Fotoran E6 (Lyophilisate) Instructions for Use

ATC Code

L01XD (Sensitizing agents used for photodynamic/radiation therapy)

Pharmacotherapeutic Group

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

Pharmacological Action

Chlorin E₆ selectively accumulates in pathological tissue (benign and malignant neoplasms of various origins and localizations, predominantly characterized by neovascularization) and, upon local exposure to light with a wavelength of 660-670 nm, provides a photosensitizing effect leading to damage of tumor tissue. Chlorin E₆ is a highly informative diagnostic agent in spectrofluorescent studies.

Pharmacokinetics

After IV administration, the C_max of Chlorin E₆ in tumors is recorded after 3 hours, then its concentration slowly decreases. In vascular endothelial cells, the C_max of Chlorin E₆ is detected 10-15 minutes after the start of the infusion. Trace amounts of Chlorin E₆ are detected in the blood 24 hours after IV administration. It penetrates well through tissue and cellular barriers and is detected in the thymus, skin, brain and bone marrow, spleen, ovaries, adrenal glands, heart, pancreas, stomach, kidneys, liver, and lungs.

Indications

In oncology: photodynamic therapy of malignant neoplasms – skin cancer (squamous cell and basal cell), melanoma, intradermal and subcutaneous metastases of melanoma, breast cancer and its intradermal metastases, cancer of the mucous membranes, including hollow organs (vulva, cervix (including cervical intraepithelial neoplasia grades I-III), esophagus, rectum, etc.); diagnosis of malignant neoplasms by the spectrofluorescent method.

In ophthalmology: photodynamic therapy in patients with central involutional chorioretinal dystrophy with classic choroidal involutional neovascularization, with subfoveal choroidal neovascularization in myopia.

ICD codes

Dosage Regimen

Administer Fotoran E6 intravenously as a slow infusion. Determine the dose individually based on the tumor type, size, and localization.

For skin cancers (basal cell, squamous cell carcinoma, melanoma), use a dose of 0.8-1.2 mg/kg body weight. For mucosal lesions (esophagus, rectum, cervix, vulva), administer 1.0-1.5 mg/kg.

In ophthalmology for choroidal neovascularization, use a dose of 1.0 mg/kg. Initiate laser light exposure at a wavelength of 660-670 nm after a 3-hour interval following infusion completion.

Reconstitute the lyophilisate immediately before use with 0.9% Sodium Chloride injection solution. Do not shake the vial vigorously; ensure complete dissolution.

Protect the reconstituted solution from light and administer promptly. Perform the entire procedure, from reconstitution to infusion, in a darkened room to prevent premature photosensitization.

Adverse Reactions

Possible increase in body temperature, pain in the irradiation zone (relieved by analgesic drugs), increased blood pressure in patients with concomitant diseases of the cardiovascular system. When administered in therapeutic doses, it has mild systemic phototoxicity. In the first week after administration of the drug, if the light regimen is violated, patients may develop hyperemia and edema of open body surfaces (without pigmentation).

Very rarely decreased visual acuity, visual field defects, lacrimation, subretinal hemorrhage, vitreous hemorrhage.

Contraindications

Hypersensitivity to the drug, severe renal or hepatic insufficiency, diseases of the cardiovascular system in the stage of decompensation; pregnancy, breastfeeding period; childhood.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children.

Special Precautions

Starting from the first day of using Chlorin E₆, open body surfaces should be treated with a photoprotective cream.

During the treatment period, it is necessary to avoid solar and ultraviolet radiation. The patient must be instructed on the need to strictly observe the light regimen (exposure to direct sunlight, watching television, etc. is excluded). The administration of Chlorin E₆ should be carried out in a darkened room.

Effect on the ability to drive vehicles and mechanisms

Given the likelihood of side ophthalmological effects, activities requiring concentration and speed of psychomotor reactions should be avoided for 24 hours after the administration of Chlorin E₆.

Drug Interactions

Concomitant use with analgesic agents is possible. The use of local anesthetics (infiltration anesthesia) is not recommended. Prescription of the drugs “bien”, reparaf, promotes early epithelialization of the wound defect, enhancement of connective tissue growth, and reduction of pain syndrome. Chlorin E₆ should not be used simultaneously with drugs that affect photosensitivity (tetracycline and fluoroquinolone antibiotics, sulfonamides, phenothiazine derivatives, hypoglycemic drugs – sulfonylurea derivatives (glibenclamide, thiazide diuretics, griseofulvin) and other drugs with known photosensitizing activity).

Chlorin E₆ should not be used simultaneously with drugs that may weaken the effectiveness of the treatment (beta-carotene, ethanol, mannitol). Simultaneous administration of drugs with known damaging effects on the liver, as well as those that may affect the metabolism of chlorin and prolong systemic phototoxicity (CYP3A4 inhibitors and inducers – cimetidine, ketoconazole, itraconazole, erythromycin, saquinavir, ritonavir, rifampicin) is excluded.

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.