For the treatment of Rheumatoid Arthritis & Granulomatosis with polyangiitis and Microscopic polyangiitis
contains the active ingredient rituximab (rch)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about MabThera intravenous infusion. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given MabThera against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What MabThera is used for
MabThera contains the active ingredient rituximab, which is a monoclonal antibody. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.
MabThera is used to treat rheumatoid arthritis (RA), Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA).
RA is an inflammatory disease of the joints. GPA and MPA are inflammatory diseases of the blood vessels.
MabThera works by binding to a protein on the surface of certain white blood cells known as B lymphocytes. B lymphocytes play a role in the inflammation observed in RA, GPA and MPA. By binding to the protein MabThera reduces the ability of B lymphocytes to cause inflammation.
In RA MabThera can also slow down the damage to your joints and improve your ability to do your normal daily activities.
Your doctor may have prescribed MabThera for another reason.
Ask your doctor if you have any questions why MabThera has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you are given MabThera
When you must not be given MabThera
Do not use MabThera:
if you have had an allergic reaction to rituximab or any of the ingredients listed at the end of this leaflet
if you have had an allergic reaction to any other proteins that are of mouse origin
Some of the symptoms of an allergic reaction may include severe skin rash, itching, hives, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, swelling of the hands, feet or ankles.
If you are not sure if you should start receiving MabThera, talk to your doctor.
Before you are given MabThera
Your doctor must know about all the following before you are given MabThera.
Tell your doctor if:
1. you have an infection, or a history of a recurring or long-term infection such as hepatitis B
2. you are taking or have previously taken medicines which may affect your immune system, such as chemotherapy or immunosuppressive medicines
If you are taking or have taken medicines which affect your immune system, you may have an increased risk of infections. There have been reports of a rare, serious brain infection called PML (progressive multifocal leuko-encephalopathy) usually affecting people with a weakened immune system. Your chance of getting PML may be higher if you are treated with MabThera and/or other medicines that weaken the immune system. PML can cause severe disability or even death.
3. you have a history of heart disease with:
cardiac arrhythmias (abnormal beating of the heart)
congestive heart failure
Your doctor will supervise you closely during treatment with MabThera.
4. you are taking medicine to control blood pressure
MabThera may cause a reduction in blood pressure at the beginning of treatment. Because MabThera may cause a temporary drop in your blood pressure, your doctor may advise you to temporarily stop taking your blood pressure medicine before you are given MabThera.
5. you have pre-existing lung disease
You may have a greater chance of breathing difficulties during treatment with MabThera.
6. you are 65 years of age or older or suffer from kidney problems and are receiving MabThera for GPA or MPA
You may have an increased risk of serious side effects. Your doctor will monitor you closely during your treatment.
7. you intend to have or have had immunisation with any vaccine (e.g. measles, rubella, flu, vaccines for travel purposes)
Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera. Your doctor will check if you should have any vaccines before you receive MabThera.
8. you are allergic to any other medicines or any other substances such as foods, preservatives or dyes
9. you are pregnant or intend to become pregnant
It is not known whether MabThera is harmful to an unborn baby. It is not recommended that you are given MabThera while you are pregnant.
If you are a woman of child bearing potential, you must use effective contraceptive methods to prevent pregnancy during treatment and for 12 months after completing treatment with MabThera.
10. you are breast feeding or plan to breast feed.
It is not known if MabThera passes into breast milk. It is recommended that you discontinue breast feeding while you are treated with MabThera.
If you have not told your doctor about any of the above, tell them before you are given MabThera.
Use in children
The safety and effectiveness of MabThera have not been established in children.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or healthfood shop.
As MabThera may cause a temporary drop in your blood pressure at the beginning of treatment, your doctor may advise you to temporarily stop taking your blood pressure medicine before you are given MabThera.
It is not known if MabThera will affect your normal response to a vaccine.
It is possible that after treatment with MabThera you may experience allergic reactions if you are treated with other medications containing monoclonal antibodies.
Your doctor and pharmacist will have more information on medicines to be careful with or to avoid while undergoing treatment with MabThera.
How MabThera is given
MabThera is given by slow infusion into a vein (intravenous infusion) by a healthcare professional. Before the infusion is given you will receive medicines to reduce the chance of any reactions to MabThera.
The dose of MabThera for treatment of RA is 1000 mg followed by a second dose of 1000 mg 2 weeks later. For RA MabThera should be used together with methotrexate.
Depending on the circumstances of your disease or response to the drug, your doctor may decide to re-treat your RA with an additional course of MabThera.
The dose of MabThera for GPA and MPA patients is 375 mg per square metre of body surface area once a week for 4 weeks. For GPA or MPA MabThera should be used together with glucocorticoids.
As MabThera is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given MabThera, tell your doctor immediately.
While you are receiving MabThera
Things you must do
If you are a woman of child bearing potential, you must use effective contraceptive methods to prevent pregnancy during treatment with MabThera and for 12 months after completing treatment.
Tell your doctor if you become pregnant while receiving MabThera.
Tell all doctors, dentists and pharmacists who are treating you that you are receiving MabThera.
Tell your partner or caregiver you are receiving MabThera and ask them to tell you if they notice any changes in your movement or behaviour. If they notice any changes you should tell your doctor about them immediately.
Your doctor may need to perform some tests and alter your treatment.
Be sure to keep all your appointments with your doctor so that your progress can be checked. Your doctor will perform regular blood tests.
Things you must not do
Do not breast feed your infant during treatment with MabThera.
It is not known whether MabThera crosses into human milk.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how MabThera affects you.
MabThera generally does not cause any problems with your ability to drive or operate machinery. However, as with many other medicines, MabThera may cause dizziness in some people.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving MabThera.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
MabThera helps many people with RA, GPA or MPA but it may have unwanted side effects.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
The following is a list of the more common side effects.
During or after an infusion
Tell your doctor if you notice any of the following during or after receiving an infusion (particularly during the first 2 hours of receiving the first infusion) and they worry you:
fever, chills and severe shivering (most likely to occur)
swelling of the tongue, face, lips, mouth or throat which may cause difficulty breathing or swallowing
itchy rash and/or pinkish, itchy swellings on the skin
difficulty breathing and/or shortness of breath
wheezing or coughing
dizziness or lightheadedness, especially on standing up
high blood pressure
nausea (feeling sick) or vomiting
fatigue (feeling tired) and/or feeling weak
rhinitis (a runny nose)
fast heart beat
stomach pain or discomfort
These side effects are temporary and less likely to occur after the first infusion.
Your doctor may recommend that you take medication to prevent pain or allergy before you receive your MabThera infusion.
The following is a list of other side effects which may occur during treatment with MabThera. Tell your doctor if you notice any of them and they worry you:
aching muscles, muscle tenderness or weakness, muscle spasms
painful, swollen joints
pins and needles, or decreased feeling in the skin
infections e.g. urinary tract infections, colds or chest infections including pneumonia
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
infections with fever, severe chills, sore throat or mouth ulcers
severe skin rash, itching, hives
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, swelling of the hands, feet or ankles
one or a combination of the following: severe shortness of breath, severe difficulty breathing, severe wheezing, severe coughing.
severe stomach pain, nausea or vomiting
vision loss associated with headaches, confusion and seizures
one or a combination of the following: confusion, disorientation or memory loss, changes in the way you move, walk or talk, decreased strength or progressive weakness in your body, blurred or loss of vision.
yellowing of skin and eyes, light coloured bowel motions, dark coloured urine
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After receiving MabThera
MabThera should be stored in the pharmacy or on the hospital ward.
The concentrated solution for infusion should be kept in a refrigerator at 2-8°C. It should not be frozen.
MabThera should be stored away from light.
MabThera is available as 100 mg/10 mL and 500 mg/50 mL single dose vials.
MabThera comes in packs of two vials for the 100 mg/10 mL presentation and packs of one vial for the 500 mg/50 mL presentation.
What MabThera looks like
MabThera is available as a clear, colourless, concentrated solution for intravenous infusion. It is diluted before infusion into a vein.
MabThera contains the active ingredient rituximab (rch). MabThera comes in two strengths, 100 mg and 500 mg. Each vial of MabThera also contains the following inactive ingredients:
sodium hydroxide and/or