Quofenix
delafloxacin
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.
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 Quofenix is and what it is used for
What you need to know before you are given Quofenix
How to use Quofenix
Possible side effects
How to store Quofenix
Contents of the pack and other information
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 caused by certain bacteria when usual antibiotics cannot be used or have not worked:
infections of the skin and tissue under the skin
infection of the lungs called ‘pneumonia’.
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.
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.
Before you are given this medicine
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 been diagnosed with leaking heart valves (heart valve regurgitation).
You have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart] ).
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, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.
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.
This medicine must not be used in children and adolescents, as it has not been studied enough in these groups.
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.
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.
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.
This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.
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.
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 for skin infections and between 5 and 10 days for pneumonia, 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.
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.
Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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):
Reduction in the number of white cells in the blood (leukopenia)
Low haemoglobin level (anaemia)
Allergic reaction
High blood glucose levels
Decreased appetite
Insomnia
Muscle weakness in the extremities
Sensations like numbness, tingling, pins and needles
Reduced tactile sensation
Change in taste
Feeling your heart beat (palpitation)
High blood pressure
Flushing (e.g. redness of the face or neck)
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
Abnormal sweat
Allergic skin reaction
Itchiness, red rash
Joint pain
Pain and swelling of the tendons
Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Increased level of creatine phosphokinase in blood (an indicator of muscle damage)
Reduced kidney function
Feeling tired
Blood test alteration related to liver function (blood alkaline phosphatase increased)
Raised body temperature (pyrexia)
Lower limb swelling
Rare side effects (may affect up to 1 in 1000 people):
Urinary tract infection
Inflammation of the nasal mucosa tract
Low white blood cell count (reduction of an amount of blood cells)
Decrease of special blood cells necessary for blood clotting
Changes in tests which measure how well your blood clots
Seasonal allergy
Low blood glucose levels
High level of uric acid
High level of blood potassium
Low level blood potassium
Hearing things that do not exist (auditory hallucination)
Anxiety
Abnormal dreams
Confusion
Somnolence
Feeling lightheaded or faint, usually because of a drop in blood pressure
Dry eye
Dizziness or loss of balance (vertigo)
Ringing or buzzing in the ears (tinnitus)
Alteration of the sense of balance
Irregular or rapid heart beats, decrease of heart beat
Swollen, red, irritated veins (phlebitis)
Blood clot, known as a thrombus in the deep vein
Heartburn/acid regurgitation
Loss of tactile sensation at the mouth
Reduced tactile sensation at the mouth
Burning sensation in the mouth
Discoloured faeces
Blood test alteration related to liver function (blood albumin decreased and gamma- glutamyltransferase increased)
Cold sweat
Night sweat
Abnormal hair loss
Muscle spasm
Muscle inflammation/pain
Inflammation of joints, pain in hands or feet, back pain
Blood in urine
Cloudy urine because of the presence of solid component
Chills
Worsening of a wound
Oedema peripheral
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.
Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.
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.
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.
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).
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.
A. Menarini – Industrie Farmaceutiche Riunite – s.r.l.
Via Sette Santi 3 50131 Florence
Italy
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.
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947
Берлин-Хеми/А. Менарини България ЕООД
тел.: +359 2 454 0950
Berlin-Chemie/A.Menarini Ceska republika
s.r.o.
Tel: +420 267 199 333
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301
Menarini - Industrie Farmaceutiche Riunite -
s.r.l.
Tel: +39-055 56801
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l.
Tel: +39-055 56801
Berlin-Chemie AG
Tel: +49 (0) 30 67070
Menarini Benelux NV/SA
Tel: +32 (0)2 721 4545
OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
Tel: +39-055 56801
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13
A. Menarini Pharma GmbH.
Tel: +43 1 879 95 85-0
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
MENARINI France
Tél: +33 (0)1 45 60 77 20
A. Menarini Portugal – Farmacêutica, S.A.
Tel: +351 210 935 500
Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361
Berlin-Chemie A. Menarini S.R.L. Tel: +40 21 232 34 32
A. Menarini Pharmaceuticals Ireland Ltd
Tel: +353 1 284 6744
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l.
Tel: +39-055 56801
Berlin-Chemie / A. Menarini Distribution
Ljubljana d.o.o.
Tel: +386 01 300 2160
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o. Tel: +421 2 544 30 730
A. Menarini - Industrie Farmaceutiche Riunite -
s.r.l.
Tel: +39-055 56801
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13
Berlin-Chemie/A.Menarini Suomi OY
Puh/Tel: +358 403 000 760
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
Tel: +39-055 56801
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
A. Menarini Farmaceutica Internazionale S.R.L.
Tel: +44 (0)1628 856400
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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.