Prescribing Information

Name and active ingredients: Fomicyt® 40mg/ml powder for solution for infusion.

One ml of solution for infusion contains 40mg fosfomycin. 2g presentation: Each bottle with 2.69g of powder contains 2.64g disodium fosfomycin, corresponding to 2g fosfomycin and 0.64g sodium, for reconstitution in 50ml of solvent. 4g presentation: Each bottle with 5.38g of powder contains 5.28g disodium fosfomycin, corresponding to 4g fosfomycin and 1.28g sodium, for reconstitution in 100ml of solvent.

Indications:

Treatment of the following infections in all age groups: 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. Fomicyt® should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed, or when these agents have failed to demonstrate efficacy. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosage and administration:

Adults and adolescents ≥ 12 years, ≥ 40kg and with normal renal function (creatinine clearance > 80ml/min); for the following conditions, use 12-24g in 2-3 divided doses: complicated urinary tract infection, bone and joint infections, infective endocarditis, hospital-acquired pneumonia, including ventilator-associated pneumonia, complicated skin and soft tissue infections, complicated intra-abdominal infections, and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed above. For the following conditions, use 16-24g in 3-4 divided doses: bacterial meningitis. Individual doses must not exceed 8g. Dose reductions in patients with renal impairment are required (please refer to the SmPC for further information). There are limited safety data in particular for doses in excess of 16 g/day. Special caution is advised when such doses are prescribed.  Paediatric population: for neonates, infants and children <12 years of age (<40kg) 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 2g pack size and at least 30 minutes for the 4g pack.

Contraindications:

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

Special warnings and precautions:

Whenever possible, 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. Clostridioides difficile-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 fosfomycin.  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, hyperaldosteronism, 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. Therefore, the leukocyte count should be monitored at regular intervals and if such reactions occur, an adequate medical treatment should be initiated. In patients with impaired renal function, adjust the dosage according to the grade of renal insufficiency. There are no data from the use of intravenously administered fosfomycin in pregnant women.

Pregnancy and breast feeding:

Fosfomycin crosses the placenta and should therefore not be prescribed to pregnant women unless the benefit outweighs the risk. Only scarce information about fosfomycin use during breastfeeding is available, therefore this treatment is not recommended as first choice for a breastfeeding woman, especially if she is breastfeeding a premature or new-born baby. No data for fertility in humans are available. For full list of excipients, please refer to the Summary of Product Characteristics.

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. Fosfomycin should not be prescribed to pregnant women unless the benefit outweighs the risk. Breastfeeding while on this medication is not recommended. This medication may also impact fertility in both men and women, so discuss potential risks with your healthcare provider if you plan to conceive.

Undesirable effects (see SmPC for full details):

Common: dysgeusia, hypernatraemia, hypokalemia, erythematous eruption and injection site phlebitis. Uncommon: headache, nausea, vomiting, diarrhoea, 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, angioedema, pruritus, urticaria.

Limited safety information is available from the paediatric population. Frequency, type and severity of adverse reactions may be expected to be similar to the adult population.

Pack size:

Clear type-I glass bottles with a rubber stopper (bromobutyl rubber) and pull-off cap containing 2 g (in 30 ml bottle) in packs of 10 bottles each, 4 g (in 30 ml bottle) in packs of 10 bottles each. Not all pack sizes may be marketed.

Legal classification: POM.

NHS Costs: £160.03 (2g), £320.06 (4g)

MARKETING AUTHORISATION HOLDER: INFECTOPHARM Arzneimittel und Consilium GmbH  

PL 15011/0017

Date of preparation:  August 2024

Job code: PP/FOM/2024/001

Fomicyt is a registered trademark of INFECTOPHARM Arzneimittel und Consilium GmbH

PP/FOM/2024/002 October 2024