Patient leaflet - KORJUNY 10 MICROGRAMS CONCENTRATE FOR SOLUTION FOR INFUSION
1. What Korjuny is and what it is used for 2. What you need to know before you are
given Korjuny
- 3. How to use Korjuny
- 4. Possible side effects
- 5. How to store Korjuny
- 6. Contents of the pack and other information
- 1.
What Korjuny is and what it is
used for
Korjuny contains the active substance catumaxomab. Catumaxomab is a monoclonal antibody, a type of protein that binds toa target on the surface of cancer cells. This target is called epithelial cell adhesion molecule (EpCAM), and it is found on the surface of different types of cancer cells. It is also present on cancer cells in ascites fluid. Malignant ascites is the build-up of fluid containing cancer cells in the abdomen of cancer patients.
Catumaxomab activates cells of the immune system (part of the body’s natural defences) to destroy the cancer cells.
Korjuny is used to treat malignant ascites in adults, when standard treatment of the cancer is no longer feasible.
2. What you need to know before you
are given Korjuny
Do not use Korjuny if you are
allergic to catumaxomab or anyofthe other ingredients of this medicine (Listed in section 6)
e allergic to rat and/or mouse proteins
Warnings and precautions
Talk to your doctor or nurse before you are given Korjuny or during treatment if you have: signs ofacondition known as cytokine release syndrome. This is a serious immune reaction with symptoms such as fever, low blood pressure, chills, difficulty breathing, fatigue, headache, fast heartbeat and increased of liver enzymes in the blood. Please consider the instructions provided in your patient card, such as when you should seek medical attention. Before each infusion of Korjuny, you may be given medicines, which help reduce possible side effects of cytokine release syndrome.
e signs of the so-called systemic inflammatory response syndrome. Possible signs are fever, increased heartbeat, faster breathing and abnormal white blood cell counts. Contact your doctor immediately if you have any of these signs and consider the instructions provided in your patient card.
an infection or signs of an infection such as feeling warm, fever, chills or shivering, sore throat or mouth ulcers. The infection will be treated before you are given Korjuny. low blood volume with symptoms such as cold hands and feet, light headedness, difficulty passing urine, increased heart rate or weakness
symptoms of low levels of blood proteins such as weakness, shortness of breath or fluid retention
low blood pressure with symptoms such as feeling dizzy, faint or weakness
e liver problems, including a blood clot or obstruction in the portal vein (a blood vessel that carries blood to the liver from the intestines, spleen, pancreas and gallbladder) e kidney problems
Tests and checks
Before you are given Korjuny, your doctor will check conditions that may affect your blood flow. This will include tests of your blood volume, level of blood proteins, pressure, pulse and kidney function. You may experience infusion-related reactions during or after the infusion of Korjuny. can sometimes be severe with symptoms as fever, low blood pressure, chills, nausea, vomiting, muscle and joint pain, fast heartbeat and shortness of breath. It is recommended that your doctor keep you under observation for at least 24 hours after the first infusion and at least 6 hours after each subsequent infusion.
Your doctor may also conduct tests to check your liver function during treatment with Korjuny.
Children and adolescents
Korjuny is not recommended in children and adolescents under 18 years, as it has not been studied in this age group.
Other medicines and Korjuny
Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Korjuny is not recommended during pregnancy, breast-feeding and in women of childbearing potential not using contraception.
The effects of Korjuny on the developing foetus are unknown anda risk to a newborn/ infant cannot be excluded.
If you could become pregnant, you must use effective contraception during treatment with Korjuny.
Inform your doctor immediately if you become pregnant while being treated with this medicine.
It is not known if catumaxomab passes into breast milk. There may be a risk to breastfed newborns/infants. Ask your doctor for advice if you are breast-feeding.
Driving and using machines
Do not drive or use machines if you have side effects such as dizziness or infusion-related side effects during or after administration.
Korjuny contains polysorbate 80
and sodium
This medicine contains 21.6 micrograms polysorbate 80 in each pre-filled syringe Korjuny 10 micrograms and 108 micrograms of polysorbate 80 in each pre-filled syringe Korjuny 50 micrograms. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. The amount of sodium administered per infusion is higher than that contained in the medicinal product due to the dilution of the concentrate with
sodium chloride 9 mg/ml (0.9%) solution. An additional 500 ml of sodium chloride 9 mg/ml (0.9%) solution for injection is given before each Korjuny administration and 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection is given in parallel with each Korjuny administration.
3. How to use Korjuny
You will be given Korjuny under supervision of a doctor experienced in the treatment of cancer.
Before starting and during treatment, you will be given medicines to reduce fever, pain or inflammation caused by Korjuny.
Korjuny is given as an infusion into the abdominal cavity over a period of at least 3 and a maximumof 6 hours.
You will be given 4 infusions that follow an increasing dose schedule: 10, 20, 50 and 150 micrograms. The infusions are separated by at least 2 infusion-free calendar days. For example, you will receive an infusion on day 0, 3, 7 and 10. However, your doctor may decide to extend the time between infusions in order to reduce the risk of side effects. The overall treatment period should not exceed a total of 21 days.
A catheter is placed in your abdominal cavity for the whole treatment period, until the day after your last infusion.
After the first Korjuny infusion your doctor will observe you for at least 24 hours for infusion-related reactions and at least 6 hours after each subsequent infusion.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediately if you have any of the following serious side effects: Very common (may affect more than 1 in 10 people)
infusion-related side effects
During and after infusion with Korjuny patients may experience infusion-related side effects. These include symptoms such as fever, low blood pressure, chills, headache, nausea, vomiting, muscle and joint pain. It can also cause rapid heartbeat, shortness of breath, skin symptoms and fatigue. These symptoms occur mainly within 24 hours after infusion and can become life-threatening. These side effects require immediate treatment.
Your doctor may consider reducing the infusion rate of Korjuny or giving you additional treatment to reduce serious symptoms.
Other side effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)
e inflammatory response syndrome called cytokine release syndrome — see section 2, “Warnings and precautions”
nausea, vomiting, diarrhoea
abdominal pain
fever, chills, fatigue, pain
e increased blood levels of C-reactive protein (a marker of inflammation)
Common (may affect up to 1 in 10 people) e infection
e reduced number of red blood cells number of white blood cells, or specific white blood cells called neutrophils lack of certain white blood cells called lymphocytes
systemic inflammatory response syndrome see section 2, “Warnings and precautions” hypersensitivity
e decreased appetite
e dehydration
low blood level of sodium, potassium or calcium
increased blood sugar level
e decrease blood level of protein, like albumin anxiety
anxiety
e dizziness
accelerated heartbeat
low or high blood pressure
e flushing, hot flush
abdominal discomfort, wind
e heartburn
© upper abdominal pain
partial bowel obstruction
increased blood level of bilirubin, a yellow breakdown substance of the blood pigment of the bile duct e allergic skin inflammation
e rash, skin reddening, itching excessive sweating
back pain, muscle pain, joint pain blood in the urine, excess of protein in the urine
weakness
chest pain
e
tissue swelling caused by excess fluid e influenza-like illness
feeling unwell
accumulation of fluid in arms and/or legs insufficient oxygen supply of the whole body or a region of the body
breathing difficulties, fluid in the thorax increased levels of liver enzymes, such as alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltransferase
increased body temperature
increased blood levels of urea, procalcitonin, amylase, creatinine phosphatase, the breakdown product from muscle tissue called creatinine
decreased red blood cell pigment level increased number of blood platelets decreased total protein
decreased weight
Uncommon (may affect up to 1 in 100 people) e thrush
skin infection
e inflammation of the fatty tissue under the skin with skin nodules on the calves herpes simplex infection, localised infection, urinary tract infection
e lung inflammation
e reduced number of blood platelets, reduced blood clotting
lack of white blood cells, such as neutrophils low blood sugar level
low blood level of magnesium fluid retention
e restlessness, depression
abnormal sensation such as prickling, tingling and itchiness
sensory disorders in hands or feet caused by nerve damage
nerve disorder effecting many nerves in the arms and/or legs simultaneously e fainting, lethargy
uncontrollable shaking, fit
taste disturbance
blurred vision
feeling of increased heartbeat, irregular heartbeat
heart weakness
e blockage of a lung artery
breathing distress, cramp of bronchial muscles KORJUNY IOMCG 50MCG
Previous Pip-Code
cough, hiccup
migration of inflammatory cells or tumour cells in the lung tissue, lung failure » pain in the throat and larynx
faster breathing, wheezing
abnormal cramps
dry mouth
loss of bowel movement
reduced stomach emptying
» lower abdominal pain
» abdominal stiffness
accumulation of fluid in the abdominal cavity » backflow of bile from the first section of the small bowel into the stomach
stomach disorder
reduced stomach and bowel movement inflammation of the membrane which lines the abdomen cavity and covers the abdominal organs
retching
small bowel obstruction
stomach discomfort
vomiting blood
inflammation of the inner lining of the mouth e liver inflammation with destruction of cells, medicine-induced liver inflammation liver failure
reduced bile flow
abnormal liver function
e yellowing of the skin or whites of the eyes caused by liver problems
night sweats
e redness of the palm, nettle-rash and other skin reactions
bone pain, flank pain
pain affecting muscles and skeleton, pain in arms and legs
painful and difficult urination, decreased output of urine
increased number of white blood cells in increased number of 1n the urine
kidney failure, kidney pain
e inflammation at application site
pain at the catheter site, leakage of a fluid feeling full after eating very little food e feeling cold or hot
site reaction
inflammation of mucous-secreting lining thirst
skin reddening at the catheter site general health deterioration
pelvic pain
abnormal liver function tests, elevated liver enzymes
increased level of the liver enzymes transaminases
e decreased oxygen saturation in the blood increased blood levels of conjugated bilirubin, uric acid, fibrinogen, lactate dehydrogenase, lipase
decreased blood levels of iron, chloride e decreased body temperature
e decreased percentage of blood cells on the blood volume
urobilin in urine
cells in urine, including white blood cells prolonged activated thromboblastin time a test to control blood coagulation
international normalised ratio, which shows that the blood is clotting too slowly problems during administration: pain, divergence of adjacent wound edges,
The following information is intended for healthcare professionals only:
Material and equipment required for dilution and administration of Korjuny
sodium chloride 9 mg/ml (0.9%) solution for injection
e 50 ml polypropylene syringes
cap for 50 ml polypropylene syringes polyethylene perfusion tubing with an inner diameter of 1 mm and a length of 150 cm polycarbonate infusion valves / Y connections polyurethane silicon-coated catheters precision perfusion pump
Dilution prior to administration
The volume of sodium chloride 9 mg/ml (0.9%) solution for injection listed in the table is extracted with a 50 ml syringe. An additional air buffer of at least 3 ml is included in the 50 ml syringe.
The Korjuny pre-filled syringe(s) of the required strength listed in the table are visually inspected for any foreign particulates or discolouration.
e With the pre-filled syringe tip pointing up, the tip cap is gently removed.
off or rotate the cap.
The enclosed cannula is attached to the pre-filled syringe and the cannula shield removed. A new cannula must be used for each syringe.
The cannula is inserted through the 50 ml syringe opening so that the cannula is immersed in the sodium chloride 9 mg/ml (0.9%) solution for injection (figure). Do not administer the Korjuny pre-filled syringe directly to a patient.
The entire content of the pre-filled syringe is injected into the sodium chloride 9 mg/ml (0.9%) solution for injection.
The plunger rod must not be drawn back to rinse the pre-filled syringe, to avoid contamination and to ensure that the correct volume is ejected.
Based on the table, the previous steps are repeated to inject the required number of pre-filled syringes into the 50 ml syringe. The 50 ml syringe is closed with a cap and shaken gently to mix the solution. e After removing the cap, any air bubbles are eliminated from the 50 ml syringe. The red peelable sticker, which is provided inside the carton lid, displaying the text “Diluted Korjuny. Intraperitoneal use only.” must be attached to the 50 ml syringe. is a precautionary measure to ensure Korjuny is intraperitoneally infused only.
The 50 ml syringe is inserted in the infusion pump.
Figure Transfer of Korjuny from the pre-
filled syringe to the 50 ml syringe | containing sodium
(0.9%) solution for injection
Korjuny pre-filled syringe
buffer
concentrate for solution for infusion
50 ml syringe
air buffer
chloride 9 mg/ml (0.9%) solution for injection
Table Number of pre-filled syringes and volumes required for preparation of Korjuny solution for intraperitoneal infusion
Final volume for administration
10.1 ml
20.2 ml
50 ml
50 ml
anastomotic complication (e.g. bleeding or leakage at connections between vessels or hollow organs)
Reporting of side effects
If you get any side effects, talk to your doctor 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 at: 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 Korjuny
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 and syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C 8 °C). Do not freeze. Store in the original package in order to protect from light.
The prepared infusion solution should be used immediately.
6. Contents of the pack and other
information
What Korjuny contains
The active substance is catumaxomab. One pre-filled syringe Korjuny 10 micrograms contains 10 micrograms of catumaxomab in 0.1 ml concentrate, corresponding to 0.1 mg/ml. One pre-filled syringe Korjuny 50 micrograms contains 50 micrograms of catumaxomab in 0.5 ml concentrate, corresponding to 0.1 mg/ml. The other ingredients are sodium citrate (E331), citric acid monohydrate (E330), polysorbate 80 (E433) and water for injections. See section 2, “Korjuny contains polysorbate 80 and sodium”.
What Korjuny looks like and contents of the PackKorjuny is a clear and colourless concentrate for solution for infusion (sterile concentrate) in pre-filled glass syringes with tip caps.
Pack sizes:
Korjuny 10 micrograms: 3 pre-filled syringes and 5 cannulas in a carton with a blue colour code Korjuny 50 micrograms: 4 pre-filled syringes and 5 cannulas in a carton with a red colour code
Marketing Authorisation Holder
Atnahs Pharma UK Limited
Sovereign House,
Miles Gray Road,
Basildon, Essex,
SS14 3FR,
United Kingdom
Manufacturer
Eurofins PHAST GmbH,
Kardinal-Wendel-Strasse 16
Homburg 66424
Saarland
Germany
This leaflet was last revised in
August 2026.
The prepared solution for infusion is physically and chemically stable for 48 hours at 2 °C to 8 °C and for 24 hours at a temperature not above 25 °C. From a microbiological point of view, the product should be used immediately. 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 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Method of administration
The catheter for intraperitoneal administration is placed under ultrasound guidance by a doctor experienced in intraperitoneal administration. The catheter is used for ascites drainage, and administration of diluted Korjuny solution for infusion and sodium chloride 9 mg/ml (0.9%) solution for injection. It is recommended that the catheter remains in the abdominal cavity during the entire treatment period. It can be removed based on the judgement of the treating doctor on the day after the last infusion.
Prior to each Korjuny administration, the ascites fluid must be drained until cessation of spontaneous flow or symptom relief (see section 4.4). Subsequently, prior to each Korjuny administration, 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection shall be infused to support distribution of the antibody in the abdominal cavity.
Diluted Korjuny solution for infusion is intraperitoneally administered over an infusion time of at least 3 hours via a constant infusion pump system, as follows:
The connected perfusion tubing equipment of the infusion pump is prefilled with the diluted Korjuny solution for infusion. The perfusion tubing is connected to the Y connection.
e Paralleltoeach Korjuny administration, 250 ml sodium chloride 9 mg/ml (0.9%) solution for injection is infused via an infusion valve / Y connection in the perfusion lead of the catheter.
The pump speed is adjusted according to the volume to be administered and the scheduled infusion time of at least 3 hours. When the 50 ml syringe containing the diluted Korjuny solution for infusion is empty, it is replaced with a 50 ml syringe containing 20 ml sodium chloride 9 mg/ml (0.9%) solution for injection, to clear the dead volume in the perfusion lead (approximately 2 ml), under unchanged conditions. The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded. The catheter is kept closed until the next infusion.
The day after the last infusion, a drainage of ascites is performed until cessation of spontaneous flow. Subsequently, the catheter can be removed.
Disposal
No special requirements.
Infusion/Dose | Number of Number of Total volume
10 micrograms | 50 micrograms| of Korjuny pre-filled pre-filled concentrate syringes syringes for solution
for infusion
1* infusion/
10 micrograms
2nd infusion/
20 micrograms
3rd infusion/
50 micrograms
infusion/
150 micrograms
Sodium chloride
9 mg/ml (0.9%)
solution for
injection
10 ml
20 ml
49.5 ml
48.5 ml
0.1 ml
0.2 ml
0.5 ml
1.5
Important safety information for patients receiving Korjuny®
Patient Card
10 mcg 50 mcg (Catumaxomab)
Please carry this card with you at all times while you are receiving Korjuny®. Show this card to any healthcare professional involved in your care. 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. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Please report suspected side effects to the MHRA through the Yellow Card scheme, via the Yellow Card website
www.mhra.gov.uk/yellowcard, or the free Yellow Card app available in the Apple App Store or Google Play Store. Alternatively you can call 0800 731 6789 for free, Monday to Friday between 9am and 5pm. By reporting side effects, you can help provide more information on the safety of this medicine.
10 mcg 50 mcg
Date of Preparation: February 2026
Date of MHRA approval: XX XX XXXX
UK 707-9310 TPO 01
UK 707-9310 BNH
Description
Korjuny 10 - 50mcg PFS
Previous Pip-Code
86 (54x86)
Guides Contact information
Patient’s name:
Information for the treating doctor
This patient has received Korjuny® (catumaxomab), which may cause cytokine release syndrome/ Systemic inflammatory
response syndrome.
e Evaluate the patient immediately and treat symptoms.
e If cytokine release syndrome/ Systemic inflammatory response syndrome is suspected, the symptoms should be treated as medically indicated and according to the current standard of care. Contact the prescribing doctor if possible.
Information for the Patient Contact your doctor immediately If you have:
fever (38°C or higher)
fast or irregular heartbeat chills or shaking chills
severe fatigue
breathing difficulty
headache
Low blood pressure
nausea, vomiting, diarrhoea muscleorjoint pain
any skin reaction, including rash
These infusion-related side effects (cytokine release syndrome) of Korjuny result from proteins released in your body during inflammation. They occur mainly within 24 hours after infusion.
Prescribing name:
Prescribing phone no.:
Date of Korjuny® initiation:
Date of last infusion:
UK 707-9310 BNH
Description
Korjuny 10 - 50mcg PFS
Previous Pip-Code 86 (54x86)
Guides