Rixathon 500 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rixathon 100mg concentrate for solution for infusion

Rixathon 500mg concentrate for solution for infusion

rituximab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rixathon is and what it is used for
2. What you need to know before you are given Rixathon
3. How Rixathon is administered
4. Possible side effects
5. How to store Rixathon
6. Contents of the pack and other information

1. 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”. It binds to the surface of a type of white blood cells known as “B-lymphocytes”. When rituximab binds to the surface of these cells, it triggers their death.

What Rixathon is used for

Rixathon can be used in adults and children for the treatment of several different diseases. 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 called B-lymphocytes.

Rixathon may be given to adults alone or in combination with other medicines called “chemotherapy”. In adult patients in whom treatment has worked, Rixathon may be used as maintenance therapy for 2 years after completion of initial treatment.

In children and adolescents, rituximab is administered in combination with “chemotherapy”.

b) Chronic lymphocytic leukaemia (CLL)

CLL is the most common form of leukaemia in adults. B-lymphocytes are involved, which are produced in the bone marrow and mature in the lymph nodes. Patients with CLL have too many abnormal lymphocytes that accumulate mainly in the bone marrow and blood. The proliferation of these abnormal lymphocytes may be responsible for some of the symptoms you may experience. Rixathon in combination with chemotherapy destroys these cells, which gradually disappear from the body through biological processes.

c) Rheumatoid arthritis

Rixathon is used in the treatment of rheumatoid arthritis. Rheumatoid arthritis is a disease affecting the joints. B-lymphocytes are involved and contribute to some of the symptoms you may experience. Rixathon is used to treat rheumatoid arthritis in people who have already been treated with other medicines that either stopped working, were not effective enough, or caused adverse effects. Rixathon is usually used together with another medicine called methotrexate.

Rixathon reduces the joint damage caused by rheumatoid arthritis and improves the ability to perform normal daily activities.

The best responses to Rixathon are observed when the blood test for rheumatoid factor (RF) and/or the anti-cyclic citrullinated peptide (anti-CCP) test is positive. Both tests are usually positive in patients with rheumatoid arthritis and help confirm the diagnosis.

d) Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Rixathon is used to treat adult patients and children aged 2 years and older with GPA (previously known as Wegener’s granulomatosis) or MPA, administered in combination with corticosteroids.

GPA and MPA are two forms of blood vessel inflammation that primarily affect the lungs and kidneys, but may also involve other organs. B-lymphocytes are involved in the cause of these diseases.

e) Pemphigus vulgaris (PV)

Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.

PV is an autoimmune disease that causes painful blisters on the skin and mucous membranes of the mouth, nose, throat, and genitals.

2. What you need to know before being given Rixathon

Do not use Rixathon

• if you are allergic to rituximab, to other proteins similar to rituximab, or to any of the other ingredients of this medicine (listed in section 6)
• if you have an active, serious infection
• if you have a weakened 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 use Rixathon if any of the above apply to you. If you are unsure, ask your doctor, pharmacist, or nurse before being given Rixathon.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Rixathon:

• if you think you have, or have had in the past, infectious hepatitis. This is because in some cases, patients who previously had hepatitis B may experience a reactivation, which can rarely be fatal. Patients with a history of hepatitis B infection will be closely monitored by their doctor for possible signs of hepatitis B.
• if you have had any heart conditions (such as chest pain, palpitations, or heart failure) or breathing problems.

If any of the above apply to you (or if you are unsure), ask your doctor, pharmacist, or nurse before being given Rixathon. Your doctor may need to monitor you during your treatment with Rixathon.

Also ask your doctor if you think you may need vaccinations in the near future, including travel vaccines. Some vaccines should not be given at the same time as Rixathon or in the months following treatment. Your doctor will check whether you need any vaccinations before you receive Rixathon.

If you have rheumatoid arthritis, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or pemphigus vulgaris (PV), you should also tell your doctor:

• if you think you may have an infection, even if it seems mild, such as a cold. The cells targeted by Rixathon help fight infections, so you should wait until the infection has resolved before using Rixathon. Also inform your doctor if you have had frequent infections in the past or if you currently have a serious infection.

Children and adolescents

Non-Hodgkin’s lymphoma

Rituximab can be used to treat children and adolescents aged 6 months and older with non-Hodgkin’s lymphoma, specifically CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukemia (acute mature B-cell leukemia) (B-AL), or Burkitt-like lymphoma (BLL).

Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Rituximab can be used to treat children and adolescents aged 2 years and older with GPA (previously known as Wegener’s granulomatosis) or MPA. There is limited information on the use of rituximab in children and young people with other diseases.

There is limited information on the use of rituximab in children and adolescents with other diseases.

Inform your doctor, pharmacist, or nurse before rituximab is administered to you or your child if they are under 18 years of age.

Other medicines and Rixathon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines, including those obtained without a prescription or herbal medicines. This is because Rixathon may affect how other medicines work. Likewise, other medicines may affect how Rixathon works.

In particular, inform your doctor if:

• you are being treated for high blood pressure. You may be advised not to take your blood pressure medication during the 12 hours before receiving Rixathon. This is because some people may experience a drop in blood pressure during Rixathon infusion.
• you have ever taken medicines that affect your immune system—such as chemotherapy or immunosuppressive medicines.

If any of the above apply to you (or if you are unsure), ask your doctor, pharmacist, or nurse before being given Rixathon.

Pregnancy and breastfeeding

Tell your doctor or nurse if you are pregnant, think you might be pregnant, or plan to become pregnant. This is because Rixathon can cross the placental barrier and affect your baby.

If you are of childbearing age, you and your partner should use an effective method of contraception during treatment with Rixathon and for 12 months after the last dose of Rixathon. Rituximab passes into breast milk in very small amounts. As the long-term effects on infants are unknown, breastfeeding is not recommended during treatment with Rixathon and for 6 months after treatment, as a precaution.

Driving and using machines

It is unknown whether rituximab has any effect on the ability to drive or operate machinery.

Rixathon contains sodium

This medicine contains 52.6 mg of sodium per 10 ml vial and 263.2 mg of sodium per 50 ml vial. This corresponds to 2.6% (per 10 ml vial) and 13.2% (per 50 ml vial) of the maximum daily recommended sodium intake for an adult.

Rixathon contains polysorbate

This medicine contains 7.0 mg of polysorbate 80 (E 433) in each 10 ml vial and 35.0 mg of polysorbate 80 (E 433) in each 50 ml vial, equivalent to 0.7 mg/ml.

Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

3. How Rixathon is administered

How Rixathon is administered

Rixathon will be administered by a doctor or nurse experienced in the use of this medicine. You will be monitored during administration of Rixathon in case you experience any adverse effects.

Rixathon is always given by intravenous infusion (drip).

Medicines administered before each Rixathon infusion

Before administration of Rixathon, you will be given other medicines (premedication) to prevent or reduce possible adverse effects.

Dose and frequency of treatment

a) If you are being treated for non-Hodgkin’s lymphoma

•If you are being treated with Rixathon alone

Rixathon will be administered once weekly for 4 weeks. Treatment cycles with Rixathon may be repeated.

•If you are being treated with Rixathon in combination with chemotherapy

Rixathon will be administered on the same day as chemotherapy. It is generally given every 3 weeks up to 8 times.

• If you respond well to treatment, you may continue Rixathon as maintenance therapy every 2 or 3 months for two years. Your doctor may adjust this depending on your response to the medicine.
  • If you are under 18 years of age, you will receive Rixathon in combination with chemotherapy. You will receive Rixathon up to 6 times over a period of 3.5 to 5.5 months.

b) If you are being treated for chronic lymphocytic leukemia (CLL)

When you are being treated with Rixathon in combination with chemotherapy, you will receive Rixathon infusions on Day 0 of Cycle 1, then on Day 1 of each cycle until a total of 6 cycles are completed. Each cycle lasts 28 days. Chemotherapy must be administered after the Rixathon infusion. Your doctor will decide whether you should receive supportive therapy.

c) If you are being treated for rheumatoid arthritis

Each treatment cycle consists of two infusions, both separated by an interval of 2 weeks. Treatment cycles with Rixathon may be repeated. Depending on the signs and symptoms of your disease, your doctor may decide at some point to administer a higher dose of Rixathon, which may occur several months later.

d) If you are being treated for granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Treatment with Rixathon consists of four separate infusions administered at weekly intervals. Corticosteroids are usually administered by injection before starting treatment with Rixathon. To treat your disease, your doctor may start oral corticosteroids at any time.

If you are 18 years of age or older and respond well to treatment, Rixathon may be given as maintenance therapy. This will be administered as two infusions separated by 2 weeks, followed by one infusion every 6 months for at least 2 years. Your doctor may decide to treat you with Rixathon for a longer period (up to 5 years), depending on your response to the medicine.

e) If you are being treated for pemphigus vulgaris (PV)

Each treatment cycle consists of two infusions, both separated by an interval of 2 weeks. If you respond well to treatment, Rixathon may be administered as maintenance therapy. This will be given 1 year and 18 months after initial treatment, and then every 6 months as needed. Your doctor may modify this depending on your response to the medicine.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Most of these adverse effects are mild to moderate in intensity, but some may be serious and require treatment. In rare cases, some of these reactions have been fatal.

Infusion reactions

During or within 24 hours after the infusion, you may experience fever, chills, and shivering. Other less common adverse effects that some patients may experience include: pain at the infusion site, skin blisters and itching, nausea and vomiting, fatigue, headache, difficulty breathing, increased blood pressure, wheezing, throat discomfort, swelling of the tongue or throat, itching or nasal congestion, vomiting, flushing or palpitations, heart attack, or low platelet count. If you have any heart disease or angina, these reactions could worsen. Inform immediately the person administering the infusion if you or your child experience any of these symptoms, as you may need the infusion to be slowed down or stopped. You may require additional treatment with antihistamines or paracetamol. Once symptoms have disappeared or improved, the infusion may continue. These reactions are less likely to occur after the second infusion. Your doctor may decide to discontinue your treatment with Rixathon if you experience severe infusion reactions.

Infections

Inform your doctor immediately if, after treatment with Rixathon, you or your child develop any symptoms of infection, such as:

• fever, cough, sore throat, burning sensation when urinating, or onset of fatigue or general malaise,
• memory loss, difficulty concentrating, difficulty walking, or vision loss. This may be due to a very rare, serious brain infection, which has been fatal (progressive multifocal leukoencephalopathy or PML),
  • fever, headache, neck stiffness, lack of coordination (ataxia), personality changes, hallucinations, altered consciousness, seizures, or coma – this could be due to a serious brain infection (enteroviral meningoencephalitis), which can be fatal.

You may become more susceptible to infections after treatment with Rixathon.

These are usually colds, but cases of pneumonia, urinary tract infections, or serious viral infections have been reported. All of these are listed below under "Other adverse effects".

If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, or pemphigus vulgaris, your doctor should have provided you with a patient information card containing this information. It is important that you carry this card and show it to your partner or caregiver.

Skin reactions

Very rarely, severe blistering of the skin may occur, which can be fatal. Redness, usually associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, genital area, or eyelids, and may be accompanied by fever. Inform your doctor immediately if you experience any of these symptoms.

Other adverse effects

a) If you or your child are being treated for non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL)

Very common (may affect more than 1 in 10 people):

• bacterial or viral infections, bronchitis,
• low white blood cell count with or without fever, or low levels of blood cells called “platelets”,
• nausea,
• hair loss (alopecia), chills, headache,
• reduced immunity due to decreased levels of antibodies called “immunoglobulins” (IgG) in the blood, which help protect against infection.

Common (may affect up to 1 in 10 people):

• blood infections (sepsis), pneumonia, herpes, common cold, bronchial infections, fungal infections, infections of unknown origin, sinusitis, hepatitis B,
• low red blood cell count (anemia), low levels of all blood cells,
• allergic reactions (hypersensitivity),
• high blood sugar levels, weight loss, peripheral and facial edema, increased blood LDH enzyme levels, decreased blood calcium levels,
• abnormal skin sensations such as numbness, tingling, pricking, burning, progressive increase in these sensations, reduced sense of touch,
• restlessness, difficulty falling asleep,
• facial redness and redness in other skin areas due to blood vessel dilation,
• dizziness or anxiety,
• excessive tearing, lacrimal duct disorders, eye inflammation (conjunctivitis),
• ringing in the ears (tinnitus), ear pain,
• heart problems such as myocardial infarction, irregular heartbeat, abnormally rapid heartbeat,
• increased or decreased blood pressure (especially low blood pressure upon standing),
• muscle tension in the airways causing breathing difficulty (bronchospasm), inflammation or irritation in the lungs, throat, and/or nasal cavities, shortness of breath, runny nose,
• vomiting, diarrhea, abdominal pain, throat or mouth irritation or ulcers, difficulty swallowing, constipation, indigestion,
• eating disorders: insufficient food intake leading to weight loss,
• hives, increased sweating, night sweats,
• muscle problems such as muscle tension, joint or muscle pain, back and neck pain,
• general malaise or restlessness or fatigue, agitation, cold-like symptoms,
• multiorgan failure.

Uncommon (may affect up to 1 in 100 people):

• coagulation disorders, reduced red blood cell production, increased destruction of red blood cells (aplastic hemolytic anemia), lymph node inflammation/swelling,
• lethargy, loss of interest in usual activities, nervousness,
• taste disturbances such as changes in food taste,
• heart problems such as reduced heart rate or chest pain (angina),
• asthma, insufficient oxygen reaching organs,
• stomach swelling.

Rare (may affect up to 1 in 10,000 people):

• temporary increase in a type of antibody in the blood (called immunoglobulins – IgM), blood chemical changes caused by the breakdown of cancer cells,
• nerve damage in arms and legs, facial paralysis,
• heart failure,
• blood vessel inflammation, including those causing skin symptoms,
• respiratory failure,
• damage to the intestinal wall (perforation),
• serious skin problems causing blisters that may be potentially fatal. Redness, usually associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, genital area, or eyelids, and may be accompanied by fever,
• kidney problems,
• severe vision loss.

Frequency not known (frequency cannot be estimated from available data):

• delayed decrease in white blood cells in the blood,
• reduced platelet count after infusion – reversible, but in rare cases may be fatal,
  • hearing loss, loss of other senses, infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Children and adolescents with non-Hodgkin’s lymphoma (NHL):

In general, adverse effects in children and adolescents with non-Hodgkin’s lymphoma were similar to those in adults with NHL or CLL. The most commonly observed adverse effects were fever associated with low levels of a type of white blood cells (neutrophils), inflammation or sores in the mouth, and allergic reactions (hypersensitivity).

b) If you are being treated for rheumatoid arthritis

Very common (may affect more than 1 in 10 people):

• infections such as pneumonia (bacterial),
• painful urination (urinary tract infection),
• allergic reactions, most likely to occur during infusion, but may occur up to 24 hours after infusion,
• changes in blood pressure, nausea, rashes, fever, hot flushes, nasal congestion, sneezing, shivering, rapid heartbeat, and fatigue,
• headache,
• changes in laboratory tests performed by your doctor. These include a decrease in certain specific proteins in the blood (immunoglobulins) that help protect against infection.

Common (may affect up to 1 in 10 people):

• infections such as bronchial inflammation (bronchitis),
• feeling of warmth, intermittent pain in the nose, cheeks, and eyes (sinusitis), abdominal pain, vomiting and diarrhea, breathing problems,
• fungal infection of the feet (athlete’s foot),
• increased blood cholesterol levels,
• abnormal skin sensations such as numbness, tingling, pricking, or burning, sciatica, headache, dizziness,
• hair loss,
• anxiety, depression,
• indigestion, diarrhea, acid reflux, throat and mouth irritation and/or ulceration,
• abdominal, back, muscle, and/or joint pain.

Uncommon (may affect up to 1 in 100 people):

• fluid retention in the face and body,
• inflammation, irritation, and/or pressure in the lungs and throat, cough,
• skin reactions including hives, pruritus, and skin rashes,
• allergic reactions including wheezing or breathing difficulty, facial and tongue swelling, collapse.

Rare (may affect up to 1 in 10,000 people):

• a group of symptoms occurring a few weeks after rituximab infusion, including allergic reactions such as rash, pruritus, joint pain, lymph node swelling, and fever,
• formation of severe blisters on the skin that may be fatal. Redness, usually associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, genital area, or eyelids, and may be accompanied by fever.

Frequency not known (frequency cannot be estimated from available data):

• serious viral infection,
  • infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Other rare adverse effects reported with rituximab include a decrease in the number of white blood cells (neutrophils) in the blood, which help fight infections. Some infections may be serious (see information on Infections within this section).

c) If you or your child are being treated for granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Very common (may affect more than 1 in 10 people):

• infections, such as chest infections, urinary tract infections (painful urination), colds, or herpes infections,
• allergic reactions, more likely to occur during infusion, but may occur up to 24 hours after,
• diarrhea,
• cough or breathing difficulty,
• nosebleeds,
• hypertension,
• joint or back pain,
• muscle spasms or tremors,
• dizziness,
• tremors (especially in the hands),
• difficulty sleeping (insomnia),
• swelling of the hands or ankles.

Common (may affect up to 1 in 10 people):

• indigestion,
• constipation,
• skin rashes, including acne or spots,
• flushing or skin redness,
• fever,
• nasal congestion or runny nose,
• tense or sore muscles,
• muscle, hand, or foot pain,
• low red blood cell count (anemia),
• low platelet count in blood,
• increased blood potassium levels,
• changes in heart rhythm or abnormally rapid heartbeat.

Rare (may affect up to 1 in 10,000 people):

• formation of severe blisters on the skin that may be fatal. Redness, usually associated with blisters, may appear on the skin or mucous membranes, such as inside the mouth, genital area, or eyelids, and may be accompanied by fever,
• reactivation of previous hepatitis B infection.

Frequency not known (frequency cannot be estimated from available data):

• serious viral infection,
  • infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Children and adolescents with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA):

In general, side effects in children and adolescents with GPA or MPA were similar to those in adults with granulomatosis with polyangiitis or microscopic polyangiitis. The most commonly observed side effects were infections, allergic reactions, and malaise (nausea).

d) If you are being treated for pemphigus vulgaris

Very common (may affect more than 1 in 10 people):

• allergic reactions, more likely to occur during infusion, but may occur up to 24 hours after,
• headache,
• infections such as chest infections,
• persistent depression,
• hair loss.

Common (may affect up to 1 in 10 people):

• infections such as common cold, herpes infections, eye infections, oral candidiasis, and urinary tract infections (painful urination),
• mood disorders such as irritability and depression,
• skin disorders such as itching, hives, and benign lumps,
• feeling of fatigue or dizziness,
• fever,
• joint or back pain,
• stomach pain,
• muscle pain,
• abnormally rapid heartbeat.

Frequency not known (frequency cannot be estimated from available data):

• serious viral infection,
• infection/inflammation of the brain and meninges (enteroviral meningoencephalitis).

Rixathon may also cause changes in laboratory tests performed by your doctor. If you are being treated with Rixathon in combination with other medicines, some of the possible adverse effects may be due to the other medicines.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rixathon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and label of the vial after EXP. The expiry date is the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze. Keep the vial in the outer packaging to protect it from light.

This medicine may also be stored in the original carton outside the refrigerator at a temperature not exceeding 30 °C for a single period of up to seven days, but not beyond the original expiry date. In this case, the medicine must not be refrigerated again. Write the new expiry date on the carton, including day/month/year. Dispose of this medicine if it has not been used by the new expiry date or by the expiry date printed 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rixathon

• The active substance of Rixathon 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 components are sodium citrate, polysorbate 80 (E 433), sodium chloride, sodium hydroxide, hydrochloric acid and water for injections. See section 2, "Rixathon contains sodium".

Appearance of the product and contents of the pack

Rixathon is a clear, colourless to slightly yellowish solution presented as a concentrate for infusion solution (sterile concentrate).

10 ml vial: pack containing 2 or 3 vials.

50 ml vial: pack containing 1 or 2 vials.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestr. 10

6336 Langkampfen

Austria

Lek Pharmaceuticals d.d. Ljubljana

Verovškova 57

1526 Ljubljana

Slovenia

Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97	Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037
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Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.