FOSCAVIR Solution for infusion Ref.[8528] Active ingredients: Foscarnet

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 24 mg/ml must be diluted. Individually dispensed doses of foscarnet should be aseptically transferred and diluted with equal parts of 0.9% sodium chloride (9 mg/ml) or 5% dextrose (50 mg/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 24 mg/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 60 mg/kg in patients with normal renal function. Dosage must be individualised for patient’s renal function (see dosing chart below). 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 re-treated with the induction regimen.

Induction therapy of mucocutaneous HSV infections unresponsive to aciclovir: Foscavir is administered for 2–3 weeks or until healing of lesions, as intermittent infusions at a dose of 40 mg/kg over one hour every 8 hours in patients with normal renal function. Dosage must be individualised for patients renal function (see dosing chart below). The infusion time should not be shorter than 1 hour.

Efficacy of Foscavir maintenance therapy following induction therapy of aciclovir unresponsive HSV infections has not been established.

Caution: Do not administer Foscavir by rapid intravenous injection.

Table 1. Foscavir Dosing Chart:

Induction Therapy:

CMV Maintenance Therapy:

* A number of patients have received 90 mg/kg as a starting dose for maintenance therapy.

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. Please refer to sections 4.4 and 5.3.

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.

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 relevant cases.

Shelf life

Unopened: 3 years.

Once opened: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.

Do not store above 30°C. Do not refrigerate. If refrigerated or exposed to temperatures below freezing point precipitation may occur. By keeping the bottle at room temperature with repeated shaking, the precipitate can be brought into solution again.

For storage conditions after first opening and/or dilution of the medicinal product, see section 6.3.

Infusion glass bottles of 250 ml.

Individually dispensed doses of foscarnet can be aseptically transferred to plastic infusion bags by the hospital pharmacy. The physico-chemical stability of foscarnet and dilutions thereof in equal parts with 0.9% sodium chloride (9 mg/ml) or 5% dextrose (50 mg/ml) in PVC bags is 7 days. However, diluted solutions should be refrigerated and storage restricted to 24 hours.

Each bottle of Foscavir should only be used to treat one patient with a single infusion.

Accidental skin and eye contact with the foscarnet sodium solution may cause local irritation and burning sensation. If accidental contact occurs, the exposed area should be rinsed with water.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.