Patient Medication Information: uses, side effects, how to take - Removab
ABOUT THIS MEDICATION
What is Removab used for:
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.
What does Removab do:
Removab contains the active substance catumaxomab, a monoclonal antibody. It recognizes a protein on the surface of cancer cells and recruits immune cells to destroy them.
When it should not be used:
Do not use Removab:
if you are allergic (hypersensitive) to catumaxomab or any of
the other ingredients of Removab
if you are allergic (hypersensitive) to murine proteins (from
rat and / or mouse)
Removab should not be used in children and adolescents under 18 years of age.
What the medicinal ingredient is:
catumaxomab
What the important nonmedicinal ingredients are: Citric acid monohydrate, polysorbate 80, sodium citrate, water (water for injections).
What dosage forms it comes in:
Removab is supplied as a 0.1 mg/mL concentrate for solution for infusion in a pre-filled syringe with a cannula. There are two filling volumes of the syringe, 0.1mL and 0.5mL, corresponding to 10 µg and 50 µg doses of catumaxomab.
WARNINGS AND PRECAUTIONS
NG
It is very important to tell your doctor if you have any of the following:
- undrained fluid in your abdominal cavity
cold hands and feet, lightheadedness, 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 Removab.
Taking other medicines
Please tell your doctor or pharmacist if you are already taking or have recently taken any other medicines including those obtained without a prescription.
Pregnancy and breast-feeding
You should not use Removab if you are pregnant unless clearly necessary. Talk to your doctor if are, might be or are planning to become pregnant.
If you are breast-feeding, talk to your doctor before starting treatment.
Driving and using machines
There are no studies on the effects of Removab on the ability to drive and use machines. However, if you experience side effects such as dizziness or chills during or after administration, you should not drive or use machines until they disappear.
INTERACTIONS WITH THIS MEDICATION
Interactions with other medications have not been studied.
PROPER USE OF THIS MEDICATION
You will be given Removab under the supervision of a doctor experienced in treating cancer. After 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.
A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
Removab is given as 4 intraperitoneal infusions in increasing doses (10, 20, 50 and 150 micrograms), separated at least by a 2-day break.
If you have any further questions about any of this information, ask your doctor.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Removab can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user in 10) reported by patients treated with Removab were:
- feeling sick (nausea), vomiting and diarrhea
- tiredness, pain and chills
- reduction in number of white blood cells.
•
Common side effects (affects 1 to 10 users in 100) reported by patients were:
- increased number of white blood cells
- increased clotting factors
- reduction in red blood cells (anaemia)
- decreased blood levels of calcium, potassium and sodium
- decreased blood protein levels
- high blood sugar
- a very fast heart beat
- spinning sensation
- constipation, indigestion, stomach problems, heartburn, passing wind and mouth ulcers
- flu-like symptoms
- fluid retention
- dizziness or headache
- chest pain
- increased sweating, feeling thirsty and weak
- liver problems and yellowing of the skin (jaundice)
- infections including bladder infections
- lumps under the skin and the back of the legs that may become sores and leave scars
- increased protein levels or white blood cells in urine
- loss of appetite
- dehydration
- back pain, aching muscles and joints
- feeling anxious and having difficulty sleeping
- passing small amounts of urine or finding blood in the urine
- skin redness, itchy rash, hives, sensitive skin or a sudden widespread rash
- high or low blood pressure
- flushing and hot flashes
If any of the side effects become serious and require medical treatment, contact your doctor or nurse.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or nurse | |
| Only if severe | In all cases | |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or nurse | ||
| Only if severe | In all cases | ||
Very Common | Abdominal pain Fever | x x | |
| Common | Abdominal pain accompanied by difficulty passing stools Shortness of breath | x x | |
| Uncommon | Very fast heart beat, fever, shortness of breath, feeling faint or light-headed within 24 hours of infusion | x | |
| Blockage in the gut or bowel | x | ||
| Bleeding in the stomach, shown by vomiting of blood or the passage of red or black stools | x | ||
| Inflammation and pain or burning and stinging in the area around the catheter | x | ||
| Infection of the skin | x | ||
| Fits | x | ||
| Lung problems including blood clot in the lungs or accumulation of fluid around the lungs which cause chest pain and breathlessness | x | ||
| Severe skin reactions such as flaking of the skin, rash and sensitive skin | x | ||
| Severe kidney problems | x | ||
This is not a complete list of side effects. For any unexpected effects while taking Removab, contact your doctor or nurse.
Keep out of the reach of children.
Do not use Removab after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2° - 8°C). Do not freeze. Store in the original package in order to protect from light.
The prepared solution for infusion should be used immediately.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use oh health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advise.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.fresenius-biotech.com
Canadian Distributor:
Date of last revised: Oct 24, 2011
Removab® is a registered trademark of Fresenius Biotech GmbH.