Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):VED
Pharmacodynamics:Live mycobacteria strain BCG-1, multiplying intracellularly, lead to nonspecific stimulation of the cellular immune response.
Pharmacokinetics:At the moment there is no detailed description of the pharmacokinetics of the drug.
Indications:ANDMmunotherapy of superficial (Ta, T1, Tis) bladder cancer; prevention of recurrence of bladder cancer after transurethral removal of the tumor.
II.C64-C68.C67 Malignant neoplasm of bladder
Contraindications:Tuberculosis in the anamnesis; diameter of the papule after intradermal injection of tuberculin in a dose of 2 TE (Mantoux test) 17 mm or more; immunodeficiency states; acute cystitis or macrohematuria (before the disappearance of clinical manifestations); severe concomitant diseases in the stage of decompensation; traumatic catheterization or the appearance of blood after a catheterization of the bladder (for instillation on a given day).
Carefully:To apply after the transferred infectious diseases; with immunodeficiency.
Pregnancy and lactation:Contraindications to use in pregnant and lactating women. There is no reliable information for today.
Dosing and Administration:Intravesical.
For 3-11 days before the immunotherapy, the patient undergoes a Mantoux intra-skin test with 2 TE purified tuberculin in standard dilution. The sample is taken and the response is taken into account in accordance with the instructions for use of tuberculin. The Mantoux test is performed in an anti-TB dispensary or by persons having a special certificate-admission. Use of the vaccine is allowed if the diameter of the papule is less than 17 mm.
On the day of BCG immunotherapy, it is prohibited to administer parenterally other medications other than those necessary for vital signs. In the presence of pyuria, bacteriuria, dysuria before the start of treatment, it is necessary to conduct antibiotic therapy before the complete elimination of clinical symptoms of cystitis.
Prevention of recurrence of superficial bladder cancer recommend starting no earlier than 3 weeks after the removal of the tumor.Catheterization of the bladder is produced by an elastic catheter, without traumatizing the urethral mucosa and bladder. After emptying the bladder, it should be washed with sterile 0.9% sodium chloride solution and make sure that there is no blood in the wash fluid. After that, the dose of the vaccine is diluted in 50 ml of 0.9% sodium chloride solution and injected through the catheter into the bladder. The solution is retained in the bladder for 2 hours. It is desirable that during this time the patient change the position of the body to evenly contact the vaccine with the walls of the bladder. After 2 hours, the bladder is emptied into a container containing at least 500 ml of disinfectant solution (5% chloramine), exposure time is 6 hours.
The recommended single dose of the vaccine is 100-120 mg once a week. Immunoprophylaxis course - 6 weekly installations. In the future it is possible to carry out maintenance immunotherapy for 100-120 mg intravesical once every 3 months to 2 years.
Treatment of carcinoma in situ and papillary superficial bladder cancer: the installation should begin no earlier than 3 weeks after tumor biopsy. The method of administration of the drug in the bladder is similar to that described above.Single dose - 100-120 mg once a week. Induction course - 6 weekly installations. After 3-4 weeks after the end of treatment, a follow-up examination is performed.
When incomplete tumor regression or positive cytological urine test result it is advisable to hold a second course. Carrying out more than two induction courses of BCG therapy is inexpedient.
When complete tumor regression it is possible to carry out maintenance immunotherapy for 100-120 mg once every 3 months to 2 years.
Special instructions:The patient should be warned about possible complications of BCG therapy.
Adverse reactions and complications are more common in patients with a small capacity of the bladder (less than 150 ml), after previous radiation therapy.
In the development of systemic side effects, the leading role belongs to the hematogenous distribution of BCG. As a rule, they develop after gross traumatic catheterization of the bladder followed by the introduction of BCG. The infection is facilitated by the weakening of immunity, caused by the infection of the human immunodeficiency virus, by the use of immunosuppressants.
The diluted vaccine should be protected from exposure to daylight and administered immediately after dilution.