Fosfomycin

CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

CONTEPO is an antibacterial drug.

Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min. The recommended dosage in patients 18 years of age and older with an estimated CLcr of 50 mL/min or less is presented in the table below. a CLcr estimated using Cockcroft-Gault Equation. b All doses of CONTEPO are administered by intravenous infusion over 1 hour. Estimated CLcr (mL/min) a Loading Dose b Maintenance Dosage b Dose Frequency 41-50 6 grams 4 grams Every 8 hours 31-40 6 grams 3 grams Every 8 hours 21-30 6 grams 5 grams Every 24 hours 11-20 6 grams 3 grams Every 24 hours Approximately 60% to 80% of the fosfomycin dose is cleared from the body by hemodialysis. Administer CONTEPO after hemodialysis on hemodialysis days.

CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients.

Serum Electrolyte Abnormalities: CONTEPO contains 1980 mg sodium in each vial. The high sodium load associated with the use of CONTEPO may result in changes in serum electrolytes, such as increased levels of sodium and decreased levels of potassium, calcium and phosphorus. A low-sodium diet is recommended during CONTEPO treatment. Monitor serum electrolyte levels and fluid status during CONTEPO treatment. Monitor signs and symptoms of edema, particularly in patients with cardiac insufficiency, renal impairment, cirrhosis, hypertension, hyperaldosteronism, hypernatremia or pulmonary edema. QT Prolongation: CONTEPO has been shown to prolong the QT interval in some patients in the clinical trial. Avoid CONTEPO in patients with known prolongation of the QT interval or ventricular arrhythmias, including a history of torsade de pointes.

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Serum Electrolyte Abnormalities QT Prolongation Increased Transaminase Levels Hypersensitivity Reactions Neutropenia Including Agranulocytosis Clostridioides difficile -Associated Diarrhea Development of Drug-Resistant Bacteria Most common adverse reactions (incidence ≥2%) are transaminase elevations, hypokalemia, neutropenia, nausea, vomiting, diarrhea, hypocalcemia, hypernatremia, headache, and hypophosphatemia.

Avoid co-administration of CONTEPO with drugs known to prolong the QT interval. Drugs that prolong QT interval Co-administration of CONTEPO with other drugs known to prolong the QT interval may increase the risk for ventricular arrhythmia. Avoid co-administration of CONTEPO with drugs known to prolong the QT interval, such as class IA or class III antiarrhythmic medications, tricyclic antidepressants, macrolides, and antipsychotics.

Store CONTEPO vials at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store CONTEPO in the carton until time of use.