Contepo

Contepo is used to treat complicated urinary tract infections (cUTI), including acute pyelonephritis, in adults 18 years and older. Contepo (fosfomycin for injection) is an intravenous antibiotic that works against susceptible strains of Escherichia coli and Klebsiella pneumoniae.

Contepo has a unique mechanism of action that may be effective against multi-drug resistant (MDR) bacterial strains that do not respond to conventional antibiotics.

Fosfomycin is an epoxide antibacterial agent that works by disrupting bacterial cell wall synthesis.

• It enters bacteria through two specialized transport channels (glycerol-3-phosphate and hexose-6-phosphate systems).
• Once inside bacteria, it permanently attaches to and blocks an enzyme called MurA (phosphoenolpyruvate transferase).
• This enzyme is essential for building peptidoglycan, the structural material that forms bacterial cell walls.
• Without functional peptidoglycan synthesis, bacteria cannot maintain their cell walls and die.
• This bactericidal (bacteria-killing) effect is particularly effective against Enterobacterales, the family of bacteria that includes E. coli and K. pneumoniae.

Contepo is indicated for complicated urinary tract infections (cUTIs), including:

• Acute pyelonephritis (kidney infection)
• cUTIs caused by susceptible E. coli
• cUTIs caused by susceptible K. pneumoniae.

The medication is approved only for patients 18 years of age and older.

Contraindications

Contepo should not be used in patients with a known serious hypersensitivity to fosfomycin or allergies to any of the ingredients in the injection.

Tell your doctor about all your medical conditions before receiving Contepo, especially if you have:

• Allergies: Any previous allergic reactions to fosfomycin (oral or intravenous) or any ingredients in Contepo
• Heart conditions: Heart rhythm problems, QT prolongation, ventricular arrhythmias, or a history of torsade de pointes
• Heart failure: Cardiac insufficiency or congestive heart failure
• Kidney problems: Renal impairment or reduced kidney function
• Liver disease: Cirrhosis or other liver conditions
• High blood pressure: Hypertension or uncontrolled blood pressure
• Fluid retention: History of edema or swelling
• Lung problems: Pulmonary edema or fluid in the lungs
• Electrolyte imbalances: Low potassium, low calcium, low phosphorus, or high sodium levels
• Hormone disorders: Hyperaldosteronism or other conditions affecting electrolyte balance
• Blood disorders: History of low white blood cell counts or neutropenia
• Dialysis: If you are receiving hemodialysis treatments.

Also, tell your doctor if you are:

• Pregnant or planning to become pregnant. It is not known if Contepo affects an unborn baby
• Breastfeeding or planning to breastfeed (not recommended during treatment and for 24 hours after last dose)
• Taking any other medications, especially those that can prolong the QT interval
• On a sodium-restricted diet or need to limit salt intake.

Most Common Side Effects

• Elevated liver enzymes (transaminases)
• Low potassium (hypokalemia)
• Low white blood cell count (neutropenia)
• Nausea
• Vomiting
• Diarrhea
• Low calcium (hypocalcemia)
• High sodium (hypernatremia)
• Headache
• Low phosphorus (hypophosphatemia).

Warnings and Precautions

Electrolyte Abnormalities:

Each vial of Contepo contains 1,980 mg of sodium. This high sodium content may cause:

• Increased sodium levels (hypernatremia)
• Decreased potassium levels (hypokalemia)
• Decreased calcium levels (hypocalcemia)
• Decreased phosphorus levels (hypophosphatemia).

Patients should follow a low-sodium diet during treatment. Healthcare providers should monitor electrolyte levels and watch for signs of fluid retention, especially in patients with heart failure, kidney problems, liver cirrhosis, high blood pressure, or lung edema.

QT Prolongation:

Contepo may prolong the QT interval on electrocardiograms. Avoid use in patients with:

• Known QT prolongation
• Ventricular arrhythmias
• History of torsade de pointes.

Liver Enzyme Elevations:

Increases in liver enzymes (ALT and AST) have been reported. Regular monitoring of liver function is recommended during treatment.

Hypersensitivity Reactions:

Allergic reactions, including rash, hives (urticaria), and anaphylaxis, may occur. Inform your healthcare provider about any previous reactions to fosfomycin before starting treatment.

Neutropenia:

Low white blood cell counts, including severe cases (agranulocytosis), have occurred with intravenous fosfomycin. Complete blood counts should be monitored during therapy.

Clostridioides difficile Infection:

Like most antibiotics, Contepo may cause severe diarrhea due to C. difficile bacteria. Contact your healthcare provider if diarrhea develops during or after treatment.

To report suspected side effects, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Contepo is administered by a healthcare provider in a clinic or hospital.

• Given by intravenous infusion over 1 hour.
• Usually given every 8 hours (3 times a day).

Standard Dosing of Contepo for cUTIs

• Dose: 6 grams every 8 hours
• Administration: Intravenous infusion over 1 hour
• Duration: Up to 14 days
• Patient requirement: Creatinine clearance greater than 50 mL/min

Renal Impairment Dosing

For patients with reduced kidney function (creatinine clearance 50 mL/min or less):

For patients on hemodialysis, Contepo should be administered after dialysis sessions, as 60% to 80% of the medication is removed during hemodialysis.

Contepo may interact with other medications. Tell your healthcare provider about all the medicines you take.

• Avoid taking Contepo with other medications that prolong the QT interval, as this may increase the risk of dangerous heart rhythm problems.

Active ingredient: 6 grams of fosfomycin (equivalent to 7.9 grams fosfomycin disodium)

Inactive ingredient: Succinic acid (150 mg) for pH adjustment.

Requires dilution before intravenous infusion.

Each gram of fosfomycin disodium contains 330 mg of sodium (each vial contains 1,980 mg of sodium).

Meitheal Pharmaceuticals acquired the North American rights to Contepo from Nabriva Therapeutics in July 2024.