Active ingredient
- rituximab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
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/1/98/067/001.
MabThera 100 mg and 500 mg Concentrate for Solution for Infusion
Package leaflet: Information for the patient
MabThera 100 mg concentrate for solution for infusion
MabThera 500 mg concentrate for solution for infusion
rituximab
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What MabThera is and what it is used for
2. What you need to know before you use MabThera
3. How to use MabThera
4. Possible side effects
5. How to store MabThera
6. Contents of the pack and other information
1. What MabThera is and what it is used for
What MabThera is
MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.
What MabThera is used for
MabThera may be used for the treatment of several different conditions in adults. Your doctor may prescribe MabThera for the treatment of:
a) Non-Hodgkin’s Lymphoma
This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
MabThera can be given alone or with other medicines called “chemotherapy”.
In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.
b) Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood. The proliferation of these abnormal B-lymphocytes is the cause of symptoms you may have. MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
c) Rheumatoid arthritis
MabThera is used for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints. B lymphocytes are involved in the cause of some of the symptoms you have. MabThera is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. MabThera is usually taken together with another medicine called methotrexate.
MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
The best responses to MabThera are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP). Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis.
d) Granulomatosis with polyangiitis or microscopic polyangiitis
MabThera is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids. Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well. B lymphocytes are involved in the cause of these conditions.
e) Pemphigus vulgaris
MabThera is used for the treatment of patients with moderate to severe pemphigus vulgaris. Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
2. What you need to know before you use MabThera
Do not take MabThera if:
Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given MabThera if:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera. Your doctor may need to take special care of you during your treatment with MabThera.
If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Children and adolescents
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and young people.
Other medicines and MabThera
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.
In particular, tell your doctor:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera.
Pregnancy and breast-feeding
You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. This is because MabThera can cross the placenta and may affect your baby.
If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.
Do not breast-feed while you are being treated with MabThera. Also do not breast-feed for 12 months after your last treatment with MabThera. This is because MabThera may pass into breast milk.
Driving and using machines
It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.
MabThera contains sodium
This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) per 50 mL vial. Take this into account if you are on a low-sodium diet.
3. How MabThera is given
How it is given
MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.
You will always be given MabThera as a drip (intra-venous infusion).
Medicines given before each MabThera administration
Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
How much and how often you will receive your treatment
a) If you are being treated for non-Hodgkin’s Lymphoma
b) If you are being treated for chronic lymphocytic leukaemia
When you are treated with MabThera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total. Each cycle has a duration of 28 days. The chemotherapy should be given after the MabThera infusion. Your doctor will decide if you should receive concomitant supportive therapy.
c) If you are being treated for rheumatoid arthritis
Each course of treatment is made up of two separate infusions which are given 2 weeks apart. Repeated courses of treatment with MabThera are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera. This may be months from now.
d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Treatment with MabThera uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of MabThera treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
If you respond well to treatment, you may be given MabThera as a maintenance treatment. This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with MabThera (up to 5 years), depending on how you respond to the medicine.
e) If you are being treated for pemphigus vulgaris
Each course of treatment is made up of two separate infusions which are given 2 weeks apart. If you respond well to treatment, you may be given MabThera as a maintenance treatment. This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate but some may be serious and require treatment. Rarely, some of these reactions have been fatal.
Infusion reactions
During or within the first 24 hours of the infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse. Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. Your doctor may decide to stop your MabThera treatment if these reactions are serious.
Infections
Tell your doctor immediately if you get signs of an infection including:
You might get infections more easily during your treatment with MabThera.
These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver.
Skin Reactions
Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms.
Other side effects include:
a) If you are being treated for non-Hodgkin’s Lymphoma or chronic lymphocytic leukaemia
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10, 000 people):
Not known (it is not known how often these side effects happen):
b) If you are being treated for rheumatoid arthritis
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10, 000 people):
Other rarely-reported side-effects due to MabThera include a decreased number of white cells in the blood (neutrophils) that help to fight against infection. Some infections may be severe (please see information on Infections within this section).
c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Very rare side effects (may affect up to 1 in 10, 000 people):
d) If you are being treated for pemphigus vulgaris
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
MabThera may also cause changes in laboratory tests carried out by your doctor.
If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store MabThera
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). Keep the container in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What MabThera contains
What MabThera looks like and contents of the pack
MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion.
10 mL vial – Pack of 2 vials
50 mL vial – Pack of 1 vial
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in July 2019
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
uk-pil-mabthera-clean-190730-100-500mg-inf
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