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  • Foscavir
    / Megapharm


    Active Ingredient
    Foscarnet Trisodium (hexahydrate) 24 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    250 ml

    partial basket chart 83426 6498

    Related information


    Dosage

    Method of administration: Foscarnet should be administered by the intravenous route only, either by a central venous line or in a peripheral vein.
    When peripheral veins are used, the solution of foscarnet 24mg/ml must be diluted. Individually dispensed doses of foscarnet should be aseptically transferred and diluted with equal parts of 0.9% sodium chloride (9mg/ml) or 5% dextrose (50mg/ml) by the hospital pharmacy. The diluted solutions should be used as soon as possible after preparation but can be stored for up to 24 hours if kept refrigerated.
    The solution of foscarnet 24mg/ml may be given without dilution via a central vein.
    Adults: Induction therapy for CMV retinitis: Foscavir is administered over 2-3 weeks depending on the clinical response, as intermittent infusions every 8 hours at a dose of 60mg/kg in patients with normal renal function. Dosage must be individualised for patient’s renal function (see dosing chart). The infusion time should not be shorter than 1 hour.
    Maintenance therapy: For maintenance therapy, following induction therapy of CMV retinitis, Foscavir is administered seven days a week as long as therapy is considered appropriate. In patients with normal renal function it is recommended to initiate therapy at 60 mg/kg. Increase to a dose of 90-120 mg/kg may then be considered in patients tolerating the initial dose level and/or
    those with progressive retinitis. A number of patients have received 90 mg/kg over a 2 hour period as a starting dose for maintenance therapy. Dosage must be reduced in patients with renal insufficiency (see dosage chart at end of dosage section).
    Patients who experience progression of retinitis while receiving maintenance therapy may be retreated with the induction regimen.
    Caution: Do not administer Foscavir by rapid intravenous injection.
    For dosing chart please refer to prescribing information.
    Foscavir is not recommended in patients undergoing haemodialysis since dosage guidelines have not been established.
    Hydration: Renal toxicity of Foscavir can be reduced by adequate hydration of the patient. It is recommended to establish diuresis by hydration with 0.5-1.0 Litre of normal saline at each infusion.
    In compliant patients, oral hydration with similar hydration regimens has been used. Clinically dehydrated patients should have their condition corrected before initiating Foscavir therapy.
    Elderly: As for adults.
    Paediatric population: The safety and efficacy of foscarnet in children have not been established.
    Renal or hepatic insufficiency: The dose must be reduced in patients with renal insufficiency, according to the creatinine clearance level as described in the table above. Dose adjustment is not required in patients with hepatic insufficiency.


    Indications

    Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    Since Foscavir can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporin A, acyclovir, methotrexate and tacrolymus. Moreover, since Foscavir can reduce serum levels of ionised calcium, extreme caution is advised when used concurrently with other drugs known to influence
    serum calcium levels, like i.v. pentamidine. Renal impairment and symptomatic hypocalcaemia (Trousseau’s and Chvostek’s signs) have been observed during concurrent treatment with Foscavir and i.v. pentamidine. Abnormal renal function has been reported in connection with the use of Foscavir in combination with ritonavir and/or saquinavir.
    There is no pharmacokinetic interaction with zidovudine (AZT), ganciclovir, didanosine (ddI), zalcitabine (ddC) or probenicide.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of foscarnet in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Foscavir is not recommended during pregnancy.
    Lactation: There is insufficient information on the excretion of foscarnet in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of foscarnet in milk.
    A risk to the newborns/infants cannot be excluded. Foscavir should not be used during breast-feeding.
    A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Foscavir therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.


    Overdose

    Overdose has been reported during the use of Foscavir, the highest being some 20 times the recommended dose. Some of the cases were relative overdoses, in that the dose of drug used had not been promptly adjusted for a patient experiencing reduced renal function. There are cases where it has been reported that no clinical sequelae were consequent on the overdose.
    The pattern of adverse events reported in association with an overdose of Foscavir is in accordance with the known adverse event profile of the drug.
    Haemodialysis increases Foscavir elimination and may be of benefit in severe over dosage.


    Manufacturer
    Fresenius Kabi
    Licence holder
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