100 mg concentrate for infusion solution
rituximab
What Truxima is and what it is used for
What Truxima is
Truxima contains the active substance rituximab. This is a type of protein called a monoclonal antibody. Rituximab binds to the surface of a type of white blood cell, B lymphocytes. When rituximab binds to the surface of this cell, it causes the cell to die.
What Truxima is used for
Truxima can be used to treat several different diseases in adults. Your doctor may prescribe Truxima to treat:
a) Non-Hodgkin’s lymphoma
This is a disease of the lymphatic system (part of the immune system) that affects a type of white blood cell, the B-lymphocytes.
Truxima can be given alone or together with chemotherapy.
In patients where the treatment works, the use of Truxima can be continued for 2 years after the initial treatment has been completed.
b) Chronic lymphocytic leukemia
Chronic lymphocytic leukemia ( CLL ) is the most common form of leukemia in adults. CLL affects a special lymphocyte, the B‑cell, which originates from bone marrow and develops in 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 the symptoms you may have. Truxima in combination with chemotherapy destroys these cells, which gradually disappear from the body through biological processes.
c) Rheumatoid arthritis
Truxima is used to treat joint rheumatism ( rheumatoid arthritis ). Rheumatoid arthritis is a disease of the joints and the B lymphocytes cause some of the symptoms you have. Truxima is used to treat rheumatoid arthritis in people who have already tried other medicines, but these have either stopped working, have not worked well enough, or have caused side effects. Truxima is usually taken together with another medicine called methotrexate.
Truxima slows down the damage to your joints caused by rheumatoid arthritis and increases your ability to perform your daily tasks.
Truxima works best in those patients who have rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP). This is demonstrated by taking one.
Both tests are usually positive for rheumatoid arthritis and aid in diagnosis.
d) Granulomatosis with polyangiitis or microscopic polyangiitis
Truxima is used in combination with corticosteroids to treat patients with granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis ) or microscopic polyangiitis. Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation in the blood vessels that mainly affect the lungs and kidneys, but can also affect other organs. B lymphocytes are a contributing factor to these conditions.
e) Pemphigus vulgaris
Truxima is used to treat patients with moderate to severe pemphigus Vulgaris. Pemphigus Vulgaris is an autoimmune disease that causes painful blisters on the skin, mouth, nose, throat, and genitals.
What you need to know before you use Truxima
Do not take Truxima if:
- you are allergic to rituximab, other proteins similar to rituximab, or any of the other ingredients of this medicine (see section 6).
- you currently have a severe active infection.
- you have a weakened immune system.
- you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus Vulgaris.
Do not take Truxima if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before you receive Truxima.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Truxima if:
- Do you think you have hepatitis B infection now or have had it in the past? In a few cases, patients who had hepatitis B have relapsed, which can be fatal in very rare cases. Patients who have previously had hepatitis B infection should be checked regularly by their doctor for signs of this infection.
- you have ever had heart disease (e.g. angina pectoris ), palpitations, heart failure, or breathing problems?
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Truxima. Your doctor may need to monitor you extra closely during treatment with Truxima.
If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus Vulgaris, you should also tell your doctor
- if you think you have an infection, even a mild infection such as a cold. The cells affected by Truxima help fight infection and you should wait until the infection has passed before you receive Truxima. Also, tell your doctor if you have had many infections in the past or suffer from severe infections.
- if you think you need a vaccination shortly, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as Truxima or in the months after you receive Truxima. Your doctor will check if you need any vaccinations before you receive Truxima.
Children and young people
Talk to your doctor, pharmacist, or nurse before you or your child receives this medicine if you or your child is under 18 years of age. This is because there is not much information on the treatment of children and adolescents with Truxima.
Other medicines and Truxima
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including over-the-counter and herbal medicines. This is because Truxima can affect how other medicines work. Other medicines can also affect how Truxima works.
Talk to your doctor especially about:
- you are taking medication for high blood pressure. You may be asked not to take your medicines for 12 hours before you receive Truxima. This is because some patients experience a drop in blood pressure when receiving Truxima.
- if you have ever taken medicines that affect your immune systems – such as chemotherapy or immunosuppressive medicines.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Truxima.
Pregnancy, breastfeeding, and fertility
You must tell your doctor or nurse if you are pregnant if you think you are pregnant or if you are planning to become pregnant. This is because Truxima can cross the placenta and affect your baby.
If you can become pregnant, you and your partner must use effective contraception during treatment with Truxima and for 12 months after the last treatment with Truxima. You should not breastfeed while you are being treated with Truxima. You should also not breastfeed for 12 months after your last treatment with Truxima. This is because Truxima can pass into breast milk.
Driving ability and use of machinery
It is not known whether Truxima affects your ability to drive or use machines.
Truxima contains sodium
This medicine contains 52.6 mg of sodium (the main ingredient in common/table salt) per 10 mL vial. This corresponds to 2.6% of the maximum recommended daily intake of sodium for adults.
How to use Truxima
How it is given
Truxima will be given to you by a doctor or nurse experienced in the use of this treatment. They will monitor you closely while you are being treated with this medicine in case you get any side effects.
You will always receive Truxima as a drip ( intravenous infusion ).
Medicines are given before each administration of Truxima
Before you receive Truxima, you will receive 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 treated with Truxima alone
Truxima will be given to you once a week for a total of 4 weeks. Repeated treatments with Truxima are possible. - If you are treated with Truxima in combination with chemotherapy
Truxima will be given to you on the same day as your chemotherapy. This is usually given every three weeks up to 8 times. - If you respond well to treatment, you can receive Truxima every two or three months for two years.
Your doctor may change this depending on how you respond to the medicine.
b) If you are being treated for pre-chronic lymphocytic leukemia
When you are treated with Truxima in combination with chemotherapy, you will receive a Truxima infusion on day 0 of the first cycle and then on day 1 of each treatment cycle, for a total of 6 cycles. Each cycle lasts 28 days. The chemotherapy should be given after the Truxima infusion. Your doctor will decide if you should receive any further supportive treatment.
c) If you are being treated for rheumatoid arthritis
Each round of treatment consists of two separate infusions given 2 weeks apart. Repeated treatments with Truxima are possible. Depending on the signs and symptoms of your disease, your doctor will decide when to give you more Truxima. This may take several months.
d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Treatment with Truxima consists of four separate infusions given one week apart. Corticosteroids will usually be given by injection before Truxima treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition. If you respond well to treatment, you can receive Truxima as maintenance treatment. It will be given as 2 separate infusions 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with Truxima (up to 5 years) depending on how you respond to the medicine.
e) If you are being treated for pemphigus Vulgaris
Each round of treatment consists of two separate infusions given 2 weeks apart. If you respond well to treatment, you can receive Truxima as maintenance treatment. It will be given for one year
after and 18 months after the first treatment and then every six months as needed, or your doctor may change this depending on how you respond to treatment.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
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 can be serious and require treatment. In rare cases, these side effects have been fatal.
Infusion reactions
During or within the first 24 hours after an infusion, you may experience fever, chills, and tremors. Less commonly, some patients may experience pain at the infusion site, blistering, itching, nausea, fatigue, headache, difficulty breathing, increased blood pressure, wheezing, sore throat, swelling of the tongue and throat, itchy or runny nose, vomiting, flushing, or irregular heartbeat, heart attack or low platelet count. If you have heart disease or angina, these infusion reactions may worsen. Tell the person giving you the infusion immediately if you develop any of these symptoms, because the infusion may need to be given more slowly or stopped. You may also need supplements for the treatment such as antihistamine or paracetamol. When the symptoms disappear 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 treatment with Truxima if these reactions are severe.
Infection you
Tell your doctor immediately if you develop symptoms of infection such as:
- fever, cough, sore throat, burning pain when urinating, or if you start to feel weak or generally ill
- memory loss, difficulty thinking, difficulty walking, or vision loss – these may be due to a very rare, serious infection of the brain that has been fatal ( progressive multifocal leukoencephalopathy or PML).
You may get an infection more easily during your treatment with Truxima. Often it is colds, but there have been cases of pneumonia or urinary tract infections. These are listed 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 card given to you by your doctor. You must keep this patient card and show it to your partner or caregiver.
Skin reactions
In very rare cases, severe skin blistering conditions, which can be life-threatening, can occur. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as in the mouth, around the genitals, or the eyelids, and fever may occur. Tell your doctor immediately if you get any of these symptoms.
Other side effects include:
a) If you are being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukemia
Very common side effects (may affect more than 1 in 10 patients):
- bacterial or viral infection, bronchitis ( tracheal catarrh )
- the low number of white blood cells in the blood, with or without fever, low number of platelets in the blood
- nausea
- bald spots on the head, chills, headache
- lower immunity due to a decrease in the number of certain specific antibodies in the blood ( immunoglobulins (IgG) which help protect against infection ).
Common side effects (may affect up to 1 in 10 patients):
- infection in the blood (blood poisoning), pneumonia, shingles, cold, tracheal infection, fungal infections, infection of unknown origin, sinusitis, hepatitis B
- the low number of red blood cells in the blood ( anemia, anemia ), low number of all blood cells
- allergic reactions (hypersensitivity)
- increased blood sugar, weight loss, swelling of the face and body, high levels of the enzyme lactate dehydrogenase (LDH) in the blood, decreased amount of calcium in the blood
- abnormal sensations such as numbness, tingling, burning sensation, crawling of the skin, reduced sensation
- restlessness, insomnia
- redness of the face and other areas of the skin as a consequence of dilated blood vessels
- dizziness, restlessness
- increased production of tears and tear secretion, eye inflammation (conjunctivitis)
- ringing in the ears, pain in the ears
- heart disease such as heart attack, irregular or abnormally high heart rate
- high or low blood pressure (low blood pressure, especially when standing up)
- the tension of the muscles in the airways causing wheezing ( bronchospasm ), inflammation, irritation of the lungs, throat, or sinuses, shortness of breath, runny nose
- vomiting, diarrhea, abdominal pain, throat and mouth irritation or sores, difficulty swallowing, constipation, indigestion
- eating disorders: decreased appetite leading to weight loss 48
- hives, increased sweating, night sweats
- symptoms in muscles such as tense muscles, joint or muscle pain, back and neck pain
- general malaise symptoms or feeling unwell or tired, shaking, flu symptoms
- deterioration of multiple organs.
Uncommon side effects (may affect up to 1 in 100 patients):
- blood clotting disorders, reduction in the production of red blood cells and increased breakdown of red blood cells (aplastic hemolytic anemia ), swollen or enlarged lymph nodes
- depressed mood and lack of interest in usual activities, nervousness
- taste change
- heart diseases such as decreased heart rate or chest pain (angina)
- asthma, too little oxygen reaching the body’s organs
- swollen abdomen.
Very rare side effects (may affect up to 1 in 10,000 patients):
- temporary increase in different types of antibodies in the blood ( immunoglobulins – IgM), chemical disturbances in the blood caused by the breakdown of dying cancer cells
- nerve damage in arms and legs, facial paralysis
- heart failure
- inflamed blood vessels, including those that can cause skin symptoms
- respiratory failure
- damage to the intestinal wall (perforation)
- severe conditions with skin blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes, such as in the mouth, around the genitals, or on the eyelids, and fever may occur.
- kidney failure
- and severe visual impairment.
Not known frequency (it is not known how often these side effects occur):
- delayed reduction of white blood cells
- decrease in platelets soon after infusion – may be temporary but in rare cases can be fatal
- hearing loss, loss of other senses
b) If you are being treated for rheumatoid arthritis
Very common side effects (may affect more than 1 in 10 patients):
- infection such as pneumonia (bacterial)
- pain when urinating (urinary tract infection)
- allergic reactions that are most likely to occur during an infusion but may occur up to 24 hours after infusion
- changes in blood pressure, nausea, rash, fever, itching, runny or stuffy nose as well as sneezing, tremors, palpitations, and fatigue
- headache
- changes in laboratory tests performed by attending physicians. These include a decrease in the number of certain specific proteins in the blood ( immunoglobulins ) that help protect against infection.
Common side effects (may affect up to 1 in 10 patients):
- infection such as bronchial catarrh ( bronchitis )
- the feeling of tightness or throbbing pain behind the nose, cheeks, and eyes (sinusitis), abdominal pain, vomiting, and diarrhea, breathing difficulties
- athlete’s foot
- high cholesterol levels in the blood
- abnormal sensations, such as numbness, tingling, burning sensation, skin crawling, sciatic pain, migraine, dizziness
- hair loss
- anxiety, depression
- indigestion, diarrhea, acid reflux, irritation, and/or sores in the throat and mouth
- pain in the stomach, back, muscles, and/or joints.
Uncommon side effects (may affect up to 1 in 100 patients):
- fluid accumulation in the face and body
- inflammation, irritation and/or tightness in the lungs and throat, cough
- skin reactions including hives, itching, and rash
- allergic reactions including wheezing, shortness of breath, swelling of the face and tongue, and collapse.
Very rare side effects (may affect up to 1 in 10,000 patients):
- a series of symptoms that appear within a few weeks after Truxima infusion including allergy-like reactions such as skin rash, itching, joint pain, swollen lymph nodes, and fever.
- severe conditions with skin blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes such as in the mouth, around the genitals, or on the eyelids, and fever may occur.
Other rarely reported side effects caused by Truxima to include a decreased number of white blood cells ( neutrophils ) that help fight infection. Some infections can be serious (see the information on Infections within this section).
c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Very common side effects (may affect more than 1 in 10 patients):
- infection, such as respiratory tract infection, urinary tract infection (pain when urinating), colds, and herpes – infection
- allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after an infusion
- diarrhea
- cough or shortness of breath
- nosebleed
- elevated blood pressure
- joint or back pain
- muscle twitching and muscle weakness
- feeling of dizziness
- tremors (often in the hands)
- difficulty sleeping (insomnia)
- swelling of the hands or ankles
Common side effects (may affect up to 1 in 10 patients):
- indigestion
- constipation
- skin rash, including acne or pimples 49
- flaring or redness of the skin
- fever
- nasal congestion or runny nose
- tense or painful muscles
- pain in the muscles or the hands or feet
- low red blood cell count ( anemia )
- the low number of platelets in the blood
- an increase in the amount of potassium in the blood
- change in heart rhythm, or the heart beating faster than usual
Very rare side effects (may affect up to 1 in 10,000 patients):
- severe conditions with skin blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or mucous membranes such as in the mouth, around the genitals, or on the eyelids, and fever may occur.
- reactivation of previous hepatitis B infection
d) If you are being treated for pemphigus Vulgaris
Very common side effects (may affect more than 1 in 10 patients):
- allergic reactions are most likely to occur during an infusion, but may occur up to 24 hours after infusion
- prolonged depression
- hair loss
Common side effects (may affect up to 1 in 10 patients):
- infection such as herpes infections and eye infections
- mood effects such as irritation and depression
- skin effects such as itching, hives, and benign nodules
- tiredness or dizziness
- fever
- headache
- stomach pain
- muscle pain
- the heart beats faster than usual
Truxima may also cause changes in laboratory tests performed by your doctor.
If you receive Truxima in combination with other medicines, some of the side effects you may experience may be due to the other medicines.
How to store Truxima
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the carton after Expiration. dat. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C). Store in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in Truxima is rituximab. The vial contains 100 mg rituximab (10 mg/ml). Each ml of concentrate contains 10 mg of rituximab.
- Other ingredients are sodium chloride, trisodium citrate dihydrate, polysorbate 80, and water for injections.
Appearance and package sizes of the medicine
Truxima is a clear, colorless solution and is available as a concentrate for infusion solution, in a glass vial. Pack of 2 vials.
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B torony
Hungary
Manufacturer
Biotec Services International Ltd.
Biotec House, Central Park, Western Avenue
Bridgend Industrial Estate
Bridgend, CF31 3RT, United Kingdom
and
Units 2100, 2110, 2010, 2120, 2130 and 2500
Phase 18, Central Park
Bridgend Industrial Estate
Bridgend, CF31 3TY, United Kingdom
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
Orion Pharma AB
Phone: + 46 8 623 64 40