MabThera can be used to treat many different conditions in adult and pediatric patients.
Your doctor may prescribe MabThera for:

a) Non-Hodgkin lymphoma
This is a disease of the lymphatic tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes.
In adult patients, MabThera can be given alone or together with other medicines called ‘chemotherapy’.
In adult patients in whom treatment is working, MabThera can be used as maintenance treatment for a period of 2 years after the end of initial treatment.
In paediatric patients, MabThera is given in combination with “chemotherapy”.

b) Chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL affects certain lymphocytes, B cells, which arise in the bone marrow and develop 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 the symptoms you may have.
MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body through biological processes.

c) Rheumatoid arthritis
MabThera is used to treat rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints. B lymphocytes are involved in causing some of the symptoms you experience. MabThera is used to treat rheumatoid arthritis in patients who have already tried other medicines that have either stopped working, were not effective enough or caused side effects. MabThera is usually given together with another medicine called methotrexate.

MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to carry out normal daily activities.
The best responses to MabThera treatment are seen in those who test positive for rheumatoid factor (RF) and/or antibodies directed against cyclic citrullinated peptides (anti-CCP).
Both tests are usually positive in rheumatoid arthritis and help confirm the diagnosis.

d) Granulomatosis with polyangiitis or microscopic polyangiitis
MabThera, given in combination with glucocorticoids, is used to treat adult patients and children aged 2 years and older with granulomatosis with polyangiitis (called Wegener's granulomatosis) or microscopic polyangiitis.
Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels that mainly affect the lungs and kidneys, but can also affect other organs.
B lymphocytes are involved in the cause of these conditions.

e) Pemphigus vulgaris
MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris.
Pemphigus vulgaris is an autoimmune disease characterized by the appearance of painful blisters on the skin and mucous membranes of the oral cavity, nasal cavity, throat, and genitals.

Do not use MabThera if:
- you are allergic to rituximab, to other proteins that are similar to rituximab, or to any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before using MabThera.

Pregnancy and breastfeeding:
You must tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. This is because MabThera can cross the placenta and affect your baby.
If you are able to become pregnant, you and your partner must use effective contraception during treatment with MabThera. You must also continue to use it for 12 months after your last dose of MabThera.
MabThera passes into breast milk in small amounts. As the long-term effects on breast-fed infants are unknown, breast-feeding is not recommended during treatment with MabThera and for 12 months after treatment.

Driving and using machines:
It is not known whether MabThera affects your ability to drive or use machines.

How it is administered to you:
MabThera will be given to you by a doctor or nurse who is experienced in using this treatment. They will monitor you carefully while you are being given this medicine.
This is in case side effects occur.

At the start of your treatment you will always be given MabThera as an infusion (given directly into a vein).

You will then be given MabThera as an injection under your skin (subcutaneous injection) over approximately 5 minutes. There is a peel-off sticker on the bottle with the name of the patient on it.
Your doctor or nurse will stick the sticker on the syringe before giving you the injection.

Your doctor will decide when you will start MabThera injections.

If you have any further questions on this medicine, ask your doctor, pharmacist or nurse.

- The active substance in MabThera is called rituximab.
The 10 ml vial contains 100 mg rituximab (10 mg/ml).
The 50 ml vial contains 500 mg rituximab (10 mg/ml).
- The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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