What is it and what is it used for?
MabThera 500 mg contains an antibody (rituximab). This is a particular type of protein.Rituximab binds to the surface of certain white blood cells, the B cells. If Rituximab binds to the surface of this cell, leads to the death of the cell.
Mabthera 500 mg can be used for the treatment of three different conditions. Your doctor may prescribe Mabthera 500 mg for the treatment of the following diseases:
- Non-Hodgkin lymphoma
The Non-Hodgkin lymphoma is a disease of the lymphatic system, and B-cells are involved in the cause of some disease symptoms that you may have. Mabthera 500 mg can be used either as monotherapy or in combination with other prescribed by your doctor drugs to induce an improvement in your condition. MabThera 500 mg can be used as maintenance therapy (maintenance therapy) over a period of 2 years in patients who have responded to the initiation of treatment.
- Chronic Lymphocytic Leukemia
In chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. In the CLL a certain type of lymphocyte is concerned, the so-called B-cells, which are formed in the bone marrow and mature in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which primarily accumulate in the bone marrow and in the blood. The proliferation of these abnormal B lymphocytes is the cause of the symptoms that you may have. Mabthera 500 mg in combination with chemotherapy destroys these cells which are gradually removed by biological processes of the body.
- Rheumatoid arthritis
Mabthera 500 mg is used to treat rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints. B-cells are involved in the cause of some of your symptoms. Mabthera 500 mg is used to treat rheumatoid arthritis used in patients who have been previously treated with other drugs already, but either no longer do these have demonstrated sufficient efficacy or causes side effects. Mabthera 500 mg is usually called together with another medicine called methotrexate applied.
Mabthera 500 mg slows the joint damage caused by rheumatoid arthritis and improves physical function for the normal daily activities.
The best response to Mabthera 500 mg is achieved in patients who have a positive blood test for rheumatoid factor (RF) and / or anti-cyclic citrullinated peptides (anti-CCP).Both tests are commonly positive in rheumatoid arthritis and support the confirmation of the diagnosis.
What you need to consider before using it?
Mabthera 500 mg should not be used,
- if you are allergic to rituximab, other similar proteins, or to any of the excipients listed in section 6 of this medicine.
- if you have an active, severe infection or a severely weakened immune system
If you are unsure, you should consult your doctor who will inform you accordingly.
Inform your doctor before use of Mabthera 500 mg
- if you suspect an active or past hepatitis B infection in itself. In some cases, patients may become ill with hepatitis B infection in the history back to a hepatitis, which can be fatal in very rare cases. Patients with past hepatitis B infection are examined by their doctor carefully for signs of active hepatitis B infection.
- if you take medicines for high blood pressure, you may be instructed by your doctor, stop taking this medication 12 hours before your infusion of Mabthera 500 mg. In some patients occurs during infusion to a drop in blood pressure.
- if heart disease (eg, angina pectoris, increased heart rate or heart failure) or pre-existing respiratory problems are known to you. In these cases your doctor will need to be particularly monitored during your treatment with Mabthera 500 mg.
Warnings and Precautions
Please talk to your doctor, pharmacist or health care professional before using Mabthera 500 mg.
- tell your doctor if you are currently taking medicines or have recently taken, which may affect your immune system, such as chemotherapy or substances which suppress the immune response.
If you suffer from rheumatoid arthritis, your doctor also,
- if you believe that you have an infection, even if it is just a minor infection such as a cold, is. Those cells that are attacked by MabThera help to fight infection and you should receive Mabthera 500 mg until the infection has cleared. Please discuss with your doctor even if you often had infections in the past or suffer from severe infections.
- if you assume that you will need in the near future vaccinations, including vaccinations for travel to other countries. Some vaccines should not be administered with Mabthera 500 mg or several months after the administration of MabThera. Your doctor will check if you should receive vaccinations prior to treatment with Mabthera 500 mg.
Not much information about the treatment of children and adolescents with MabThera are. If you are under 18, ask your parents if appropriate / your guardian, your doctor if MabThera is right for you.
Mabthera 500 mg in combination with other drugs
Before starting treatment, your doctor should absolutely know what other medicines you are taking / taking or have recently taken taken / (including those who have bought yourself at the pharmacy, supermarket or health food store). This is extremely important as the use of more than one drug at the same time can strengthen or weaken the effect of medicines. MabThera should not be used together with other medicines unless your doctor has told you that such use is safe.
pregnancy and breast feeding period
You must tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant. Mabthera 500 mg is an antibody and can cross the placenta and affect your baby.
If you can get pregnant, you need during treatment with Mabthera 500 mg and for 12 months after your last treatment with MabThera use an effective contraceptive measure.
Mabthera 500 mg can pass into breast milk, and therefore you should not breast-feed during treatment with Mabthera 500 mg and for 12 months after your last treatment with MabThera.
Driving and using machines
It is not known whether Mabthera 500 mg your ability to drive or use machines.
How is it used?
Mabthera 500 mg is given an infusion ( "drip") directly into the vein. During the infusion of Mabthera 500 mg They are observed by trained medical personnel, in case you have any side effects during the infusion.
Before infusion, you will be given medicines to prevent or reduce possible reactions to MabThera.
- If you are being treated for non-Hodgkin's lymphoma
If you are treated with Mabthera 500 mg alone you will receive four infusions at weekly intervals (on days 1, 8, 15 and 22), so that a course of treatment usually lasts for 22 days. Repeated treatment courses with Mabthera 500 mg are possible. If you are treated with MabThera in combination with other medicines, you will receive an infusion of Mabthera 500 mg on the same day as the other medicines, usually given 8 times at 3-week interval. If you have responded to treatment and Mabthera 500 mg as continuous (maintenance) treatment, you will receive every two or three months (according to your doctor's advice) an infusion with MabThera over a period of 2 years. Your doctor may change the number of infusions depending on your disease.
- If you are being treated for chronic lymphocytic leukemia
If you are treated with Mabthera 500 mg in combination with chemotherapy, you will get a total of 6 cycles of treatment doses of MabThera. At the first treatment cycle to get MabThera on day 0, in the subsequent treatment cycles on day 1. Each treatment cycle has a duration of 28 days. The chemotherapy should be given after Mabthera 500 mg infusion. Your doctor will decide whether you should receive a supportive treatment.
- If you are being treated for rheumatoid arthritis
Each treatment cycle consists of two separate infusions to be administered will at intervals of two weeks. Repeated treatment courses with MabThera are possible.Depending on how the signs and symptoms of your disease, your doctor will decide whether you can receive further doses of Mabthera 500 mg. That may be the case even after months.
If you have any further questions on the use of this medicine, contact your doctor, pharmacist or nurse.
What are possible side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some side effects can be serious and require treatment. In rare cases, some of these reactions have been fatal.
During or within the first 2 hours of the first infusion you may develop fever, chills and shivering. Less frequent pain at the infusion site, blisters, itching, nausea, fatigue, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or increased heart rate, a heart attack or a small number may appear to platelets in some patients. An existing heart disease or angina may worsen. If you experience any of these symptoms, please notify the person who will administer the infusion, immediately, because the infusion should then be slowed or interrupted. Possibly, an additional treatment may be required, such as the taking of an antiallergic agent or of paracetamol. Once symptoms improve or completely disappear, the infusion can be continued. The occurrence of these reactions is less likely to after the second infusion. If you experience a serious infusion related reaction occurs, your doctor may decide to discontinue your treatment with MabThera.
Inform your doctor immediately after your treatment with Mabthera 500 mg , if you experience signs of infection such as fever, cough, sore throat, burning pain when urinating, or if you start to feel weak or generally unwell. After treatment with MabThera you might be more prone to infection. These are often colds, but there were also cases of pneumonia or urinary infections.
Very rarely suffered some patients who received MabThera, a serious inflammation of the brain, which was fatal. Inform immediately your doctor if you suffer from memory loss, have difficulty thinking or difficulty walking or suffer from vision loss.
If you are being treated for rheumatoid arthritis, you also find this information in the Patient Alert Card Your doctor has given you. It is important that you have this pass with her and your partner or caregiver show.
- If you against non-Hodgkin's lymphoma or chronic lymphocytic
Leukemia are treated
The side effects most observed (occurring in more than 1 patient in 10) as a result of treatment with Mabthera 500 mg were:
- Infections such as pneumonia (bacterial infection) and Herpes (viral infection) or bronchial inflammation (bronchitis)
- low number of white blood cells, with or without fever, low number of platelets in the blood (thrombocytopenia)
- allergic reactions to the infusion
- Rash, itching, bald spots on the scalp, fever, chills, weakness, headache
- decreased immune defenses (decreased IgG levels)
Common side effects (occurring in more than 1 in 100 patients) include due to treatment with MabThera:
- Infections such as sepsis (blood infection), pneumonia (bacterial infection), herpes and hepatitis B (viral) or fungal infection, inflammation of the bronchi or paranasal sinuses and other infections of unknown origin
- low number of red blood cells (anemia), low red and white blood cells and platelet (pancytopenia)
- allergic reactions (hypersensitivity)
- high blood sugar levels, weight loss, increased fluid retention in the face and body, elevated levels of the enzyme lactate dehydrogenase (LDH) in the blood, decreased serum calcium levels
- abnormal sensation on the skin such as numbness, tingling, pricking, burning or "insect Running", reduced sense of touch, restlessness, difficulty falling asleep, facial flushing and skin lesions as a result of dilation of blood vessels, dizziness, anxiety
- increased lacrimation, disturbance of tear secretion and formation, inflammation of the eye (conjunctivitis)
- Ears (tinnitus), earache
- Heart disease (heart attack, irregular heart rate, abnormally rapid heart rate)
- high or low blood pressure, low blood pressure when changing to standing position
- Inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of breath, lack of oxygen, so the body's organs are not adequately supplied with oxygen, cough
- Vomiting, diarrhea, abdominal pain, irritation and / or ulceration of the throat and mouth, difficulty swallowing, constipation, indigestion. Eating disorders with the result that too little food is taken up, which can lead to a dangerous weight loss
- Skin disorders, burning sensation on the skin, itching, increased sweating, night sweats
- Musculoskeletal disorders, abnormal increased muscle tone, pain, joint pain, muscle pain, back and neck pain
- General disorders, tumor pain, redness of the face and skin, discomfort or discomfort, cold symptoms, fatigue, tremors, multiorgan dysfunction
Uncommon side effects (occurring in more than 1 in 1,000 patients) include due to treatment with Mabthera 500 mg:
- Coagulation disorders, decreased production of blood cells, autoimmune decrease of red blood cells, swollen / enlarged lymph nodes
- gloomy mood, loss of interest or pleasure in normal activities, nervousness
- Disturbance of taste
- Heart disease (heart attack, abnormally increased heart rate, decreased heart rate, irregular heart rate, chest pain), inflammation, irritation and / or tightness of the lungs, asthma, shortness of breath
- Enlargement of the abdominal cavity
- Pain at the infusion site
Very rare side effects (occurring in less than 1 in 10,000 patients) include due to treatment with Mabthera 500 mg:
- temporarily increased immunoglobulins, disorders of the blood chemistry caused by the breakdown of dying cancer cells, which can lead to kidney failure
- Nerve damage in the arms and legs, facial paralysis
- Heart failure
- Inflammation of blood vessels, including those that cause skin disorders
- Perforation of the intestinal wall
- kidney failure
- severe skin disease with blistering, which can be life-threatening
Side effects with unknown frequency:
- delayed decrease in white blood cells
- infusion-related immediate reductions in platelet counts (reversible); can be fatal in rare cases
- hearing loss
- Loss of other senses
- If you are being treated for rheumatoid arthritis
The most reported side effects (occurring in more than 1 patient in 10) as a result of treatment with MabThera were:
- Infections such as pneumonia (bacterial infection)
- Painful urination (urinary tract infection)
- allergic reactions, which very likely to occur during an infusion, but may occur even up to 24 hours after the infusion can
- Changes in blood pressure, nausea, rash, fever, itching, runny or stuffy nose and sneezing, tremors, increased heart rate and fatigue
- a headache
Commonly reported side effects associated with MabThera (reported in more than 1 in 100 patients) include:
- Infections such as inflammation of the bronchi (bronchitis)
- a feeling of pressure or throbbing pain in the nose, cheeks and eyes (sinusitis), abdominal pain, vomiting and diarrhea, breathing problems
- Athlete's foot disease (athlete's foot)
- high cholesterol levels in the blood
- abnormal skin sensations such as numbness, tingling, stinging or burning, sciatica, migraine, dizziness
- hair loss
- Anxiety, depression
- Indigestion, diarrhea, heartburn, irritation and / or ulceration of the throat and mouth
- Pain in the abdomen, back, muscle and / or joints
Uncommon reported side effects associated with MabThera (reported in more than 1 in 1,000 patients) include:
- Excessive accumulation of fluid in the face and body
- Inflammation, irritation and / or tightness of the lungs and throat, coughing
- Skin reactions including hives, itching and rash
- Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse
Very rarely reported side effects associated with Mabthera 500 mg (reported in less than 1 in 10,000 patients) include:
- Complex of symptoms that occur several weeks after the infusion of MabThera, with reactions similar to an allergy such as rash, itching, joint pain, swollen lymph glands and fever.
Other infrequently reported side effects due to treatment with Mabthera 500 mg include a decreased number of white blood cells (neutrophils), which are used to fight infections. Some infections may be severe (see information about infections in this section).
Mabthera 500 mg may also cause changes in laboratory values, which raises your doctor.These include a decrease of certain proteins in the blood (immunoglobulins) which protect against infection.
If you receive Mabthera 500 mg in combination with other drugs, some of these side effects that may occur when you be due to the other medicine.
If you notice any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
How should it be stored?
Keep this medicine out of reach of children.
Do not use this medicine after the expiry date 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 vial in the outer carton to protect from light.