cefepime dihydrochloride monohydrate;Enmetazobactam

HOS-288097 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most common adverse reactions that occurred in the Phase 3 study were alanine aminotransferase (ALT) increased (4.8%), aspartate aminotransferase (AST) increased (3.5%), diarrhoea (2.9%), and infusion site phlebitis (1.9%). A serious adverse reaction of Clostridioides difficile colititis occurred in 0.2% (1/516). Tabulated list of adverse reactions The following adverse reactions have been reported with cefepime alone during clinical studies or post marketing surveillance and/or identified during Phase 2 or/and Phase 3 studies with cefepime- enmetazobactam. Adverse reactions are classified according to System Organ Class, frequency, preferred term using MedDRA terminology. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2. Frequency of adverse reactions by system organ class System organ class Frequency MedDRA preferred term (PT) Infections and infestations Uncommon Clostridioides difficile associated diarrhoea (CDAD), oral candidiasisa, vaginal infection 6 System organ class Frequency MedDRA preferred term (PT) Rare Candida infectiona Blood and lymphatic system disorders Very common Coombs test positivea Common Prothrombin time prolongeda, partial thromboplastin time prolongeda, anaemiaa, eosinophiliaa Uncommon Thrombocytopenia, leukopeniaa, neutropeniaa Not known Aplastic anaemiab, haemolytic anaemiab, agranulocytosisa Immune system disorders Rare Anaphylactic reactiona, angioedemaa, dermatitis allergic

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HOS-288093 · has-contraindication-information · PDF-Seite 4

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Hypersensitivity to any cephalosporin antibacterial agent. - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins, carbapenems or monobactams).

HOS-288092 · has-indication-information · PDF-Seite 2

EXBLIFEP is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with 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.

HOS-288095 · has-interaction-information · PDF-Seite 5

No clinical interaction studies have been performed with enmetazobactam. However, based on in vitro studies and considering routes of elimination, the pharmacokinetic interaction potential for enmetazobactam is low. Concomitant treatment with bacteriostatic antibiotics may interfere with the action of beta-lactam antibiotics. Cephalosporin antibiotics can potentiate the action of coumarin anticoagulants as seen with cefepime.

HOS-288096 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data from the use of cefepime-enmetazobactam in pregnant women. 5 Animal studies indicate reproductive toxicity at relevant clinical exposure of enmetazobactam but no signs of teratogenicity (see section 5.3). Enmetazobactam should only be used during pregnancy when clearly indicated and only if the benefit for the mother outweighs the risk for the child. Breast-feeding Physico-chemical data suggest excretion of cefepime-enmetazobactam in human milk and cefepime- enmetazobactam has been shown to be excreted in milk from rat. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from cefepime-enmetazobactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility The effects of cefepime and enmetazobactam on fertility in humans have not been studied. No impairment of fertility has been seen in male and female rats treated with cefepime or enmetazobactam (see section 5.3).

HOS-288094 · has-warning-information · PDF-Seite 4

Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions have been reported with cefepime and cefepime-enmetazobactam (see section 4.3 and 4.8). Patients who have a history of hypersensitivity to other beta-lactam antibiotics may also be hypersensitive to cefepime-enmetazobactam. Before treatment initiation, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to beta-lactam antibiotics (see section 4.3). Cefepime-enmetazobactan should be administered with caution to patients with a history of asthma or allergic diathesis. The patient must be carefully monitored during the first administration. If an allergic reaction occurs, treatment must be discontinued immediately and adequate emergency measures must be initiated. Renal impairment Dose adjustments should be made in patients with renal impairment who have an absolute eGFR less than 60 mL/min (see section 4.2). Reversible encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures (including nonconvulsive status epilepticus), and/or renal failure have been reported with cefepime/enmetazobactam when the dose has not been reduced in patients with renal impairment. In some cases, neurotoxicity was reported in patients with renal impairment despite dose adjustments. Renal function should be monitored carefully if medicinal products with nephrotoxic potential, such as aminoglycosides and potent diuretics, are administered concomitantly with cefepime- enmetazobactam. Clostridioides difficile associated diarrhoea (CDAD) CDAD has been reported with cefepime-enmetazobactam, and may range in severity from mild diarrhoea to fatal colitis. CDAD must be considered in patients who present with diarrhoea during or subsequent to the administration of cefepime-enmetazobactam. Discontinuation of therapy with cefepime-enmetazobactam and the use of supportive measures together with the administration of specific treatment for C. difficile should be considered. Medicinal products that inhibit peristalsis should not be given. 4 Non-susceptible organisms The use of cefepime-enmetazobactam may result in overgrowth of non-susceptible organisms, which may require interruption of treatment or other appropriate measures. Elderly No dose adjustment based on age is required. Because elderly patients are more likely to have dec

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