Vero-Bleomycin, lyophilizate 15 mg

Bleomycin is used both as monotherapy and in combination with other cytostatics and/or radiation therapy for the treatment of squamous cell skin, head and neck, esophageal cancers;

lymphogranulematosis, non-Hodgkin’s lymphoma; reticulosarcoma, Kaloshi’s sarcoma in AIDS, osteogenic sarcoma;

Melanoma;

Germ cell and ovarian tumors; penile cancer, vulvar cancer, cervical cancer;

Metastatic pleurisy, ascites in the background of malignant tumors (treatment and prevention as a sclerosing agent).

Active ingredient

Composition

1 vial contains:

the active ingredient:

Bleomycetin hydrochloride (in terms of bleomycin) 15 mg;

excipients:

Mannitol (mannitol).

How to take, the dosage

Intravenously, intramuscularly, in the cavity.

In each individual case, the dose and mode of administration should be guided by the evidence in the literature.

The drug is usually given:

– Intramuscularly (in 3-5 ml of 0.9% sodium chloride solution or water for injection, alternating injection sites) or intravenously slowly (in 15-20 ml of 0.9% sodium chloride solution or water for injection over 5-10 minutes) at a dose of B-10 mg (4-5 mg/m2) three times a week or 15-20 mg (8-10 mg/m2) twice a week;

– as an intravenous infusion (in 200-1000 ml of 0.9% sodium chloride solution) for 6 to 24 hours in a dose of 10-15 mg/m2 daily for 4-7 days with the course repeated every 3 to 4 weeks;

In intrapleural or abdominal cavity 50-60 mg in 40 ml of 0.9% sodium chloride solution after evacuation of the maximum possible amount of exudate.

Because of the risk of developing an anaphylactic reaction, the initial dose especially for lymphoma patients may be reduced (e.g., to 2-3 mg/m2). If an acute reaction does not develop, the drug can be used in the usual dose.

The total cumulative dose should not exceed 250-300 mg. Further administration of the drug can be done with great caution and only after determination of lung function.

Injection of bleomycin in children should be done only in special cases, and the dose should be based on body surface area.

In case of radiation therapy, the dose of bleomycin should be reduced because irradiated tissue is more sensitive to the drug. Dose adjustments should also be made if the drug is used in combination with other chemotherapy agents.

In patients with impaired renal function, the bleomycin dose should be changed as follows: if serum creatinine levels are 130-180 μmol/l, the drug dose should be decreased by 50%; if serum creatinine levels are greater than 180 μmol/l, the drug should be delayed until creatinine levels normalize.

Interaction

The simultaneous administration of bleomycin with carmustine, mitomycin, cyclophosphamide and methotrexate, as well as the use of oxygen (especially during surgical interventions) and other agents that have a toxic effect on the lungs (smoking) increases the risk of pulmonary toxicity.

The combined use of bleomycin and vincaalkaloids increases the risk of vascular disorders.

Myelotoxic drugs and radiation therapy increase the incidence of adverse events.

Special Instructions

The treatment should be carried out under the supervision of a physician experienced in antitumor therapy.

For early detection of side effects during treatment it is necessary to perform: body temperature measurement every 3 hours after administration of the drug, examination of the skin and visible mucous membranes at least twice a week, lung auscultation, lung X-ray once a month, blood and urine tests at least once a week.

In newborns, premature infants and young children can be prescribed only on vital signs, under constant supervision.

The sensitivity to bleomycin is increased in elderly patients.

The use of the drug after radiation therapy (especially in the chest, head and neck) requires great caution.

In case of ulcerative stomatitis and allergic rash, treatment is stopped; if pneumonia is suspected, treatment is stopped immediately and glucocorticosteroids are given under the guise of antibiotics.

In surgical procedures, oxygen is used with caution; in operating rooms, it is recommended that oxygen content in the air not exceed 25%.

Women of reproductive age and men should use reliable contraception during treatment with bleomycin and for three months after.

The solution should be avoided if the color changes and large particles are present. Freshly prepared solutions should be used for administration.

Please use caution when preparing and administering the solution; flush immediately with copious amounts of water if the product gets on the skin or mucous membranes.

Contraindications

High sensitivity to the ingredients of the drug, severe renal insufficiency, respiratory failure (pulmonary fibrosis, chronic interstitial pneumonia), decompensated heart failure, pregnancy, breast-feeding period.

With caution:

Inhibition of medullary hematopoiesis, renal and/or hepatic insufficiency, prior or concomitant radiation therapy to the chest area, varicocele, advanced age, childhood, acute infections of viral, fungal or bacterial nature (including varicella, shingles).

Side effects

Respiratory system: interstitial pneumonia, pulmonary fibrosis, pleurisy with pain syndrome, cough, shortness of breath.

Nervous system disorders: headache, dizziness.

Digestive system disorders: decreased appetite, nausea, vomiting, diarrhea, weight loss (with long-term use); liver function disorders.

Urinary system disorders: impaired renal function.

Skin and skin appendages: hyperkeratosis, peeling, hyperemia, hyperpigmentation and itching of the skin, stretch marks, deformity and fragility of nails, hyperaesthesia of the skin and distal (nail) phalanges, hyperaemia of the fingertips, scleroderma-like skin changes, stomatitis, alopecia.

Allergic reactions: urticaria, anaphylactoid reactions, idiosyncrasy (decreased blood pressure, confusion, fainting, increased body temperature, chills, wheezing).

Reproductive system disorders: azoospermia, amenorrhea.

Local reactions: phlebitis and thrombosis (if the rate of intravenous administration is exceeded); intrapleural administration – local pain.

Others: hyperthermia (2 h after injection, with a maximum of 4-8 h); bleeding due to rapid decay of the tumor; vascular disorders (including cerebral arteritis, stroke, myocardial infarction, thrombotic microangiopathy, Raynaud’s syndrome); pain in the area of tumor lesions; feeling of general malaise; rarely leukopenia; conjunctivitis, vulvitis and other mucosal manifestations (more often in 2-5 weeks after the therapy start after reaching total doses of 150-200 mg).

Overdose

Symptoms: decreased blood pressure, fever, rapid pulse and general symptoms of shock.

Treatment: symptomatic. In complications of the bronchopulmonary system glucocorticosteroids and broad-spectrum antibiotics are prescribed.