Safety information

Indications: Treatment of the following infections in all age groups when it is considered inappropriate to use antibacterial agents that are commonly recommended for their initial treatment:

complicated urinary tract infections
infective endocarditis
bone and joint infections
hospital-acquired pneumonia, including ventilator-associated pneumonia
complicated skin and soft tissue infections
bacterial meningitis
complicated intra-abdominal infections
bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosage and administration: Adults and adolescents ‑ 12 years, > 40 kg and with normal renal function (creatinine clearance > 80 ml/min): complicated urinary tract infection 12–24 g in 2–3 divided doses, bone and joint infections 12–24 g in 2–3 divided doses, infective endocarditis 12-24 g in 2–3 divided doses, hospital-acquired pneumonia including ventilator-associated pneumonia 12–24 g in 2–3 divided doses; complicated skin and soft tissue infections 12–24 g in 2–3 divided doses; bacterial meningitis 16–24 g in 3–4 divided doses; complicated intra-abdominal infections 12–24 g in 2–3 divided doses; bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above 12–24 g in 2–3 divided doses. Individual doses must not exceed 8 g. Dose reductions in patients with renal impairment are required (please refer to the SmPC for further information). Paediatric population: for neonates, infants and children <12 years of age (<40 kg) the dosage should be based on age and body weight (please refer to the SmPC for further information). Method of administration: intravenous infusion only. The solvent must be water for injections, 5% or 10% glucose infusion. The duration of infusion should be at least 15 minutes for the 2 g pack size, at least 30 minutes for the 4 g pack size and at least 60 minutes for the 8 g pack size. Please refer to the SmPC for further information.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions: It is recommended that fosfomycin is administered as part of a combination antibacterial drug regimen to reduce the risk of selecting for resistance. It is recommended that fosfomycin is selected to treat the listed indications only when it is considered inappropriate to use antibacterial agents that are commonly recommended for their initial treatment. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment. If such reactions occur, treatment with fosfomycin must be discontinued immediately and adequate emergency measures must be initiated.. Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported. It is important to consider this diagnosis in patients presenting with diarrhoea during or subsequent to administration of Fomicyt. Sodium and potassium levels should be monitored regularly in patients receiving fosfomycin, in particular during prolonged treatment. Given the high content of sodium (0.32 grams) per gram of fosfomycin, the risk of hypernatraemia and fluid overload should be assessed before starting treatment, especially in patients with a history of congestive heart failure or underlying comorbidities such as nephrotic syndrome, liver cirrhosis, hypertension, pulmonary oedema or hypoalbuminemia as well as in neonates under sodium restriction. A low-sodium diet is recommended during treatment. An increase in the infusion length and/or a reduction to the individual dose (with more frequent administration) could also be considered. Fosfomycin may decrease potassium levels in serum or plasma, therefore potassium supplementation should be always considered. In patients receiving fosfomycin intravenously haematological reactions including neutropenia or agranulocytosis have occurred. Please refer to the SmPC for further information.

Interactions: Numerous cases of increased oral anticoagulant activity have been reported in patients receiving antibiotic therapy. The severity of the infection or inflammation, patient age and general state of health appear to be risk factors. Under these circumstances, it is difficult to determine to what extent the infection itself or its treatment play a role in the INR imbalance. However, certain classes of antibiotics are more involved, particularly: fluoroquinolones, macrolides, cyclins, cotrimoxazole, and certain cephalosporins.

Undesirable effects (see SmPC for full details): Common: dygeusia, hypernatraemia, hypokalemia, erythematous eruption, injection site phlebitis. Uncommon: headache, nausea, vomiting, diarrhea, blood alkaline phosphatase increased (transient), transaminases increased (ALAT, ASAT), gamma-GT increased, rash, asthenia. Very rare: anaphylactic reactions including anaphylatic shock and hypersensitivity, Unknown frequency: agranulocytosis (transient), leucopenia, thrombocytopenia, neutropenia, antibiotic-associated colitis, hepatitis, pruritus, urticaria, angioedema. Please refer to the SmPC for further information.

Pack size: 30/50/100 ml clear glass bottle with rubber stopper and pull off cap containing 2 g, 4 g, or 8 g.

Name and active ingredients: Fomicyt 40 mg/ml powder for solution for infusion. One ml of reconstituted solution contains 40 mg fosfomycin. 2 g presentation: Each bottle with 2.69 g of powder contains 2.64 g disodium fosfomycin, corresponding to 2 g fosfomycin and 0.64 g sodium, for reconstitution in 50 ml of solvent. Fomicyt 4 g presentation: Each bottle with 5.38 g of powder contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium, for reconstitution in 100 ml of solvent. Fomicyt 8 g presentation: Each bottle with 10.76 g of powder contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium, for reconstitution in 200 ml of solvent

Date of preparation: October 2020