Mabtera concentrate for infusions 500 mg/50 ml. 50 ml. №1 vial


It is used to treat non-Hodgkin’s lymphoma (cancer of the lymphatic system), as well as recurrent / chemotherapy-resistant B-cell, CD20-positive, low-grade, non-Hodgkin’s lymphoma, or molecular.



Mabtera composition:
active substance: rituximab;
1 ml of the drug contains 10 mg of rituximab; 1 vial (10 mg) contains 100 mg of rituximab;
1 vial (50 mg) contains 500 mg of rituximab;
excipients: sodium citrate, dihydrate; polysorbate 80; sodium chloride; water for injections; hydrochloric acid or sodium hydroxide (to pH 6.5).

Dosage form
Concentrate for solution for infusion.

It is used to treat non-Hodgkin’s lymphoma (cancer of the lymphatic system), as well as recurrent / chemotherapy-resistant B-cell, CD20-positive, low-grade, non-Hodgkin’s lymphoma, or molecular.
The drug is also effective in CD20-positive diffusion large B-cell non-Hodgkin lymphomas in combination with chemotherapy according to the CHOP regimen, in the past incurable follicular lymphomas III-IV in combination with chemotherapy. In addition, with lymphocytic leukemia of a different nature, as well as with chemically resistant leukemia. For some forms of rheumatoid arthritis. It can be used as a maintenance therapy for follicular lymphomas.

It is prohibited for use if the patient has acute or chronic infectious diseases, primary or secondary immunodeficiency, intolerance to rituximab, other active ingredients of the drug.
It should be prescribed with caution if respiratory failure, tumor pulmonary infiltration, neutropenia, thrombocytopenia are detected.

Application during pregnancy and lactation

Method of administration and dosage
In all cases, premedication is mandatory before the administration of the drug.

  • With non-Hodgkin’s lymphoma or follicular lymphoma, in the case of combination therapy, the first dose is 375 mg / m2 of body surface. The drug is administered every 7 days for 4 weeks. The same treatment is prescribed for the treatment of relapse, provided that for the first time the patient’s body has responded positively to its use.
  • With combined treatment, simultaneously with chemotherapy, the dose of the drug is 375 mg / m2 per cycle. A more detailed description of the cycles should be found in the recommendations for the prescription of the drug issued for doctors, in particular, in the current Compendium.
  • In case of relapse, treatment with Mabtera is recommended only if the patient has a positive response during the first course. The dosage is the same.
  • Supportive therapy – a dose of 375 mg / m2 is prescribed, injecting the drug once every 3 months of the disease, but not more than 24 months.
  • For diffuse B-cell non-Hodgkin’s lymphoma, the drug is given in combination with CHOP chemotherapy. The recommended dose of 375 mg / m2 is administered on the first day of each cycle of 8-cycle chemotherapy.
  • In rheumatoid arthritis, the drug is administered twice, 1000 mg at a time (drip, intravenous).

The interval between the first and second administration of Mabtera is 2 weeks. Further treatment with MabThera depends on the symptoms of the course of the disease. As a premedication in this case, it is recommended to use methylprednisolone in a dosage of 100 mg, intravenously.
Mabtera is administered exclusively by intravenous infusion (drip). The first infusion can be carried out at a rate of 50 mg / h, the second at 100 mg / h. The fastest, the drug can be administered at a rate of 400 mg / hour. The attending physician is personally responsible for the preparation and administration of Mabtera.

Overdose cases have not been recorded.

Side effects
Adverse reactions such as the development of viruses, arrhythmias, or respiratory tract infections, as well as fungal infection, hemolytic anemia, vomiting, tachycardia, bradycardia, arterial hypotension, hyperglycemia, thrombocytopenia, leukopenia, granulocytopenia, anemia, sepsis, rhinitis may occur.
In addition, with the appointment of MabThera, lymphadenopathy, angina pectoris, coronary heart disease, heart attack, hypoxia, dyspepsia, weight loss, an increase in abdominal volume, alopecia, hepatitis B can develop.

Storage conditions and periods
Mabtera can be stored for a period of 2.5 years, subject to a temperature regime of +7 to + 8 ° C.