What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/19/1393/001.


Quofenix 300 mg powder for concentrate for solution for infusion

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

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 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.

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
  • 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 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.

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

This leaflet was last revised in 12/2019

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