MabThera® (rituximab), 100 mg in 10 mL and 500 mg in 50 mL concentrate for solution for infusion, is a Prescription Medicine used to treat rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Do not use MabThera if: you have had an allergic reaction to MabThera or any of the ingredients, or to proteins of mouse origin.
Tell your doctor if: you are pregnant or breastfeeding or plan to become pregnant or breast-feed; you are taking medication to control blood pressure; you have any disorders or conditions affecting your lungs; you have a history of heart disease, or hepatitis B; you have an infection, or a history of a recurring or long-term infection; you intend to have or recently had immunisation with any vaccine; you are allergic to any other medicines, foods, dyes or preservatives.
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 or hives; swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, swelling of the hands, feet or ankles; severe shortness of breath, severe difficulty breathing, severe wheezing, severe coughing; numbness of the face; severe vision or hearing loss; vision loss associated with headaches, confusion and seizures; severe stomach pain, nausea or vomiting; 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 or dark coloured urine. Possible common side effects may also include: pain in stomach area; aching or painful muscles; painful or swollen joints; indigestion, heartburn; severe headache; high cholesterol; tingling, numbness of feet and hands or decreased sensitivity; infection; mouth ulcers; athlete’s foot; hair loss; anxiety; depression; diarrhoea; feeling faint; insomnia (inability to sleep).
MabThera has risks and benefits. Ask your doctor if MabThera is right for you. Use strictly as directed. If symptoms continue or you have side effects, see your healthcare professional. For further information on MabThera, please talk to your health professional or visit www.medsafe.govt.nz for MabThera Consumer Medicine Information.
MabThera is a funded medicine for patients with RA who meet pre-defined criteria. A prescription charge and normal doctor’s fees may apply.
Consumer panel dated 16 January 2015 based on CMI dated 9 July 2014.
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