Uro-BCG

The specific immunomodulatory drug Uro-BCG has immunological and biological properties inherent in BCG vaccines.

Indications Uro-BCG

Uro-BCG may be prescribed for the following purposes:

• for the treatment of preinvasive cancer;
• as a preventative measure against recurrent development of cancer in the bladder after radical therapy;
• for the treatment of bladder cancer at stage T _a;
• for the treatment of bladder cancer at stage T ₁;
• for the prevention of urothelial preinvasive carcinoma.

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Release form

The medicine Uro-BCG is produced in the form of a powder mass for the preparation of a suspension, which is subsequently used for infusion into the bladder cavity. The powder is packaged in 25 ml vials packed in cardboard boxes.

The composition of Uro-BCG is represented by live cells of BCG bacteria (strain RIVM, 2 * 108-8 * 108).

In addition to the Uro-BCG drug, the package contains 50 ml of solvent in the form of a saline solution, adapters with a syringe adapter for connecting to a catheter, and a bag for collecting used material.

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Pharmacodynamics

The powdered mass of Uro-BCG contains viable BCG bacteria, which, when introduced into the bladder cavity, lead to a non-specific local immune reaction, which becomes the main provocateur of the antitumor effect of Uro-BCG.

Intravesical infusion of the drug results in an increased number of granulocytes, monocytes and T-lymphocytes, as well as increased production of cytokines and TNF-α (tumor necrosis factor).

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Pharmacokinetics

The majority of mycobacteria are eliminated from the body along with urine fluid during the first few hours after intravesical infusion.

It is unknown whether bacteria penetrate through the mucous tissues of the bladder - at the moment, the possibility of penetration of bacilli has not been proven.

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Dosing and administration

The volume of one bottle of Uro-BCG is sufficient for a single infusion into the bladder cavity.

• For the treatment of preinvasive cancer in the bladder, one Uro-BCG injection is administered per week for one and a half months. If the tumor growth has not been stopped during the proposed time, the therapy regimen can be repeated. After a time interval of 1 month, Uro-BCG can be resumed as maintenance therapy.
• Preventive immunotherapy is started 2-3 weeks after transurethral resection surgery or after tissue biopsy, if the urinary tract was not injured after catheterization. Usually, the treatment regimen includes one administration of Uro-BCG into the bladder once a week for one and a half months. If there are tumor processes with an increased risk of recurrence, then the administration of Uro-BCG is continued as maintenance therapy.
• Maintenance therapy consists of three weekly injections in the third, sixth, twelfth, eighteenth, twenty-fourth, thirtieth and thirty-sixth months after transurethral resection. In total, 27 injections of Uro-BCG into the bladder are performed over a period of 3 years.

The powdered mass of Uro-BCG from the vial should be diluted in the supplied solvent - saline solution. The resulting suspension should be gently but thoroughly mixed.

Work with the drug must be carried out under aseptic conditions, using rubber gloves.

How to use Uro-BCG correctly:

1. Tear the protective film on the container with saline solution without removing it completely.
2. Remove the protective caps from the bottle and adapter and place them in a special disposal bag.
3. Press the bottle onto the adapter.
4. The displacement mechanism for installing the connection is damaged.
5. The saline solution is pumped into a bottle.
6. Wrap the container so that the bottle with the suspension is on top and the suspension flows freely into the container.
7. Hold the container with the suspension vertically, remove the remains of the protective film, connect the adapter to the catheter. Damage the displacement mechanism inside the tube and administer the Uro-BCG suspension into the bladder.
8. Leave the container compressed and discard it and the catheter in a disposal bag.

Patients are advised not to drink liquids four hours before and two hours after the introduction of Uro-BCG into the bladder. Immediately before the introduction, it is necessary to visit the toilet to urinate.

It is desirable that the administered substance remains in the bladder for two hours. For better distribution of the Uro-BCG preparation, the patient should frequently change the position of the body - for example, turn onto the stomach and back every 15 minutes. Two hours after the administration, the bladder can be emptied while in a sitting position.

It is recommended to drink more liquids for two days after the procedure (if there are no contraindications).

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Use Uro-BCG during pregnancy

The drug Uro-BCG is not used to treat pregnant and lactating patients.

Contraindications

Uro-BCG cannot be used:

• if there is a tendency for the body to have an allergic response to the administration of the drug;
• if the patient previously suffered from tuberculosis;
• if the Mantoux test resulted in the development of a local reaction with a diameter of 17 mm or more;
• if the patient has previously undergone radiation therapy on the bladder;
• in case of congenital or acquired immunodeficiency associated with leukemia, HIV, lymphoma;
• during treatment with cytostatics, or during the use of radiation or immunosuppressive therapy;
• in various decompensated conditions;
• in childhood.

A relative contraindication is the appearance of bloody discharge during bladder catheterization.

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Side effects Uro-BCG

Uro-BCG infusion is almost always accompanied by the appearance of side effects of varying severity. The most common negative symptoms are:

• inflammatory process in the bladder, frequent urination, pain during urination, obstruction of the urinary ducts;
• granulomatous prostatitis, inflammation of the testicles;
• feverish condition with a rise in temperature to 38.5°C, flu-like condition, weakness, septic condition, infection of implants (arthroprostheses, vascular implants);
• nausea, hepatitis;
• anemia, cytopenia;
• miliary pneumonia, pulmonary granuloma;
• skin rashes, abscesses;
• joint pain, bone marrow damage, osteomyelitis;
• decreased blood pressure, infectious vascular complications;
• swelling of the eyelids, coughing;
• Reiter's syndrome, characterized by inflammation of the conjunctiva of the eye, asymmetric oligoarthritis and inflammation of the bladder.

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Overdose

In case of overdose of Uro-BCG, an increase in side effects may be observed.

Symptomatic drugs and antibiotics are used for treatment.

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Interactions with other drugs

During the period of Uro-BCG therapy, you cannot take anti-tuberculosis medications such as Ethambutol, Streptomycin, PAS, Rifampicin, Isoniazid. You should also not take fluoroquinolone antibiotics, Gentamicin, Doxycycline, since mycobacteria may be sensitive to the listed drugs.

Uro-BCG is not compatible with hypotonic and hypertonic solutions.

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Storage conditions

Uro-BCG packages are stored in a special room in a locked refrigerator, out of reach of children and unauthorized persons who are not related to medical personnel. The temperature regime for storing the drug is from +2 to +8°C. The drug must not be frozen.

The diluted Uro-BCG suspension should be used immediately.

If the suspension gets on the skin, it is necessary to treat it with 0.5% chloramine and warm running water with detergent.

If the suspension is accidentally spilled on the floor, it should be neutralized with 5% chloramine.

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Shelf life

Vials with Uro-BCG can be stored for up to 2 years if the number of viable bacteria in the preparation is less than 5*10 ⁸ CFU in the vial.

Vials with Uro-BCG are stored for up to 3 years if the number of viable bacteria in the preparation exceeds 5*10 ⁸ CUE in the vial.

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