Redditux (rituximab) concentrate for infusions 10 mg/ml. 10 ml/100 mg. vial №1

$282.60

Hodgkin’s lymphoma (NHL). Recurrent or chemotherapy-resistant B-cell, CD20-positive low-grade non-Hodgkin’s lymphoma or follicular; CD20-positive diffuse B-large-cell non-Hodgkin’s lymphoma, in combination with chemotherapy according to the SNOR scheme. Stage i–IV follicular lymphomas that are resistant to chemotherapy or have a relapse after chemotherapy. Previously untreated follicular lymphomas of stage i-IV in combination with CVP-chemotherapy. Maintenance therapy for recurrent / resistant follicular lymphoma that responds to induction therapy with chemotherapy with / or without rituximab.

Category: Manufacturer: India

Description

Redditux Composition
Active ingredient: rituximab (10 mg / ml).

Release form
Redditux is produced in the form of a concentrate for solution preparation.

Pharmacological properties
It is an antineoplastic agent. The active component of the drug (monoclonal antibody) specifically binds to the transmembrane antigen CD20, which is located on pre-B-lymphocytes, mature B-lymphocytes, but is absent on hematopoietic stem cells, normal plasma cells, pro-B cells, cells of other tissues. The CD20 antigen is expressed in over 95% of B-cell non-Hodgkin lymphomas. After binding to the antibody, the CD20 antigen expressed on the cell is not internalized, ceases to flow from the membrane into the extracellular space, and does not circulate in the plasma. Rituximab binds to CD20 on B-lymphocytes, initiating immunological reactions leading to B-cell lysis.

Indications
Redditux is used:

  • with non-Hodgkin’s lymphoma;
  • with chronic lymphocytic leukemia.

Contraindications
Redditux is not used:

  • with hypersensitivity to the active substance (rituximab), any component of the drug, mouse proteins;
  • with acute infectious diseases;
  • with severe primary or secondary immunodeficiency;
  • during pregnancy;
  • during breastfeeding;
  • under the age of 18.

Carefully:

  • with a history of respiratory failure;
  • with tumor infiltration of the lungs;
  • when the number of circulating malignant cells is more than 25000 / μl, high tumor load;
  • with neutropenia (less than 1500 / μl);
  • with thrombocytopenia (less than 75,000 / μl);
  • with chronic infection.

Application during pregnancy and lactation
Contraindicated.
During the period of treatment, as well as within 12 months after the end of treatment, women of childbearing age should use effective methods of contraception.

Method of administration and dosage
Redditux is administered intravenously.
Dosage and duration of treatment depend on the indications of the therapy and is determined by a doctor who has experience in such therapy.
The recommended rate of the first infusion is 50 mg / hour, further it can be increased by 50 mg / hour every 30 minutes, bringing to a maximum rate of 400 mg / hour. Subsequent infusions begin at 100 mg / hr, increasing by 100 mg / hr every 30 minutes to a maximum rate of 400 mg / hr.

Overdose
Exceeding the dose may lead to an increased risk of infectious complications when the pool of B-lymphocytes is depleted.
If an overdose is suspected, it is necessary to monitor the composition of the peripheral blood, if necessary, prescribe symptomatic and supportive treatment.

Side effects:

  • Infectious / parasitic diseases: bacterial, fungal, viral infections, incl. respiratory tract infections, herpes zoster, sepsis.
  • Hematological disorders: leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, anemia, bleeding disorders, hemolytic anemia, partial aplastic anemia.
  • Respiratory disorders: rhinitis, respiratory diseases, bronchospasm, cough, shortness of breath, hypoxia, chest pain, impaired lung function, bronchial asthma, bronchiolitis obliterans.
  • Immune disorders: angioedema, hypersensitivity reactions.
  • Metabolic disorders: hyperglycemia, peripheral edema, weight loss, facial edema, hypocalcemia, increased LDH activity.
  • General disorders: headache, chills, fever, asthenia, pain in tumor foci, hot flashes, flu-like syndrome, weakness, pain at the injection site.
  • Digestive disorders: nausea, diarrhea, dyspepsia, vomiting, lack of appetite, stomatitis, dysphagia, constipation, sore throat, abdominal pain, abdominal enlargement.
  • Cardiovascular disorders: lowering blood pressure, orthostatic hypotension, increased blood pressure, tachycardia, atrial fibrillation, arrhythmia, cardiac pathology, left ventricular heart failure, supraventricular / ventricular tachycardia, myocardial ischemia, bradycardia, angina pectoris.
  • Neurological / mental disorders: dizziness, hypesthesia, paresthesia, sleep disturbance, agitation, anxiety, vasodilation, taste perversion, depression, nervousness.
  • Musculoskeletal disorders: neck pain, myalgia, muscle hypertonia, arthralgia, back pain.
  • Dermatological disorders: itching, rash, urticaria, sweating, increased sweating at night, alopecia.
  • Ophthalmic disorders: conjunctivitis, lacrimation disorders.
  • Otolaryngological disorders: noise and pain in the ears.
  • Change in laboratory data: decrease in IgG levels.

Storage conditions and periods
Store Redditux at temperatures from +2 to + 8 ° C for no more than 2 years. It is prohibited to use the medicinal product after the expiration date indicated on the package. It is necessary to ensure the inaccessibility of the medicine for children.