 mg/dL above baseline. VISTIDE (cidofovir) 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: VISTIDE (cidofovir) 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 must be administered orally with each VISTIDE (cidofovir) dose. Two grams must be administered 3 hr prior to the VISTIDE (cidofovir) dose and one gram administered at 2 and again at 8 hr after completion of the 1 hr VISTIDE (cidofovir) 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).
Patients must receive at least one liter of 0.9% (normal) saline solution intravenously with each infusion of VISTIDE (cidofovir) . The saline solution should be infused over a 1-2 hr period immediately before the VISTIDE (cidofovir) 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 VISTIDE (cidofovir) 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 VISTIDE (cidofovir) 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 1 hr period. Use of a standard infusion pump for administration is recommended.
It is recommended that VISTIDE (cidofovir) 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 (2-8°C) for no more than 24 hr. Refrigerated admixtures should be allowed to equilibrate to room temperature prior to use.
The chemical stability of VISTIDE (cidofovir) 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.
VISTIDE (cidofovir) is supplied in single-use 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 VISTIDE (cidofovir) . 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 VISTIDE (cidofovir) contacts the skin, wash membranes and flush thoroughly with water. Excess VISTIDE (cidofovir) and all other materials used in the admixture preparation and administration should be placed in a leakproof, puncture-proof container. The recommended method of disposal is high temperature incineration.
Serum creatinine and urine protein must be monitored within 48 hours prior to each dose. White blood cell counts with differential should be monitored prior to each dose. In patients with proteinuria, intravenous hydration should be administered and the test repeated. Intraocular pressure, visual acuity and ocular symptoms should be monitored periodically.
VISTIDE (cidofovir injection) 75 mg/mL for intravenous infusion, is supplied as a non-preserved solution in single-use clear glass vials as follows:
NDC 61958-0101-1...............................375 mg in a 5 mL vial in a single-unit carton
VISTIDE (cidofovir) should be stored at controlled room temperature 20°-25°C (68°-77°F).
Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146-0568. Manufactured for and distributed by: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404.. September 2000. FDA Rev date: 06/26/01
Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.
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