Patient Information Leaflet

Quofenix 300 mg powder for concentrate for solution for infusion

delafloxacino

Read this leaflet carefully beforeyou receivethis medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Quofenix is an antibiotic that contains the active ingredient delafloxacino. It belongs to a group of medications called fluoroquinolones.

It is used for the treatment in adults of severe and short-duration infections caused by certain bacteria, when usual antibiotics cannot be used or have not been effective:

• skin and subcutaneous tissue infections
• lung infection called "pneumonia"

It blocks the enzymes that bacteria need to copy and repair their DNA. By blocking these enzymes, Quofenix kills the bacteria that cause the infection.

Do not administer Quofenix

• If you are allergic to delafloxacino or any of the other components of this medication (including those listed in section 6).
• If you are allergic to any other fluoroquinolone or quinolone antibiotic.
• If you have ever had a problem with tendons, such as tendinitis, related to treatment with "quinolone-type antibiotics". A tendon is the cord that connects the muscle to the skeleton.
• If you are pregnant, intend to become pregnant, or think you may be pregnant.
• If you are breastfeeding.
• If you are a child or adolescent under the age of 18 years.

Warnings and precautions

Before this medication is administered

Do not administer fluoroquinolone/quinolone antibiotics, including Quofenix, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

When this medication is administered

• In rare cases, pain and swelling in the joints, inflammation, or tendon rupture may occur. Your risk increases if you are an elderly patient (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and ruptures can occur within the first 48 hours of treatment and even several months after stopping Quofenix treatment. If you experience any pain or inflammation in a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), do not administer Quofenix, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• In rare cases, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms, may occur. If this happens, do not administer Quofenix, and inform your doctor immediately to prevent the development of a potentially irreversible alteration.

Consult your doctor, pharmacist, or nurse before Quofenix is administered if:

• You have been diagnosed with an enlarged or bulging large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aorta wall).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other predisposing risk factors (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• You have had tendon problems during previous treatment with a quinolone or fluoroquinolone antibiotic.
• You have or may have central nervous system problems (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that may increase the risk of seizures (attacks). In these cases, your doctor will consider whether this treatment is the best option for you.
• You have myasthenia gravis (a type of muscle weakness), as symptoms may worsen.
• You have diarrhea, or have had diarrhea when taking antibiotics or up to 2 months after. Contact your doctor immediately if you have diarrhea during or after treatment. Do not take any medication to treat diarrhea without consulting your doctor first.
• You have kidney problems.
• You have had prolonged antibiotic treatment; this may mean you contract another infection caused by other bacteria (superinfection) that cannot be treated with the antibiotic. Consult your doctor if you have any doubts or questions about this and about the use of Quofenix.
• You may have a severe skin reaction, such as blisters or lesions.
• You or a family member has glucose-6-phosphate dehydrogenase deficiency.
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause blood glucose levels to rise or fall too low. If you have diabetes, you must carefully control your blood glucose levels.

If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may be at increased risk if you are receiving systemic corticosteroid treatment.

If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Severe, prolonged, incapacitating, and potentially irreversible side effects

Fluoroquinolone/quinolone antibiotics have been associated with very rare but severe side effects, some of which are of long duration (lasting months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as tingling, numbness, or burning (paresthesia), sensory disorders such as vision, taste, and smell deterioration, and hearing, depression, memory deterioration, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after receiving Quofenix, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering another class of antibiotic.

Children and adolescents

This medication should not be used in children and adolescents, as it has not been sufficiently studied in these groups.

Other medications and Quofenix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Quofenix should not be administered with any solution containing substances such as calcium and magnesium through the same intravenous route.

Pregnancy and lactation

Quofenix should not be used if you are pregnant or breastfeeding. Quofenix should not be used in fertile women who do not use effective contraceptive methods.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before Quofenix is administered.

If you may become pregnant, use effective contraceptive methods during Quofenix treatment.

Driving and operating machinery

Quofenix may cause dizziness and disorientation. Until you know how Quofenix affects you, do not drive, operate machinery, or perform other activities that require mental acuity or coordination.

Quofenix contains cyclodextrins

This medication contains 2480 mg of sodium sulfobutyl beta-cyclodextrin in each vial.

Quofenix contains sodium

This medication contains 175 mg of sodium (main component of cooking salt) in each vial. This is equivalent to 8.8% of the recommended daily maximum sodium intake for an adult.

Quofenix will be administered to you by a nurse or doctor through an infusion (drip) into a vein.

You will receive an infusion of Quofenix, which contains 300 mg of the medication, two times a day for 5 to 14 days for skin infections and 5 to 10 days for pneumonia, as determined by your doctor. Each infusion will last approximately one hour. Your doctor will decide how many days of treatment are needed.

Inform your doctor if you have kidney problems, as you may need to adjust your dosage.

If you have any questions about the use of this medication, ask your doctor.

If you are given more Quofenix than you should

Tell your doctor or nurse immediately if you are concerned that you have been given more Quofenix than you should.

If you forget a dose of Quofenix

Tell your doctor or nurse immediately if you are concerned that you have forgotten a dose.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Please inform your doctor or nurse immediately if you experience any of the following symptoms, as treatment with the medicine should be discontinued and you may need urgent medical attention:

• Difficulty swallowing or difficulty breathing and coughing; swelling of the lips, face, throat, or tongue; dry or constricted throat and severe itching. These may be signs and symptoms of an allergic reaction (hypersensitivity) and can be potentially fatal. These severe reactions are rare side effects that can affect up to 1 in 100 people.
• Low blood pressure; blurred vision; dizziness. This severe reaction is a rare side effect that can affect up to 1 in 100 people.
• Abdominal pain (stomach) with possible severe diarrhea, fever, and nausea. These may be signs of intestinal infection, which should not be treated with medications that stop intestinal movement. Intestinal infection (Clostridioides difficile infection) is a rare side effect that can affect up to 1 in 100 people.

Other side effects may include:

Frequent side effects (can affect up to 1 in 10 people):

• Fungal infection
• Headache
• Vomiting
• Swelling, redness, or pain around the vein at the site where the medicine is administered (perfusion site reaction)
• Increased levels of liver enzymes, called transaminases, shown in blood tests
• Itching

Rare side effects (can affect up to 1 in 100 people):

• Reduction in the number of white blood cells in the blood (leucopenia)
• Low hemoglobin levels (anemia)
• Allergic reaction
• High blood sugar levels
• Loss of appetite
• Insomnia
• Weakness in the muscles of the extremities
• Sensations of numbness, tingling, and prickling
• Decreased sensation of touch
• Alteration of taste
• Feeling of heartbeats (palpitations)
• High blood pressure
• Redness (e.g., on the face or neck)
• Inflammation of the stomach wall, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort, dry mouth, flatulence
• Abnormal sweating
• Skin allergic reaction
• Red, itchy, and prickling rash
• Joint pain
• Tendon pain and swelling
• Musculoskeletal pain (e.g., pain in the extremities, back pain, neck pain), muscle weakness
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• Decreased kidney function
• Feeling of fatigue
• Alteration of blood tests related to liver function (increase in alkaline phosphatase in the blood)
• Increased body temperature (pyrexia)
• Swelling of the lower extremities

Rare side effects (can affect up to 1 in 1000 people):

• Urinary tract infection
• Inflammation of the nasal mucosa
• Low white blood cell count (reduction in the number of blood cells)
• Decreased levels of a special type of blood cell necessary for blood coagulation
• Changes in blood tests that measure blood coagulation function
• Seasonal allergy
• Low blood sugar levels
• High levels of uric acid
• High levels of potassium in the blood
• Low levels of potassium in the blood
• Heard things that do not exist (auditory hallucinations)
• Anxiety
• Alterations in sleep
• Confusion
• Drowsiness
• Feeling of dizziness or fainting, usually due to low blood pressure
• Dry eyes
• Dizziness or loss of balance (vertigo)
• Ringing in the ears (tinnitus)
• Alteration of balance
• Irregular or rapid heartbeats, decreased heartbeats
• Swollen, red, and irritated veins (phlebitis)
• Clot of blood, known as deep vein thrombosis
• Acid reflux, regurgitation of acid
• Loss of sensation of touch in the mouth
• Reduction of tactile sensation in the mouth
• Sensation of burning in the mouth
• Change in stool color
• Alteration of blood tests related to liver function (decrease in albumin in the blood and increase in gamma-glutamyltransferase)
• Cold sweat
• Nocturnal sweating
• Abnormal hair loss
• Muscle spasms
• Muscle inflammation
• Inflammation of the joints, pain in the hands or feet, back pain
• Blood in the urine
• Cloudy urine due to the presence of solid components
• Chills
• Worsening of the wound
• Peripheral edema
• Blockage of the medical device for administration

There have been associations with the administration of quinolone and fluoroquinolone antibiotics, in some cases independently of pre-existing risk factors, very rare cases of permanent or long-lasting (up to months or years) adverse reactions, such as tendon inflammation, tendon rupture, joint pain, pain in the extremities, difficulty walking, abnormal sensations such as tingling and prickling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory alterations, as well as alterations in hearing, vision, taste, and smell.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.*. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or packaging after CAD. The expiration date is the last day of the month indicated.

After reconstitution: Chemical and physical stability in use has been demonstrated for 24 hours between 20 to 25°C or between 2 to 8°C. From a microbiological standpoint, the product should be used immediately after reconstitution and dilution. If not used immediately, storage times and conditions in use before use are the responsibility of the user, and are normally not to exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution and dilution were performed in controlled and validated aseptic conditions.

Do not freeze.

Composition of Quofenix

• The active ingredient is delafloxacino. Each vial of powder contains 300 mg of delafloxacino (as meglumina).
• The other components (excipients) are meglumina, sulfobutil betadex of sodium, edetate disodium, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Quofenix 300mg powder for concentrate for solution for infusionis presented in a transparent glass vial of 20 ml.

The vial contains compact yellowish powder.

It is available in packages containing 10 vials.

Marketing authorization holder and responsible manufacturer

A. Menarini – Industrie Farmaceutiche Riunite – s.r.l.

Via Sette Santi 3

50131 Florence

Italy

Responsible 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:08/2024

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

For single use only.

Quofenix must be reconstituted under aseptic conditions, using 10.5 ml of dextrose 50 mg/ml (5%) injectable solution (D5W) or sodium chloride 9 mg/ml (0.9%) injectable solution for each vial of 300 mg.

• The vial must be shaken vigorously until the contents are completely dissolved. The reconstituted vial contains 300 mg per 12 ml of delafloxacino, as a yellowish to amber solution.
• Subsequently, the reconstituted solution must be diluted in a 250 ml intravenous infusion bag (already containing a 0.9% sodium chloride solution or D5W) prior to administration.
• Prepare the required dose for intravenous infusion by removing 12 ml from the reconstituted vial for Quofenix 300 mg or 8 ml for Quofenix 200 mg.

• The required dose of the reconstituted Quofenix solution must be transferred aseptically from the vial to a 250 ml intravenous infusion bag. (Any unused portion of the reconstituted solution must be discarded).
• After reconstitution and dilution, Quofenix must be administered by intravenous infusion, over a total infusion time of 60 minutes.

Quofenix must not be infused with other medications. If a common intravenous route is used to administer other medications in addition to Quofenix, the route must be flushed before and after each infusion of Quofenix with a 0.9% sodium chloride solution or D5W. Any unused medication or residue must be disposed of in accordance with local regulations.