Mabthera

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 in 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 gradulally 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 or have not worked well enough. MabThera is usually taken together with another medicine called methotrexate.

How does it work?

MabThera contains an antibody (rituximab) which is a type of protein. Rituximab binds to the surface of a type of white blood cell, the B lymphocyte. When rituximab binds to the surface of this cell it causes the cell to die.

When and how do I take it?

MabThera is an infusion (“drip”) which is given directly into your veins. You will be observed by a health care professional while you are being given MabThera in case you have any side effects during the infusion.
Before the infusion is given you will be given medicines to prevent or reduce possible reactions to MabThera.

What’s the dose?

a) If you are being treated for non-Hodgkin’s Lymphoma
If you are treated with MabThera alone you will receive infusions at weekly intervals for a total of four infusions (days 1, 8, 15 and 22), so that the a course of treatment usually lasts for 22 days. Repeated treatment courses with MabThera are possible. If you are treated with MabThera in combination with other medicines, you will receive an infusion of MabThera on the same day as the other medicines, which are usually given 8 times at 3-week intervals. If you have responded to treatment and are further treated with MabThera as continuous (maintenance) treatment, you will receive one infusion of MabThera every 3 months for two years. Your doctor may change the number of infusions depending on your disease.

b) If you are being treated for chronic lymphocytic leukemia
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.

Could it interact with other tablets?

Before starting treatment, make sure your doctor knows if you are taking or have recently taken any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store). This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect. MabThera should not be used with other drugs unless your doctor has told you it is safe to do so.

Herbal products should also only be taken after talking with your doctor.

What are the possible risks or side-effects?

If you are being treated for non-Hodgkin’s Lymphoma or chronic lymphocytic leukaemia
The most commonly reported side effects due to MabThera (reported in more than 1 out of 10 patients
are:
· infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation
(bronchitis)
· low number of white blood cells, with or without fever, low number of platelets in the blood
· allergic reactions after infusion
· nausea
· skin rashes, itching ,bald spots on the scalp, fever, chills, physical weakness, headache
· decreased immunity (decreased IgG levels)
Common side effects due to MabThera (reported in more than 1 out of 100 patients) include:
· infections such as sepsis and pneumonia (bacterial), herpes and hepatitis B (viral) or candidal
(fungal) bronchial tube and sinuses inflammation, or other general infections of unknown
origin
· low number of red blood cells, elow number of red and white blood cells and platlets
· allergic reactions (hypersensitivity)
· high sugar level in the blood, weight loss, excess fluid in the face and the body, increased
blood levels of the enzyme (LDH), low blood level of calcium
· abnormal sensations of the skin, such as numbness, tingling, pricking, burning, a creeping
skin sensation, decreased sense of touch. Feeling restless, difficulty falling asleep, becoming
red in the face and bruising of the skin as a consequence of dilation of the blood vessels,
dizziness, anxiety
· an increased production of tears, secretion and shedding disorders, inflammation of the eye
(conjunctivitis)
· ringing sound in the ears, ear pain
· heart disorders (heart attack, irregular heart rate, abnormally fast heart rate)
· high or low blood pressure, a decrease in blood pressure upon assuming an upright posture
· inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of
breath, too little oxygen reaching the body organs, coughing
· vomiting , diarrhoea, pain in the abdomen, irritation and /or ulceration of the throat and the
mouth,difficulties in swallowing, constipation, indigestion. Eating disorders: decrease in the
amount of food eaten with a consequential dangerous loss in weight
· skin disorders, burning sensation of the skin, itching, increased perspiration, night sweats
· musculoskeletal disorders, abnormal increase in tightness of muscle tone, pain, joint pain,
muscle pain, back and neck pain
· general disorders, tumour pain, becoming markedly red in the face and other areas of the
skin, general discomfort or uneasiness, flu syndrome, fatigue, shaking, multi-organ
dysfunction

Can I drink alcohol while taking it?

There are no known interactions between alcohol and Mabthera.

Always ask you doctor or pharmacist however as other medications you are taking may have a bearing on this.

What if I’m pregnant/breastfeeding?

You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become
pregnant. This is because MabThera is an antibody and can cross the placenta and affect your baby.
If you can get pregnant, you must use an effective method of birth control during therapy with
MabThera and for 12 months after the last time you were treated with MabThera.

MabThera might also get into breast milk and so you should not breast-feed your baby during therapy with MabThera and for 12 months after the last time you were treated with MabThera

If you have any more questions please ask your Intervene Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.