Quofenix

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 

  



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quofenix 300 mg powder for concentrate for solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin. 
After reconstitution each ml contains 25 mg of delafloxacin. 
 
Excipient(s) with known effect: 
Each vial contains 2480 mg of sulfobutylbetadex sodium. 
Each vial contains 175 mg of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for concentrate for solution for infusion (powder for concentrate). 
Light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and 
colour. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) 
in adults when it is considered inappropriate to use other antibacterial agents that are commonly 
recommended for the initial treatment of these infections (see sections 4.4 and 5.1). 
 
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by 
intravenous infusion. Switch to delafloxacin 450 mg tablet orally every 12 hours is possible at the 
discretion of the physician. The total duration of treatment is 5 to 14 days. 
 
Special population 
 
Elderly 
No dose adjustment is required. As per fluoroquinolone class patients aged over 60 years are at 
increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and 
5.2). 
 
Renal impairment 
No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 
mL/min). Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased 



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to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin 
orally every 12 hours (see section 4.4 and 5.2). 
Quofenix is not recommended in patients with End Stage Renal Disease (ESRD). 
 
Hepatic impairment 
No dosage adjustment is necessary (see section 5.2). 
 
Paediatric population 
Quofenix is contraindicated in children and adolescents  (see section 4.3). 
 
Method of administration 
 
Intravenous use. 
For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product. 
Previous history of tendon disorders related to fluoroquinolone administration.  
Pregnancy, women of childbearing potential not using contraception and breast-feeding (see section 
4.6). 
Children or growing adolescents below 18 years of age (see section 4.2). 
 
4.4 Special warnings and precautions for use 
 
The use of delafloxacin should be avoided in patients who have experienced serious adverse reactions 
in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment 
of these patients with delafloxacin should only be initiated in the absence of alternative treatment 
options and after careful benefit/risk assessment (see also section 4.3). 
 
Contraception 
 
If women of a sexually mature age are treated, effective contraception must be used during treatment 
(see section 4.6). 
 
Aortic dissection and aneurysm 
 
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of 
fluoroquinolones, particularly in the older population. 
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after 
consideration of other therapeutic options in patients with positive family history of aneurysm disease, 
or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of 
other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan 
syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, 
hypertension, known atherosclerosis). 
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a 
physician in an emergency department. 
 
Tendinitis and tendon rupture 
 
Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may 
occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have 
been reported to occur even up to several months after discontinuation of treatment. The risk of 
tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients 
with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, 



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concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful 
swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative 
treatment should be considered. The affected limb(s) should be appropriately treated (e.g. 
immobilisation). Corticosteroids should not be used if signs of tendinopathy occur (see section 4.8). 
 
Peripheral neuropathy 
 
Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, 
or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under 
treatment with delafloxacin should be advised to inform their doctor prior to continuing treatment if 
symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to 
prevent the development of potentially irreversible condition (see section 4.8). 
 
Central nervous system effects 
 
Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) 
reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) 
and toxic psychosis. Fluoroquinolones may also cause CNS reactions of nervousness, agitation, 
insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and 
suicidal thoughts or acts. These adverse reactions may occur following the first dose. If these reactions 
occur in patients receiving delafloxacin, delafloxacin should be discontinued immediately and 
appropriate measures should be instituted. Delafloxacin should be used when the benefits of treatment 
exceed the risks in patients with known or suspected CNS disorders (e.g. severe cerebral 
arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or 
lower the seizure threshold. 
 
Exacerbation of myasthenia gravis 
 
Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in 
persons with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and 
requirement for ventilator support, have been associated with fluoroquinolone use in persons with 
myasthenia gravis. The use of delafloxacin is not recommended in patients with known history of 
myasthenia gravis. 
 
Clostridioides difficile-associated disease 
 
Clostridioides difficile-associated disease has been reported in users of nearly all systemic antibacterial 
medicinal products, with severity ranging from mild diarrhoea to fatal colitis. Clostridioides difficile-
associated disease must be considered in all patients who present with diarrhoea. If Clostridioides 
difficile-associated disease is suspected or confirmed treatment with delafloxacin should be 
discontinued and appropriate supportive measures together with the specific antibacterial treatment of 
C. difficile should be considered. 
Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated 
disease is suspected. 
 
Hypersensitivity reactions 
 
Patients with known hypersensitivity to delafloxacin or other fluoroquinolones must not take Quofenix 
(see section 4.3). Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been 
reported in patients receiving fluoroquinolone antibacterial medicinal products. Before initiating 
therapy with Quofenix, careful inquiry should be made about previous hypersensitivity reactions to 
other quinolone or fluoroquinolone antibacterial medicinal products. If an anaphylactic reaction to 
Quofenix occurs, the medicinal product should be discontinued immediately and appropriate therapy 
should be instituted. 
 
Patients with renal impairment 
 



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Dose adjustment is needed in patients with severe renal impairment (see section 4.2). 
The safety and efficacy of the dose adjustment guidance in patients with severe renal impairment has 
not been clinically evaluated and is based on pharmacokinetic modelling data. Delafloxacin should 
only be used in such patients when it is considered that the expected clinical benefit outweighs the 
potential risk. Clinical response to treatment and renal function should be closely monitored in these 
patients. 
Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to 
severe renal impairment; therefore serum creatinine levels should be closely monitored in these 
patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet 
every 12 hours. 
Quofenix is not recommended in patients with End Stage Renal Disease (ESRD). 
 
Limitations of the clinical data 
 
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, 
abscesses and wound infections only. Other types of skin infections have not been studied. Patients 
with toxic shock, neutropenia (neutrophil counts < 500 cells/mm3) or severely immunocompromised 
patients were not included in the studies. There is limited experience in patients aged > 75 years. 
 
Prolonged, disabling and potentially irreversible serious adverse drug reactions 
 
Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible 
serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, 
nervous, psychiatric and senses) have been reported in patients receiving quinolones and 
fluoroquinolones irrespective of their age and pre-existing risk factors. Delafloxacin should be 
discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients 
should be advised to contact their prescriber for advice. 
 
Superinfection 
 
Fluoroquinolone-insusceptible microorganisms may result in superinfection with the use of 
delafloxacin. If superinfection occurs during therapy, appropriate measures should be taken. 
 
Dysglycaemia 
 
As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and 
hyperglycaemia have been reported (see section 4.8), usually in diabetic patients receiving 
concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin. Cases 
of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose 
is recommended. 
There are no data available on severe cases of hypoglycaemia resulting in coma or death after 
delafloxacin use. 
 
Serious bullous skin reactions 
 
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have 
been reported with other fluoroquinolones. Patients should be advised to contact their doctor 
immediately prior to continuing treatment if skin and/or mucosal reactions occur. 
 
Patients with glucose-6-phosphate dehydrogenase deficiency 
 
Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to 
haemolytic reactions when treated with other quinolones. Therefore, delafloxacin should be used with 
caution in these patients. 
 
Excipients 
 



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This medicinal product contains sulfobutylbetadex sodium. In patients with moderate to severe renal 
impairment, accumulation of cyclodextrins occurs. 
 
This medicinal product contains 175 mg sodium per vial, equivalent to 8.8% of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effect of other medicinal products on delafloxacin 
 
There are no available data concerning specific effects of other medicinal products on delafloxacin. 
Known fluoroquinolones-associated possible interactions shall be considered. 
 
Effect of delafloxacin on other medicinal products 
 
Chelation active substance: antacids, sucralfate, metal cations, multivitamins 
There are no data concerning an interaction of intravenous delafloxacin with multivitamins, 
didanosine, or metal cations. However, delafloxacin should not be co-administered with any solution 
containing multivalent cations, e.g. magnesium, through the same intravenous line (see section 4.2 and 
6.2). 
 
Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low 
potential to alter the disposition of other medicinal products (see section 5.2). 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women of childbearing potential have to use effective contraception during treatment with 
delafloxacin. 
 
Pregnancy 
 
There are no or limited amount of data from the use of delafloxacin in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). In the absence of human data and findings 
in non-clinical studies at human therapeutic exposures, delafloxacin is contraindicated during 
pregnancy and in women of childbearing potential not using contraception (see sections 4.3 and 4.4). 
 
Breast-feeding 
 
It is unknown whether delafloxacin/metabolites are excreted in human milk. 
Available pharmacodynamic/toxicological data in animals have shown excretion of 
delafloxacin/metabolites in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. 
Breast-feeding is contraindicated during treatment with delafloxacin. 
 
Fertility 
 
The effects of delafloxacin on fertility in humans have not been studied. Nonclinical studies conducted 
with delafloxacin in rats do not indicate harmful effects with respect to fertility or reproductive 
performance (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Quofenix has moderate influence on the ability to drive and use machines. Some adverse drug 
reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and 
react, and therefore may constitute a risk in situations where the patient operates an automobile or 
machinery or engages in other activities requiring mental alertness and coordination. 



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4.8 Undesirable effects 
 
Summary of safety profile 
 
The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 
patients exposed to delafloxacin, intravenous or oral formulation, were diarrhoea and nausea (6.91% 
and 7.83%, respectively) which were mild to moderate in intensity. 
 
Tabulated list of adverse reactions 
 
The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 
studies classified by preferred term and System Organ Class, and by frequency. 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). 
 
System Organ 
Class  

Common  Uncommon 

Infections and 
infestations 

Fungal infection Clostridioides difficile infection (see section 4.4) 
Urinary tract infection 
Sinusitis 

Blood and 
lymphatic system 
disorders 

 Thrombocytopenia 
Haematocrit decreased 
White blood cell count decreased 
Haemoglobin decreased 
Red blood cell count decreased 

Immune system 
disorders 

 Hypersensitivity (see section 4.4) 
Seasonal allergy 

Metabolism and 
nutrition 
disorders 

 Hypoglycaemia (see section 4.4) 
Hyperglycaemia (see section 4.4) 
Decreased appetite 

Psychiatric 
disorders* 

 Hallucination, auditory 
Anxiety 
Insomnia 
Abnormal dreams 

Nervous system 
disorders* 

Headache Peripheral neuropathy (including paraesthesia and 
hypoaesthesia) (see section 4.4) 
Dizziness 
Presyncope 
Dysgeusia 

Eye disorders*  Vision blurred 
Dry eye 

Ear and labyrinth 
disorders* 

 Vertigo 
Tinnitus 

Cardiac disorders  Sinus tachycardia 
Palpitations 
Bradycardia 

Vascular 
disorders 

 Hypertension 
Hypotension 
Flushing 
Phlebitis 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Dyspnoea 
Cough 
Dry throat 



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System Organ 
Class  

Common  Uncommon 

Gastrointestinal 
disorders 

Diarrhoea 
Vomiting 
Nausea 

Gastritis erosive 
Stomatitis 
Abdominal pain 
Dyspepsia 
Gastrooesophageal reflux disease 
Paraesthesia oral 
Hypoaesthesia oral 
Glossodynia 
Dry mouth 
Flatulence 
Constipation 
Faeces discoloured 

Hepatobiliary 
disorders 

Hypertransaminasaemia Blood alkaline phosphatase increased 
Blood albumin decreased 

Skin and 
subcutaneous 
tissue disorders 

Pruritus Dermatitis allergic 
Urticaria 
Rash 
Alopecia 
Hyperhidrosis 
Cold sweat 
Night sweat 

Musculoskeletal 
and connective 
tissue disorders* 

 Arthritis reactive 
Arthralgia 
Myalgia 
Myositis 
Tendonitis (see section 4.4) 
Musculoskeletal pain (e.g. pain in extremity, back 
pain, neck pain), muscle weakness 
Muscle spasm 
Blood creatine phosphokinase increased 

Renal and urinary 
disorders 

 Renal impairment 
Haematuria 
Crystal urine present 

General disorders 
and 
administration 
site conditions* 

Injection/infusion site 
reaction  

Pyrexia 
Oedema peripheral 
Local swelling 
Fatigue 
Chills 
Medical device complication 

Injury, poisoning 
and procedural 
complications 

 Wound complication 

 
Description of selected adverse drug reactions 
 
Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious 
drug reactions affecting several, sometimes multiple, system organ classes and senses (including 
reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, 
neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, 
and impairment of hearing, vision, taste and smell) have been reported in association with the use of 
quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 
4.4). 
 
Reporting of suspected adverse reactions 
 



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Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who 
receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings 
during the study. Treatment of overdose with delafloxacin should consist of observation and general 
supportive measures. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 
 
Mechanism of action 
 
Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes 
required for bacterial DNA replication, transcription, repair, and recombination. 
 
Resistance 
 
Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions 
of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance 
Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms. 
 
Cross-resistance between delafloxacin and other fluoroquinolones may be observed, although some 
isolates resistant to other fluoroquinolone may retain susceptibility to delafloxacin. 
 
Susceptibility testing breakpoints 
 
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows: 
 

Organism  
MIC breakpoints 

(mg/L) 
Susceptible (S ≤) Resistant (R >) 

Staphylococcus aureus  0.25 0.25 
Streptococcus pyogenes  0.03 0.03 
Streptococcus dysgalactiae 0.03 0.03 
Streptococcus agalactiae 0.03 0.03 
Streptococcus anginosus group 0.03 0.03 
Escherichia coli 0.125 0.125 
 
Pharmacokinetic/pharmacodynamic relationship 
 
The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ 
pharmacodynamic parameter most closely associated with the efficacy of delafloxacin. 
 
Clinical efficacy against specific pathogens 
 
Efficacy has been demonstrated in clinical studies against the following pathogens that were 
susceptible to delafloxacin in vitro. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Gram-positive micro-organisms: 

• Staphylococcus aureus (including methicillin-resistant [MRSA]) 
• Staphylococcus haemolyticus 
• Staphylococcus hominis 
• Staphylococcus lugdunensis 
• Streptococcus agalactiae 
• Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus 

intermedius, and Streptococcus constellatus) 
• Streptococcus dysgalactiae 
• Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii, 

Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis) 
• Streptococcus pyogenes 
• Enterococcus faecalis 

 
Gram-negative micro-organisms: 

• Escherichia coli 
• Enterobacter cloacae 
• Klebsiella oxytoca 
• Klebsiella pneumoniae 
• Proteus mirabilis  
• Pseudomonas aeruginosa 

 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and 
subcutaneous tissues (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Following intravenous use of 300 mg delafloxacin every 12 hours, steady state concentrations are 
achieved after approximately 3-5 days with about 10% accumulation after multiple administrations. 
The half-life of IV delafloxacin is approximately 10 hours. Delafloxacin pharmacokinetic is 
comparable in patients with ABSSSI and healthy volunteers. 
 
Absorption 
 
Peak plasma delafloxacin concentrations are achieved at the end of the 1 hour intravenous infusion. 
The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC). 
 
Distribution 
  
The steady state volume of distribution of delafloxacin is about 40 L which approximates total body 
water. The plasma protein binding of delafloxacin is approximately 84%; it primarily binds to 
albumin. Plasma protein binding of delafloxacin is not significantly affected by the degree of renal 
impairment. 
 
Biotransformation 
 
Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism 
representing <1% of an administered dose. The glucuronidation of delafloxacin is mediated mainly by 
UGT1A1,UGT1A3 and UGT2B15. Unchanged parent drug is the predominant component in plasma. 
There are no significant circulating metabolites (mean=9.6%) in humans. 
 In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit 
cytochrome P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 
and CYP3A4/5 nor UDP glucuronosyltransferases isoforms UGT1A1 and UGT2B7. Delafloxacin 
does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5. 



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Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, 
BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP. 
Delafloxacin is a probable substrate of BCRP. 
 
Elimination 
 
After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity is excreted in the 
urine and 28% is excreted in the faeces. Delafloxacin is excreted both unchanged and as glucuronide 
metabolites in urine. The radioactivity recovered from faeces is unchanged delafloxacin. 
 
Obese patients (≥ 30 kg/m2 BMI) 
 
Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2). 
 
Hepatic impairment  
 
No clinically meaningful changes in delafloxacin Cmax and AUC∞ were observed, following 
administration of a single 300 mg intravenous dose of delafloxacin into patients with mild, moderate 
or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control 
subjects. 
 
Renal impairment 
 
Following single intravenous (300 mg) administration to patients with mild, moderate, or severe renal 
impairment or ESRD on haemodialysis with and without haemodialysis after dosing, mean total 
exposure (AUCt) were 1.3, 1.7, 2.1, 3.5 and 4.1-fold higher than values for matched control subjects. 
Peak concentrations for the mild and moderate renal impairment patients were similar to that of 
healthy subjects, whereas peak concentrations were 2.1-fold, 5.9-fold and 6.4-fold higher for patients 
with severe renal impairment and ESRD on haemodialysis with and without haemodialysis after 
dosing, respectively. 
In patients with moderate, or severe renal impairment or ESRD on haemodialysis, accumulation of the 
intravenous vehicle sulfobutylbetadex sodium occurs. The mean systemic exposure (AUC) increased 
2.2-fold, 5.3-fold, 8.5-fold and 29.8-fold for patients with moderate impairment, severe impairment 
and ESRD with and without haemodialysis after dosing, respectively compared to the normal control 
group. The mean peak exposure (Cmax) increased about 2-fold, 5-fold and 7-fold for patients with 
severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to 
the normal control group. 
For dosing instructions in subjects with renal impairment refer to section 4.2. 
 
Elderly 
 
The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment 
is not necessary based on age. 
 
Paediatric population 
 
No clinical trials have been conducted with delafloxacin in paediatric patients. 
 
Gender  
 
Clinically significant gender-related differences in delafloxacin pharmacokinetics have not been 
observed in healthy subjects or in patients with ABSSSI. No dose adjustment is recommended based 
on gender. 
 
5.3 Preclinical safety data 
 



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In repeat dose toxicity studies in rats and dogs, gastrointestinal effects were the main findings: these 
included dilated cecum (oral only), abnormal stool, and decreased food intake and / or body weight in 
rats, and emesis, salivation and abnormal stool / diarrhoea in dogs. In addition increases in serum ALT 
and ALP, and reduced total protein and globulin values were recorded at the end of the treatment 
period in the pivotal 4-week IV dog study at the high dose (75 mg/kg) in individual dogs. Importantly, 
gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with 
histopathological changes of gastrointestinal and annexed tissues (pancreas, liver). No adverse effects 
were seen in rats at exposures about 2-fold higher than humans, or in dogs at exposures approximately 
equal to humans. 
In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of 
teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose 
producing maternal toxicity. In rats foetal effects occurred at a level of exposure exceeding about 2-
fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely 
sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of 
exposure well below that observed in humans. As delafloxacin is excreted in milk, severe toxicity was 
observed in newborn rats during lactation when mothers were treated during pregnancy and lactation 
with delafloxacin at a dose producing a systemic exposure about 5-fold higher than observed in 
humans. However, no such effects and no other developmental abnormalities occurred in the progeny 
of mothers exposed up to a level about 2-fold higher than observed in humans. No effects were 
detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed 
in humans. 
 
Long-term carcinogenicity studies have not been conducted with delafloxacin. 
 
No genotoxicity hazard was identified in vitro and it was negative in vivo at the highest possible dose 
≥ 15 times the estimated human plasma exposure based on AUC. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Meglumine 
Sulfobutylbetadex sodium 
Disodium edetate 
Sodium hydroxide (for pH-adjustment) 
Hydrochloric acid, concentrated (for pH-adjustment) 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
4 years. 
Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C. 
From a microbiological point of view, the product should be used immediately after reconstitution and 
dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility 
of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and 
dilution has taken place in controlled and validated aseptic conditions. 
Do not freeze. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
For storage conditions after dilution of the medicinal product, see section 6.3. 



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6.5 Nature and contents of container 
 
20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps. 
Pack-size: 10 vials. 
 
6.6 Special precautions for disposal 
 
Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) 
solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 
mg vial. 

• The vial should be vigorously shaken until contents are completely dissolved. The 
reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber 
coloured solution. 

• The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium 
Chloride Injection or D5W) prior to administration. 

• Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for 
Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial. 

• The required dose of Quofenix reconstituted solution should be aseptically transferred from 
the vial to a 250 mL intravenous bag. (Any unused portion of the reconstituted solution should 
be discarded). 

• After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, 
using a total infusion time of 60 minutes. 

 
Quofenix must not be co-infused with other medications. If a common intravenous line is being used 
to administer other medicinal products in addition to Quofenix the line should be flushed before and 
after each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W. Any 
unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3, 50131 Florence, Italy 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1393/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 December 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


14 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quofenix 450 mg tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin. 
 
Excipient(s) with known effect: 
Each tablet contains 39 mg of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tablet. 
 
Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length. 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) 
in adults when it is considered inappropriate to use other antibacterial agents that are commonly 
recommended for the initial treatment of these infections (see sections 4.4 and 5.1). 
 
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended regimen of delafloxacin is 450 mg oral every 12 hours for a total duration of 5 to 
14 days at the discretion of the physician. Delafloxacin tablets can be taken with or without food.  
 
Special population 
 
Elderly 
No dose adjustment is required. As per fluoroquinolone class patients aged over 60 years are at 
increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and 
5.2). 
 
Renal Impairment 
No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 
5.2). Quofenix is not recommended in patients with ESRD. 
 
 
Hepatic impairment 
No dosage adjustment is necessary (see section 5.2). 



15 

 
Paediatric population 
Quofenix is contraindicated in children and adolescents (see section 4.3). 
 
Method of administration 
 
Oral use. 
Tablets should be swallowed and can be taken with or without food. 
The patient should drink a sufficient amount of fluids while taking Quofenix. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product. 
Previous history of tendon disorders related to fluoroquinolone administration. 
Pregnancy, women of childbearing potential not using contraception and breast-feeding (see section 
4.6). 
Children or growing adolescents below 18 years of age (see section 4.2). 
 
4.4 Special warnings and precautions for use 
 
The use of delafloxacin should be avoided in patients who have experienced serious adverse reactions 
in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment 
of these patients with delafloxacin should only be initiated in the absence of alternative treatment 
options and after careful benefit/risk assessment (see also section 4.3). 
 
Contraception 
 
If women of a sexually mature age are treated, effective contraception must be used during treatment 
(see section 4.6). 
 
Aortic dissection and aneurysm 
 
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of 
fluoroquinolones, particularly in the older population. 
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after 
consideration of other therapeutic options in patients with positive family history of aneurysm disease, 
or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of 
other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan 
syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, 
hypertension, known atherosclerosis). 
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a 
physician in an emergency department. 
 
Tendinitis and tendon rupture 
 
Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may 
occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have 
been reported to occur even up to several months after discontinuation of treatment. The risk of 
tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients 
with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, 
concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful 
swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative 
treatment should be considered. The affected limb(s) should be appropriately treated (e.g. 
immobilisation). Corticosteroids should not be used if signs of tendinopathy occur (see section 4.8). 
 
Peripheral neuropathy 



16 

 
Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, 
or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under 
treatment with delafloxacin should be advised to inform their doctor prior to continuing treatment if 
symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to 
prevent the development of potentially irreversible condition (see section 4.8). 
 
Central Nervous System Effects 
 
Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) 
reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) 
and toxic psychosis. Fluoroquinolones may also cause CNS reactions of nervousness, agitation, 
insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and 
suicidal thoughts or acts. These adverse reactions may occur following the first dose. If these reactions 
occur in patients receiving delafloxacin, delafloxacin should be discontinued immediately and 
appropriate measures should be instituted. Delafloxacin should be used when the benefits of treatment 
exceed the risks in patients with known or suspected CNS disorders (e.g., severe cerebral 
arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or 
lower the seizure threshold. 
 
Exacerbation of myasthenia gravis 
 
Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in 
persons with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and 
requirement for ventilator support, have been associated with fluoroquinolone use in persons with 
myasthenia gravis. The use of delafloxacin is not recommended in patients with known history of 
myasthenia gravis. 
 
Clostridioides difficile-associated disease 
 
Clostridioides difficile-associated disease has been reported in users of nearly all systemic antibacterial 
medicinal products, with severity ranging from mild diarrhoea to fatal colitis. Clostridioides difficile-
associated disease must be considered in all patients who present with diarrhoea. If Clostridioides 
difficile-associated disease is suspected or confirmed treatment with delafloxacin should be 
discontinued and appropriate supportive measures together with the specific antibacterial treatment of 
C. difficile should be considered. 
Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated 
disease is suspected. 
 
Hypersensitivity reactions 
 
Patients with known hypersensitivity to delafloxacin or other fluoroquinolones should not take 
Quofenix (see section 4.3). Serious and occasionally fatal hypersensitivity (anaphylactic) reactions 
have been reported in patients receiving fluoroquinolone antibacterial medicinal products. Before 
initiating therapy with Quofenix, careful inquiry should be made about previous hypersensitivity 
reactions to other quinolone or fluoroquinolone antibacterial medicinal products. If an anaphylactic 
reaction to Quofenix occurs, the medicinal product should be discontinued immediately and 
appropriate therapy should be instituted. 
 
Patients with renal impairment 
The safety and efficacy of the dose recommendation in patients with severe renal impairment has not 
been clinically evaluated and is based on pharmacokinetic modelling data. Delafloxacin should only 
be used in such patients when it is considered that the expected clinical benefit outweighs the potential 
risk. Clinical response to treatment and renal function should be closely monitored in these patients. 
Administration of oral delafloxacin in patients with severe renal impairment and low body weight may 
lead to increased systemic exposures. Quofenix is not recommended in patients with ESRD. 
 



17 

Limitations of the clinical data 
 
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, 
abscesses and wound infections only. Other types of skin infections have not been studied. Patients 
with toxic shock, neutropenia (neutrophil counts <500 cells/mm3) or severely immunocompromised 
patients were not included in the studies. There is limited experience in patients aged > 75 years. 
 
Prolonged, disabling and potentially irreversible serious adverse drug reactions 
 
Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible 
serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, 
nervous, psychiatric and senses) have been reported in patients receiving quinolones and 
fluoroquinolones irrespective of their age and pre-existing risk factors. Delafloxacin should be 
discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients 
should be advised to contact their prescriber for advice. 
 
Superinfection 
 
Fluoroquinolone-insusceptible microorganisms may result in superinfection with the use of 
delafloxacin. If superinfection occurs during therapy, appropriate measures should be taken. 
 
Dysglycaemia 
 
As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and 
hyperglycaemia have been reported (see section 4.8), usually in diabetic patients receiving 
concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin. Cases 
of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose 
is recommended. 
There are no data available on severe cases of hypoglycaemia resulting in coma or death after 
delafloxacin use. 
 
Serious bullous skin reactions 
 
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have 
been reported with other fluoroquinolones. Patients should be advised to contact their doctor 
immediately prior to continuing treatment if skin and/or mucosal reactions occur. 
 
Patients with glucose-6-phosphate dehydrogenase deficiency 
 
Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to 
haemolytic reactions when treated with other quinolones. Therefore, delafloxacin should be used with 
caution in these patients. 
 
Excipients 
 
This medicinal product contains 39 mg sodium per tablet, equivalent to 2% of the WHO recommended 
maximum daily intake of 2 g sodium for an adult. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effect of other medicinal products on delafloxacin 
 
Chelation active substance: antacids, sucralfate, metal cations, multivitamins 
Fluoroquinolones form chelates with alkaline earth and transition metal cations. Oral administration of 
delafloxacin with antacids containing aluminium or magnesium, with sucralfate, with metal cations 
such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent 
and trivalent cations such as didanosine buffered tablets for oral suspension or the paediatric powder 



18 

for oral solution, may substantially interfere with the absorption of delafloxacin, resulting in systemic 
concentrations considerably lower than desired. Therefore, delafloxacin should be taken at least 
2 hours before or 6 hours after these agents. 
 
Effect of delafloxacin on other medicinal products 
 
Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low 
potential to alter the disposition of other medicinal products (see section 5.2). 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
 
Women of childbearing potential have to use effective contraception during treatment with 
delafloxacin. 
 
Pregnancy 
 
There are no or limited amount of data from the use of delafloxacin in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). In the absence of human data and findings 
in non-clinical studies at human therapeutic exposures, delafloxacin is contraindicated during 
pregnancy and in women of childbearing potential not using contraception (see sections 4.3 and 4.4). 
 
Breast-feeding 
 
It is unknown whether delafloxacin/metabolites are excreted in human milk. 
Available pharmacodynamic/toxicological data in animals have shown excretion of 
delafloxacin/metabolites in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. 
Breast-feeding is contraindicated during treatment with delafloxacin. 
 
Fertility 
 
The effects of delafloxacin on fertility in humans have not been studied. Nonclinical studies conducted 
with delafloxacin in rats do not indicate harmful effects with respect to fertility or reproductive 
performance (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Quofenix has moderate influence on the ability to drive and use machines. Some adverse drug 
reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and 
react, and therefore may constitute a risk in situations where the patient operates an automobile or 
machinery or engages in other activities requiring mental alertness and coordination. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 
patients exposed to delafloxacin intravenous or oral formulation, were diarrhoea and nausea ( 6.91% 
and 7. 83%, respectively) which were mild to moderate in intensity. 
 
Tabulated list of adverse reactions 
 
The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 
studies classified by preferred term and System Organ Class, and by frequency. 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). 



19 

 
System Organ Class  Common  Uncommon 
Infections and 
infestations 

Fungal infection 
 

Clostridioides difficile infection (see 
section 4.4) 
Urinary tract infection 
Sinusitis 

Blood and lymphatic 
system 
disorders 

 Thrombocytopenia 
Haematocrit decreased 
White blood cell count decreased 
Haemoglobin decreased 
Red blood cell count decreased 

Immune system 
disorders 

 Hypersensitivity (see section 4.4) 
Seasonal allergy 

Metabolism and 
nutrition disorders 

 Hypoglycaemia (see section 4.4) 
Hyperglycaemia (see section 4.4) 
Decreased appetite 

Psychiatric disorders*  Hallucination auditory 
Anxiety 
Insomnia 
Abnormal dreams 

Nervous system 
disorders* 

Headache 
 

Peripheral neuropathy (including 
paraesthesia and hypoaesthesia) (see 
section 4.4) 
Dizziness 
Presyncope 
Dysgeusia  

Eye disorders*  Vision blurred 
Dry eye 

Ear and labyrinth 
disorders* 

 Vertigo 
Tinnitus 

Cardiac disorders  Sinus tachycardia 
Palpitations 
Bradycardia 

Vascular disorders  Hypertension 
Hypotension 
Flushing 
Phlebitis 

Respiratory, thoracic 
and mediastinal 
disorders 

 Dyspnoea  
Cough 
Dry throat 

Gastrointestinal 
disorders 

Diarrhoea 
Vomiting 
Nausea 

Gastritis erosive 
Stomatitis 
Abdominal pain 
Dyspepsia 
Gastrooesophageal reflux disease 
Paraesthesia oral 
Hypoaesthesia oral 
Glossodynia 
Dry mouth 
Flatulence 
Constipation 
Faeces discoloured 

Hepatobiliary disorders Hypertransaminasaemia 
 

Blood alkaline phosphatase increased 
Blood albumin decreased 

Skin and subcutaneous 
tissue disorders 

Pruritus Dermatitis allergic 
Urticaria 



20 

Rash Alopecia 
Hyperhidrosis 
Cold sweat 
Night sweat 

Musculoskeletal and 
connective tissue 
disorders* 

 Arthritis reactive 
Arthralgia 
Myalgia 
Myositis 
Tendonitis (see section 4.4) 
Musculoskeletal pain (e.g. pain in 
extremity, back pain, neck pain), muscle 
weakness 
Muscle spasm 
Blood creatine phosphokinase increased 

Renal and urinary 
disorders 

 Renal impairment 
Haematuria 
Crystal urine present 

General disorders and 
administration site 
conditions* 

 Pyrexia 
Oedema peripheral 
Local swelling 
Fatigue 
Chills 

Injury, poisoning and 
procedural 
complications 

 Wound complication 

 
 
Description of selected adverse drug reactions 
 
Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious 
drug reactions affecting several, sometimes multiple, system organ classes and senses (including 
reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, 
neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, 
and impairment of hearing, vision, taste and smell) have been reported in association with the use of 
quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 
4.4). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The highest daily oral dose administered in clinical studies was 1600 mg; the patients who receive this 
dose did not have any adverse drug reactions or notable clinical laboratory test findings during the 
study. Treatment of overdose with delafloxacin should consist of observation and general supportive 
measures. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 

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21 

 
Mechanism of action 
 
Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes 
required for bacterial DNA replication, transcription, repair, and recombination. 
 
Resistance 
 
Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions 
of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance 
Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms. 
 
Cross-resistance between delafloxacin and other fluoroquinolones may be observed, although some 
isolates resistant to other fluoroquinolone may retain susceptibility to delafloxacin. 
 
Susceptibility testing breakpoints 
 
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on 
Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows: 
 

Organism  
MIC breakpoints 

(mg/L) 
Susceptible (S ≤) Resistant (R >) 

Staphylococcus aureus  0.25 0.25 
Streptococcus pyogenes  0.03 0.03 
Streptococcus dysgalactiae 0.03 0.03 
Streptococcus agalactiae 0.03 0.03 
Streptococcus anginosus group 0.03 0.03 
Escherichia coli 0.125 0.125 
 
Pharmacokinetic/pharmacodynamic relationship 
 
The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ 
pharmacodynamic parameter most closely associated with efficacy of delafloxacin. 
 
Clinical efficacy against specific pathogens 
 
Efficacy has been demonstrated in clinical studies against the following pathogens that were 
susceptible to delafloxacin in vitro. 
 
Gram-positive micro-organisms: 

• Staphylococcus aureus (including methicillin-resistant [MRSA]) 
• Staphylococcus haemolyticus 
• Staphylococcus hominis 
• Staphylococcus lugdunensis 
• Streptococcus agalactiae 
• Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus 

intermedius, and Streptococcus constellatus) 
• Streptococcus dysgalactiae 
• Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii, 

Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis) 
• Streptococcus pyogenes 
• Enterococcus faecalis 

 
Gram-negative micro-organisms: 

• Escherichia coli 



22 

• Enterobacter cloacae 
• Klebsiella oxytoca 
• Klebsiella pneumoniae 
• Proteus mirabilis 
• Pseudomonas aeruginosa 

 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and 
subcutaneous tissues (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Following oral administration of 450 mg of delafloxacin every 12 hours, steady state concentrations 
are achieved after approximately 5 days with about 36% accumulation after multiple administrations. 
The half-life of oral delafloxacin is approximately 14 hours. Delafloxacin pharmacokinetic is 
comparable in patients with ABSSSI and healthy volunteers. 
 
Absorption 
 
Peak plasma delafloxacin concentrations are achieved within about 1 hour after oral administration 
under fasting conditions. The 450-mg tablet and 300-mg IV formulations are bioequivalent with 
regard to total exposure (AUC). Delafloxacin may be administered with or without food as total 
systemic exposure (AUC∞) is unchanged between fasted and fed (high-fat, high-calorie) conditions. 
 
Distribution 
  
The steady state volume of distribution of delafloxacin is about 40 L which approximates total body 
water. The plasma protein binding of delafloxacin, is approximately 84%; it primarily binds to 
albumin. Plasma protein binding of delafloxacin is not significantly affected by the degree of renal 
impairment. 
 
Biotransformation 
 
Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism 
representing <1% of an administered dose. The glucuronidation of delafloxacin is mediated mainly by 
UGT1A1, UGT1A3 and UGT2B15. Unchanged parent drug is the predominant component in plasma. 
There are no significant circulating metabolites (mean=9.6%) in humans. 
In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit cytochrome 
P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and 
CYP3A4/5 nor UDP glucuronosyl transferases isoforms UGT1A1 and UGT2B7. Delafloxacin does 
not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5. 
Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, 
BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP. 
Delafloxacin is a probable substrate of BCRP. 
 
Elimination 
 
Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity is excreted in the 
urine as unchanged delafloxacin and glucuronide metabolites and 48% is excreted unchanged in the 
faeces. 
 
Obese patients (≥30 kg/m2 BMI) 
 
Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2). 
 
Hepatic impairment 
 



23 

No clinically meaningful changes in delafloxacin pharmacokinetics when administered delafloxacin in 
patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared 
to matched healthy control subjects. Therefore, no dosage adjustment is necessary. 
 
Renal impairment 
 
Following a single oral (400 mg) administration to patients with mild, moderate or severe renal 
impairment, mean total exposure (AUCt) was about 1.5-fold higher for subjects with moderate and 
severe renal impairment compared with healthy subjects, whereas total systemic exposures were 
comparable to subjects with mild renal impairment. Peak exposure (Cmax) was not statistically 
significantly different between renal impaired and healthy subjects. 
For dosing instructions in subjects with renal impairment refer to section 4.2. 
 
Elderly 
 
The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment 
is not necessary based on age. 
 
Paediatric population 
 
No clinical trials have been conducted with delafloxacin in paediatric patients. 
 
Gender 
 
Clinically significant gender-related differences in delafloxacin pharmacokinetics have not been 
observed in healthy subjects or in patients with ABSSSI. No dose adjustment is recommended based 
on gender. 
 
5.3 Preclinical safety data 
 
In repeat dose toxicity studies in rats and dogs, gastrointestinal effects were the main findings: these 
included dilated cecum (oral only), abnormal stool, and decreased food intake and / or body weight in 
rats, and emesis, salivation and abnormal stool / diarrhoea in dogs. In addition increases in serum ALT 
and ALP, and reduced total protein and globulin values were recorded at the end of the treatment 
period in the pivotal 4-week IV dog study at the high dose (75 mg/kg) in individual dogs. Importantly, 
gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with 
histopathological changes of gastrointestinal and annexed tissues (pancreas, liver). No adverse effects 
were seen in rats at exposures about 2-fold higher than humans, or in dogs at exposures approximately 
equal to humans. 
In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of 
teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose 
producing maternal toxicity. In rats foetal effects occurred at a level of exposure exceeding about 2-
fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely 
sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of 
exposure well below that observed in humans. As delafloxacin is excreted in milk, severe toxicity was 
observed in newborn rats during lactation when mothers were treated during pregnancy and lactation 
with delafloxacin at a dose producing a systemic exposure about 5-fold higher than observed in 
humans. However, no such effects and no other developmental abnormalities occurred in the progeny 
of mothers exposed up to a level about 2-fold higher than observed in humans. No effects were 
detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed 
in humans. 
 
Long-term carcinogenicity studies have not been conducted with delafloxacin. 
 
No genotoxicity hazard was identified in vitro and it was negative in vivo at the highest possible dose 
≥ 15 times the estimated human plasma exposure based on AUC. 
 



24 

 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Cellulose, microcrystalline 
Povidone 
Crospovidone 
Sodium hydrogen carbonate 
Sodium dihydrogen phosphate monohydrate 
Citric acid  
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
Store in the original package in order to protect from light. 
 
6.5 Nature and contents of container 
 
Laminated aluminium/aluminium foil blisters. 
 
Pack sizes of 10, 20, 30, 50, 60 or 100 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements. 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3, 50131 Florence, Italy 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/19/1393/002-007 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 December 2019 
 
 
10. DATE OF REVISION OF THE TEXT 



25 

 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 
  

http://www.ema.europa.eu/


26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



27 

A.  MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Tablets 
 
 
AlfaSigma 
1 Via Enrico Fermi 
65020 Alanno (PE) 
Italy 
 
Powder for concentrate for solution for infusion 
 
Patheon Italia S.p.A. 
2° Trav. SX Via Morolense 5 
03013 Ferentino (FR) 
Italy 
 
or 
 
AlfaSigma 
1 Via Enrico Fermi 
65020 Alanno (PE) 
Italy 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. 
 
 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 

 



28 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 
 

 
 
  



29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (VIALS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quofenix 300 mg powder for concentrate for solution for infusion 
delafloxacin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 300 mg of delafloxacin (as meglumine). 
After reconstitution, each ml contains 25 mg of delafloxacin. 
 
 
3. LIST OF EXCIPIENTS 
 
Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid, 
concentrated. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for concentrate for solution for infusion. 
10 single-dose vials 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intravenous use after reconstitution and dilution. 
For single use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



32 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3, 50131 Florence, Italy 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1393/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Quofenix 300mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



33 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Quofenix 300 mg powder for concentrate 
delafloxacin 
Intravenous use after reconstitution and dilution 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
300 mg 
 
 
6. OTHER 
 
 
  



34 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (TABLETS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quofenix 450 mg tablets 
delafloxacin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 450 mg of delafloxacin (as meglumine) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 tablets  
20 tablets 
30 tablets 
50 tablets 
60 tablets 
100 tablets  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use.  
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original package in order to protect from light. 



35 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3, 50131 Florence, Italy 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1393/002 10  tablets 
EU/1/19/1393/003 20  tablets 
EU/1/19/1393/004 30  tablets 
EU/1/19/1393/005 50  tablets 
EU/1/19/1393/006 60  tablets 
EU/1/19/1393/007 100  tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Quofenix 450 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



36 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
ALUMINIUM/ALUMINIUM BLISTER (TABLETS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Quofenix 450mg tablets 
delafloxacin 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



38 

Package leaflet: Information for the user 
 

Quofenix 300 mg powder for concentrate for solution for infusion 
delafloxacin 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Quofenix is and what it is used for 
2. What you need to know before you are given Quofenix 
3. How to use Quofenix 
4. Possible side effects 
5. How to store Quofenix 
6. Contents of the pack and other information 
 
 
1. What Quofenix is and what it is used for 
 
Quofenix is an antibiotic that contains the active substance delafloxacin. It belongs to a group of 
medicines called fluoroquinolones. 
 
It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused 
by certain bacteria when usual antibiotics cannot be used or have not worked. 
It works by blocking bacteria enzymes needed to copy and to repair their DNA. By blocking these 
enzymes, Quofenix kills bacteria that cause the infection. 
 
 
2. What you need to know before you are given Quofenix 
 
You must not be given Quofenix: 

• If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in 
section 6). 

• If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine. 
• If you have ever had a problem with your tendons such as tendonitis that was related to 

treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your 
skeleton. 

• If you are pregnant, might become pregnant, or think you might be pregnant. 
• If you are breast-feeding. 
• If you are a child or growing adolescent below 18 years of age. 

 
Warnings and precautions 
 
Before you are given this medicine 



39 

You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if 
you have experienced any serious adverse reaction in the past when taking a quinolone or 
fluoroquinolone. In this situation, you should inform your doctor as soon as possible. 
 
When you are given this medicine 

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your 
risk is increased if you are elderly (above 60 years of age), have received an organ transplant, 
have kidney problems or if you are being treated with corticosteroids. Inflammation and 
ruptures of tendons may occur within the first 48 hours of treatment and even up to several 
months after stopping Quofenix therapy. At the first sign of pain or inflammation of a tendon 
(for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact 
your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase 
the risk of a tendon rupture. 

• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, 
tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this 
happens, stop taking Quofenix and inform your doctor immediately in order to prevent the 
development of potentially irreversible condition. 

 
Talk to your doctor or pharmacist or nurse before you are given Quofenix if: 

• You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic 
aneurysm or large vessel peripheral aneurysm). 

• You have experienced a previous episode of aortic dissection (a tear in the aorta wall). 
• You have a family history of aortic aneurysm or aortic dissection or other risk factors or 

predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or 
vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell 
arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis). 

• You have had tendon problems during previous treatment with a fluoroquinolone or 
quinolone antibiotic. 

• You have or may have problems with the central nervous system (e.g. severe cerebral 
arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having 
seizures (fits). In those cases your doctor will consider if this treatment is the best option for 
you. 

• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become 
worse. 

• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking 
antibiotics or up to 2 months afterwards. Contact your doctor straight away if you have 
diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea 
without first checking with your doctor. 

• You have kidney problems. 
• You had sometimes long treatment with antibiotics; it can mean that you get another infection 

caused by other bacteria (superinfection) which cannot be treated by the antibiotic. Talk to 
your doctor if you have any concerns or questions about this and using Quofenix. 

• You may have a severe skin reaction such as blistering or lesion. 
• You or a member of your family is known to have a deficiency in glucose-6-phosphate 

dehydrogenase. 
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause levels of 

glucose in the blood to rise too high or fall too low. If you have diabetes, you should monitor 
your blood glucose levels carefully. 

 
If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency 
room. 
 
Prolonged, disabling and potentially irreversible serious side effects 
Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious 
side effects, some of them being long lasting (continuing months or years), disabling or potentially 
irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in 



40 

walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning 
(paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, 
depression, memory impairment, severe fatigue, and severe sleep disorders. 
If you experience any of these side effects after receiving Quofenix, contact your doctor immediately 
prior to continuing treatment. You and your doctor will decide on continuing the treatment considering 
also an antibiotic from another class. 
 
Children and adolescents 
This medicine must not be used in children and adolescents, as it has not been studied enough in these 
groups. 
 
Other medicines and Quofenix 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other 
supplements or didanosine. However, Quofenix should not be given together with any solution 
containing substances such as calcium and magnesium, through the same intravenous line. 
 
Pregnancy and breast-feeding 
Quofenix must not be used if you are pregnant or breast-feeding. Quofenix must not be used in women 
of childbearing potential not using contraception. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell 
your doctor before you are given this medicine. 
If you might become pregnant you have to use effective contraception during treatment with 
Quofenix. 
 
Driving and using machines 
Quofenix can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other 
activities that require mental alertness or coordination until you know how Quofenix affects you.  
 
Quofenix contains cyclodextrin 
This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial. 
 
Quofenix contains sodium 
This medicine contains 175 mg of sodium (main component of cooking salt) in each vial. This is 
equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult. 
 
 
3. How to use Quofenix 
 
Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein. 
 
You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 
5 and 14 days at the discretion of your doctor. Each infusion will last about an hour. Your doctor will 
decide how many days treatment is needed. 
 
Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
If you are given more Quofenix than you should 
Tell your doctor or nurse immediately if you are concerned that you may have been given too much 
Quofenix. 
 
If you miss a dose of Quofenix 
Tell your doctor or nurse immediately if you are concerned that you may have missed a dose. 



41 

If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects 
 
Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine 
should be stopped and you may need urgent medical attention: 
 
- Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or 
tongue; dry throat or throat tightening and severe rash. These may be signs and symptoms of a 
hypersensitivity (allergic) reaction and may be life-threatening. These severe reactions are uncommon 
side effects that may affect up to 1 in 100 people. 
- Drop in blood pressure; blurred vision; dizziness. This severe reaction is an uncommon side effect 
that may affect up to 1 in 100 people. 
- Abdominal (belly) pain with possible severe diarrhoea; fever and nausea. These may be signs of an 
infection of the bowel, which shouldn’t be treated with diarrhoea medicines that stop your bowels 
from moving. Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect 
that may affect up to 1 in 100 people. 
 
Other side effects may include: 
 
Common side effects (may affect up to 1 in 10 people): 

• Fungal infection  
• Headache 
• Vomiting 
• Swelling, redness or pain around the needle where the medicine is given into a vein (infusion 

site reaction) 
• Increase in the amount of enzymes produced by your liver called transaminases - shown in 

blood tests 
• Itching 

 
Uncommon side effects (may affect up to 1 in 100 people): 

• Urinary tract infection 
• Inflammation of the nasal mucosa tract 
• Haematocrit decreased (reduction of an indicator of amount of blood cells) 
• Low white blood cell count (reduction of an amount of blood cells) 
• Low haemoglobin level (anaemia) 
• Low red blood cell count (reduction of amount of blood cells) 
• Decrease of special blood cells necessary for blood clotting 
• Allergic reaction 
• Seasonal allergy 
• Low blood glucose levels 
• High blood glucose levels 
• Decreased appetite 
• Hearing things that do not exist (auditory hallucination) 
• Anxiety 
• Insomnia 
• Abnormal dreams 
• Muscle weakness in the extremities  
• Feeling lightheaded or faint, usually because of a drop in blood pressure 
• Sensations like numbness, tingling, pins and needles 



42 

• Reduced tactile sensation 
• Change in taste 
• Dry eye 
• Dizziness or loss of balance (vertigo) 
• Ringing or buzzing in the ears (tinnitus) 
• Irregular or rapid heart beats, feeling your heart beat (palpitation), decrease of heart beat 
• High blood pressure 
• Flushing (e.g. redness of the face or neck) 
• Swollen, red, irritated veins 
• Inflammation of the lining of the stomach, inflammation of the internal tissues of the mouth, 

abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence, discoloured 
faeces 

• Heartburn/acid regurgitation 
• Loss of tactile sensation at the mouth 
• Reduced tactile sensation at the mouth 
• Burning sensation in the mouth 
• Abnormal sweat 
• Cold sweat 
• Night sweat 
• Allergic skin reaction 
• Itchiness, red rash 
• Abnormal hair loss 
• Joint pain 
• Pain and swelling of the tendons 
• Inflammation of joints, pain in hands or feet, back pain, muscle spasm 
• Muscle inflammation/pain 
• Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle 

weakness 
• Reduced kidney function 
• Blood in urine 
• Cloudy urine because of the presence of solid component 
• Feeling tired 
• Chills 
• Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased, 

blood albumin decreased) 
• Worsening of a wound 
• Lower limb swelling  
• Medical device occlusion  

 
Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as 
tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal 
sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), 
depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and 
taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, 
in some cases irrespective of pre-existing risk factors. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Quofenix 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


43 

Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions if kept unopened in the original 
container. 
 
After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 
to 25ºC or at 2 to 8°C. From a microbiological point of view, the product should be used immediately 
after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to 
use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, 
unless reconstitution and dilution has taken place in controlled and validated aseptic conditions. 
 
Do not freeze. 
 
 
6. Contents of the pack and other information 
 
What Quofenix contains 
- The active substance is delafloxacin. Each vial of powder contains 300 mg of delafloxacin (as 

meglumine). 
- The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium 

hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment). 
 
What Quofenix looks like and contents of the pack 
Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial. The 
vial contains light yellow to tan cake powder. 
It is available in packs containing 10 vials. 
 
Marketing Authorisation Holder 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3 
50131 Florence 
Italy 
 
Manufacturer 
Patheon Italia S.p.A. 
2° Trav. SX Via Morolense 5 
03013 Ferentino (FR) 
Italy 
 
or 
 
AlfaSigma 
1 Via Enrico Fermi 
65020 Alanno (PE) 
Italy 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 
 

Lietuva 
UAB “BERLIN-CHEMIE MENARINI 
BALTIC” 
Tel: +370 52 691 947 
 



44 

България 
Берлин-Хеми/А. Менарини България ЕООД 
тел.: +359 2 454 0950 
 

Luxembourg/Luxemburg 
Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 

Česká republika 
Berlin-Chemie/A.Menarini Ceska republika 
s.r.o. 
Tel: +420 267 199 333 
 

Magyarország 
Berlin-Chemie/A. Menarini Kft. 
Tel.: +36 23501301 

Danmark 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Malta 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Deutschland 
Berlin-Chemie AG 
Tel: +49 (0) 30 67070 

Nederland 
Menarini Benelux NV/SA 
Tel: +32 (0)2 721 4545 

Eesti 
OÜ Berlin-Chemie Menarini Eesti 
Tel: +372 667 5001 

Norge 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 

Ελλάδα 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Österreich 
A. Menarini Pharma GmbH. 
Tel: +43 1 879 95 85-0 

España 
Laboratorios Menarini S.A. 
Tel: +34-93 462 88 00 

Polska 
Berlin-Chemie/Menarini Polska Sp. z o.o. 
Tel.: +48 22 566 21 00 

France 
MENARINI France 
Tél: +33 (0)1 45 60 77 20 

Portugal 
A. Menarini Portugal – Farmacêutica, S.A. 
Tel: +351 210 935 500 

Hrvatska 
Berlin-Chemie Menarini Hrvatska d.o.o. 
Tel: + 385 1 4821 361 

România 
Berlin-Chemie A. Menarini S.R.L. 
Tel: +40 21 232 34 32 

Ireland 
A. Menarini Pharmaceuticals Ireland Ltd 
Tel: +353 1 284 6744 

Slovenija 
Berlin-Chemie / A. Menarini Distribution 
Ljubljana d.o.o.  
Tel: +386 01 300 2160 

Ísland 
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l. 
Tel: +39-055 56801 

Slovenská republika 
Berlin-Chemie / A. Menarini Distribution 
Slovakia s.r.o. Tel: +421 2 544 30 730 

Italia 
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l. 
Tel: +39-055 56801 

Suomi/Finland 
Berlin-Chemie/A.Menarini Suomi OY 
Puh/Tel: +358 403 000 760 



45 

Κύπρος 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Sverige 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Latvija 
SIA Berlin-Chemie/Menarini Baltic 
Tel: +371 67103210 
 

United Kingdom 
A. Menarini Farmaceutica Internazionale S.R.L. 
Tel: +44 (0)1628 856400 
 

  
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
For single use only. 
 
Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) 
solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg 
vial. 
• The vial should be vigorously shaked until contents are completely dissolved. The reconstituted 
vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution. 
• The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride 
Injection or D5W) prior to administration. 
• Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for 
Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial. 
• The required dose of Quofenix reconstituted solution should be aseptically transferred from the 
vial to a 250 mL intravenous bag. (Any unused portion of the reconstituted solution should be 
discarded). 
• After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using 
a total infusion time of 60 minutes. 
 
Quofenix must not be co-infused with other medications. If a common intravenous line is being used to 
administer other medicinal products in addition to Quofenix the line should be flushed before and after 
each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W. Any 
unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
  

http://www.ema.europa.eu/


46 

Package leaflet: Information for the user 
Quofenix 450 mg tablets 

delafloxacin  
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Quofenix is and what it is used for 
2. What you need to know before you take Quofenix 
3. How to take Quofenix 
4. Possible side effects 
5. How to store Quofenix 
6. Contents of the pack and other information 
 
1. What Quofenix is and what it is used for 
 
Quofenix is an antibiotic that contains the active substance delafloxacin. It belongs to a group of 
medicines called fluoroquinolones. 
 
It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused 
by certain bacteria when usual antibiotics cannot be used or have not worked. 
It works by blocking bacteria enzymes needed to copy and to repair their DNA. By blocking these 
enzymes Quofenix kills bacteria that cause the infection. 
 
 
2. What you need to know before you take Quofenix 
 
Do not take Quofenix: 

• If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in 
section 6). 

• If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine. 
• If you have ever had a problem with your tendons such as tendonitis that was related to 

treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your 
skeleton. 

• If you are pregnant, might become pregnant, or think you might be pregnant. 
• If you are breast-feeding. 
• If you are a child or growing adolescent below 18 years of age. 

 
Warnings and precautions 
 
Before taking this medicine 
You should not take fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you 
have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. 
In this situation, you should inform your doctor as soon as possible. 



47 

 
When taking this medicine 

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your 
risk is increased if you are elderly (above 60 years of age), have received an organ transplant, 
have kidney problems or if you are being treated with corticosteroids. Inflammation and 
ruptures of tendons may occur within the first 48 hours of treatment and even up to several 
months after stopping Quofenix therapy. At the first sign of pain or inflammation of a tendon 
(for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact 
your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase 
the risk of a tendon rupture. 

 
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, 

tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this 
happens, stop taking Quofenix and inform your doctor immediately in order to prevent the 
development of potentially irreversible condition. 

 
Talk to your doctor or pharmacist or nurse before taking Quofenix if: 

• You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic 
aneurysm or large vessel peripheral aneurysm). 

• You have experienced a previous episode of aortic dissection (a tear in the aorta wall). 
• You have a family history of aortic aneurysm or aortic dissection or other risk factors or 

predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or 
vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell 
arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis). 

• You have had tendon problems during previous treatment with a fluoroquinolone or 
quinolone antibiotic. 

• You have or may have problems with the central nervous system (e.g. severe cerebral 
arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having 
seizures (fits). In those cases yor doctor will consider if this treatment is the best option for 
you. 

• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become 
worse. 

• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking 
antibiotics or up to 2 months afterwards. Contact your doctor straight away if you have 
diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea 
without first checking with your doctor. 

• You have kidney problems. 
• You had sometimes long treatment with antibiotics; it can mean that you get another infection 

caused by other bacteria (superinfection) which cannot be treated by the antibiotic. Talk to 
your doctor if you have any concerns or questions about this and using Quofenix. 

• You may have a severe skin reaction such as blistering or lesion. 
• You or a member of your family is known to have a deficiency in glucose-6-phosphate 

dehydrogenase. 
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause levels of 

glucose in the blood to rise too high or fall too low. If you have diabetes, you should monitor 
your blood glucose levels carefully. 

 
If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency 
room. 
 
Prolonged, disabling and potentially irreversible serious side effects 
Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious 
side effects, some of them being long lasting (continuing months or years), disabling or potentially 
irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in 
walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning 



48 

(paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, 
depression, memory impairment, severe fatigue and severe sleep disorders. 
If you experience any of these side effects after taking Quofenix, contact your doctor immediately 
prior to continuing treatment. You and your doctor will decide on continuing the treatment considering 
also an antibiotic from another class. 
 
Children and adolescents 
This medicine must not be used in children and adolescents as it has not been studied enough in these 
groups. 
 
Other medicines and Quofenix 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
Quofenix tablets should be taken at least 2 hours before or 6 hours after: 

• an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc 
• sucralfate 
• didanosine buffered tablets for oral suspension or the paediatric powder for oral solution 

 
Pregnancy and breast-feeding 
Quofenix must not be used if you are pregnant or breast-feeding. Quofenix must not be used in women 
of childbearing potential not using contraception.  
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell 
your doctor before you are taking this medicine. 
If you might become pregnant you have to use effective contraception during treatment with 
Quofenix. 
 
Driving and using machines 
Quofenix can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other 
activities that require mental alertness or coordination until you know how Quofenix affects you. 
 
Quofenix contains sodium 
This medicine contains 39 mg of sodium (main component of cooking salt) in each tablet. This is 
equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult. 
 
3. How to take Quofenix 
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the 
discretion of your doctor. The tablets are swallowed whole with a sufficient amount of water, and can 
be taken with or without food. 
 
If you take more Quofenix than you should 
If you accidentally take more tablets than you should, tell a doctor or get other medical advice. Take 
the medicine pack with you. 
 
If you forget to take Quofenix 
If you miss a dose, you should take it as soon as possible anytime up to 8 hours prior to the next 
scheduled dose. If less than 8 hours remain before the next dose, wait until the next scheduled dose. 
Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Quofenix 
If you stop taking Quofenix without the advice of your doctor, your symptoms may get worse. Talk to 
your doctor or pharmacist before you stop taking your medicine. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 



49 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects 
 
Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine 
should be stopped and you may need urgent medical attention: 
 
- Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or 
tongue; dry throat or throat tightening and severe rash. These may be signs and symptoms of a 
hypersensitivity (allergic) reaction and may be life-threatening. These severe reactions are uncommon 
side effects that may affect up to 1 in 100 people. 
- Drop in blood pressure; blurred vision; dizziness. This severe reaction is an uncommon side effect 
that may affect up to 1 in 100 people. 
- Abdominal (belly) pain with possible severe diarrhoea; fever and nausea. These may be signs of an 
infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels 
from moving. Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect 
that may affect up to 1 in 100 people. 
 
Other side effects may include: 
 
Common side effects (may affect up to 1 in 10 people): 

• Fungal infection 
• Headache 
• Vomiting 
• Increase in the amount of enzymes produced by your liver called transaminases -shown in 

blood tests 
• Itching 

 
Uncommon side effects (may affect up to 1 in 100 people): 

• Urinary tract infection 
• Inflammation of the nasal mucosa tract 
• Haematocrit decreased (reduction of an indicator of amount of blood cells) 
• Low white blood cell count (reduction of amount of blood cells) 
• Low haemoglobin level (anaemia) 
• Low red blood cell count (reduction of amount of blood cells) 
• Decrease of special blood cells necessary for blood clotting 
• Allergic reaction 
• Seasonal allergy 
• Low blood glucose levels 
• High blood glucose levels 
• Decreased appetite 
• Hearing things that do not exist (auditory hallucination) 
• Anxiety 
• Insomnia 
• Abnormal dreams 
• Muscle weakness in the extremities  
• Feeling lightheaded or faint, usually because of a drop in blood pressure 
• Sensations like numbness, tingling, pins and needles) 
• Reduced tactile sensation 
• Change in taste 
• Dry eye 
• Dizziness or loss of balance (vertigo) 
• Ringing or buzzing in the ears (tinnitus) 



50 

• Irregular or rapid heart beats, feeling your heart beat (palpitation), decrease of heart beat  
• High blood pressure 
• Flushing (e.g. redness of the face or neck) 
• Swollen, red, irritated veins 
• Inflammation of the lining of the stomach, inflammation of the internal tissues of the mouth, 

abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence, discoloured 
faeces 

• Heartburn/acid regurgitation 
• Loss of tactile sensation at the mouth 
• Reduced tactile sensation at the mouth 
• Burning sensation in the mouth 
• Abnormal sweat 
• Cold sweat 
• Night sweat 
• Allergic skin reaction 
• Itchiness, red rash 
• Abnormal hair loss 
• Joint pain 
• Pain and swelling of the tendons  
• Inflammation of joints, pain in hands or feet, back pain, muscle spasm 
• Muscle inflammation/pain 
• Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle 

weakness 
• Reduced kidneys function 
• Blood in urine 
• Cloudy urine because of the presence of solid component 
• Feeling tired 
• Chills 
• Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased, 

blood albumin decreased) 
• Worsening of a wound 
• Lower limb swelling 

 
Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as 
tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal 
sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), 
depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and 
taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, 
in some cases irrespective of pre-existing risk factors. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Quofenix 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special temperature storage conditions. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


51 

 
Store in the original package in order to protect from light. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
 
6. Contents of the pack and other information 
 
What Quofenix contains 
- The active substance is delafloxacin. Each tablet contains 450 mg of delafloxacin (as 

meglumine). 
- The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen 

carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate. 
 
What Quofenix looks like and contents of the pack 
Quofenix is a beige to mottled beige, oblong biconvex tablets. 
 
It is available in blister pack of 5 tablets, into pack size of 10,20,30,50, 60 or 100 tablets per carton. 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. 
Via Sette Santi 3 
50131 Florence 
Italy 
 
Manufacturer 
 
 
 
AlfaSigma 
1 Via Enrico Fermi 
65020 Alanno (PE) 
Italy 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 
België/Belgique/Belgien 
Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 

Lietuva 
UAB “BERLIN-CHEMIE MENARINI 
BALTIC” 
Tel: +370 52 691 947 
 

България 
Берлин-Хеми/А. Менарини България ЕООД 
тел.: +359 2 454 0950 
 

Luxembourg/Luxemburg 
Menarini Benelux NV/SA 
Tél/Tel: + 32 (0)2 721 4545 

Česká republika 
Berlin-Chemie/A.Menarini Ceska republika 
s.r.o. 
Tel: +420 267 199 333 
 

Magyarország 
Berlin-Chemie/A. Menarini Kft. 
Tel.: +36 23501301 



52 

Danmark 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Malta 
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l. 
Tel: +39-055 56801 
 

Deutschland 
Berlin-Chemie AG 
Tel: +49 (0) 30 67070 

Nederland 
Menarini Benelux NV/SA 
Tel: +32 (0)2 721 4545 

 
Eesti 
OÜ Berlin-Chemie Menarini Eesti 
Tel: +372 667 5001 
 

 
Norge 
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l. 
Tel: +39-055 56801 
 

Ελλάδα 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Österreich 
A. Menarini Pharma GmbH. 
Tel: +43 1 879 95 85-0 

España 
Laboratorios Menarini S.A. 
Tel: +34-93 462 88 00 

Polska 
Berlin-Chemie/Menarini Polska Sp. z o.o. 
Tel.: +48 22 566 21 00 

France 
MENARINI France 
Tél: +33 (0)1 45 60 77 20 

Portugal 
A. Menarini Portugal – Farmacêutica, S.A. 
Tel: +351 210 935 500 

Hrvatska 
Berlin-Chemie Menarini Hrvatska d.o.o. 
Tel: + 385 1 4821 361 

România 
Berlin-Chemie A. Menarini S.R.L. 
Tel: +40 21 232 34 32 

Ireland 
A. Menarini Pharmaceuticals Ireland Ltd 
Tel: +353 1 284 6744 

Slovenija 
Berlin-Chemie / A. Menarini Distribution 
Ljubljana d.o.o.  
Tel: +386 01 300 2160 
 

Ísland 
A. Menarini -Industrie Farmaceutiche Riunite -
s.r.l. 
Tel: +39-055 56801 
 

Slovenská republika 
Berlin-Chemie / A. Menarini Distribution 
Slovakia s.r.o. Tel: +421 2 544 30 730 

Italia 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 

Suomi/Finland 
Berlin-Chemie/A.Menarini Suomi OY 
Puh/Tel: +358 403 000 760 

Κύπρος 
MENARINI HELLAS AE 
Τηλ: +30 210 8316111-13 

Sverige 
A. Menarini - Industrie Farmaceutiche Riunite - 
s.r.l. 
Tel: +39-055 56801 
 



53 

Latvija 
SIA Berlin-Chemie/Menarini Baltic 
Tel: +371 67103210 

United Kingdom 
A. Menarini Farmaceutica Internazionale S.R.L. 
Tel: +44 (0)1628 856400 

 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A.  MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET