FDA Approves CONTEPO™ (fosfomycin for injection) for Treatment of Complicated Urinary Tract Infections, including Acute Pyelonephritis

Dear Colleagues and Partners,

We're delighted to inform you that today the U.S. Food and Drug Administration (FDA) approved CONTEPO™ (fosfomycin for injection) for treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

For more information on today's announcement, you can click here for the press release distributed today by Nabriva, and visit the product website at www.contepo.com to sign up for future announcements including information on the timing and logistics of product availability in the U.S.

Regards,

[insert name]
Medical Science Liaison
Nabriva Therapeutics

Important Safety Information And Indications

INDICATIONS

CONTEPO™ (Fosfomycin for injection) is indicated for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis caused by the following susceptible microorganisms: Escherichia coli and Klebsiella pneumoniae in patients 18 years or older.

USAGE:

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 susceptible bacteria. When culture and susceptibility information are available, for instance when resistant populations of Escherichia coli or Klebsiella pneumoniae have been identified in a patient sample, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS:

CONTEPO™ (fosfomycin) for injection is contraindicated in patients with known serious hypersensitivity to fosfomycin or any of the excipients.

IMPORTANT SAFETY INFORMATION:

WARNINGS AND PRECAUTIONS:

Each 6 g vial of CONTEPO™ contains 1980 mg of sodium. The high sodium load associated with the use of CONTEPO™ may result in changes in serum electrolytes, such as decreased levels of potassium. A low-sodium diet is recommended during CONTEPO™ treatment. The supplementation of potassium may be necessary in some cases. Serum electrolyte levels and water balance should be monitored during CONTEPO™ treatment. Caution is advised when CONTEPO™ is used in patients with cardiac insufficiency, hypertension, hyperaldosteronism, hypernatremia, or pulmonary edema.

Serum transaminase levels (ALT and AST) should be monitored during CONTEPO™ treatment.
Electrolyte disturbances, such as hypokalemia and hypocalcemia, are associated with cardiac effects, including QT prolongation.
Hypersensitivity reactions were reported with the use of CONTEPO™. Before initiating therapy with CONTEPO™, it is important to inquire about previous hypersensitivity reactions to oral or parenteral fosfomycin. If an allergic reaction occurs, discontinue CONTEPO™.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CONTEPO™, and may range in severity from mild diarrhea to fatal colitis. Evaluate patient if diarrhea occurs.

ADVERSE REACTIONS:

The most common adverse reactions (incidence ≥2%) associated with CONTEPO™ are diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), headache, hypokalemia, nausea and vomiting.

To report suspected adverse reactions, contact Nabriva Therapeutics at 1-855-5NABRIVA (1-855-562-2748) or FDA at 1-800-FDA-1088 www.fda.gov/medwatch.

Full Prescribing Information & Instructions For Use