Removab
catumaxomab
catumaxomab
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Removab is and what it is used for
What you need to know before you use Removab
How to use Removab
Possible side effects
How to store Removab
Contents of the pack and other information
Medicinal product no longer authorised
Removab contains the active substance catumaxomab, a monoclonal antibody. It recognises a protein on the surface of cancer cells and recruits immune cells to destroy them.
Removab is used to treat malignant ascites, when standard treatment is not available or no longer feasible. Malignant ascites is an accumulation of fluid in the abdominal space (peritoneal cavity) resulting from certain types of cancer.
if you are allergic to catumaxomab or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to murine proteins (from rat and / or mouse)
Talk to your doctor or nurse before using Removab. It is important to tell your doctor if you have any of the following:
undrained fluid in your abdominal cavity
cold hands and feet, light headedness, difficulty passing urine, increased heart rate, and weakness (symptoms of low blood volume)
weight gain, weakness, shortness of breath and fluid retention (symptoms of low blood protein levels)
feeling dizzy and faint (symptoms of low blood pressure)
problems with your heart and circulation
kidney or liver problems
an infection.
Before you start using Removab your doctor will check your:
Body Mass Index (BMI), which depends on your height and weight
Karnofsky Index, a measure of your general performance status.
You are required to have a BMI above 17 (after drainage of the ascites fluid) and a Karnofsky Index above 60 to use this medicine.
Infusion-related side effects and abdominal pain are very common (see section 4). You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Removab should not be used in children and adolescents under 18 years of age.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.You should not use Removab if you are pregnant unless clearly necessary.
If you experience side effects such as dizziness or chills during or after administration, you should not drive or use machines until they disappear.
Medicinal product no longer authorised
You will be given Removab under the supervision of a doctor experienced in treating cancer. After the Removab infusion you will be observed as decided by your doctor.
Before starting and during treatment, you will be given other medicines to reduce fever, pain or inflammation caused by Removab.
Removab is given as 4 intraperitoneal infusions with increasing dose (10, 20, 50 and
150 micrograms), separated at least by 2 infusion-free calendar days (for example you will receive infusion on day 0, 3, 7, 10). The infusion must be administered at constant rate with duration time of at least 3 hours. The overall treatment period should not exceed 20 days.
A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
If you have any further questions on the use of this product, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common serious side effects of Removab are infusion-related side effects and side effects related to the gastrointestinal system (stomach and gut).
Infusion-related side effects
During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects. The most common infusion-related side effects, which are mostly mild to moderate, are fever, chills, feeling sick and vomiting.
A complex of symptoms including very fast heartbeat, fever and shortness of breath can develop in up to 4 out of 100 patients. These symptoms occur mainly within 24 hours after a Removab infusion and can become life-threatening, but can be treated well with additional therapy.
Side effects related to the gastrointestinal system
Gastrointestinal reactions like abdominal pain, feeling sick, vomiting and diarrhoea occur in more than 1 in 10 patients (very common), but are mostly mild to moderate and respond well to additional treatment.
Very common serious side effects (may affect more than 1 in 10 people):
Tiredness
Common serious side effects (may affect up to 1 in 10 people):
Loss of appetite
Dehydration
Reduction in red blood cells (anaemia)
Decreased blood levels of calcium and sodium
A very fast heart beat
High or low blood pressure
Medicinal product no longer authorised
Abdominal pain accompanied by difficulty or blockage passing stools, constipation
Shortness of breath
Accumulation of fluid around the lungs which cause chest pain and breathlessness
Inflammation of the bile ducts
Skin redness, rash
Very fast heartbeat, fever, shortness of breath, feeling faint or light-headed
Complex of reactions due to the release of mediators of inflammation
Worsening of general state of health, generally feeling unwell and weak
Fluid retention
Hypersensitivity
Uncommon serious side effects (may affect up to 1 in 100 people):
Lumps under the skin on the back of the legs that may become sores and leave scars
Inflammation and pain or burning and stinging in the area around the catheter
Reduction in number of blood platelets, blood clotting problems
Bleeding in the stomach or gut, shown by the vomiting of blood or the passage of red or black
stools
Skin reaction, severe allergic skin reaction (dermatitis)
Fits
Lung problems including blood clot in the lungs
Low blood oxygen levels
Severe kidney problems
Extravasation (inadvertent leakage of administered medicinal product from the intraperitoneal
catheter system into surrounding tissue)
Common side effects (may affect up to 1 in 10 people):
Pain
Reduction or increase in number of white blood cells
Decreased blood levels of potassium
Decreased blood protein levels
Increase of bilirubin in blood
Spinning sensation
Indigestion, stomach problems, heartburn, feeling bloated, passing wind, dry mouth
Flu-like symptoms
Dizziness or headache
Chest pain
Increased sweating
Infections
Increased protein levels in urine
Back pain, aching muscles and joints
Feeling anxious and having difficulty sleeping
Itchy rash or hives
Redness of the skin in the area around the catheter
Flushing
Cough
Medicinal product no longer authorised
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 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.
The active substance is catumaxomab (10 micrograms in 0.1 ml, corresponding to 0.1 mg/ml).
The other ingredients are sodium citrate, citric acid monohydrate, polysorbate 80 and water for injections.
Removab is presented as a clear and colourless concentrate for solution for infusion in a pre-filled syringe with a cannula. Pack size of 1.
Neovii Biotech GmbH Am Haag 6-7
82166 Graefelfing Germany
For any information about this medicine, please contact the Marketing Authorisation Holder.
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The following information is intended for healthcare professionals only:
Medicinal product no longer authorised
For information on dilution and administration of Removab please refer to section 6.6 of the Summary of Product Characteristics (SmPC) included in each package of Removab 10 micrograms and Removab 50 micrograms, respectively.