FOSCARNET PACKAGE INSERT PDF

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FOSCARNET PACKAGE INSERT PDF

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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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Nephrotoxicity is the major toxicity associated with foscarnet therapy; the majority of drug recipients will experience a decline in renal function during therapy. In most cases foscarnet-induced renal toxicity is identified during the second week of induction therapy, but may occur at anytime during treatment. The foscarnet dose MUST be individualized based on the patient’s renal function.

Safety and efficacy data are limited for patients with renal impairment as assessed by baseline serum creatinine SCr levels over 2. Treatment should be discontinued in those whose CrCl drops below 0.

The renal adverse effects are usually, but not always, reversible upon discontinuation or dose adjustment. Dehydration increases the risk for renal toxicity; therefore, maintaining adequate hydration is very important during foscarnet therapy. In certain patients, oral rehydration with similar regimens may be considered. Seizures, including cases of status epilepticus, have been reported with foscarnet therapy, and are associated with foscarnet-induced alterations in plasma minerals and electrolytes.

Therefore, patients must be carefully monitored for such electrolyte imbalances and potential sequelae. Supplementation may be required to normalize mineral and electrolyte balance.

In addition, foscarnet may decrease ionized serum calcium levels without altering total serum calcium concentrations.

Foscavir (foscarnet sodium) dose, indications, adverse effects, interactions from

Instruct patients to immediately report symptoms associated with low ionized calcium perioral tingling, extremity numbness, paresthesias that develop during therapy. Particular caution is recommended for patients in which changes in electrolyte balance may increase the risk of developing neurologic and cardiac dysfunction, such as those individuals who are receiving other drugs that influence serum electrolytes, patients with baseline renal impairment, or those with preexisting cardiac disease, seizure disorder or other neurological disease.

Ensure policies and procedures for managing abnormalities such as tetany, seizures, and cardiac disturbances are in place prior to administering foscarnet. Antiviral agent; organic analog of inorganic pyrophosphate; not associated with myelosuppression; does not require phosphorylation for activation; used in CMV, herpes simplex, and varicella-zoster. In one study, 14 patients with no response to acyclovir were randomized to receive foscarnet or vidarabine.

In all 8 patients assigned to receive foscarnet, lesions healed completely within 10—24 days, while none of the 6 patients assigned to vidarabine demonstrated a clinical response. Infection recurred in most patients a median of 14 days after foscarnet therapy was discontinued. Treatment duration depends on the immune status of the patient. For HIV-infected patients who have had a sustained immune response to highly active antiretroviral therapy i.

However, because relapses may occur at any CD4 count, all patients who have had maintenance CMV therapy discontinued should continue to undergo regular ophthalmologic monitoring every 3 months for early detection of CMV relapse as well as for immune reconstitution uveitis. Routine follow-up every 3 to 6 months with an ophthalmologist is recommended.

The optimal duration of therapy has not been established. The HIV guidelines suggest foscarnet as second-line induction therapy; induction should be followed-up with chronic maintenance therapy secondary prophylaxis. In HIV-infected patients, the HIV guidelines suggest that a combination of ganciclovir and foscarnet may be used in patients with sight-threatening disease.

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Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. No dosage adjustment necessary. No dosage adjustment required. Foscarnet is administered by slow intravenous infusion. Do not administer by rapid IV infusion or by direct IV injection. Monitor renal function and adjust doses accordingly. Adequate hydration is recommended both prior to and during treatment to minimize renal toxicity.

It is recommended that — mL of 0. Equivalent oral rehydration may be considered for certain patients. After the first dose, the hydration fluid should be administered concurrently with each drug infusion. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. No dilution is necessary if administered via a central vein. Dilute under aseptic conditions.

Foscavir 24 mg/ml Solution for Infusion

Administer within 24 hours of first entry into a sealed bottle. Administer packagw slow IV infusion using a controlled infusion device. All doses innsert be infused over at least 1 hour. Foscarnet is not approved by the FDA for administration via intravitreal injection. In clinical studies, intravitreal injection was prepared and administered as follows: Remove required dose from the commercially available vial i. Pass the solution through a packge. Slowly injection into the lower temporal quadrant using a tuberculin syringe and 30 gauge needle.

Remove needle and apply a cotton-tippled applicator to the injection point to avoid reflux. Do not store for later use. Foscarnet is only indicated for use in immunocompromised patients with CMV retinitis and mucocutaneous acyclovir-resistant HSV infections. Human studies regarding use of foscarnet during pregnancy have not been conducted; however in animal studies, exposure to foscarnet was associated with a slight increase in skeletal anomalies. The safety of foscarnet in pregnancy has not nisert established, so it should be used only when clearly needed.

According to the manufacturer, it is unknown if foscarnet is distributed into breast milk.

Animal studies have shown that foscarnet distributes into breast milk at concentrations foscarneg are three times greater than pakage plasma concentrations. Due to the potential for serious toxicities in a nursing infants, breast-feeding should be avoided during foscarnet therapy until further clarification of the risk has been made. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.

If a breast-feeding infant experiences an adverse effect related to a drug insrrt to the mother, health care providers are encouraged to report the adverse effect to the FDA. Anemic patients receiving foscarnet should be monitored for decreases in hemoglobin, which could exacerbate the symptoms of anemia. Instruct patients to avoid driving or operating machinery until the effects of foscarnet on the individual patient are known.

In some patients, foscarnet has been associated with the development of seizures, dizziness, and somnolence. To avoid infusion-related reactions, ensure foscarnet is only administered into veins with adequate blood flow to permit rapid dilution and distribution.

Failure to do so may result in local irritation. Postmarketing use of foscarnet has been associated with prolongation of the QT interval. In some cases, patients insett confounding risk factors such as underlying cardiac disease, electrolyte abnormalities, and other concomitant medications.

Exercise caution when administering the drug to patients with a history of QT prolongation, long QT syndrome, electrolyte imbalances, or other risk factors for QT prolongation.

In addition, concurrent use of foscarnet with other medications known to prolong the QT interval should be avoided whenever possible. Obtain electrocardiograms ECGs and electrolyte concentrations before and periodically during treatment with foscarnet. Minor Concurrent use of foscarnet and zidovudine, ZDV may be associated with a higher incidence of anemia; clinicians should follow normal recommendations for blood count monitoring and other parameters.

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Minor Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents, such as foscarnet, may lead to additive nephrotoxicity. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Major The risk of renal toxicity may be increased if foscarnet is used in conjuction with other nephrotoxic agents, such as acyclovir. Avoid concurrent use, unless the potential benefits outweigh the risks to the patient.

Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as short-acting beta-agonists. Foscarnet has been associated with postmarketing reports of both QT prolongation and torsade de pointes TdP.

Beta-agonists pacjage be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses, when associated with hypokalemia, or when used with other drugs known to prolong the QT interval.

This risk may be more clinically significant with long-acting beta-agonists as compared to short-acting beta-agonists. If these drugs are administered together, obtain an electrocardiogram and electrolyte concentrations before and periodically during treatment.

Moderate Aldesleukin may cause nephrotoxicity. Concurrent administration of drugs possessing nephrotoxic effects with Aldesleukin, such as foscarnet, may increase the risk of kidney dysfunction. In addition, reduced kidney function secondary to Aldesleukin treatment may delay elimination of concomitant medications and increase the risk of adverse events from those drugs.

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

Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as alfuzosin. Based on electrophysiology studies performed by the manufacturer, alfuzosin may prolong the QT interval in a dose-dependent manner.

Major The risk of renal toxicity may be increased if foscarnet is used in conjunction with other nephrotoxic agents such as aminoglycosides. Aminosalicylate sodium, Aminosalicylic acid: Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as amiodarone. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after discontinuation of amiodarone.

Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as tricyclic antidepressants. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy elevated serum concentrations. Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as clarithromycin.

Clarithromycin is also associated with an established risk for QT prolongation and TdP. Major The risk of renal toxicity may be increased if foscarnet is used in conjunction with other nephrotoxic agents such as amphotericin B. Amphotericin B liposomal LAmB: Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as anagrelide.

Torsade de pointes TdP and ventricular packae have also been reported with anagrelide. In addition, dose-related increases in mean QTc and heart rate were observed in healthy subjects.

Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as apomorphine.