MabThera - immune therapy drug.
The active ingredient of the drug is rituximab MabThera (Rituximabum), which is a monoclonal antibody (immune cells) mice. Excipients: sodium chloride, sodium citrate, polysorbate, buffer substances, water for injection.
MabThera is available in fire-resistant glass vials as a solution for infusion: №1 - 500mg (50ml), №2 - 100mg (10ml). Normally, it is a clear, colorless liquid, with turbidity, change in color and the presence of the use of sludge can not be.
Step MabThera based on the fact that Rituximab, reacting the antigen-antibody "mark" pathological (abnormal) cells, making them vulnerable to the immune system as well as to influence cytostatics. This property allows us to consider it MabThera the targeted drug (target) effects, that is, in contrast to the action of cytostatic agents, it does not hit healthy tissue cells. Especially pronounced effects of the substance on the immature B-lymphocytes, which gave reason to treat lymphoma MabThera.
Indications for use of MabThera
Treatment with MabThera shown:
- As monotherapy in follicular non-Hodgkin's lymphomas in stages III-IV, if the previous chemotherapy has not had a positive impact, as well as any recurrence;
- In the combined therapy protocol CHOP for certain types of diffuse large non-Hodgkin's lymphoma;
- In combination with the chemotherapy drugs in the primary treatment of follicular non-Hodgkin's lymphoma in stage III-IV;
- As maintenance treatment of follicular non-Hodgkin's lymphoma after successful induction therapy course;
- In chronic lymphocytic leukemia in combination with cytostatics as induction therapy, and in patients with recurrent chronic lymphocytic leukemia in combination with chemotherapeutic drugs.
There are positive medical reviews of MabThera used in combination therapy with methotrexate in rheumatoid arthritis. The mechanism of action in this instance is not fully understood, but we have found that the introduction of the therapy MabThera would greatly slow the degenerative changes in articular tissue. Therefore, treatment with MabThera is indicated for active rheumatoid arthritis in combination with methotrexate in the ineffectiveness of the previously conducted therapy.
Instructions for use of MabThera
According to the instructions, MabThera has a recommended dosage is calculated according to the following scheme: 375 mg of 1m
of body surface per cycle. Reduced dosage is not expected in the presence of drug intolerance monotherapy canceled and combined treatment with MabThera and reduce the dosage of cytostatics cytostatics.
When induction (initial) treatment of follicular non-Hodgkin's lymphoma is assigned to 8 cycles of treatment with MabThera monotherapy, combination therapy with cytostatics - 1 time in 2 months for a long time, up to 2 years.
When recurrent lymphoma drug prescribed 1 time in 3 months to progression in the absence of progression for up to 2 years. Repeated course monotherapy follicular lymphoma MabThera instructions prescribed 1 time per week for 4 weeks.
When diffuse large non-Hodgkin's lymphoma in combination with CHOP protocol prescribed medication on the first day cycle for eight cycles. When using other protocols MabThera treatment in the form of the disease is not applied, since its effectiveness has not been proved.
In chronic lymphocytic leukemia MabThera recommended dosage instructions on the first day of the cycle is the standard 375mg / m
body surface, increasing to 500 mg / m
in the first days following cycles, the number to 6. In this case, you must take measures to prevent the development of toxic reactions, which prescribe hydrating agents, drugs to reduce uric acid and prednisolone.
In rheumatoid arthritis, MabThera treatment performed according to the scheme for the preparation 1000mg twice, two weeks by another 1000mg twice. For the next 24 weeks observe the reaction of the organism, if necessary, repeat the course. In this case, the necessary premedication (analgesic / antipyretic + antihistamine) and preliminary prednisolone or methylprednisolone.
Contraindications to treatment with MabThera
The drug is not prescribed to children, because there are no data on its impact on the child's body. Contraindications are acute infectious disease, all types of immunodeficiency, rheumatoid arthritis in combination with heart failure and arrhythmias intractable. According to the instruction does not apply MabThera in patients with hypersensitivity to any component of the formulation or to mouse protein. This medication is not used in pregnant and breastfeeding women due to lack of data supporting its safety in these cases.
Physician reviews of MabThera characterize it as a drug with good tolerance, the majority of adverse reactions associated infusion reactions - there is a possibility of tumor lysis syndrome and cytokine release syndrome. That is why the statement of MabThera prescribes preventive measures and strict rules for infusion, which can reduce the risk. Infusion reactions are quite frequent during the first infusion, subsequent extremely rare. Typically, such a reaction is a sudden onset of high fever (tumor lysis), and / or shortness of breath, accompanied by signs of hypoxia (release of cytokines), less immediate allergic reactions, even rarer - delayed type.
Also, in practice, treatment with MabThera as the following negative effects:
- Common: pain of unknown location, or localized in the lower back, chest, infusion site, headache, joint, muscle, fatigue, malaise, sweating, worse at night, swelling of the extremities;
- From the heart: exacerbation of chronic heart disease, angina, an increase or decrease in blood pressure, tachycardia, bradycardia, arrhythmia;
- From the blood: neutropenia, thrombocytopenia, hemolytic anemia, transient aplastic anemia, lymphadenopathy, impaired blood clotting;
- CNS: paresthesia, increased nervousness and anxiety, sleep disturbances, agitation;
- On the part of the peripheral nervous system: there are rare reviews of MabThera talking about bringing about taste perversion, abuse department of tear fluid;
- From the digestive tract: symptoms of dyspepsia, loss of appetite;
- On the part of the respiratory system: bronchitis, pneumonia, cough, asthma.
Storage and release
According to the instructions MabThera should be stored at 2-8 ° C out of reach of direct sunlight. The shelf life of the preparation - 2 years. After opening, the vial is to be used during the day when stored at a temperature range 2-8 ° C, at room temperature for 12 hours.
Apply strictly on prescription.