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Name of the medicinal product. Foscavir 24 mg/ml Solution for Infusion. 2. Qualitative and quantitative composition. Foscarnet trisodium hexahydrate 24 mg /ml. Package leaflet: Information for the user. Foscavir®. 24 mg/ml Solution for Infusion foscarnet. M UK. Read all of this leaflet carefully before you start. Foscavir™ (Foscarnet Sodium) Injection Product Insert rubber latex has not been used in the manufacture of this device or drug container closure system.

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Foscavir 24 mg/ml Solution for Infusion

Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as alfuzosin. If coadministration cannot be avoided, conduct periodic monitoring with electrocardiograms ECGs and electrolytes. Administer within 24 hours of first entry into a sealed bottle.

The most pronounced effects noted during general toxicity studies performed with foscarnet are perturbation of some serum electrolytes, and kidney and bone changes. Major Systemic polymyxin B should not be used concurrently or sequentially with other drugs that have the potential for nephrotoxicity or neurotoxicity such as foscarnet. Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as droperidol.

Potential QT prolongation has been reported in limited case reports with metronidazole. Since colistimethate sodium is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including foscarnet, may increase serum concentrations of either drug. The mechanism behind the kidney changes e. Pasireotide may also prolong the QT interval. Supplementation may be required to normalize mineral and electrolyte balance. Major The risk of renal toxicity may be increased if foscarnet is used in conjunction with other nephrotoxic agents such as cisplatin.

Dosage must be individualised for patients renal function see dosing chart below. Obtain electrocardiograms ECGs and electrolyte concentrations before and periodically during treatment with foscarnet. Remove required dose from the commercially available vial i. Moderate Entecavir may affect renal function and should be used cautiously in combination with other drugs that may also affect renal function including foscarnet.


Ibutilide administration can also cause QT prolongation and TdP; proarrhythmic events should be anticipated. For secondary cytomegalovirus CMV retinitis prophylaxis chronic maintenance therapy in HIV-infected adult and adolescent patients after treatment of the acute CMV retinitis infection. Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: Rare case reports of QT prolongation have also been described when tamoxifen is used at lower doses. Droperidol administration is associated with an established risk for QT prolongation and TdP.

Aminosalicylate sodium, Aminosalicylic acid: Bedaquiline has also been reported to prolong the QT interval. In most cases foscarnet-induced renal toxicity is identified during the second week of induction therapy, but may occur at anytime during treatment. Foscavir is not recommended in patients undergoing haemodialysis since dosage guidelines have not been established.

Theoretically, the chronic coadministration of these drugs may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Eribulin has also been associated with QT prolongation. Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as buprenorphine. Since bradycardia is a risk factor for development of TdP, the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval.

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Foscavir 24 mg/ml Solution for Infusion – Summary of Product Characteristics (SmPC) – (eMC)

Both QT prolongation andTdP have been reported during postmarketing use of foscarnet. Major When possible, avoid concurrent use of foscarnet with other drugs known inwert prolong the QT interval, such as erythromycin. Renal toxicity of Foscavir can be reduced by adequate hydration fooscarnet the patient. Quinolones have been associated with a risk of QT prolongation and TdP. Major Avoid coadministration of encorafenib and foscarnet due to QT prolongation.

Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. In Fosarnet patients, the HIV guidelines suggest that a combination of ganciclovir and foscarnet may be used in patients with sight-threatening disease.


;ackage HIV-infected patients who have had a sustained immune response to highly active antiretroviral therapy i. Major There have been postmarketing reports of QT prolongation and torsade de pointes TdP during treatment with sertraline and the manufacturer of sertraline recommends avoiding concurrent use with drugs known to prolong the QTc interval. The dose must be reduced in patients with renal insufficiency according to the creatinine clearance level as described in the table above.

There is no evidence of an increased myelotoxicity when foscarnet is used in combination with zidovudine AZT. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: The safety and efficacy of foscarnet in children have not been established. Minor The risk of renal toxicity may be increased if foscarnet is used in conjuction with other nephrotoxic agents, such as nonsteroidal antiinflammatory drugs NSAIDs.

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Because of the potential for TdP, use packags foscarnet with dofetilide is contraindicated. Major Avoid coadministration of foscarnet with toremifene due to the risk of additive QT prolongation.

Creatinine renal clearance decreased, electrocardiogram abnormal, gamma-glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased. Renal function should be monitored closely and vancomycin doses should be adjusted according to vancomycin serum concentrations. Also, closely monitor renal function.

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To view the changes to a medicine you must sign up and log in. Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as clarithromycin. Emtricitabine; Tenofovir ppackage fumarate: