Maltin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Nord, JSC (Russia)

ATC Code

L01DC01 (Bleomycin)

Active Substance

Bleomycin (Rec.INN registered by WHO)

Dosage Form

Maltin

Lyophilisate for preparation of solution for injection 15 IU: fl. 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for injection in the form of a porous mass or powder from white to yellowish-white.

15 IU – Vials with a capacity of 10 ml (1) – cardboard packs.
15 IU – Vials with a capacity of 10 ml (10) – cardboard packs.
15 IU – Vials with a capacity of 10 ml (2) (2-100 pcs.) – group packaging (for hospitals).

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 creatinine clearance greater 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’s 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, hematological status, and the chosen antineoplastic therapy protocol.

For subcutaneous, intramuscular, intravenous, or intra-arterial administration, dissolve the contents of the vial in 1-5 ml of water for injection or 0.9% sodium chloride solution.

For intracavitary administration, dissolve the lyophilisate in a larger volume of 0.9% sodium chloride solution.

Administer the drug once or twice weekly. The total course dose for adults should not exceed 300 mg due to the cumulative risk of pulmonary toxicity.

For patients over 70 years of age, reduce the total cumulative dose to a maximum of 150 mg.

In patients with significant renal impairment (creatinine clearance less than 35 ml/min), avoid use or implement a substantial dose reduction with careful monitoring.

Prior to the first administration, administer a test dose of 2 mg or less to assess for acute hypersensitivity reactions.

Monitor pulmonary function tests and chest X-rays regularly before and during therapy. Discontinue treatment immediately upon appearance of new or worsening pulmonary symptoms.

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 individuals,

Special Precautions

Use with caution in patients with lung diseases (including in the anamnesis), with renal impairment, with coronary artery disease, heart defects, in elderly individuals, 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), with 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 appears, 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 effects 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 8°C (46°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.