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MabThera (rituximab) – Package leaflet - L01XC02

Updated on site: 08-Oct-2017

Medication nameMabThera
ATC CodeL01XC02
Substancerituximab
ManufacturerRoche Registration Ltd

Package leaflet: Information for the patient

MabThera 100 mg concentrate for solution for infusion rituximab

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What MabThera is and what it is used for

2.What you need to know before you use MabThera

3.How to use MabThera

4.Possible side effects

5.How to store MabThera

6.Contents of the pack and other information

1.What MabThera is and what it is used for

What MabThera is

MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.

What MabThera is used for

MabThera may be used for the treatment of several different conditions in adults. Your doctor may prescribe MabThera 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.

MabThera can be given alone or with other medicines called “chemotherapy”.

In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.

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. MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.

c)Rheumatoid arthritis

MabThera 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. MabThera 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. MabThera is usually taken together with another medicine called methotrexate.

MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.

The best responses to MabThera 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

MabThera is used for inducing remission in 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.

2. What you need to know before you use MabThera

Do not take MabThera 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)

you have a severe active infection at the moment

you have a weak immune system.

you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis.

Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given MabThera if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection

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 MabThera. Your doctor may need to take special care of you during your treatment with MabThera.

If you have rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis 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 MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera. Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.

if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera. Your doctor will check if you should have any vaccines before you receive MabThera.

Children and adolescents

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and young people.

Other medicines and MabThera

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is

because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.

In particular, tell your doctor:

if you are taking medicines for high blood pressure. You may be asked not to take these other medicines 12 hours before you are given MabThera. This is because some people have a fall in their blood pressure while they are being given MabThera.

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 MabThera.

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 MabThera can cross the placenta and may affect your baby.

If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.

Do not breast-feed while you are being treated with MabThera. Also do not breast-feed for 12 months after your last treatment with MabThera. This is because MabThera may pass into breast milk.

Driving and using machines

It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.

3.How MabThera is given

How it is given

MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.

You will always be given MabThera as a drip (intra-venous infusion).

Medicines given before each MabThera administration

Before you are given MabThera, 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 MabThera alone

MabThera will be given to you once a week for 4 weeks. Repeated treatment courses with MabThera are possible.

If you are having MabThera with chemotherapy

MabThera 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 MabThera 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.

b)If you are being treated for chronic lymphocytic leukaemia

When you are treated with MabThera in combination with chemotherapy, you will receive MabThera 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 MabThera 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 MabThera are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera. This may be months from now.

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

Treatment with MabThera uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of MabThera treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.

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 2 hours of the first infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness, tiredness, headache, breathing difficulties, 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 develop 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 MabThera treatment if these reactions are serious.

Infections

Tell your doctor immediately if you get 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).

You might get infections more easily during your treatment with MabThera.

These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.

If you are being treated for rheumatoid arthritis, 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 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

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 (it is not known how often these side effects happen): 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

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 heart beat, 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 MabThera 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.

Other rarely-reported side-effects due to MabThera 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 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

blocked 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

MabThera may also cause changes in laboratory tests carried out by your doctor.

If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine

5.How to store MabThera

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). Keep the container in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What MabThera contains

The active ingredient in MabThera is called rituximab. The vial contains 100 mg of rituximab (10 mg/mL).

The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What MabThera looks like and contents of the pack

MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion. Vials of 10 mL are available as a pack of 2 vials.

Marketing Authorisation Holder

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

N.V. Roche S.A.

UAB “Roche Lietuva”

Tél/Tel: +32 (0) 2 525 82 11

Tel: +370 5 2546799

България

Luxembourg/Luxemburg

Рош България ЕООД

(Voir/siehe Belgique/Belgien)

Тел: +359 2 818 44 44

 

Česká republika

Magyarország

Roche s. r. o.

Roche (Magyarország) Kft.

Tel: +420 - 2 20382111

Tel: +36 - 23 446 800

Danmark

Malta

Roche a/s

(See United Kingdom)

Tlf: +45 - 36 39 99 99

 

Deutschland

Nederland

Roche Pharma AG

Roche Nederland B.V.

Tel: +49 (0) 7624 140

Tel: +31 (0) 348 438050

Eesti

Norge

Roche Eesti OÜ

Roche Norge AS

Tel: + 372 - 6 177 380

Tlf: +47 - 22 78 90 00

Ελλάδα

Österreich

Roche (Hellas) A.E.

Roche Austria GmbH

Τηλ: +30 210 61 66 100

Tel: +43 (0) 1 27739

España

Polska

Roche Farma S.A.

Roche Polska Sp.z o.o.

Tel: +34 - 91 324 81 00

Tel: +48 - 22 345 18 88

France

Portugal

Roche

Roche Farmacêutica Química, Lda

Tél: +33 (0)1 47 61 40 00

Tel: +351 - 21 425 70 00

Hrvatska

România

Roche d.o.o.

Roche România S.R.L.

Tel: + 385 1 47 22 333

Tel: +40 21 206 47 01

Ireland

Slovenija

Roche Products (Ireland) Ltd.

Roche farmacevtska družba d.o.o.

Tel: +353 (0) 1 469 0700

Tel: +386 - 1 360 26 00

Ísland

Slovenská republika

Roche a/s

Roche Slovensko, s.r.o.

c/o Icepharma hf

Tel: +421 - 2 52638201

Sími: +354 540 8000

 

Italia

Suomi/Finland

Roche S.p.A.

Roche Oy

Tel: +39 - 039 2471

Puh/Tel: +358 (0) 10 554 500

Kύπρος

Sverige

Γ.Α.Σταμάτης & Σια Λτδ.

Roche AB

Τηλ: +357 - 22 76 62 76

Tel: +46 (0) 8 726 1200

Latvija

United Kingdom

Roche Latvija SIA

Roche Products Ltd.

Tel: +371 - 6 7039831

Tel: +44 (0) 1707 366000

This leaflet was last revised in

 

Other sources of information

 

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Package leaflet: Information for the patient

MabThera 500 mg concentrate for solution for infusion rituximab

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What MabThera is and what it is used for

2.What you need to know before you use MabThera

3.How to use MabThera

4.Possible side effects

5.How to store MabThera

6.Contents of the pack and other information

1. What MabThera is and what it is used for

What MabThera is

MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.

What MabThera is used for

MabThera may be used for the treatment of several different conditions in adults. Your doctor may prescribe MabThera 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.

MabThera can be given alone or with other medicines called “chemotherapy”.

In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.

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. MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.

c)Rheumatoid arthritis

MabThera 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. MabThera 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. MabThera is usually taken together with another medicine called methotrexate.

MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.

The best responses to MabThera 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

MabThera is used for inducing remission in 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.

2. What you need to know before you use MabThera

Do not take MabThera 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)

you have a severe active infection at the moment

you have a weak immune system

you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis.

Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given MabThera if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.

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 MabThera. Your doctor may need to take special care of you during your treatment with MabThera.

If you have rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis 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 MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera. Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.

if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera. Your doctor will check if you should have any vaccines before you receive MabThera.

Children and adolescents

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and young people.

Other medicines and MabThera

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.

In particular, tell your doctor:

if you are taking medicines for high blood pressure. You may be asked not to take these other medicines 12 hours before you are given MabThera. This is because some people have a fall in their blood pressure while they are being given MabThera.

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 MabThera.

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 MabThera can cross the placenta and may affect your baby.

If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.

Do not breast-feed while you are being treated with MabThera. Also do not breast-feed for 12 months after your last treatment with MabThera. This is because MabThera may pass into breast milk.

Driving and using machines

It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.

3. How MabThera is given

How it is given

MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.

You will always be given MabThera as a drip (intra-venous infusion)..

Medicines given before each MabThera administration

Before you are given MabThera, 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 MabThera alone

MabThera will be given to you once a week for 4 weeks. Repeated treatment courses with MabThera are possible.

If you are having MabThera with chemotherapy

MabThera 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 MabThera 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.

b)If you are being treated for chronic lymphocytic leukaemia

When you are treated with MabThera in combination with chemotherapy, you will receive MabThera 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 MabThera 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 MabThera are possible. Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera. This may be months from now.

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

Treatment with MabThera uses four separate infusions given at weekly intervals. Corticosteroids will usually be given by injection before the start of MabThera treatment. Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.

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 2 hours of the first infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness, tiredness, headache, breathing difficulties, 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 develop 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 MabThera treatment if these reactions are serious.

Infections

Tell your doctor immediately if you get 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).

You might get infections more easily during your treatment with MabThera.

These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.

If you are being treated for rheumatoid arthritis, 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 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

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 (it is not known how often these side effects happen):

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

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 heart beat, 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 MabThera 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.

Other rarely-reported side-effects due to MabThera 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 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

blocked 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

MabThera may also cause changes in laboratory tests carried out by your doctor.

If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store MabThera

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). Keep the container in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What MabThera contains

The active ingredient in MabThera is called rituximab. The vial contains 500 mg of rituximab (10 mg/mL).

The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What MabThera looks like and contents of the pack

MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion. Pack of 1 vial.

Marketing Authorisation Holder

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

N.V. Roche S.A.

UAB “Roche Lietuva”

Tél/Tel: +32 (0) 2 525 82 11

Tel: +370 5 2546799

България

Luxembourg/Luxemburg

Рош България ЕООД

(Voir/siehe Belgique/Belgien)

Тел: +359 2 818 44 44

 

Česká republika

Magyarország

Roche s. r. o.

Roche (Magyarország) Kft.

Tel: +420 - 2 20382111

Tel: +36 - 23 446 800

Danmark

Malta

Roche a/s

(See United Kingdom)

Tlf: +45 - 36 39 99 99

 

Deutschland

Nederland

Roche Pharma AG

Roche Nederland B.V.

Tel: +49 (0) 7624 140

Tel: +31 (0) 348 438050

Eesti

Norge

Roche Eesti OÜ

Roche Norge AS

Tel: + 372 - 6 177 380

Tlf: +47 - 22 78 90 00

Ελλάδα

Österreich

Roche (Hellas) A.E.

Roche Austria GmbH

Τηλ: +30 210 61 66 100

Tel: +43 (0) 1 27739

España

Polska

Roche Farma S.A.

Roche Polska Sp.z o.o.

Tel: +34 - 91 324 81 00

Tel: +48 - 22 345 18 88

France

Portugal

Roche

Roche Farmacêutica Química, Lda

Tél: +33 (0)1 47 61 40 00

Tel: +351 - 21 425 70 00

Hrvatska

România

Roche d.o.o.

Roche România S.R.L.

Tel: + 385 1 47 22 333

Tel: +40 21 206 47 01

Ireland

Slovenija

Roche Products (Ireland) Ltd.

Roche farmacevtska družba d.o.o.

Tel: +353 (0) 1 469 0700

Tel: +386 - 1 360 26 00

Ísland

Slovenská republika

Roche a/s

Roche Slovensko, s.r.o.

c/o Icepharma hf

Tel: +421 - 2 52638201

Sími: +354 540 8000

 

Italia

Suomi/Finland

Roche S.p.A.

Roche Oy

Tel: +39 - 039 2471

Puh/Tel: +358 (0) 10 554 500

Kύπρος

Sverige

Γ.Α.Σταμάτης & Σια Λτδ.

Roche AB

Τηλ: +357 - 22 76 62 76

Tel: +46 (0) 8 726 1200

Latvija

United Kingdom

Roche Latvija SIA

Roche Products Ltd.

Tel: +371 - 6 7039831

Tel: +44 (0) 1707 366000

This leaflet was last revised in

Other sources of information

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Package leaflet: Information for the patient

MabThera 1400 mg solution for subcutaneous injection rituximab

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What MabThera is and what it is used for

2.What you need to know before you are given MabThera

3.How MabThera is given

4.Possible side effects

5.How to store MabThera

6.Contents of the pack and other information

1. What MabThera is and what it is used for

What MabThera is

MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.

MabThera is available as a medicine given as a drip (called MabThera 100 mg or MabThera 500 mg, concentrate for solution for infusion) and as a medicine for injection under your skin (called MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous injection).

What MabThera is used for

MabThera 1400 mg is used to treat Non-Hodgkin’s lymphoma in adults.

This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.

MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.

You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.

After this, you will be given MabThera as an injection under your skin. Your doctor will decide when to start MabThera injections.

In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.

2 What you need to know before you are given MabThera

Do not have MabThera 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)

you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected

active substance)

you have a severe active infection at the moment

you have a weak immune system.

Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given MabThera if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection

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 MabThera. Your doctor may need to take special care of you during your treatment with MabThera.

Children and adolescents

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and young people.

Other medicines and MabThera

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.

In particular, tell your doctor:

if you are taking medicines for high blood pressure. You may be asked not to take these other medicines 12 hours before you are given MabThera. This is because some people have a fall in their blood pressure while they are being given MabThera

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 MabThera.

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 MabThera can cross the placenta and may affect your baby.

If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.

Do not breast-feed while you are being treated with MabThera. Also do not breast-feed for 12 months after your last treatment with MabThera. This is because MabThera may pass into breast milk.

Driving and using machines

It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.

3 How MabThera is given

How it is given

MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.

You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.

After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 5 minutes. There is a peel-off sticker on the glass vial that specifies the medication. Your doctor or nurse will place the sticker on the syringe before injection.

Your doctor will decide when to start MabThera injections.

When injected under your skin, it is given in the stomach area, not in other sites of the body, and not into areas of the stomach where the skin is red, bruised, tender, hard or where there are moles or scars.

Medicines given before each MabThera administration

Before you are given MabThera, 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

MabThera 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 MabThera 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 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 need treatment. Rarely, some of these side effects have been fatal.

Reactions where the medicine is injected

Many patients get some local side effects where MabThera is injected. These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.

Your doctor may decide to stop your MabThera treatment if these reactions are serious.

Infections

Tell your doctor immediately if you get signs of an infection including:

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).

You might get infections more easily during your treatment with MabThera. These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.

Other side effects include:

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

kidney failure

Severe vision loss (sign of brain nerves damage).

Not known (it is not known how often these side effects happen):

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.

MabThera may also cause changes in laboratory tests carried out by your doctor.

If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store MabThera

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the container in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What MabThera 1400 mg solution for subcutaneous injection contains

The active ingredient is rituximab. Each vial contains 1400 mg/11.7 mL of rituximab. Each mL contains 120 mg of rituximab.

The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, ,-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.

What MabThera 1400 mg solution for subcutaneous injection looks like and contents of the pack

MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk.

Each vial contains 1400 mg/11.7 mL of rituximab. Each carton contains one vial.

Marketing Authorisation Holder

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

N.V. Roche S.A.

UAB “Roche Lietuva”

Tél/Tel: +32 (0) 2 525 82 11

Tel: +370 5 2546799

България

Luxembourg/Luxemburg

Рош България ЕООД

(Voir/siehe Belgique/Belgien)

Тел: +359 2 818 44 44

 

Česká republika

Magyarország

Roche s. r. o.

Roche (Magyarország) Kft.

Tel: +420 - 2 20382111

Tel: +36 - 23 446 800

Danmark

Malta

Roche a/s

(See United Kingdom)

Tlf: +45 - 36 39 99 99

 

Deutschland

Nederland

Roche Pharma AG

Roche Nederland B.V.

Tel: +49 (0) 7624 140

Tel: +31 (0) 348 438050

Eesti

Norge

Roche Eesti OÜ

Roche Norge AS

Tel: + 372 - 6 177 380

Tlf: +47 - 22 78 90 00

Ελλάδα

Österreich

Roche (Hellas) A.E.

Roche Austria GmbH

Τηλ: +30 210 61 66 100

Tel: +43 (0) 1 27739

España

Polska

Roche Farma S.A.

Roche Polska Sp.z o.o.

Tel: +34 - 91 324 81 00

Tel: +48 - 22 345 18 88

France

Portugal

Roche

Roche Farmacêutica Química, Lda

Tél: +33 (0)1 47 61 40 00

Tel: +351 - 21 425 70 00

Hrvatska

România

Roche d.o.o.

Roche România S.R.L.

Tel: + 385 1 47 22 333

Tel: +40 21 206 47 01

Ireland

Slovenija

Roche Products (Ireland) Ltd.

Roche farmacevtska družba d.o.o.

Tel: +353 (0) 1 469 0700

Tel: +386 - 1 360 26 00

Ísland

Slovenská republika

Roche a/s

Roche Slovensko, s.r.o.

c/o Icepharma hf

Tel: +421 - 2 52638201

Sími: +354 540 8000

 

Italia

Suomi/Finland

Roche S.p.A.

Roche Oy

Tel: +39 - 039 2471

Puh/Tel: +358 (0) 10 554 500

Kύπρος

Sverige

Γ.Α.Σταμάτης & Σια Λτδ.

Roche AB

Τηλ: +357 - 22 76 62 76

Tel: +46 (0) 8 726 1200

Latvija

United Kingdom

Roche Latvija SIA

Roche Products Ltd.

Tel: +371 - 6 7039831

Tel: +44 (0) 1707 366000

This leaflet was last revised in

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Package leaflet: Information for the patient

MabThera 1600 mg solution for subcutaneous injection rituximab

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What MabThera is and what it is used for

2.What you need to know before you are given MabThera

3.How MabThera is given

4.Possible side effects

5.How to store MabThera

6.Contents of the pack and other information

1. What MabThera is and what it is used for

What MabThera is

MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies.

MabThera is available as a medicine given as a drip (called MabThera 100 mg or MabThera 500 mg, concentrate for solution for infusion) and as a medicine for injection under your skin: called MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous injection).

What MabThera is used for

MabThera 1600 mg is used to treat chronic lymphocytic leukaemia -in adults.

Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects a type of white blood cell called B-lymphocytes, 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.

MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes-.

You will be given MabThera 1600 mg with other medicines called “chemotherapy”.

You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.

After this, you will be given MabThera as an injection under your skin. Your doctor will decide when to start MabThera injections.

2 What you need to know before you are given MabThera

Do not have MabThera 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)

you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected active substance)

you have a severe active infection at the moment

you have a weak immune system.

Do not have MabThera if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given MabThera if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection

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 MabThera. Your doctor may need to take special care of you during your treatment with MabThera.

Children and adolescents

Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age. This is because there is not much information about the use of MabThera in children and young people.

Other medicines and MabThera

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because MabThera can affect the way some other medicines work. Also some other medicines can affect the way MabThera works.

In particular, tell your doctor:

if you are taking medicines for high blood pressure. You may be asked not to take these other medicines 12 hours before you are given MabThera. This is because some people have a fall in their blood pressure while they are being given MabThera

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 MabThera.

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 MabThera can cross the placenta and may affect your baby.

If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera. You must also do this for 12 months after your last treatment with MabThera.

Do not breast-feed while you are being treated with MabThera. Also do not breast-feed for 12 months after your last treatment with MabThera. This is because MabThera may pass into breast milk.

Driving and using machines

It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.

3 How MabThera is given

How it is given

MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. They will watch you closely while you are being given this medicine. This is in case you get any side effects.

You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.

After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 7 minutes. There is a peel-off sticker on the glass vial that specifies the medication. Your doctor or nurse will place the sticker on the syringe before injection.

Your doctor will decide when to start MabThera injections.

When injected under your skin, it is given in the stomach area, not in other sites of the body, and not into areas of the stomach where the skin is red, bruised, tender, hard or where there are moles or scars.

Medicines given before each MabThera administration

Before you are given MabThera, 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

When you are treated with MabThera in combination with chemotherapy, you will receive a MabThera infusion on day 0 of cycle 1, then subcutaneous injections on day 1 of each subsequent cycle. The total number of cycles is of 6. Each cycle has a duration of 28 days. The chemotherapy should be given after the MabThera administration.

Your doctor will decide if you should receive concomitant supportive therapy.

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 need treatment. Rarely, some of these side effects have been fatal.

Reactions where the medicine is injected

Many patients get some local side effects where MabThera is injected. These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.

Your doctor may decide to stop your MabThera treatment if these reactions are serious.

Infections

Tell your doctor immediately if you get signs of an infection including:

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).

You might get infections more easily during your treatment with MabThera. These are often colds, but there have been cases of pneumonia or urinary infections. These are listed below under “Other side effects”.

Other side effects include:

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

kidney failure

Severe vision loss (sign of brain nerves damage).

Not known (it is not known how often these side effects happen):

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.

MabThera may also cause changes in laboratory tests carried out by your doctor.

If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store MabThera

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the container in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What MabThera 1600 mg solution for subcutaneous injection contains

The active ingredient is rituximab. Each vial contains 1600 mg/13.4 mL of rituximab. Each mL contains 120 mg of rituximab.

The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, ,-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.

What MabThera 1600 mg solution for subcutaneous injection looks like and contents of the pack

MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk.

Each vial contains 1600 mg/13.4 mL of rituximab. Each carton contains one vial.

Marketing Authorisation Holder

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

N.V. Roche S.A.

UAB “Roche Lietuva”

Tél/Tel: +32 (0) 2 525 82 11

Tel: +370 5 2546799

България

Luxembourg/Luxemburg

Рош България ЕООД

(Voir/siehe Belgique/Belgien)

Тел: +359 2 818 44 44

 

Česká republika

Magyarország

Roche s. r. o.

Roche (Magyarország) Kft.

Tel: +420 - 2 20382111

Tel: +36 - 23 446 800

Danmark

Malta

Roche a/s

(See United Kingdom)

Tlf: +45 - 36 39 99 99

 

Deutschland

Nederland

Roche Pharma AG

Roche Nederland B.V.

Tel: +49 (0) 7624 140

Tel: +31 (0) 348 438050

Eesti

Norge

Roche Eesti OÜ

Roche Norge AS

Tel: + 372 - 6 177 380

Tlf: +47 - 22 78 90 00

Ελλάδα

Österreich

Roche (Hellas) A.E.

Roche Austria GmbH

Τηλ: +30 210 61 66 100

Tel: +43 (0) 1 27739

España

Polska

Roche Farma S.A.

Roche Polska Sp.z o.o.

Tel: +34 - 91 324 81 00

Tel: +48 - 22 345 18 88

France

Portugal

Roche

Roche Farmacêutica Química, Lda

Tél: +33 (0)1 47 61 40 00

Tel: +351 - 21 425 70 00

Hrvatska

România

Roche d.o.o.

Roche România S.R.L.

Tel: + 385 1 47 22 333

Tel: +40 21 206 47 01

Ireland

Slovenija

Roche Products (Ireland) Ltd.

Roche farmacevtska družba d.o.o.

Tel: +353 (0) 1 469 0700

Tel: +386 - 1 360 26 00

Ísland

Slovenská republika

Roche a/s

Roche Slovensko, s.r.o.

c/o Icepharma hf

Tel: +421 - 2 52638201

Sími: +354 540 8000

 

Italia

Suomi/Finland

Roche S.p.A.

Roche Oy

Tel: +39 - 039 2471

Puh/Tel: +358 (0) 10 554 500

Kύπρος

Sverige

Γ.Α.Σταμάτης & Σια Λτδ.

Roche AB

Τηλ: +357 - 22 76 62 76

Tel: +46 (0) 8 726 1200

Latvija

United Kingdom

Roche Latvija SIA

Roche Products Ltd.

Tel: +371 - 6 7039831

Tel: +44 (0) 1707 366000

This leaflet was last revised in

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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