MABTHERA® Rheumatoid Arthritis
Rituximab
100 mg in 10 mL and 500 mg in 50 mL concentrate for solution for infusion
What is in this leaflet
This leaflet answers some common questions about MABTHERA 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 expected 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.
MABTHERA is used to treat rheumatoid arthritis. Rheumatoid arthritis is an
inflammatory disease of the joints.
MABTHERA belongs to a group of medicines known as monoclonal antibodies.
Monoclonal antibodies are proteins which specifically recognise and bind to
another unique protein called an antigen.
MABTHERA works by binding to an antigen on the surface of certain white
blood cells known as B lymphocytes. It is the B lymphocytes that are causing
the inflammation responsible for rheumatoid arthritis. By binding to the
antigen MABTHERA reduces the ability of B lymphocytes to cause inflammation.
MABTHERA should be used together with methotrexate.
Your doctor, however, may have prescribed MABTHERA for another purpose. (If
you have been prescribed MABTHERA for the treatment of non-Hodgkin's lymphoma
(NHL) please read the Consumer Medicine Information for NHL.)
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
You should not be given MABTHERA if:
- you have had an allergic reaction to MABTHERA or any of the
ingredients listed at the end of this leaflet - 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
Tell your doctor if:
- you are pregnant or plan to become pregnant
It is not known whether MABTHERA is
harmful to an unborn baby. MABTHERA is not recommended for use in pregnant
women unless the benefits of treatment outweigh the risk to the unborn baby.
It is not recommended that you become pregnant during or for twelve months
following the end of treatment with MABTHERA. - you are breast-feeding or plan to breast-feed
It is not known if MABTHERA passes into
breast milk. Breast feeding is not recommended while you are being treated
with MABTHERA. - you are taking medication to control blood pressure
MABTHERA may cause a temporary drop in
blood pressure at the beginning of treatment. Your doctor will advise you
about when to take your blood pressure medication before you are given
MABTHERA. - you have any disorders or conditions affecting your lungs
- you have a history of heart disease (e.g. angina, irregular heart
rhythm, heart failure or heart attacks) - you have an infection, or a history of a recurring or long-term
infection - you have a history of hepatitis B
- you intend to have or recently had immunisation with any vaccine (e.g.
measles, rubella, flu)
It is not known if MABTHERA will affect
your normal response to a vaccine. - you are allergic to any other medicines, foods, dyes or preservatives
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 from a pharmacy, supermarket or health food shop.
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 may 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.
The dose of MABTHERA for treatment of rheumatoid arthritis is 1000 mg
followed by a second dose of 1000 mg two weeks later.
Your doctor may decide to re-treat you with an additional course of
MABTHERA. Depending on the circumstances of your disease or response to the
medicine, this may be months from now. Your doctor will decide when you should
receive more MABTHERA.
While you are receiving MABTHERA
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are receiving MABTHERA.
If you are a woman of child bearing potential, you should use effective
contraception during treatment with MABTHERA and for twelve months following
therapy.
Tell your doctor if you become pregnant while receiving MABTHERA.
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
You should 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.
However, MABTHERA is not expected to affect your ability to drive or
operate machinery.
Side effects
Tell your doctor, nurse or pharmacist as soon as possible if you do not
feel well while you are receiving MABTHERA.
MABTHERA helps many people with rheumatoid arthritis but it may have
unwanted side effects in some people. All medicines can have side effects.
Sometimes they are serious. You may need medical treatment if you get some of
the side effects.
Ask your doctor, nurse or pharmacist to answer any questions you may
have.
Tell your doctor if you notice any of the following and they worry you:
The following symptoms can occur after receiving an infusion of
Mabthera, often within the first few hours:
- fever and chills (most likely to occur)
- hypotension (temporary drop in blood pressure. You may feel this as
dizziness or fainting) - high blood pressure
- swelling of the face, lips, mouth, tongue or throat which may cause
difficulty in swallowing or breathing; throat irritation - shortness of breath or cough
- nausea (feeling as if you may vomit) and/or vomiting
- flushing
- a runny nose, sneezing
- skin rash and/or redness of the skin, itchiness
Please note:
- The above events are temporary and less likely to occur with subsequent
infusions. - Your doctor may recommend that you take medication to prevent pain or
allergy before you receive your MABTHERA infusion.
Other events that may happen during or after you receive an infusion:
- pain in stomach area
- aching muscles, muscle tenderness or weakness, muscle spasms
- joint pain, painful swollen joints
- indigestion,
- feeling weak
- severe headache, severe shivering
- high cholesterol
- tingling, numbness of feet and hands or decreased sensitivity
- infections e.g. urinary tract infections, colds, or chest infections
including pneumonia - Tell your doctor immediately or go to your nearest Accident and
Emergency Centre 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 - numbness of the face
- severe vision or hearing loss
- severe stomach pain, nausea, vomiting
These are serious side effects. You may need urgent medical attention.
This is not a complete list of all possible side effects. Others may occur
in some people and there may be some side effects not yet known.
Medicines you have been given while you are being treated with MABTHERA may
have different side effects to those for MABTHERA.
Tell your doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
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
Storage
MABTHERA should be stored in the pharmacy or on the hospital ward. MABTHERA
should be stored away from light.
Product description
Availability
MABTHERA concentrate for solution for infusion comes in two strengths:
Mabthera 100 mg in 10 mL vials (each vial contains 100 mg rituximab), 2
vials per pack
Mabthera 500 mg in 50 mL vials (each vial contains 500 mg rituximab), 1
vial per pack
What MABTHERA looks like
MABTHERA is available as a clear, colourless to pale yellow, concentrated
solution for intravenous infusion. It is diluted before infusion into a vein.
Ingredients
Active ingredient
- rituximab
Inactive ingredients
Each vial of MABTHERA also contains:
- sodium citrate dihydrate, polysorbate 80, sodium chloride, hydrochloric
acid or sodium hydroxide, water for injection