Aranose (Lyophilisate) Instructions for Use

Instructions
Dosage forms

ATC Code

L01XX (Other anticancer drugs)

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent, alkylating compound

Pharmacological Action

Antineoplastic agent (alkylating compound). It suppresses DNA synthesis in tumor cells.

The advantage over analogues (nitrosourea derivatives) is a wider range of therapeutic doses and the possibility of use in outpatient settings.

Indications

Skin melanoma.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
C43	Malignant melanoma of skin

ICD-11 code	Indication
2C30.Z	Melanoma of skin, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Lyophilisate

The drug is administered intravenously by bolus, daily or every other day in a single dose determined at the rate of 0.55-0.8 g/m² of the patient’s body surface area (on average 1-1.5 g).

The course of treatment is 3.0-4.5 g (3 injections).

The solution is prepared immediately before administration by dissolving the contents of the vial in 20 ml of a 5% dextrose solution.

Repeated courses are conducted at 4-week intervals (in the absence of manifestations of toxicity).

Adverse Reactions

From the hematopoietic system: leukopenia, thrombocytopenia, erythropenia.

Other: impaired gastrointestinal function; immunosuppression.

Contraindications

Hypersensitivity; general severe condition of the patient; leukopenia (below 3000/µl); thrombocytopenia (below 120,000/µl); gastric and duodenal ulcer (in the acute phase); cardiovascular and neurological diseases; impaired liver and kidney function; pregnancy.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Use in Renal Impairment

Contraindicated in impaired kidney function.

Special Precautions

Treatment should be carried out under the control of leukocyte, platelet, and erythrocyte counts in the blood. It should be borne in mind that hematotoxicity may manifest 1-3 weeks after the end of the treatment course.

Drug Interactions

Use in combination with other antineoplastic drugs leads to increased efficacy in the treatment of disseminated skin melanoma and is not accompanied by increased toxicity.

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.

Medical Disclaimer