Fresenius Kabi Introduces First-Ever Generic for Foscavir® (Foscarnet Sodium) Injection

Increasing access and lowering costs for medicine used to treat immune-compromised patients

Fresenius Kabi announced today the immediate availability in the United States of Foscarnet Sodium Injection. Fresenius Kabi Foscarnet Sodium Injection is available in 6000 mg / 250 mL bottle.

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Fresenius Kabi has launched the first generic for Foscavir® (Foscarnet Sodium Injection). (Photo: Business Wire)

"We're pleased to offer this first-to-market generic for Foscavir in the United States, an important treatment for immune-compromised patients," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi is committed to providing clinicians high-quality, high-value products, at lower costs, to treat a wide variety of disease states."

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. It has special expertise in injectable medicines used in hospitals and other sites of care. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.

About Foscarnet Sodium Injection

Foscarnet Sodium Injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with Foscarnet Sodium Injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. Safety and efficacy of Foscarnet Sodium Injection have not been established for treatment of other CMV infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal CMV disease; or non-immunocompromised individuals. Foscarnet Sodium Injection is also indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. Safety and efficacy of Foscarnet Sodium Injection have not been established for treatment of other HSV infections (e.g., retinitis, encephalitis); congenital or neonatal HSV disease; or HSV in nonimmunocompromised individuals.

Important Safety Information

WARNING

RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCARNET. FREQUENT MONITORING OF SERUM CREATININE, WITH DOSE ADJUSTMENT FOR CHANGES IN RENAL FUNCTION, AND ADEQUATE HYDRATION WITH ADMINISTRATION OF FOSCARNET IS IMPERATIVE.

SEIZURES, RELATED TO ALTERATIONS IN PLASMA MINERALS AND ELECTROLYTES, HAVE BEEN ASSOCIATED WITH FOSCARNET TREATMENT. THEREFORE, PATIENTS MUST BE CAREFULLY MONITORED FOR SUCH CHANGES AND THEIR POTENTIAL SEQUELAE. MINERAL AND ELECTROLYTE SUPPLEMENTATION MAY BE REQUIRED.

FOSCARNET IS INDICATED FOR USE ONLY IN IMMUNOCOMPROMISED PATIENTS WITH CMV RETINITIS AND MUCOCUTANEOUS ACYCLOVIR-RESISTANT HSV INFECTIONS.

Foscarnet Sodium Injection is contraindicated in patients with clinically significant hypersensitivity to Foscarnet sodium.

THE MAJOR TOXICITY OF FOSCARNET IS RENAL IMPAIRMENT. Renal function should be monitored carefully during both induction and maintenance therapy.

SINCE FOSCARNET HAS THE POTENTIAL TO CAUSE RENAL IMPAIRMENT, DOSE ADJUSTMENT BASED ON SERUM CREATININE IS NECESSARY. Hydration may reduce the risk of nephrotoxicity. After the first dose, the hydration fluid should be administered concurrently with each infusion of Foscarnet.

Foscarnet has been associated with changes in serum electrolytes including hypocalcemia, hypophosphatemia, hyperphosphatemia, hypomagnesemia, and hypokalemia. Patients should be advised to report symptoms of low ionized calcium such as perioral tingling, numbness in the extremities and paresthesias. Physicians should be prepared to treat these abnormalities and their sequelae such as tetany, seizures or cardiac disturbances. The rate of Foscarnet infusion may also affect the decrease in ionized calcium. Therefore, an infusion pump must be used for administration to prevent rapid intravenous infusion.

Serious acute hypersensitivity reactions (e.g., anaphylactic shock, urticaria, angioedema) have been reported postmarketing in patients receiving Foscarnet. If such an acute reaction occurs, therapy should be discontinued and appropriate medical therapy immediately instituted.

Foscarnet has been associated with prolongation of the QT interval, an ECG abnormality that has been associated with torsades de pointes, which has been reported during postmarketing surveillance for Foscarnet. Use with caution in patients who have a history of QT prolongation, in patients who are taking medications known to prolong the QT interval, in patients with electrolyte disturbances, or in patients who have other risk factors for QT prolongation. Electrocardiograms (ECGs) and measurement of electrolytes should be obtained prior to treatment initiation and periodically during treatment with Foscarnet.

Care must be taken to infuse solutions containing Foscarnet only into veins with adequate blood flow to permit rapid dilution and distribution to avoid local irritation. Local irritation and ulcerations of penile epithelium have been reported in male patients receiving Foscarnet, possibly related to the presence of drug in the urine. Cases of male and female genital irritation/ulceration have been reported in patients receiving foscarnet. Adequate hydration with close attention to personal hygiene may minimize the occurrence of such events.

Due to the sodium content of Foscarnet (240 micromoles (5.5 mg) of sodium per mL), avoid foscarnet use when intravenous infusion of a large amount of sodium or water may not be tolerated (e.g. in patients with cardiomyopathy). Foscarnet should also be avoided in patients on a controlled sodium diet.

Anemia has been reported in patients receiving foscarnet in controlled studies. Granulocytopenia has been reported in patients receiving foscarnet in controlled studies.

Because Foscarnet can reduce serum levels of ionized calcium, extreme caution is advised when used concurrently with other drugs known to influence serum calcium levels (e.g., intravenous pentamidine).

Because of Foscarnet's tendency to cause renal impairment, the use of Foscarnet should be avoided in combination with potentially nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, acyclovir, methotrexate, tacrolimus and intravenous pentamidine unless the potential benefits outweigh the risks to the patient.

When diuretics are indicated, thiazides are recommended over loop diuretics because the latter inhibit renal tubular secretion, and may impair elimination of Foscarnet, potentially leading to toxicity.

Abnormal renal function has been observed in clinical practice during the use of foscarnet and ritonavir, or foscarnet, ritonavir, and saquinavir.

The use of foscarnet should be avoided in combination with agents known to prolong the QT interval including Class IA (e.g., quinidine or procainamide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents, phenothiazines, tricyclic antidepressants, and certain macrolides and fluoroquinolones.

The most common adverse events include: fever, nausea, anemia, diarrhea, vomiting, headache, granulocytopenia, seizures.

Serious adverse events include: renal impairment, hypokalemia, hypocalcemia, hypomagnesemia, hypophosphatemia, hyperphosphatemia, seizures, hypersensitivity reactions, prolongation of QT interval, increased serum creatinine, acute renal failure, pancreatitis, pancytopenia, renal tubular necrosis.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients. The company's U.S. headquarters is in Lake Zurich, Illinois. The company's global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at https://www.fresenius-kabi.com/us/join-us.

Foscavir^® is a registered trademark of Pfizer Inc.

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