R-Mab
Rituximab
INN: Rituximab
Presentations:
concentrate for solution for infusion 100 mg/10 ml: 10 ml 30 ml or 50 ml in vials.
Pharmacotherapeutic Group:
Ant-Tumor Agent, A Monoclonal Antibody.
ATC code: L01XC02.
Pharmacological properties:
Rituximab a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes.
Upon binding to CD20 rituximab mediates B-cell lysis.
Possible mechanisms of cell lysis include complement dependent cytotoxicity (CDC) antibody dependent cell mediated cytotoxicity (ADCC) and apoptosis induction of B-cells.
Indications:
Non-Hodgkin’s Lymphoma (NHL)
Relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL as a single agent.
Previously untreated follicular, CD20-positive 8-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituximab in combination with chemotherapy, as single-agent maintenance therapy.
Nonprogressing (including stable disease, low-grad CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy.
Previously untreated diffuse large B-cell CD20-positive NHL in combination with CHOP chemotherapy regimen.
Chronic lymphocytic Leukemia(CLL)
in combination with chemotherapy, for the treatment of patients with previously untreated and previously treated CLL.
Granulomatosis With Polyangiitis (GPA) (Wegener’s Granulomatosis) And Microscopic Polyangiitis (MPA)
in combination with glucocorticoids indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyanglitis (MPA).
Contraindications:
Hypersensitivity to Rituximab, to any component of the drug R-Mab or mouse proteins.
Acute infectious diseases expressed primary or secondary immunodeficiency.
Children under the age of 18 years (effectiveness and safety haven’t been (established). Pregnancy and lactation.
Severe heart failure (IV class according to the classification of the New York Heart Association (NYHA).
Carefully:
Respiratory failure or a history of tumor infiltration of the lungs; the number of circulating malignant cells > 25 thousand / ml or high tumor burden, neutropenia (less than 1500/ microliter), thrombocytopenia less than 75.000/ microliter, chronic infections.
Pregnancy and Nursing Mothers:
Use of the drug is forbidden in pregnancy During treatment and for 12 months after the end of treatment with R-Mab” women of childbearing age should use effective methods of contraception Breastfeeding is not recommended during Rituximab treatment and at least, within 12 months after the end of therapy.
Dosage and Administration:
Constitution withdraw necessary amount of Rituximab and dilute to a final concentration of 1 4 mg/ml into an infusion bag containing either NS or DSW in sterile, a pyrogenic conditions right prior infusion The doctor is responsible for the preparation, storage conditions and time of final solution before use Administer by slow IV infusion only. Do not administer as an intravenous push or bolus.
Peculiarity of dosing regimens for various indications- see full text of R-Mab Prescription Information.
Adverse Effect:
Overall the safety profile of rituximab when the NHL and CLL is based on data from clinical studies and post-marketing surveillance. In this case, patients received either rituximab monotherapy (as induction therapy or maintenance treatment after induction therapy) or in combination with chemotherapy. The most common adverse reactions in patients treated with rituximab were IR developed in the majority of them during the first infusion, IR rate is significantly reduced in subsequent administrations, and is less than 1% after the use of the 8th dose of rituximab. In clinical studies of infection were observed (mainly bacterial and viral, in about 30-55% of patients with NHL and in 35-50% of patients with CLL The most frequent reported or observed serious adverse reactions were IR (including cytokine release syndrome, tumor lysis syndrome), infections, the cardiovascular system reactions Other serious adverse reactions included the reactivation of hepatitis B and progressive multifocal leukoencephalopathy.
Special instructions:
Preparation of R-Mab administered under the close supervision of an oncologist or hematologist if the necessary conditions for the resuscitation.
Prescription Status:
Available on prescription.
Storage conditions:
In the dark place at a temperature between 2 and8 C.
Freezing is not allowed. Keep out of the reach of children.
Expiration date:
2 years and 6 months.