Rituximab

The concentrate for the preparation of solution for infusion "Redditux" is used for the following indications:

• non-Hodgkin lymphomas (NHL);
• recurrent or chemotherapy resistant B-cell, CD20-positive non-Hodgkin lymphomas of low malignancy or follicular; CD20-positive diffuse B-large cell non-Hodgkin lymphomas, in combination with chemotherapy according to the CHOP regimen;
• stage III-IV follicular lymphomas that are resistant to chemotherapy or have a relapse after chemotherapy;
• stage III-IV follicular lymphomas that have not previously been treated, in combination with CVP chemotherapy;
• supportive therapy for recurrent / resistant follicular lymphoma, which responds to induction therapy with chemotherapy with / without rituximab.

Structure

The active substance is rituximab (1 ml of the concentrate for the preparation of a solution for infusion contains 10 mg of rituximab).

Excipients: sodium citrate, polysorbate 80, sodium chloride, water for injection.

Contraindications

• hypersensitivity to the active substance or to an auxiliary substance, or to mouse proteins;
• active severe infections;
• severe immunodeficiency.

Mode of application

The required amount of concentrate for the preparation of the Redditux infusion solution is diluted under aseptic conditions with the calculated rituximab concentration of 1-4 mg / ml in the infusion vial (bag) with sterile and pyrogen-free 0.9% sodium chloride solution or 5% glucose solution. To agitate the solution, the vessel is carefully inverted (preventing foaming). The drug must be visually checked for impurities or discoloration before use. Since the concentrate for the preparation of the Redditux infusion solution does not contain preservatives, the prepared solution must be used immediately. The prepared Redditux infusion solutions are stable for 12 hours at room temperature or for no more than 24 hours at a temperature of 2-8 ° C.

Standard dosage regimen. Prepared rituximab solution at a dose of 375 mg / m² it is necessary to enter infusion (slowly) through a separate catheter once a week. Do not inject intravenously in a stream or bolus.

The first infusion of each course. Recommended infusion rate is 50 mg / hour; after the first 30 minutes, it can be increased by 50 mg / hour every 30 minutes to a maximum value of 400 mg / hour.

The second infusion of each course. Subsequent doses of rituximab can be infused at an initial rate of 100 mg / hour and increased by 100 mg / hour every 30 minutes to a maximum of 400 mg / hour.

Before each infusion with this drug, premedication with analgesics / antipyretics, such as paracetamol and antihistamines, such as diphenhydramine, should be performed. GCS should also be premedicated if the concentrate for the preparation of the Redditux infusion solution is not used in combination with CHOP or CVP chemotherapy.

Dose adjustment during therapy. It is not recommended to reduce the dose of this drug. If the concentrate for the preparation of the Redditux infusion solution is administered in combination with CHOP or CVP chemotherapy, it is necessary to follow standard recommendations for reducing the dose of chemotherapeutic drugs.

Non-Hodgkin lymphoma or follicular lymphoma. With monotherapy with this drug, the recommended dose is 375 mg / m² Once a week for 4 weeks. With combined treatment with CVP chemotherapy, the recommended dose of this drug is 375 mg / m² on the 1st day of each cycle of chemotherapy, after the administration of the glucocorticoid component of chemotherapy, 8 cycles (21 days / cycle).

Repeated administration in case of relapse. The recommended dose of rituximab for patients who responded to the first course of therapy is 375 mg / m² Once a week for 4 weeks.

Maintenance therapy Patients who received a response to induction therapy, this drug is prescribed at a dose of 375 mg / m² 1 time in 3 months no more than 2 years or until disease progression.

Diffuse B-large cell non-Hodgkin lymphoma. In combination with CHOP chemotherapy, the recommended dosage is 375 mg / m² on the 1st day of each chemotherapy cycle, after intravenous infusion of GCS for 8 cycles. Other components of the CHOP regimen are administered after infusion of this drug.

Dose adjustment for elderly patients is not required.

Application features

Pregnant women

The effects of rituximab in pregnant women have not been studied. It is known that IgG immunoglobulins can cross the placental barrier. The harmful effects of the concentrate for the preparation of the Redditux infusion solution on the fetus and the effect of the drug on reproductive function are unknown, however, temporary depletion of B-cells and lymphocytopenia have been reported in some children whose mothers received treatment during pregnancy. Therefore, the concentrate for the preparation of the Redditux infusion solution should not be prescribed to pregnant women if the benefits of using the drug do not exceed the potential risk.

Given the long delay time of rituximab in the body of patients with B-cell depletion, women of reproductive age should use effective contraceptives when treating with rituximab and 12 months later.

It is not known whether rituximab passes into breast milk. However, since maternal IgG is excreted in breast milk, during treatment with rituximab and for 12 months after treatment, women should not breast-feed.

Children

Rituximab is not recommended for use in children, since there is no data on safety and effectiveness.

Drivers

Studies of the effect of rituximab on the ability to drive a car and work with mechanisms have not been carried out, however, the pharmacological activity and side effects known today indicate that such an effect is unlikely.

Overdose

There have been no cases of overdose in humans. Single doses of more than 1000 mg were not used. In case of an overdose, immediately stop the infusion and conduct a detailed examination of the patient. It is necessary to conduct careful monitoring of blood cells and take measures to reduce the risk of infectious complications in patients with depleted B cells.

Side effects

The most frequent adverse reactions in patients who received rituximab were associated with an infusion reaction and developed mainly during the first infusion. The incidence of adverse reactions associated with infusion is significantly reduced during the next infusion and is less than 1% after the introduction of the eighth dose of the drug.

Storage conditions

Store at a temperature of 2-8 ° C, out of the reach of children and protected from light. Do not freeze.

Shelf life is 2 years.