100 mg, 500 mg concentrate for solution for infusion rituximabum
(rituximab)
What Rixathon is and what it is used for
What Rixathon is
Rixathon 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 Rixathon is used for
Fixation can be used to treat several different diseases in adults and children. Your doctor may prescribe Rixathon for the treatment of:
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.
In adults, Rixathon can be given alone or in combination with chemotherapy.
In adult patients where the treatment works, Rixathon can be used as maintenance treatment for 2 years after the initial treatment has been completed.
In children and adults, rituximab is given in combination with “chemotherapy”.
b) Chronic lymphocytic leukemia
Chronic lymphocytic leukemia ( CLL ) is the most common form of leukemia in adults. KLL affects a specific lymphocyte, B-cell one, 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 development of these abnormal B lymphocytes is the cause of the symptoms you may have. Fixation in combination with chemotherapy drugs destroys these cells which gradually disappear from the body through biological processes.
c) Rheumatoid arthritis
Fixation is used to treat rheumatoid arthritis ( rheumatoid arthritis ). Rheumatoid arthritis is a disease of the joints and the B lymphocytes that causes some of the symptoms you have. Fixation 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. Fixation is usually taken with another medicine called methotrexate.
Rixathon slows down the damage to your joints caused by rheumatoid arthritis and increases your ability to perform your daily chores.
Rixathon has the best effect in patients with rheumatoid factor (RF) and / or anti-cyclic citrulline peptide (anti-CCP). This is demonstrated by taking a blood sample.
Both tests are usually positive for rheumatoid arthritis and aid in diagnosis.
d) Granulomatosis with polyangiitis or microscopic polyangiitis
Fixation is used in combination with corticosteroids for the treatment of adult patients and children from 2 years of age with granulomatosis with polyangiitis (formerly called 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 which can also affect other organs. B lymphocytes are a contributing cause of these conditions.
e) Pemphigus Vulgaris
Fixation 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 get Rixathon
Do not take Rixathon 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 polyangitis, or pemphigus Vulgaris.
Do not take Rixathon if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Rixathon.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Rixathon if:
- you think you have hepatitis B infection now or have had it before. In a few cases, patients with hepatitis B have regained the disease, 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 (eg angina pectoris ), palpitations, or heart failure ) or had breathing problems.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before receiving Rixathon. Your doctor may need to monitor you extra closely during treatment with Rixathon.
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 Rixathon help fight infection and you should wait until the infection has passed before receiving Rixathon. Also, tell your doctor if you have had many infections in the past or are suffering 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 Rixathon or during the months after receiving Rixathon. Your doctor will check if you need any vaccinations before you receive Rixathon.
Children and young people
Non-Hodgkin’s lymphoma
Rituximab can be used to treat children and adolescents, 6 months of age and older, with non-Hodgkin’s lymphoma, specifically CD20 positive diffuse large cell B -cell lymphoma (DLBCL ), Burkitt lymphoma (BL) / Burkitt leukemia (mature acute leukemia in B cells ) (BAL) or Burkitt-like lymphoma (BLL).
Granulomatosis with polyangiitis or microscopic polyangiitis
Rituximab can be used to treat children and adolescents from 2 years of age and older who have granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis ) or microscopic polyangiitis. There is not much information on the use of rituximab in children and young people with other diseases.
Talk to your doctor, pharmacist, or nurse before you or your child receives this medicine if you or your child are under 18 years of age.
Other drugs and Rixathon
Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies. This is because Rixathon may affect the way other medicines work. Other medicines may also affect the way Rixathon works.
Talk to your doctor specifically about:
- you are taking medicines for high blood pressure. You may be asked not to take your medication for 12 hours before receiving Rixathon. This is because some patients get a drop in blood pressure when they receive Rixathon.
- 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 you are not sure), talk to your doctor, pharmacist, or nurse before receiving Rixathon.
Pregnancy and breastfeeding
You must tell your doctor or nurse if you are pregnant, if you think you may be pregnant or if you are planning to have a baby. This is because Rixathon can pass the placenta and affect your baby.
If you could become pregnant, you and your partner must use an effective contraceptive during treatment with Rixathon and for 12 months after the last treatment with Rixathon. You should not breast-feed when you are being treated with Rixathon. You should also not breastfeed for 12 months after your last treatment with Rixathon. This is because Rixathon can pass into breast milk.
Driving and using machines
It is not known if rituximab affects your ability to drive or use machines.
Rixathon contains sodium
This medicine contains 52.6 mg sodium (the main ingredient in table salt / table salt) in each 10 ml vial and 263.2 mg sodium in each 50 ml vial. This corresponds to 2.6% (for 10 ml vial ) and 13.2% (for 50 ml vial ) of the highest recommended daily sodium intake for adults.
How Rixathon is given
How it is given
The fixation will be given to you by a doctor or nurse who has experience using this treatment. They will monitor you closely when you are treated with this medicine in case you get any side effects .
You will always receive Rixathon as a drip ( intravenous infusion ).
Medicines are given before each administration of Rixathon
Before you are given Rixathon, you will be given other medicines (pre-medication) to prevent or reduce any 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 being treated with Rixathon alone
The fixation will be given to you once a week for a total of 4 weeks. Repeated treatments with Rixathon are possible.
- If you are being treated with Rixathon in combination with chemotherapy
The fixation 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 the treatment, you can receive Rixathon as a maintenance treatment every two or three months for two years. Your doctor may change this depending on how you respond to the medicine.
- If you are younger than 18 years
you will be given Rixathon in combination with chemotherapy. You will receive rituximab up to 6 times over a period of 3.5-5.5 months.
b) If you are being treated for chronic lymphocytic leukemia
When you are treated with Rixathon in combination with chemotherapy, you will receive Rixathon 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 Rixathon infusion. Your doctor will decide if you should receive any additional supportive care.
c) If you are being treated for rheumatoid arthritis
Each course of treatment consists of two separate infusions given at 2-week intervals. Repeated treatments with Rixathon are possible. Depending on the signs and symptoms of your illness, your doctor will decide when to take more Rixathon. This can take several months.
d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Fixation treatment consists of four separate infusions given one week apart. Corticosteroids will usually be given as an injection before Rixathon treatment. Corticosteroids given by mouth can be started at any time by your doctor to treat your condition. If you are 18 years of age or older and respond well to treatment, you can receive rituximab as maintenance therapy. It will be given as 2 separate infusions at 2-week intervals, followed by 1 infusion every 6 months for at least 2 years. Your doctor may decide to treat you longer with rituximab (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 consists of two separate infusions given at 2-week intervals. If you respond well to the treatment, you can get Rixathon as a maintenance treatment. It will be given 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 the treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Possible side effects
This medicine can cause side effects like all medicines, 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 infusion one, you may experience fever, chills, and tremors. Less often, some patients may experience pain at the infusion site, blisters, itching, nausea, fatigue, headache, difficulty breathing, high blood pressure, wheezing, sore throat, swelling of the tongue and throat, itchy or runny nose, vomiting, reddening of the skin or irregular rash. , heart attack or low platelet count . If you have heart disease or angina, these reactions may 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 given more slowly or discontinued. You may also need treatment supplements such as antihistamine or paracetamol. When the symptoms disappear or improve, the infusion can be continued. These reactions are less likely to occur after the second infusion. Your doctor may decide to stop your treatment with Rixathon if these reactions are severe.
Infection is
Tell your doctor immediately if you or your child develop symptoms of infection such as:
- fever, cough, sore throat, burning pain when you urinate, or if you start to feel weak or generally ill
- memory loss, difficulty thinking, difficulty walking or loss of vision – these can be due to a very rare, serious infection in the brain that has had a fatal outcome ( progressive multifocal leukoencephalopathy or PML).
You can get infection more easily during your treatment with Rixathon.
There are often colds, but there have been cases of pneumonia or urinary tract infection. 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 care that you have received from your doctor. It is important that you keep this patient card and show it to your partner or caregiver.
Skin reactions
In very rare cases, severe conditions with skin blisters, which can be life-threatening, can occur. Redness , often associated with blisters, can occur on the skin or the mucous membranes, such as in the mouth, around the genitals or on the eyelids, and fever may occur. 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 leukemia
Very common side effects (may affect more than 1 in 10 people):
- 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)) that help protect against infection ).
Common side effects (may affect up to 1 in 10 people):
- infection in the blood (blood poisoning), pneumonia, shingles, colds, tracheal infections, fungal infections, infections of unknown origin, sinusitis, hepatitis B
- low number of red blood cells in the blood ( anemia, anemia ), low number of all blood cells
- allergic reactions (hypersensitivity)
- elevated blood sugar, weight loss, swelling of the face and body, high levels of enzyme and LDH in the blood, decreased amount of calcium in the blood
- abnormal sensations such as numbness, tingling, burning sensation, tingling in the skin, decreased sensation
- restlessness, insomnia
- redness of the face and other areas of the skin as a consequence of dilated blood vessels
- dizziness, anxiety
- increased production of tears and tear secretions, eye inflammation (conjunctivitis)
- ringing sounds 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 upright)
- the tension of the muscles of the airways which gives rise to wheezing ( bronchospasm ), inflammation , irritation of the lungs, throat, or sinuses, shortness of breath, runny nose
- vomiting, diarrhea, abdominal pain, irritation or sore throat and mouth, difficulty swallowing, constipation, indigestion
- eating disorders: decreased appetite which leads to weight loss
- hives, increased sweating, night sweats
- symptoms in muscles such as tense muscles, joint or muscle pain, back and neck pain
- tumor pain
- general symptoms of discomfort or feeling of discomfort or tiredness, shaking, flu symptoms
- deterioration of several organs.
Uncommon side effects (may affect up to 1 in 100 people):
- coagulation disorders in the blood, decrease in the production of red blood cells and increased degradation of red blood cells (aplastic hemolytic anemia ), swollen or enlarged lymph nodes
- depression and lack of interest in normal activities, nervousness
- taste change
- heart disease 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 people):
- temporary increase in different types of antibodies in the blood ( immunoglobulins – IgM), chemical disorders 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 blisters that can be life-threatening. Redness , often associated with blisters, can occur on the skin or the mucous membranes, such as in the mouth, around the genitals, or the eyelids, and fever may occur.
- kidney failure
- severe visual impairment.
No known frequency (it is not known how often these side effects occur):
- delayed decrease in white blood cells
- reduction of platelets shortly after infusion – may be transient but may in rare cases be fatal
- hearing loss, loss of other senses
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 leukemia. The most common side effects observed were fever associated with low levels of a white blood cell type ( neutrophils ), inflammation or sores in 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):
- infection is 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 the 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 treating physicians. These include a reduction 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 people):
- infection is such as bronchitis _
- feeling of tightness or throbbing pain behind the nose, cheeks and eyes (sinusitis), abdominal pain, vomiting, and diarrhea, difficulty breathing
- athlete’s foot
- high cholesterol levels in the blood
- abnormal sensations, such as numbness, tingling, burning sensation, tingling in the skin, sciatica, migraine, dizziness
- hair loss
- anxiety, depression
- indigestion, diarrhea, acid regurgitation, irritation and / or sore throat and mouth
- pain in the abdomen, back, muscles, and/or joints.
Uncommon side effects (may affect up to 1 in 100 people):
- accumulation of fluid on the face and body
- inflammation, irritation and / or feeling of 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 people):
- a range of symptoms that occur within a few weeks after rituximab infusion including allergic reactions such as skin rash, itching, joint pain, swollen lymph nodes, and fever.
- severe conditions with blisters that can be life-threatening. Redness , often associated with blisters, can occur on the skin or mucous membranes such as in the mouth, around the genitals, or the eyelids, and fever may occur.
Other rarely reported side effects caused by rituximab include a decrease in the number of white blood cells ( neutrophils ) that help fight infections . Some infections can be serious (see the information on Infections in 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 respiratory infections , urinary tract infections (pain when urinating), colds, and herpes infections
- allergic reactions that are most likely to occur during an infusion , but may occur up to 24 hours after the infusion
- diarrhea
- cough or shortness of breath
- nosebleeds
- high blood pressure
- joint or back pain
- muscle twitching and muscle weakness
- feeling of dizziness
- shaking (often in the hands)
- difficulty sleeping (insomnia)
- swelling of hands or ankles
Common side effects (may affect up to 1 in 10 people):
- indigestion
- constipation
- rash, including acne or pimples
- flare or redness of the skin
- fever
- nasal congestion or runny nose
- tense or aching muscles
- pain in muscles or hands or feet
- low red blood cell count ( anemia )
- low platelet count in the blood
- an increase in the amount of potassium in the blood
- change in heart rhythm, or that the heart beats faster than usual
Very rare side effects (may affect up to 1 in 10,000 people):
- severe conditions with blisters that can be life-threatening. Redness, often associated with blisters, can occur on the skin or mucous membranes such as in the mouth, around the genitals, or the eyelids, and fever may occur.
- reactivation of previous hepatitis B infection
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 are of the same type as those in adults with granulomatosis with polyangiitis or microscopic polyangiitis. The most common side effects were infection, allergic reactions, and 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 may occur up to 24 hours after the infusion
- headache
- infection is like infection in the airways
- prolonged depression
- hair loss
Common side effects (may affect up to 1 in 10 people):
- infections such as colds, herpes infections, eye infections , fungal infections of the mouth, and urinary tract infections (pain when urinating)
- mood effects such as irritation and depression
- skin effects such as itching , hives and benign lumps
- fatigue or dizziness
- fever
- pain in joints and back
- abdominal pain
- muscle pain
- the heart beats faster than usual
Rixathon can also cause changes in laboratory tests performed by your doctor.
If you are taking Rixathon in combination with other medicines, some of the side effects you may experience are due to the other medicines.
How to store Rixathon
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Keep the vial in the outer carton. Sensitive to light.
This medicine can also be stored in the original package outside the refrigerator at a maximum of 30 ° C for a single period of up to 7 days, but without exceeding the original expiry date. In such a situation, it should not be stored in the refrigerator again. Write the new expiration date on the box, with day / month / year. Discard the medicine if it is not used before the new expiry date or the expiry date which is stated on the carton, whichever comes first.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance in Rixathon is rituximab.The 10 ml vial contains 100 mg rituximab (10 mg / ml).The 50 ml vial contains 500 mg rituximab (10 mg / ml).
- The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections (see section 2).
What the medicine looks like and the contents of the pack
Rixathon is a clear colorless to slightly yellowish solution and is available as a concentrate for solution for infusion.
10 ml vial – Pack of 2 or 3 vials.
50 ml vial – Pack of 1 or 2 vials
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemistry. 10
6250 Kundl
Austria
Manufacturer
Sandoz GmbH Schaftenau
Biochemistry. 10
6336 Langkampfen
Austria
Lek Pharmaceuticals dd Ljubljana
Verovškova 57
1526 Ljubljana
Slovenia