Special Warning : אזהרת שימוש

4.4      Special Warnings and Precautions for Use
Foscavir 24mg/ml should be used with caution in patients with reduced renal function.
Since renal function impairment may occur at any time during Foscavir 24mg/ml administration, serum creatinine should be monitored every second day during induction therapy and once weekly during maintenance therapy and appropriate dose adjustments should be performed according to renal function. Adequate hydration should be maintained in all patients (See 4.2 Posology and Method of Administration).
The renal function of patients with renal disease or receiving concomitant treatment with other nephrotoxic medicinal products must be closely monitored (see section 4.5 Interaction with other medicinal products and other forms of interaction ).


This medicinal product contains 1.38 g of sodium per 250 ml bottle, equivalent to equivalent to 69% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The maximum recommended daily dose of this product is 12 g of Foscavir 24mg/ml per day (180 mg/kg/day in average 70 kg male), which is equivalent to 138% of the WHO recommended maximum daily dietary intake for sodium.
Foscavir 24mg/ml is considered high in sodium. This should be particularly taken into account for those on a low sodium diet. Its use should be avoided when a saline load cannot be tolerated (e.g. in cardiomyopathy).


Due to Foscavir’s 24mg/ml propensity to chelate bivalent metal ions, such as calcium, Foscavir 24mg/ml administration may be associated with an acute decrease of ionised serum calcium proportional to the rate of Foscavir 24mg/ml infusion, which may not be reflected in total serum calcium levels. The electrolytes, especially calcium and magnesium, should be assessed prior to and during Foscavir 24mg/ml therapy and deficiencies corrected.


Foscarnet has been associated with cases of prolongation of QT interval and more rarely with cases of torsade de pointes (see section 4.8 Undesirable effects).
Patients with known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances (hypokalaemia, hypomagnesaemia), bradycardia, as well as patients with underlying cardiac diseases such as congestive heart failure or who are taking medications known to prolong the QT interval should be carefully monitored due to increased risk of ventricular arrhythmia. Patients should be advised to promptly report any cardiac symptoms.


Foscavir 24mg/ml is deposited in teeth, bone and cartilage. Animal data show that deposition is greater in young animals. The safety of Foscavir 24mg/ml and its effect on skeletal development have not been investigated in children. (Please refer to Section 5.3 Preclinical safety data)
Seizures, related to alterations in plasma minerals and electrolytes, have been associated with Foscavir 24mg/ml treatment. Cases of status epilepticus have been reported. Therefore, patients must be carefully monitored for such changes and their potential sequelae. Mineral and electrolyte supplementation may be required.


Foscavir 24mg/ml is excreted in high concentrations in the urine and may be associated with significant genital irritation and/or ulceration. To prevent irritation and ulceration, close attention to personal hygiene is recommended and cleaning of the genital area after each micturition is recommended.


Should patients experience extremity paresthesia or nausea, it is recommended to reduce the speed of infusion.


When diuretics are indicated, thiazides are recommended.

Development of resistance: If the administration of Foscavir 24mg/ml does not lead to a therapeutic response or leads to a worsened condition after an initial response, this may result from a reduced sensitivity of viruses towards Foscarnet. In this case, termination of Foscavir 24mg/ml therapy and a change to an appropriate other medicinal product should be considered.

Effects on Driving

4.7      Effects on Ability to Drive and Use Machines
Foscavir 24mg/ml has moderate influence on the ability to drive and use machines.
Due to the disease itself and possible undesirable effects of Foscavir 24 mg/ml (such as dizziness and convulsions , see section 4.8 Undesirable Effects), the ability to drive and use machines can be impaired. The physician is advised to discuss this issue with the patient, and based upon the condition of the disease and the tolerance of medication, give a recommendation in the individual case.