Quofenix 300 mg powder for concentrate for solution for infusion

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Quofenix 300 mg powder for concentrate for solution for infusion

delafloxacin

Read the entire leaflet carefully before you are administered this medicine, as it contains important information for you.

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

Contents of this leaflet

1. What Quofenix is and what it is used for
2. What you need to know before you are administered 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 in adults to treat serious, short-term infections caused by certain bacteria, when commonly used antibiotics cannot be used or have not worked:

• infections of the skin and subcutaneous tissue
• lung infection known as "pneumonia"

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

2. What you need to know before starting to take Quofenix

Do not administer Quofenix to

• If you are allergic to delafloxacin or to any of the other components of this medicine (listed in section 6).
• If you are allergic to any other antibacterial medicine of the fluoroquinolone or quinolone type.
• If you have ever had tendon problems, such as tendinitis, related to treatment with "quinolone-type antibiotics". A tendon is the cord that connects muscle to bone.
• If you are pregnant, intend to become pregnant, or think you might be pregnant.
• If you are breastfeeding.
• If you are a child or a growing adolescent under 18 years of age.

Warnings and precautions

Before you are given this medicine

Do not receive fluoroquinolone/quinolone-type antibacterial medicines, including Quofenix, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. In such case, inform your doctor as soon as possible.

When you are given this medicine

• Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. Your risk increases if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and ruptures may occur within the first 48 hours of treatment and even several months after stopping treatment with Quofenix. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), do not receive Quofenix, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this could increase the risk of tendon rupture.

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

Consult your doctor or pharmacist or nurse before receiving Quofenix if:

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

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

If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Serious, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone-type antibacterial medicines have been associated with very rare but serious side effects, some of which may last for months or years, be disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, prickling, numbness, or burning (paresthesia), sensory disturbances such as impaired vision, taste, 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 before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering an antibiotic from another class.

Children and adolescents

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

Other medicines and Quofenix

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

Quofenix must not be administered together with any solution containing substances such as calcium and magnesium through the same intravenous line.

Pregnancy and breastfeeding

Quofenix must not be used if you are pregnant or breastfeeding. Quofenix must not be used in women of childbearing potential who are not using contraceptive methods.

If you are pregnant or breastfeeding, think you might be pregnant, or intend to become pregnant, consult your doctor before receiving this medicine.

If you could become pregnant, you must use effective contraception during treatment with Quofenix.

Driving and using machines

Quofenix may cause dizziness and lightheadedness. Until you know how Quofenix affects you, do not drive, operate machinery, or perform other activities requiring mental alertness or coordination.

Quofenix contains cyclodextrins

This medicine contains 2480 mg of sodium sulfobutyl betadex in each vial.

Quofenix contains sodium

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

3. How to use Quofenix

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

You will receive a Quofenix infusion containing 300 mg of the medicine, twice a day for 5 to 14 days for skin infections and for 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 necessary.

Inform your doctor if you have kidney problems, as your dose may need to be adjusted.

If you have any further questions about 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 have been given more Quofenix than you should have.

If you miss a dose of Quofenix

Tell your doctor or nurse immediately if you are concerned that a dose has been missed.

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

4. Possible adverse effects

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

Serious adverse effects

Please inform your doctor or nurse immediately if you experience any of the following symptoms, as treatment with this medicine must be stopped and you may require urgent medical attention:

• Difficulty swallowing or breathing, or coughing; swelling of the lips, face, throat, or tongue; dry throat or tightness in the throat, and severe rash. These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be potentially life-threatening. These serious reactions are uncommon adverse effects that may affect up to 1 in 100 people.
• Decreased blood pressure; blurred vision; dizziness. This serious reaction is an uncommon adverse effect that may affect up to 1 in 100 people.
• Abdominal (stomach) pain possibly with severe diarrhoea, fever, and nausea. These may be signs of a bowel infection, which should not be treated with anti-diarrhoeal medicines that stop intestinal movement. Bowel infection (infection by Clostridioides difficile) is an uncommon adverse effect that may affect up to 1 in 100 people.

Other adverse effects may include:

Common adverse effects (may affect up to 1 in 10 people):

• Fungal infection
• Headache
• Vomiting
• Swelling, redness, or pain around the site of the vein where the medicine is administered (infusion site reaction)
• Increased levels of liver enzymes known as transaminases, detected in blood tests
• Itching

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

• Decreased number of white blood cells in the blood (leucopenia)
• Low levels of haemoglobin (anaemia)
• Allergic reaction
• High blood glucose levels
• Decreased appetite
• Insomnia
• Muscle weakness in the limbs
• Sensations such as numbness, tingling, and prickling
• Reduced sense of touch
• Taste disturbances
• Awareness of heartbeats (palpitations)
• High blood pressure
• Flushing (e.g. in the face or neck)
• Inflammation of the stomach lining, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence
• Abnormal sweating
• Skin allergic reaction
• Itchy red rash
• Joint pain
• Tendon pain and swelling
• Musculoskeletal pain (e.g. limb pain, back pain, neck pain), muscle weakness
• Increased level of creatine phosphokinase in blood (a marker of muscle damage)
• Decreased kidney function
• Feeling of tiredness
• Abnormal blood test related to liver function (increased alkaline phosphatase in blood)
• Increased body temperature (pyrexia)
• Swelling of the lower limbs

Rare adverse effects (may affect up to 1 in 1,000 people):

• Urinary tract infection
• Inflammation of the nasal cavity lining
• Low white blood cell count (reduction in blood cells)
• Decrease in a special type of blood cell essential for blood clotting
• Changes in blood tests measuring blood clotting function
• Seasonal allergy
• Low blood glucose levels
• High levels of uric acid
• High levels of potassium in blood
• Low levels of potassium in blood
• Hearing things that are not real (auditory hallucinations)
• Anxiety
• Sleep disturbances
• Confusion
• Drowsiness
• Dizziness or faintness, usually due to a drop in blood pressure
• Dry eyes
• Dizziness or loss of balance (vertigo)
• Ringing in the ears (tinnitus)
• Balance disturbances
• Irregular or rapid heartbeat, decreased heart rate
• Swollen, red, and irritated veins (phlebitis)
• Blood clot known as deep vein thrombosis
• Heartburn, acid regurgitation
• Loss of sense of touch in the mouth
• Reduced tactile sensation in the mouth
• Burning sensation in the mouth
• Change in stool colour
• Abnormal blood tests related to liver function (decreased albumin in blood and increased gamma-glutamyltransferase)
• Cold sweating
• Night sweats
• Abnormal hair loss
• Muscle spasms
• Muscle inflammation/pain
• Joint inflammation, pain in hands or feet, back pain
• Blood in urine
• Cloudy urine due to presence of solid components
• Chills
• Wound deterioration
• Peripheral oedema
• Obstruction of the medical delivery device

Very rare cases of long-term or permanent adverse drug reactions, including in some cases regardless of pre-existing risk factors, have been associated with the administration of quinolone and fluoroquinolone antibiotics. These include tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling and prickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory disturbances, as well as disturbances in hearing, vision, taste, and smell.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quofenix

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

Do not use this medicine after the expiry date stated on the carton or container after EXP. The expiry date refers to the last day of the month indicated.

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

Do not freeze.

6. Contents of the pack and other information

Composition of Quofenix

• The active substance is delafloxacin. Each vial of powder contains 300 mg of delafloxacin (as meglumine).
• The other components (excipients) are meglumine, sodium sulfobutyl betadex, disodium edetate, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the pack

Quofenix 300 mg powder for concentrate for solution for infusion is supplied as a 20 ml clear glass vial.

The vial contains compact, light yellow powder.

It is available in packs containing 10 vials.

Marketing Authorization Holder and Manufacturer

• 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: 08/2024

Other sources of information

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

This 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%) injectable solution (D5W) or sodium chloride 9 mg/ml (0.9%) injectable solution per 300 mg vial.

• The vial should be shaken vigorously until the contents are completely dissolved. The reconstituted vial contains 300 mg in 12 ml of delafloxacin, as a solution ranging in color from pale yellow to amber.
• The reconstituted solution should then be diluted in an intravenous infusion bag containing 250 ml (either 0.9% sodium chloride injectable solution or D5W) prior to administration.
• Prepare the required dose for intravenous infusion by withdrawing 12 ml from the reconstituted vial for Quofenix 300 mg or 8 ml for Quofenix 200 mg.
• The required dose of 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 simultaneously with other medicinal products. If a common intravenous line is used to administer other medicinal products in addition to Quofenix, the line must be flushed before and after each Quofenix infusion with 9 mg/ml (0.9%) sodium chloride injectable solution or D5W. Any unused or waste medicinal product must be disposed of in accordance with local requirements.