Fotoditazin^® (Concentrate) Instructions for Use

Marketing Authorization Holder

Veta-Grand, LLC (Russia)

Manufactured By

Deko Company, LLC (Russia)

ATC Code

L01XD (Sensitizing agents used for photodynamic/radiation therapy)

Dosage Form

Photoditazine®

Concentrate for solution for infusion 5 mg/ml: vial 10 ml

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion is a dark green liquid with a yellowish tint.

* chlorine E6 dimeglumine.

Excipients: water for injections – up to 1 ml.

10 ml – dark glass vials (1) – cardboard packs.

Clinical-Pharmacological Group

Photosensitizing drug

Pharmacotherapeutic Group

Antineoplastic agents; other antineoplastic agents; sensitizing agents used in photodynamic/radiation therapy

Pharmacological Action

Photoditazine is a second-generation photosensitizer intended for fluorescent diagnosis and photodynamic therapy of malignant tumors.

The drug selectively accumulates in malignant neoplasms. Upon subsequent irradiation of the tumor focus with monochromatic light with a wavelength of 661-662 nm, a photosensitizing effect occurs, which consists in the generation of reactive oxygen species (singlet oxygen) and other free radical particles in the tumor tissue, leading to the development of biochemical and structural-functional changes in tumor cells and their death.

The high photocytotoxicity of Fotoditazin^® is characteristic of various types of tumor cells. It is a highly informative diagnostic tool for spectrofluorescent research methods.

An important feature of the drug Photoditazine is the practical absence of dark cytotoxicity, rapid (within 24-28 hours) elimination from the body, primarily from the skin and mucous membranes, and high tropism (i.e., the ratio of drug concentrations in the tumor and normal tissue), reaching, depending on the type of tumors, maximum values exceeding 20.

These features of the drug practically exclude the damaging effect on healthy organs and tissues during PDT, as well as the formation of skin photosensitivity.

Pharmacokinetics

After intravenous administration of Fotoditazin^®, the maximum concentration in the tumor is reached 1.5-2.5 hours after administration (depending on the nosological type of the tumor). After 4-5 hours, the concentration of Fotoditazin^® in the tumor gradually decreases.

T_1/2 is 12 hours. Trace amounts of the drug are detected in the blood 28 hours after intravenous administration.

The maximum accumulation contrast ratio of the drug (tumor/normal tissue) depends on the nosological type of the tumor and can range from 3.0 to 24. The drug is actively metabolized in the liver (over 95%). Plasma protein binding is 92-96%.

Indications

• Fluorescent diagnosis of skin cancer and lung cancer;
• Photodynamic therapy of skin cancer (squamous cell, basal cell), lung cancer (only in cases where there are contraindications to surgical treatment).

ICD codes

Dosage Regimen

The drug is administered once as an intravenous drip infusion over 30 minutes at a dose of 0.7-1.4 mg/kg of the patient’s body weight.

2-3 hours after administration of the drug, a session of local tumor irradiation is performed at a dose of 150-600 J/cm² with a power density of 150-300 mW/cm².

The dose and power of the light flux are set depending on the tumor location, tumor volume, and nosological type. The irradiation session is carried out using laser devices that generate radiation with a wavelength of 661-662 nm.

Preparation of the solution for intravenous infusion.

The calculated dose of Fotoditazin^® is dissolved in 100 ml of 0.9% sodium chloride solution.

Adverse Reactions

Increased body temperature (37-38°C (98.6-100.4°F)) within 30 minutes, and pain in the irradiation area, which are relieved by the administration of analgesics and antihistamines. Increased blood pressure in patients with concomitant cardiovascular diseases.

Contraindications

• Hypersensitivity to the drug;
• Severe renal or hepatic impairment;
• Cardiovascular diseases in the decompensation phase;
• Pregnancy and breastfeeding period;
• Childhood.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Contraindicated in children.

Special Precautions

Within 24 hours after administration of the drug, the patient must strictly observe the light regimen (exposure to direct sunlight, watching television programs, etc. is excluded).

Starting from the first day of using Fotoditazin^®, exposed body surfaces should be treated with a photoprotective cream.

Overdose

Symptoms: shortness of breath, tachycardia, increased blood pressure, agitation followed by depression, hypothermia.

Treatment: symptomatic therapy (there is no specific antidote).

Drug Interactions

Concomitant use with analgesics is possible. The use of local anesthetics (infiltration anesthesia) is not recommended.

Storage Conditions

Store at a temperature not exceeding 10°C (50°F) in a place protected from light and out of the reach of children.

Shelf Life

Shelf life – 1 year.

Dispensing Status

By prescription.

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.