Index of drugs

Prevention of acute transplant rejection afterde novo allogeneic renal transplantation in adults and children (1-17 years). It is intended for simultaneous use with immunosuppressive treatment of cyclosporin in the form of microemulsions and corticosteroids in patients with a panel of reactive antibodies below 80% or in triple maintenance immunosuppressive therapy, which includes: cyclosporin in the form of microemulsions, corticosteroids and azathioprine or mycophenolate mofetil.

1 vial contains 20 mg basiliximab.

Basiliximab is a mouse-human monoclonal antibody (IgG_1κ) (a chimera) directed against the α-chain of the interleukin-2 receptor (CD25 antigen) that is expressed on the surface of T lymphocytes during antigen response. Basiliximab binds with high affinity selectively to CD25 antigen on activated T lymphocytes, displaying high affinity for the interleukin-2 receptor (IL-2R). In this way, it blocks the attachment of interleukin-2, a decisive signal for the proliferation of T lymphocytes in the cellular immune response associated with allograft rejection. The total and permanent blocking of the interleukin-2 receptor is maintained as long as the concentration of basiliximab in the serum is> 0.2 μg / ml (which usually occurs up to 4-6 weeks after administration). If the concentration of the drug decreases below this level, expression of the CD25 antigen within 1-2 weeks returns to pre-treatment values. Bazyliximab does not suppress bone marrow suppression. After intravenous administration of C_max reaches in the blood within 30 min; it binds only to activated lymphocytes and macrophages / monocytes. T_0,5 is 7.2 +/- 3.2 days.

Hypersensitivity to the components of the preparation. Pregnancy and breastfeeding.

The preparation must not be administered until it is absolutely certain that the patient will undergo a transplant and simultaneous immunosuppression. The efficacy and safety of the medicine in preventing severe rejection of allogeneic solid organ transplantation with the exception of kidneys has not been demonstrated. In several clinical trials involving a small group of heart transplant patients, serious cardiac adverse events such as cardiac arrest, atrial flutter, and palpitations have been reported more frequently with basiliximab than with other induction drugs. Immunosuppressive treatment, including treatment with a combination of drugs, increases the propensity to infections, including opportunistic infections, death-related infections and septicemia: the risk increases with total immunosuppression. If a severe hypersensitivity reaction occurs, treatment must be discontinued and no further doses should be administered. Caution should be exercised when initiating treatment in patients who have previously taken this medicine, as there is an increased risk of hypersensitivity reactions in a subset of patients. This group includes patients who have been discontinued prematurely after the first administration of a second immunosuppressive drug due to, e.g., discontinuation of transplantation or due to early graft loss. In some of these patients, acute hypersensitivity reactions were observed after re-administration of the preparation prior to subsequent transplantation. Patients after transplantation receiving combination immunosuppressive therapy, including basiliximab or without basiliximab, are at increased risk of developing lymphoproliferative diseases (LPDs), such as lymphoma and opportunistic infections (including cytomegalovirus-CMV infection). During treatment with the preparation, the use of live attenuated vaccines should be avoided. Inactive vaccines may be administered to patients with immunosuppression, but the response to vaccination may depend on the degree of immunosuppression in a given patient, therefore vaccination during therapy with basiliximab may be less effective.

The preparation is contraindicated in pregnancy and breast-feeding. Basiliximab may have dangerous imminosuppressive effects during pregnancy and for breast-fed newborns. Bazyliximab is IgG₁ and it should be expected that it will penetrate into milk. Women of childbearing potential must use effective contraception during treatment and up to 16 weeks after treatment.

There was no statistically significant difference in the number of treatment-related adverse reactions between the basiliximab group and the placebo group. The most common (> 20%) were: constipation, urinary tract infections, pain, nausea, peripheral edema, hypertension, anemia, headache, hyperkalemia, hypercholesterolemia, postoperative wound complications, weight gain, increased blood creatinine, hypophosphatemia , diarrhea and upper respiratory tract infections. In children, the most common were: urinary tract infections, hypertrichosis, rhinitis, elevated body temperature, hypertension, upper respiratory tract infections, viral infections, sepsis and constipation. The overall incidence of malignancies among patients receiving basiliximab and the control group was similar. The overall incidence and severity of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with biphasic or triple immunosuppressive therapy were comparable between both groups. In addition, hypersensitivity reactions / anaphylactic reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnea, pulmonary edema, heart failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome and cytokine release syndrome have been observed with unknown frequency. .

The drug should only be prescribed by physicians experienced in immunosuppressive therapy after organ transplantation. Administration of the preparation should be carried out under the supervision of qualified medical personnel, in centers with a laboratory and an intensive care unit equipped with means to treat severe hypersensitivity reactions. It is used in combination with other immunosuppressive medicines (ciclosporin, corticosteroids, aztioprine, mycophenolate mofetil).
Intravenously in the form of a bolus or 20-30 minutes of infusion. Adults: The total standard dose is 40 mg (2 times 20 mg). Children (1-17 years old): total body weight: 20 mg (2 times 10 mg); about mc. ≥35 kg total dose is 40 mg (2 times 20 mg). The first dose should be given within 2 h before transplantation. The second dose should be given 4 days after transplantation. Do not give a second dose in case of severe hypersensitivity or post-operative complications such as loss of transplantation. Elderly patients do not need to change their dosage.