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Vistide is a brand name for Cidofovir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vistide is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.
Verbatim from this product's EMA label. Tap a section to expand.
The therapy should be prescribed by a physician experienced in the management of HIV infection. Before each administration of Vistide, serum creatinine and urine protein levels should be investigated. 6 for information on obtaining probenecid).
Posology Adults:
Induction treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks. Maintenance treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks.
Suspension of maintenance treatment with cidofovir should be considered in accordance with local recommendations for the management of HIV infected patients.
Elderly population:
The safety and efficacy of Vistide have not been established for the treatment of CMV disease in patients over 60 years of age. Since elderly individuals frequently have reduced glomerular function,Medicinal product no longer authorised 3 particular attention should be paid to assessing renal function before and during administration of Vistide.
4).
Hepatic insufficiency:
The safety and efficacy of Vistide have not been established in patients with hepatic disease and therefore it should be used with caution in this patient population.
Paediatric population:
The safety and efficacy of Vistide in children below 18 years of age have not been established. No data are available. Vistide is not recommended for use in children below 18 years of age. Method of administration Precautions to be taken before handling or administering the medicinal product: Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide.
The preparation of Vistide reconstituted solution should be done in a laminar flow biological safety cabinet. Personnel preparing the reconstituted solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs.
The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or not known (cannot be estimated from the available data). Adverse reactions identified from post-marketing experience are included in italics.
g. blood creatinine increased, proteinuria, glycosuria) received during post-marketing surveillance include some which were fatal. Cases of acute renal failure have been reported after only one or two doses of cidofovir. The finding of any glycosuria, proteinuria/aminoaciduria, hypouricemia, hypophosphatemia and/or hypokalemia, should prompt for the consideration of cidofovir-related Fanconi syndrome.
The following table lists adverse reactions possibly or probably related to probenecid based on clinical trial experience: System Organ Class Adverse reactions Nervous system disorders Common Headache Gastrointestinal disorders Very common Nausea, vomiting Skin and subcutaneous tissue disorders Very common Rash General disorders and administration site conditions Very common Common Fever Asthenia, chills In addition probenecid may also cause other adverse reactions including anorexia, gingival pain, flushing, alopecia, dizziness, anaemia, and pollakiuria.
Hypersensitivity reactions, with dermatitis, pruritus, urticaria and, rarely, anaphylaxis, and Stevens-Johnson syndrome have occurred. There have been reports of leukopenia, hepatic necrosis, nephrotic syndrome, and aplastic anaemia.
Haemolytic anaemia has also occurred, and may be associated with G6DP deficiency. Therefore, when co- prescribing probenecid with cidofovir, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) for full information on the safety profile and other features of that product.
4 Prevention of nephrotoxicity). 2). 4). Direct intraocular injection of Vistide is contraindicated; direct injection may be associated with significant decreases in intraocular pressure and impairment of vision. 4 Special warnings and precautions for use Vistide is formulated for intravenous infusion only and must not be administered by other methods including intraocular injection or topically.
Vistide should be infused only into veins with adequate blood flow to permit rapid dilution and distribution. The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in adults with AIDS. Renal insufficiency/Haemodialysis Treatment with Vistide must not be initiated in patients with creatinine clearance ≤ 55 ml/min, or ≥ 2+ proteinuria (≥ 100 mg/dl), as the optimum induction and maintenance doses for patients with moderateMedicinal product no longer authorised 4 to severe renal impairment are not known.
The efficacy and safety of cidofovir in such conditions has not been established. High flux haemodialysis has been shown to reduce the serum levels of cidofovir by approximately 75%. 0%. 8). g. tenofovir, aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, adefovir and vancomycin).
5). It is recommended to discontinue potentially nephrotoxic agents at least 7 days before starting cidofovir. 0 mg/kg or 10 mg/kg without concomitant probenecid developed evidence of proximal tubular cell injury, including glycosuria, and decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
The signs of nephrotoxicity were partially reversible in some patients. Concomitant use of probenecid is essential for reducing the pronounced nephrotoxicity of cidofovir to an extent that results in an acceptable benefit/risk balance of cidofovir therapy.
6 for information on obtaining probenecid) with each cidofovir dose. All clinical trials relevant to clinical efficacy evaluation were performed using probenecid concomitantly with cidofovir. Two grams of probenecid should be administered 3 hours prior to the cidofovir dose and one gram administered at 2 and again at 8 hours after completion of the 1 hour cidofovir infusion (for a total of 4 grams).
Hypersensitivity to the active substance or to any of the excipients. Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfa- containing medication (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If Vistide contacts the skin, wash membranes and flush thoroughly with water. ) Vistide is for intravenous infusion only. The recommended dose, frequency, or infusion rate must not be exceeded. 9% (normal) saline prior to administration.
The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump. 4).
In order to reduce the potential for nausea and/or vomiting associated with administration of probenecid, patients should be encouraged to eat food prior to each dose of probenecid. The use of an anti-emetic may be necessary. , rash, fever, chills and anaphylaxis), prophylactic or therapeutic use of an appropriate antihistamine and/or paracetamol should be considered.
Cidofovir administration is contraindicated in patients unable to receive probenecid because of a clinically significant hypersensitivity to the active substance or medicinal product or to other sulfa- containing medicines. Use of cidofovir without concomitant probenecid has not been clinically investigated.
A probenecid desensitisation program is not recommended for use. 9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir. 9% saline intravenously with each dose of cidofovir. The first litre of saline solution should be infused over a 1 hour period immediately before the cidofovir infusion, and the second litre, if given, infused over a 1-3 hour period beginning simultaneously with the cidofovir infusion or starting immediately after the infusion of cidofovir.
5 mg/dl), or if persistent proteinuria ≥ 2+ develops. In patients exhibiting ≥ 2+ proteinuria, intravenous hydration should be performed and the test repeated. If following hydration, a ≥ 2+ proteinuria is still observed, cidofovir therapy should be discontinued.
Continued administration of cidofovir to patients with persistent ≥ 2+ proteinuria followingMedicinal product no longer authorised 5 intravenous hydration may result in further evidence of proximal tubular injury, including glycosuria, decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Interruption, and possibly discontinuation, is required for changes in renal function. For those patients who fully recover from cidofovir associated renal toxicity, the benefits-risk balance of reintroducing cidofovir has not yet been evaluated.
Patient monitoring Proteinuria appears to be an early and sensitive indicator of cidofovir-induced nephrotoxicity. Patients receiving cidofovir must have their serum creatinine and urine protein levels determined on specimens obtained within 24 hours prior to the administration of each dose of cidofovir.
8). Ocular events Patients receiving cidofovir should be advised to have […]