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Brand Name
Contepo
Generic Name
Fosfomycin
View Brand Information FDA approval date: October 22, 2025
Form: Injection
What is Contepo (Fosfomycin)?
CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.
Approved To Treat
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Brand Information
Contepo (fosfomycin disodium)
1DOSAGE FORMS AND STRENGTHS
CONTEPO for Injection contains 6 grams of fosfomycin, and is supplied as a white or almost white, sterile powder in single-dose vials, for constitution and further dilution.
2CONTRAINDICATIONS
CONTEPO is contraindicated in patients with known serious hypersensitivity to fosfomycin, or any of the excipients
3ADVERSE REACTIONS
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 [see Warnings and Precautions (
- Development of Drug-Resistant Bacteria
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
CONTEPO was evaluated in a comparator-controlled clinical trial (Trial 1) in patients with cUTI, including acute pyelonephritis, which included 233 patients treated with CONTEPO and 231 treated with comparator (piperacillin/tazobactam 4.5 g every 8 hours) for 7 days, allowing bacteremic patients to receive up to 14 days. No switch to oral antibacterial drugs was allowed. The median age of treated patients was 54 years (range 18-89 years) and 64% were female. All patients were white (100%). Patients (99%) were predominantly enrolled in Eastern Europe. Concomitant bacteremia was identified in 9% of patients at baseline.
3.2Postmarketing Experience
The following additional adverse reactions were not reported with CONTEPO-treated patients in Trial 1 but have been identified with the use of oral fosfomycin tromethamine or during use of intravenous fosfomycin sodium outside of the United States for various indications and dosing regimens. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Blood and lymphatic system disorders: aplastic anemia, eosinophilia, agranulocytosis, leukopenia, pancytopenia
Cardiac disorders: torsade de pointes
Ear and labyrinth disorders: vertigo
Eye disorders: visual impairment
Gastrointestinal disorders: dyspepsia, C. difficile-associated diarrhea and colitis, toxic megacolon
Hepatobiliary disorders: alkaline phosphatase increased, cholestatic hepatitis, icterus, hepatic necrosis
Immune system disorders: anaphylaxis
Metabolism and nutrition disorders: decreased appetite
Nervous system disorders: cerebral edema, dizziness, optic neuritis
Psychiatric disorders: confusion
Respiratory, thoracic, and mediastinal disorders: asthma attack, pulmonary edema
Skin and subcutaneous tissue disorders: angioedema, facial edema
Vascular disorders: hypertension
4OVERDOSAGE
To date, no cases of accidental overdose with clinically relevant intolerances have been reported. In the event of an overdose, the patient must be monitored and treated symptomatically. Fosfomycin is cleared from the body by hemodialysis, during which patients with end stage renal disease have an increased mean fosfomycin elimination half-life to approximately 4 hours.
5DESCRIPTION
CONTEPO (fosfomycin) for injection, for intravenous use, contains fosfomycin disodium, an epoxide antibacterial drug.
Fosfomycin disodium is a powder with the chemical name of disodium [(2R,3S)-3-methyloxiran-2-yl]-dioxido-oxophosphorane, an empirical formula of C
Figure 1 Chemical Structure of Fosfomycin Disodium
Each CONTEPO for Injection single-dose vial contains white to almost white sterile powder with 6 grams of fosfomycin (equivalent to 7.9 grams fosfomycin disodium) and the inactive ingredient succinic acid (150 mg) for pH adjustment. It is intended for constitution and further dilution prior to intravenous infusion . Each gram of fosfomycin disodium contains 330 mg of sodium (i.e., each vial contains 1,980 mg of sodium).
6PRINCIPAL DISPLAY PANEL - CONTEPO 6 grams per vial Container Label
NDC 71288-
Rx Only
Contepo
(fosfomycin) for injection
6 grams per vial
For Intravenous Infusion only
Must be constituted and further diluted.
Single-Dose Vial - Discard Unused Portion
7PRINCIPAL DISPLAY PANEL - CONTEPO 6 grams per vial Carton Label
NDC 71288-
Rx Only
Contepo
(fosfomycin) for injection
6 grams per vial
For Intravenous Infusion only
Must be constituted and further diluted.
12 Single-Dose Vials -
Discard Unused Portion
