Photolon (Lyophilisate) Instructions for Use

ATC Code

L01XD (Sensitizing agents used for photodynamic/radiation therapy)

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Photosensitizing agent

Pharmacological Action

The active substance, Chlorin E6, selectively accumulates in malignant tumors and, upon local exposure to light with a wavelength of 660-670 nm, provides a photosensitizing effect leading to damage of the tumor tissue.

Pharmacokinetics

After intravenous administration of Photolon, the time to reach C_max is 3 hours, after which the concentration slowly decreases; after 24 hours, trace amounts of the drug are detected in the blood.

It selectively accumulates in tumor tissue, penetrates well through tissue and cellular barriers; it is detected in the thymus, skin, bone marrow, spleen, ovaries, adrenal glands, heart, pancreas, stomach, kidneys, liver, and lungs.

Indications

Photodynamic therapy of malignant neoplasms: skin cancer (squamous cell and basal cell); melanoma; breast cancer and their intradermal metastases; cancer of the mucous membranes (vulva, esophagus, rectum).

Diagnosis of malignant neoplasms by the spectrofluorescent method.

ICD codes

Dosage Regimen

Administer Photolon lyophilisate as an intravenous drip infusion.

Calculate the dose based on patient body weight at 2.5-3 mg/kg.

Reconstitute the calculated dose in 200 ml of 0.9% sodium chloride solution.

Infuse the total volume intravenously over a period of 30 minutes.

Initiate the laser irradiation session 3-4 hours after the completion of the drug infusion.

Use laser devices generating light at a wavelength of 660-670 nm.

Deliver a light energy dose of at least 300 J/cm² per treatment session to the tumor area.

Adhere strictly to light protection protocols for the patient immediately following administration.

Adverse Reactions

Increased body temperature and pain in the irradiation area (relieved by analgesic medications), increased blood pressure in patients with concomitant cardiovascular diseases.

When administered in therapeutic doses, it has mild systemic phototoxicity. In the first week after drug administration, if the light regimen is violated, patients may develop redness and swelling of exposed body surfaces (without pigmentation).

Contraindications

Hypersensitivity; severe renal or hepatic impairment; diseases of the cardiovascular system in the stage of decompensation (chronic heart failure, arterial hypertension); pregnancy; lactation period; childhood.

Use in Pregnancy and Lactation

Contraindications: pregnancy; lactation period.

Use in Hepatic Impairment

Contraindication — severe hepatic impairment.

Use in Renal Impairment

Contraindication — severe renal impairment.

Pediatric Use

Contraindication — childhood.

Special Precautions

During the treatment period, it is necessary to avoid solar and UV radiation. The patient must be instructed on the need to strictly adhere to the light regimen (exposure to direct sunlight, watching television, etc., is excluded).

Administration of the drug should be carried out in a darkened room.

Starting from the first day of using Photolon, exposed body surfaces should be treated with a sun protection cream.

Drug Interactions

The use of local anesthetic medications (infiltration anesthesia) is not recommended.

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.