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The product code(s) for this leaflet is: PLGB 00031/0866.
MabThera 1400 mg Solution for Subcutaneous Injection
MabThera 1400 mg solution for subcutaneous injection
rituximab
1. What MabThera is and what it is used for
2. What you need to know before you are given MabThera
3. How MabThera is given
4. Possible side effects
5. How to store MabThera
6. Contents of the pack and other information
MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.
MabThera is available as a medicine given as a drip (called MabThera 100 mg or MabThera 500 mg, concentrate for solution for infusion) and as a medicine for injection under your skin (called MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous injection).
MabThera 1400 mg is used to treat Non-Hodgkin’s lymphoma in adults.
MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
After this, you will be given MabThera as an injection under your skin. Your doctor will decide when to start MabThera injections.
In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.
Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Talk to your doctor, pharmacist or nurse before you are given MabThera if:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera. Your doctor may need to take special care of you during your treatment with MabThera.
Also talk to your doctor if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. 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.
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and adolescents.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.
In particular, tell your doctor:
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera.
You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. This is because MabThera can cross the placenta and may affect your baby.
If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.
MabThera passes into breast milk in very small amounts. As the long-term effects on breastfed infants are not known, for precautionary reasons, breast-feeding is not recommended during treatment with MabThera and for 6 months after the treatment.
It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.
Sodium
MabThera 1400 mg contains less than 1 mmol sodium (main component of the cooking/table salt) per dose, i.e. it is essentially sodium-free.
MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.
You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 5 minutes. There is a peel-off sticker on the glass vial that specifies the medication. Your doctor or nurse will place the sticker on the syringe before injection.
Your doctor will decide when to start MabThera injections.
When injected under your skin, it is given in the stomach area, not in other sites of the body, and not into areas of the stomach where the skin is red, bruised, tender, hard or where there are moles or scars.
Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Your doctor may change this, depending on how you respond to the medicine.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate but some may be serious and need treatment. Rarely, some of these side effects have been fatal.
Many patients get some local side effects where MabThera is injected. These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Your doctor may decide to stop your MabThera treatment if these reactions are serious.
Infections
Tell your doctor immediately if you get signs of an infection including:
You might get infections more easily during your treatment with MabThera. These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10, 000 people):
Not known (it is not known how often these side effects happen):
MabThera may also cause changes in laboratory tests carried out by your doctor.
If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the container in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk.
Each vial contains 1400 mg/11.7 mL of rituximab. Each carton contains one vial.
This leaflet was last revised in August 2023
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