MabThera - Rituximab uses, dose and side effects

MabThera contains the active substance rituximab. This is a type of protein called a monoclonal antibody . Rituximab binds to the surface of a type of white blood cell , B lymphocytes . When rituximab binds to the surface of this cell, it causes the cell to die.

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

What MabThera is used for

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

This is a disease of the lymphatic system (part of the immune system) that affects a type of white blood cell, the B lymphocytes .

MabThera 1400 mg can be given alone or in combination with other medicines called chemotherapy .

You will always receive MabThera as a drip ( intravenous infusion ) at the beginning of your treatment.

You will then receive MabThera as an injection under the skin. Your doctor will decide when to start your injection of MabThera.

In patients where the treatment works, MabThera can be used as maintenance treatment for 2 years after the initial treatment has been completed.

What you need to know before using MabThera

Do not take MabThera

if you are allergic to rituximab, other proteins similar to rituximab or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to hyaluronidase (an enzyme that helps increase the absorption of an injected active substance)
if you have an active, severe infection
if you have a weakened immune system.

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

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using MabThera about:

You think you have infection with hepatitis B now or have had it before. In a few cases, patients with hepatitis B have regained the disease, which can be fatal in very rare cases. Patients who have previously had hepatitis B infection should be checked regularly by their doctor for signs of this infection.
if you have ever had a heart disease (eg angina pectoris ), palpitations or heart failure ) or had breathing problems.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before receiving MabThera. Your doctor may need to monitor you extra closely during treatment with MabThera.

Also talk to a doctor if you think you need a vaccination 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 during the months after receiving MabThera. Your doctor will check if you need any vaccinations before receiving MabThera.

Children and young people

Talk to your doctor, pharmacist or nurse before you or your child receive this medicine if you or your child are under 18 years of age. This is because there is not much information on the treatment of children and adolescents with MabThera.

Other medicines and MabThera

Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies. This is because MabThera may affect the way other medicines work. Other medicines may also affect the way MabThera works.

Talk to your doctor specifically about:

you are taking medicines for high blood pressure . You may be asked not to take your medication for 12 hours before receiving MabThera. This is because some patients experience a drop in blood pressure when they receive MabThera
if you have ever taken medicines that affect your immune system – such as chemotherapy or immunosuppressive medicines.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before receiving MabThera.

Pregnancy and breastfeeding

You must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. This is because MabThera can pass through the placenta and affect your baby.

If you could become pregnant, you and your partner must use an effective contraceptive during treatment with MabThera and for 12 months after the last treatment with MabThera.

MabThera passes into breast milk in small amounts. As the long-term effect on breast-fed infants is not known, it is recommended not to breast-feed during treatment with MabThera and for 12 months after stopping treatment.

Driving and using machines

It is not known if MabThera affects your ability to drive or use machines.

Sodium

MabThera 1400 mg contains less than 1 mmol sodium (the main ingredient in table salt / table salt) per dose , ie it is essentially ‘sodium-free’.

How to get MabThera

How it is given

MabThera will be given to you by a doctor or nurse who has experience using this treatment. They will monitor you closely when you are treated with this medicine should you experience any side effects .

You will always receive MabThera as a drip ( intravenous infusion ) at the beginning of your treatment.

You will then receive MabThera as an injection under the skin ( subcutaneous injection ) for about 5 minutes. The glass vial contains a removable adhesive label with a description of the medicine. Your doctor or nurse will put the sticker on the syringe before injecting one.

Your doctor will decide when to start your injection of MabThera.

When the drug is injected under the skin, it should be given in the stomach area and not elsewhere on the body. It should also not be injected into areas of the abdomen where the skin is red, bruised, tender, hard or where there are birthmarks or scars.

Medicines given before each administration of MabThera

Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce any side effects .

How much and how often you will receive your treatment

MabThera will be given to you on the same day as your chemotherapy . This is usually given every three weeks up to 8 times.

If you respond well to the treatment, you can receive MabThera as a maintenance treatment every two or three months for two years.

Your doctor may change this depending on how you respond to the medicine.

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

Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Most side effects are mild to moderate but some can be serious and require treatment. In rare cases, these side effects have been fatal.

Injection site reactions

Many patients experience local side effects where MabThera is injected. These include: pain, swelling, bruising, bleeding, reddening of the skin, itching and rash.

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

Infection is

Tell your doctor immediately if you get symptoms of infection such as:

fever, cough, sore throat, burning pain when you urinate, or if you start to feel weak or generally ill
memory loss, difficulty thinking, difficulty walking or loss of vision – these can be due to a very rare, serious infection in the brain that has had a fatal outcome ( progressive multifocal leukoencephalopathy or PML).

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

Other side effects include:

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

bacterial or viral infection, bronchitis
low number of white blood cells in the blood, with or without fever, low number of platelets in the blood
nausea
bald spots on the head, chills, headache
lower immunity due to a decrease in the number of certain specific antibodies in the blood ( immunoglobulins (IgG)) that help protect against infection .

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

infection in the blood (blood poisoning), pneumonia , shingles , colds, bronchitis , fungal infections, infections of unknown origin, sinusitis, hepatitis B
low number of red blood cells in the blood ( anemia , anemia ), low numbers of all blood s
allergic reactions (hypersensitivity)
elevated blood sugar, weight loss, swelling of the face and body, high levels of enzyme and LDH in the blood, decreased amount of calcium in the blood
abnormal sensations such as numbness, tingling, burning sensation, tingling in the skin, decreased sensation
restlessness, insomnia
redness of the face and other areas of the skin as a consequence of dilated blood vessels,
dizziness, anxiety
increased production of tears, problems with the tear duct, eye inflammation (conjunctivitis)
ringing sounds in the ears, pain in the ears
heart disease such as heart attack, irregular or abnormally high heart rate
high or low blood pressure (low blood pressure , especially when standing upright)
tension of the muscles of the airways which gives rise to wheezing ( bronchospasm ), inflammation , irritation of the lungs, throat or sinuses, shortness of breath, runny nose
vomiting, diarrhea, abdominal pain, irritation or sore throat and mouth, difficulty swallowing, constipation, indigestion
eating disorders, decreased appetite which leads to weight loss
hives, increased sweating, night sweats
symptoms in muscles such as tense muscles, joint or muscle pain, back and neck pain
tumor pain
general symptoms of discomfort or feeling of discomfort or tiredness, shaking, flu symptoms
deterioration of several organs.

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

coagulation disorders in the blood, decrease in the production of red blood cells and increased degradation of red blood cells (aplastic hemolytic anemia ), swollen or enlarged lymph nodes
depression and lack of interest in normal activities, nervousness
taste change
heart disease such as decreased heart rate or chest pain (angina)
asthma , too little oxygen reaching the body’s organs
swollen abdomen.

Very rare side effects (may affect up to 1 in 10,000 people):

transient increase in different types of antibodies in the blood ( immunoglobulins – IgM), chemical disorders in the blood caused by the breakdown of dying cancer cells
nerve damage in arms and legs, facial paralysis
heart failure
inflamed blood vessels, including those that can cause skin symptoms
respiratory failure
damage to the intestinal wall (perforation)
severe conditions with blisters that can be life-threatening
kidney failure
severe visual impairment (signs of brain nerve damage).

No known frequency (it is not known how often these side effects occur):

delayed decrease in white blood cells
reduction of platelets shortly after infusion one – may be transient but may in rare cases be fatal
hearing loss, loss of other senses.

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

If you are receiving MabThera in combination with other medicines, some of the side effects you may have may be due to the other medicines.

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. dat. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What MabThera 1400 mg, solution for injection for subcutaneous injection contains

The active substance is rituximab. Each vial contains 1400 mg / 11.7 ml rituximab. Each ml contains 120 mg of rituximab.
The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α, α-trehalose dihydrate, L-methionine, Polysorbate 80 and water for injections.

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

MabThera is a clear to opalescent, colorless to yellowish solution that is ready to use. It is provided as a solution for subcutaneous injection in a stained glass vial with a butyl rubber stopper with an aluminum seal and a detachable pink plastic seal.

Each vial contains 1400 mg / 11.7 ml rituximab. Each pack contains 1 vial .

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen