INQLEXZO® 225 mg – patient leaflet, side effects, dosage

1 What INQLEXZO is and what it is used for

INQLEXZO is used to treat adult patients with certain types of bladder cancer. INQLEXZO is a small, flexible, curled silicone tube that contains the active substance ‘gemcitabine’.

Gemcitabine belongs to a group of medicines called ‘cytotoxics’. These medicines kill dividing cells, including cancer cells.

Your healthcare professional will insert INQLEXZO into your bladder. INQLEXZO releases gemcitabine into the bladder and it is placed in the bladder with an Inserter (small flexible plastic tube) known as a Urinary Placement Catheter.

INQLEXZO releases gemcitabine into your bladder over time. Each time INQLEXZO is inserted into your bladder, it will be left in for 3 weeks. After that, it will be removed by your healthcare professional - see section 3.

2 What you need to know before you are given INQLEXZO

Do not have INQLEXZO if:

• you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
• your healthcare professional tells you that the Urinary Placement Catheter should not be inserted into your bladder.
• you have a tear or hole (perforation) of your bladder.

Warnings and precautions

Talk to your healthcare professional before INQLEXZO is given.

Before starting treatment with INQLEXZO:

Your healthcare professional will explain the possible risks associated with the treatment with INQLEXZO.

After starting treatment with INQLEXZO

MRI scans and INQLEXZO

Tell your healthcare professional that you have INQLEXZO in your bladder before having a type of medical scan called an ‘MRI’ or ‘magnetic resonance imaging’. MRIs can only be done safely under specific conditions whilst INQLEXZO is in your bladder.

Children and adolescents

Do not have INQLEXZO if you are below the age of 18. This medicine has not been studied in this age group, and it is not known if it is safe and effective.

Other medicines and INQLEXZO

Tell your healthcare professional if you are taking, have recently taken or might take any other medicines. This includes medicines you can get without a prescription and herbal medicines.

Pregnancy and breast-feeding

Tell your healthcare professional before you are given INQLEXZO if you are pregnant or breast-feeding, think you might be pregnant or planning to have a baby.

• Ask your healthcare professional for advice before being given this medicine.
• This is because the effects of INQLEXZO in pregnant or breast-feeding women are not known.

You must tell your healthcare professional immediately if you become pregnant while being treated with this medicine. It is possible that this medicine may harm your unborn baby.

Contraception

Female patients:

If you are able to become pregnant, pregnancy testing is recommended prior to starting treatment with INQLEXZO.

You must use effective contraception during treatment and for 6 months after last removal of INQLEXZO.

Male patients:

If your partner could become pregnant, you must use effective contraception during treatment and for 3 months after last removal of INQLEXZO.

Driving and using machines

INQLEXZO does not influence your ability to drive and use tools or machines.

3 How INQLEXZO is given

You will always be given INQLEXZO by a healthcare professional. Your treatment with INQLEXZO will last in total 2 years:

• First, your healthcare professional will insert INQLEXZO every 3 weeks for 6 months (8 insertions).
• Afterwards, INQLEXZO will be inserted once every 12 weeks, and removed 3 weeks later, for up to 18 months (6 additional insertions).

Before you are given INQLEXZO

• You will be asked not to urinate immediately before INQLEXZO is given to you.
• You may be given antibiotics to prevent the risk of urinary tract infections.

Being given INQLEXZO

• First, your genital area will be cleaned with a sterile solution.
• A healthcare professional will then pass a small flexible plastic tube known as a Urinary Placement Catheter into your bladder.
• INQLEXZO will be put into your bladder by passing it through the Urinary Placement Catheter. This will only take a few minutes.
• The Urinary Placement Catheter will then be removed, and INQLEXZO will stay in your bladder.

• INQLEXZO will float in the urine inside your bladder.

  After you get INQLEXZO

  • You can urinate normally. You do not need to hold it in.

  • Drink plenty of non-alcoholic, caffeine-free drinks (approximately 1500 mL per day) whilst INQLEXZO is in your bladder. This helps the bladder produce urine so that INQLEXZO can work properly.

  • Avoid contact between your skin and urine.
  • To urinate, women and men should sit on the toilet and flush after each use.
  • Wash your hands with soap and water and wash your genital area with water after each time you urinate.
  • Wash clothing soiled with urine right away and separately from other clothing.
  • Each time INQLEXZO is inserted into your bladder, it will be left in for 3 weeks.

Removing INQLEXZO

A healthcare professional will remove INQLEXZO using a viewing tube. The viewing tube has:

• A small camera, which is used to find INQLEXZO.
• Gripping parts to grasp and remove INQLEXZO from your bladder.

Replacing INQLEXZO

• Your healthcare professional will decide how often you will be given a new INQLEXZO.
• Your healthcare professional may give you a new INQLEXZO immediately after removing the previous INQLEXZO.

If you forget your appointment to insert or remove INQLEXZO

It is very important to go to all your appointments. If you miss an appointment, make another one as soon as possible.

If you have any further questions on the use of this medicine, ask your healthcare professional.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• blood in the urine
• infection of parts of the body that collect and pass urine
• pain when passing urine
• pain in the urinary tract (felt in the lower abdomen or lower back)
• genital pain (pain in lower abdomen and external reproductive organs)
• bladder irritation (feeling of bladder pain, pressure or extreme urge to pass urine)
• urgent need to pass urine
• frequently need to pass urine during the day
• diarrhoea
• feeling very tired

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

• lung infection
• swelling of the kidney caused by a build-up of urine in the kidney
• being unable to pass urine or empty the bladder completely
• loss of control of the bladder
• waking up at night to pass urine
• problem affecting parts of the body that collect and pass urine

Blood test outcomes:

Very common (may affect more than 1 in 10 people):

• decreased haemoglobin (protein in red blood cells that carries oxygen around the body)
• decreased white blood cells
• increased lipase (an enzyme that help to digest fats)
• increased creatinine (a compound that is excreted from the body in urine and measured to monitor kidney function)
• increased potassium
• increased level of liver enzymes in the blood

• decreased sodium

  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 INQLEXZO

The following information is intended for doctors only.

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

INQLEXZO will be stored at the hospital or clinic by your healthcare professional. Your healthcare professional should not use INQLEXZO after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. This medicine does not require any special temperature storage conditions. Do not throw away any medicines via wastewater or household waste. Your healthcare provider will throw away any medicines that are no longer being used. These measures will help protect the environment.

6 Contents of the pack and other information

What INQLEXZO contains:

• the active substance is gemcitabine. INQLEXZO contains 225 mg of gemcitabine.

• the other ingredients are:

  • Gemcitabine minitablets: polyethylene glycol 8000 (E1521) (Macrogol), povidone K30 (E1201), urea (E927B)
  • Osmotic (urea) minitablets: urea (E927B), polyethylene oxide 600,000 (E1521), brilliant Blue FCF (E133)
  • Intravesical delivery system: silicone, nitinol wire

What INQLEXZO looks like and contents of the pack

INQLEXZO is a small, flexible, curled silicone tube, which contains gemcitabine and is co-packaged with the Urinary Placement Catheter (made of thermoplastic elastomer and polyethene), that is used to insert INQLEXZO into your bladder. Each carton contains one INQLEXZO and one Urinary Placement Catheter.

Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

2340 Beerse

Belgium

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last revised in 06/2026.

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