Patient leaflet - Ruxience 100 mg concentrate for solution for infusion
1. What Ruxience is and what it is used for What Ruxience is
Ruxience 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.
What Ruxience is used for
Ruxience may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe Ruxience for the treatment of: a) Non-Hodgkin’s Lymphoma
This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B‑Lymphocytes.
In adults Ruxience can be given alone or with other medicines called “chemotherapy”.
In adult patients where the treatment is working, Ruxience may be used as a maintenance treatment for 2 years after completing the initial treatment.
In children and adolescents, Ruxience is given in combination with “chemotherapy”.
- b) Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects a particular lymphocyte, the B‑cell, which originates from the bone marrow and develops in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood. The proliferation of these abnormal B‑lymphocytes is the cause of symptoms you may have. Ruxience in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
- c) Rheumatoid arthritis
Ruxience is used for the treatment of rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints. B‑lymphocytes are involved in the cause of some of the symptoms you have. Ruxience is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. Ruxience is usually taken together with another medicine called methotrexate. Ruxience slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
The best responses to Ruxience are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti‑Cyclic Citrullinated Peptide (anti‑CCP). Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis.
- d) Granulomatosis with polyangiitis or microscopic polyangiitis
Ruxience is used for the treatment of adults and children 2 years of age and older with granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well. B lymphocytes are involved in the cause of these conditions.
- e) Pemphigus vulgaris
Ruxience is used for the treatment of patients with moderate to severe pemphigus vulgaris. Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
2. What you need to know before you are given
Ruxience
Do not have Ruxience
if you are allergic to rituximab, other proteins which
are like rituximab, or any of the other ingredients of this medicine (listed in section 6).
- if you have a severe active infection at the moment.
- if you have a weak immune system.
if you have severe heart failure or severe uncontrolled
heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Do not have Ruxience if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ruxience.
Warnings and precautions
It is important that you and your doctor record the brand name and batch number of your medication. Talk to your doctor, pharmacist or nurse before you are given Ruxience if:
you have ever had or might now have a hepatitis
you have ever had heart problems (such as angina,
palpitations or heart failure) or breathing problems. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Ruxience. Your doctor may need to take special care of you during your treatment with Ruxience.
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 Ruxience or in the months after you receive Ruxience. Your doctor will check if you should have any vaccines before you receive Ruxience. If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
if you think you may have an infection, even a mild one
like a cold. The cells that are affected by Ruxience help to fight infection and you should wait until the infection has passed before you are given Ruxience. Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Children and adolescents
Non-Hodgkin’s lymphoma
Ruxience can be used for the treatment of children and adolescents, 6 months of age and older, with non‑Hodgkin’s lymphoma, specifically CD20 positive diffuse large B‑cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B‑cell acute leukaemia) (BAL) or Burkitt‑like lymphoma (BLL).
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Granulomatosis with polyangiitis or microscopic polyangiitis Ruxience can be used for treatment of children and adolescents, 2 years of age and older, with granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis) or microscopic polyangiitis. There is not much information about the use of rituximab in children and adolescents with other diseases.
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Other medicines and Ruxience
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 Ruxience can affect the way some other medicines work. Also some other medicines can affect the way Ruxience works. In particular, tell your doctor:
if you are taking medicines for high blood pressure.
You may be asked not to take these other medicines 12 hours before you are given Ruxience. This is because some people have a fall in their blood pressure while they are being given Ruxience.
if you have ever taken medicines which affect your
immune system – such as chemotherapy or immune‑suppressive medicines.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Ruxience.
Pregnancy and breast-feeding
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 Ruxience 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 Ruxience. You must also do this for 12 months after your last treatment with Ruxience.
Ruxience 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 Ruxience and for 6 months after the treatment.
Driving and using machines
It is not known whether rituximab has an effect on you being able to drive or use any tools or machines. Ruxience sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium‑free’.
3. How Ruxience is given
How it is given
Ruxience 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 Ruxience as a drip (intra‑venous infusion).
Medicines given before each Ruxience administration
Before you are given Ruxience, you will be given other medicines (pre‑medication) to prevent or reduce possible side effects.
How much and how often you will receive your treatment
- a)
If you are being treated for non-Hodgkin’s lymphoma
If you are having Ruxience alone
Ruxience will be given to you once a week for 4 weeks. Repeated treatment courses with Ruxience are possible.
- If you are having Ruxience with chemotherapy Ruxience will be given to you on the same day as your chemotherapy. This is usually given every 3 weeks up to 8 times.
- If you respond well to treatment, you may be given Ruxience as a maintenance treatment every 2 or 3 months for two years. Your doctor may change this, depending on how you respond to the medicine.
- If you are less than 18 years of age, you will be given Ruxience with chemotherapy. You will receive Ruxience up to 6 times over a 3.5 – 5.5 month period.
- b) If you are being treated for chronic lymphocytic leukaemia
When you are treated with Ruxience in combination with chemotherapy, you will receive Ruxience infusions on Day 0 cycle 1 then Day 1 of each cycle for 6 cycles in total. Each cycle has a duration of 28 days. The chemotherapy should be given after the Ruxience infusion. Your doctor will decide if you should receive concomitant supportive therapy.
- c) If you are being treated for rheumatoid arthritis
Each course of treatment is made up of two separate infusions which are given 2 weeks apart. Repeated courses of treatment with Ruxience are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Ruxience. This may be months from now.
- d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis Treatment with Ruxience uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of Ruxience treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
If you are 18 years of age and older and respond well to treatment, you may be given Ruxience as a maintenance treatment. This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with Ruxience (up to 5 years), depending on how you respond to the medicine. e) If you are being treated for pemphigus vulgaris
Each course of treatment is made up of two separate infusions which are given 2 weeks apart. If you respond well to treatment, you may be given Ruxience as a maintenance treatment. This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or 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.
4. Possible side effects
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 require treatment. Rarely, some of these reactions have been fatal.
Infusion reactions
During or within the first 24 hours of the infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse. Tell the person giving you the infusion immediately if you or your child develops any of these symptoms, as the infusion may need to be slowed down or stopped. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. Your doctor may decide to stop your Ruxience treatment if these reactions are serious. Infections
Tell your doctor immediately if you or your child gets signs of an infection including:
fever, cough, sore throat, burning pain when passing
urine or feeling weak or generally unwell,
memory loss, trouble thinking, difficulty walking or
sight loss – these may be due to a very rare, serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or PML),
fever, headache and stiff neck, incoordination (ataxia),
personality change, hallucinations, altered consciousness, seizures or coma – these may be due to a serious brain infection (enteroviral
meningoencephalitis), which can be fatal. You might get infections more easily during your treatment with Ruxience.
These are often colds, but there have been cases of pneumonia, or urinary infections and serious viral infections. These are listed below under “Other side effects”. If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver.
Skin Reactions
Very rarely, severe blistering skin conditions that can be life‑threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms.
Other side effects include:
- a) If you or your child are being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia
Very common side effects (may affect more than 1 in 10 people):
- bacterial or viral infections, bronchitis,
low number of white blood cells, with or without fever
or blood cells called “platelets”,
- feeling sick (nausea),
- bald spots on the scalp, chills, headache,
lower immunity – because of lower levels of
anti‑bodies called “immunoglobulins” (IgG) in the blood which help protect against infection. Common side effects (may affect up to 1 in 10 people):
infections of the blood (sepsis), pneumonia, shingles,
cold, bronchial tube infections, fungal infections,
infections of unknown origin, sinus inflammation, hepatitis B,
low number of red blood cells (anaemia), low number
of all blood cells,
- allergic reactions (hypersensitivity),
high blood sugar level, weight loss, swelling in the
face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood,
unusual feelings of the skin – such as numbness,
tingling, pricking, burning, a creeping skin feeling, reduced sense of touch,
- feeling restless, problems falling asleep,
becoming very red in the face and other areas of the
skin as a consequence of dilation of the blood vessels,
- feeling dizzy or anxious,
producing more tears, tear duct problems, inflamed
eye (conjunctivitis),
- ringing sound in the ears, ear pain,
heart problems – such as heart attack, uneven or fast
heart rate,
high or low blood pressure (low blood pressure
especially when standing upright),
tightening of the muscles in the airways which causes
wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose,
being sick (vomiting), diarrhoea, pain in the stomach,
irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion,
eating disorders, not eating enough, leading to weight
loss,
- hives, increased sweating, night sweats,
muscle problems – such as tight muscles, joint or
muscle pain, back and neck pain,
- tumour pain,
general discomfort or feeling uneasy or tired, shaking,
signs of flu,
- multiple‑organ failure.
Uncommon side effects (may affect up to 1 in 100 people):
blood clotting problems, decrease of red blood cell
production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes,
low mood and loss of interest or enjoyment in doing
things, feeling nervous,
taste problems – such as changes in the way things
taste,
heart problems – such as reduced heart rate or chest
pain (angina),
- asthma, too little oxygen reaching the body organs,
- swelling of the stomach.
Very rare side effects (may affect up to 1 in 10, 000 people):
short term increase in the amount of some types of
anti‑bodies in the blood (called immunoglobulins – IgM), chemical disturbances in the blood caused by break‑down of dying cancer cells,
- nerve damage in arms and legs, paralysed face,
- heart failure,
inflammation of blood vessels including those leading
to skin symptoms,
- respiratory failure,
- damage to the intestinal wall (perforation),
severe skin problems causing blisters that can be
life‑threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present,
- kidney failure,
- severe vision loss.
Not known (frequency cannot be estimated from the available data):
a reduction in white blood cells which does not
happen straight away,
reduced platelets number just after the infusion – this
can be reversed, but can be fatal in rare cases,
- hearing loss, loss of other senses,
brain and meningeal infection/inflammation
(enteroviral meningoencephalitis).
Children and adolescents with non-Hodgkin’s lymphoma:
In general, side effects in children and adolescents with non‑Hodgkin’s lymphoma were similar to those in adults with non‑Hodgkin’s lymphoma or chronic lymphocytic leukaemia. The most common side effects seen were fever associated with low levels of a type of white blood cell (neutrophil), inflammation or sores in the lining of the mouth, and allergic reactions (hypersensitivity). b) If you are being treated for rheumatoid arthritis
Very common side effects (may affect more than 1 in 10 people):
- infections such as pneumonia (bacterial),
- pain on passing water (urinary tract infection),
allergic reactions that are most likely to occur during
an infusion, but can occur up‑to 24‑hours after infusion,
changes in blood pressure, nausea, rash, fever, feeling
itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness,
- headache,
changes in laboratory tests carried out by your doctor.
These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Common side effects (may affect up to 1 in 10 people):
infections such as bronchial tube inflammation
(bronchitis),
a feeling of fullness or a throbbing pain behind the
nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems,
- fungal foot infection (athlete’s foot),
- high cholesterol levels in the blood,
abnormal sensations of the skin, such as numbness,
tingling, pricking or burning, sciatica, migraine, dizziness,
- loss of hair,
- anxiety, depression,
indigestion, diarrhoea, acid reflux, irritation and /or
ulceration of the throat and the mouth
- pain in the tummy, back, muscles and/or joints. Uncommon side effects (may affect up to 1 in 100 people):
- excess fluid retention 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 rare side effects (may affect up to 1 in 10, 000 people):
a complex of symptoms occurring within a few weeks
of an infusion of rituximab including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever,
severe blistering skin conditions that can be life‑
threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Not known (frequency cannot be estimated from the available data):
- serious viral infection,
brain and meningeal infection/inflammation
(enteroviral meningoencephalitis).
Other rarely‑reported side‑effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection. Some infections may be severe (please see information on Infections within this section).
- c) If you or your child are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Very common side effects (may affect more than 1 in 10 people):
infections, such as chest infections, urinary tract infections
(pain on passing water), colds and herpes infections,
allergic reactions that are most likely to occur during
an infusion, but can occur up‑to 24‑hours after infusion,
- diarrhoea,
coughing or shortness of breath,
- nose bleeds,
- raised blood pressure,
- painful joints or back,
- muscle twitches or shakiness,
- feeling dizzy,
- tremors (shakiness, often in the hands),
- difficulty sleeping (insomnia),
- swelling of the hands or ankles.
Common side effects (may affect up to 1 in 10 people):
- indigestion,
- constipation,
- skin rashes, including acne or spots,
- flushing or redness of the skin,
- fever,
- blocked or runny nose,
- tight or painful muscles,
- pain in the muscles or in the hands or feet,
- low number of red blood cells (anaemia),
- low numbers of platelets in the blood,
- an increase in the amount of potassium in the blood,
- changes in the rhythm of the heart, or the heart beating faster than normal.
Very rare side effects (may affect up to 1 in 10, 000 people):
- severe blistering skin conditions that can be life‑threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present,
- recurrence of a previous Hepatitis B infection. Not known (frequency cannot be estimated from the available data):
- serious viral infection,
brain and meningeal infection/inflammation
(enteroviral meningoencephalitis).
Children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis
In general, side effects in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis were of a similar type to those in adults with granulomatosis with polyangiitis or microscopic polyangiitis. Most common side effects seen were infections, allergic reactions and feeling sick (nausea). d) If you are being treated for pemphigus vulgaris
Very common side effects (may affect more than 1 in 10 people):
- allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion,
- headache,
- infections such as chest infections,
- long lasting depression,
- loss of hair.
Common side effects (may affect up to 1 in 10 people):
- infections such as common cold, herpes infections, eye infection, oral thrush and urinary tract infections (pain on passing urine),
- mood disorders such as irritability and depression,
- skin disorders such as itching, hives, and benign lumps,
- feeling tired or dizzy,
- fever,
- painful joints or back,
- pain in the tummy,
- pain in the muscles,
- heart beating faster than normal.
Not known (frequency cannot be estimated from the available data):
- serious viral infection,
- brain and meningeal infection/inflammation (enteroviral meningoencephalitis).
Ruxience may also cause changes in laboratory tests carried out by your doctor.
If you are having Ruxience with other medicines, some of the side effects you may get may be due to the other medicines.
Reporting of side effects
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 Yellow Card Scheme website:
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.
5. How to store Ruxience
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 – 8 °C). Do not freeze. Keep the vial 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.
6. Contents of the pack and other information
What Ruxience contains
The active substance is rituximab.
The 10 mL vial contains 100 mg of rituximab (10 mg/mL). The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
- The other ingredients are L‑histidine, L‑histidine hydrochloride monohydrate, disodium edetate, polysorbate 80, sucrose, water for injection. See section 2 “Ruxience sodium content”.
What Ruxience looks like and contents of the pack
Ruxience is a clear to slightly opalescent, colourless to pale brownish‑yellow solution, supplied as a concentrate for solution for infusion [sterile concentrate]. 10 mL vial – Pack of 1 vial
50 mL vial – Pack of 1 vial
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs‑Sint‑Amands
Belgium
For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in 09/2025.
Ref: bRI 13_0
Package leaflet: Information for the patient
Ruxience® 100 mg
concentrate for solution for infusion
Ruxience® 500 mg
concentrate for solution for infusion
rituximab
PAA241123
158