Vero-Bleomycin (Lyophilisate) Instructions for Use

ATC Code

L01DC01 (Bleomycin)

Active Substance

Bleomycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antineoplastic antibiotic

Pharmacotherapeutic Group

Antineoplastic agent, antibiotic

Pharmacological Action

Antineoplastic agent. It is the A₂ fraction isolated from the culture of Streptomyces verticillus, containing the actual antineoplastic antibiotic.

The mechanism of action is associated with the ability to cause fragmentation of DNA molecules.

It has weakly expressed myelodepressive and immunosuppressive activity.

Pharmacokinetics

Protein binding is 1%.

It undergoes metabolism, the pathways of which are not precisely established.

T_1/2 with a creatinine clearance of more than 35 ml/min is 115 min.

It is excreted by the kidneys, 60-70% predominantly unchanged.

Indications

Cancer of the skin, esophagus, lung, cervix, thyroid gland, kidney; malignant tumors of the head and neck; soft tissue sarcomas, osteogenic sarcoma; lymphogranulomatosis, non-Hodgkin lymphomas, germ cell tumors of the testis and ovaries.

Treatment and prevention of exudative pleurisy and treatment of exudative peritonitis in malignant tumors (intracavitary administration).

ICD codes

Dosage Regimen

Determine the dosage individually based on the specific malignancy, disease stage, patient’s hematopoietic status, and the chosen antineoplastic therapy protocol.

For lymphomas, administer 5-10 mg/m² (0.15-0.30 mg/kg) once or twice weekly, intravenously, intramuscularly, or subcutaneously.

For testicular cancer, use a dose of 30 units weekly, intravenously, as part of a combination chemotherapy regimen.

For pleural or peritoneal effusions, administer 15-60 mg as a single intracavitary instillation dissolved in 50-100 ml of 0.9% sodium chloride solution.

Reconstitute the lyophilisate with an appropriate volume of sterile water for injection, 0.9% sodium chloride, or 5% dextrose solution to achieve a concentration of 3-5 units/ml.

For subcutaneous or intracavitary use, further dilute the reconstituted solution. For intravenous administration, dilute the dose in 50-100 ml of 0.9% sodium chloride and infuse over at least 10 minutes.

The total cumulative lifetime dose must not exceed 400 units (400,000 IU) due to the high risk of irreversible pulmonary toxicity.

Reduce the dose by 50-75% in patients with a creatinine clearance below 35-50 ml/min. Avoid administration if creatinine clearance is less than 35 ml/min.

Monitor renal function before each dose and adjust accordingly. Perform baseline pulmonary function tests and chest X-ray before initiation and regularly during therapy.

Adverse Reactions

From the respiratory system: interstitial pneumonia, pulmonary tissue fibrosis.

From the digestive system: nausea, vomiting, anorexia, angular stomatitis, liver function disorders.

From the urinary system: kidney function disorders, frequent and painful urination.

From the CNS: headache, dizziness.

From the reproductive system: azoospermia, amenorrhea.

Allergic reactions: erythema, urticaria, anaphylactoid reactions.

Dermatological reactions: focal hyperkeratoses, hyperpigmentation, dermatitis, nail deformation, alopecia.

Other: fever, leukopenia; rarely – toxic effect on blood vessels (including cerebral arteritis, stroke, myocardial infarction).

Contraindications

Severe respiratory dysfunction, pulmonary tissue fibrosis, severe renal (creatinine clearance less than 35 ml/min) and/or hepatic impairment, severe cardiovascular diseases, pregnancy, hypersensitivity to bleomycin.

Use in Pregnancy and Lactation

Bleomycin is contraindicated during pregnancy. If it is necessary to use during lactation, breastfeeding should be discontinued.

Women of childbearing potential receiving bleomycin therapy should use reliable methods of contraception.

In experimental studies, the teratogenic and embryotoxic effects of bleomycin have been established.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment (creatinine clearance less than 35 ml/min).

Use with caution in patients with renal impairment.

Pediatric Use

The safety of use in pediatric practice has not been established.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in patients with lung diseases (including history), renal impairment, coronary artery disease, heart defects, elderly patients, as well as in patients who have received or are receiving radiation therapy.

Use with caution in patients with chickenpox (including recently had or after contact with sick individuals), herpes zoster, and acute infectious diseases.

During treatment, systematic monitoring of respiratory function, chest X-ray, monitoring of kidney and liver function is necessary. If cough or dyspnea occurs, treatment should be discontinued and glucocorticosteroids and antibiotics should be prescribed.

The safety of use in pediatric practice has not been established.

In experimental studies, the carcinogenic and mutagenic effects of bleomycin have been established. In this regard, extreme caution is necessary when using bleomycin for the treatment of other diseases (mycosis fungoides, common warts).

Drug Interactions

Bleomycin increases the risk of pneumotoxic action in patients receiving oxygen (for example, as part of general anesthesia).

With simultaneous use with drugs that have myelotoxic and pneumotoxic effects, an increase in the risk of adverse reactions is possible.

Slowing of bleomycin clearance and enhancement of its toxic effect is possible even when used in low doses due to the nephrotoxic effect of cisplatin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.