Project Description
Fotolon
lyophilized powder to prepare solution for injections 0,1g – Photolonum 0,1 pro injectionibus
international nonproprietary name
Not established
Ref
BP-0053
Pharmacotherapeutic group
Antitumoral drug
Composition of the preparation
A vial contains 100 mg of chlorine Е6 threenatrium salt.
Pharmacological action
Pharmacodynamics Fotolon is used for photodynamic therapy for malignant tumors and their diagnostics. Active Fotolon substance — chlorine Е6 — accumulates in malignant tumors selectively and under local light of 660—670 nm wave-length provides with photosensibilised effect which damages tumorous tissue. Fotolon is a highly informative diagnostic drug for spectrofluorescence investigation. Pharmacokinetics Maximum quantity of Fotolon registers in the tumor in 3 hours after intravenous injection, then the concentration of active substance gradually decreases. Trace quantity of the drug is discovered in blood in 24 hours after intravenous injection of Fotolon. Fotolon selectively accumulates in malignant tumors, penetrates well through tissue and cellular barriers, discovered in thymus, skin, marrow, spleen, ovaries, epinephroses, heart, pancreas, stomach, kidneys, liver, lungs.
Indications
Used for photodynamic therapy for malignant neoplasms, including skin cancer (basal cell carcinoma), black cancer, breast cancer and their intracutaneous metastases, carcinoma confined to mucosa ( of vulva, esophagus, rectum, others). Used for diagnostics of malignant neoplasms through spectrofluorescence method.
Special indication
When Fotolon is used sunscreen cream should be applied on open body area.
Special warning
Not established
Dosage and method of administration
Used intravenously as 2,5—3,0 mg/kg of the patient’s weight. The calculated dose of Fotolon is dissolved in 200 ml of physiologic saline and infused intravenously drop-by-drop within 30 minutes. In 3—4 hours after the injection of photosensitizer there should be the session of local irradiation of the tumor in dose 100—600 J/sm2 a session using the laser apparatus which generates 660—670 nm wave-length radiation.
Overdosage
Symptoms: anhelation, tachicardia, rise in arterial pressure, excitement replaced by distress, hypotermy. Treatment: symptomatic therapy (there is no specific antidote).
Safety measures
During Fotonol treatment solar and ultraviolet radiation should be avoided. The patient should be informed about the necessity to keep light regimen (direct solar irradiation, watching TV and other should be excluded). The drug should be injected in black-out room.
Side effects
Temperature rise and pains in irradiation zone which are stopped by the injection of analgesics. There may be AP rise of cardiovascular system patients. In therapeutical doses of Fotolon the systemic phototoxicity is mild. Within the first week under light irregularity in patients there may be hyperemia and edema of open body area (without pigmentation).
Contraindications
Hypersensitivity to Fotolon, renal or liver insufficiency, cardiovascular diseases in decompensation phase, pregnancy, lactation, childhood.
Interactions with other medicinal preparations
Simultaneous use with analgesics is possible. Use of local anesthetic drugs is not recommended (infiltration anaesthesia). The prescription of antioxidants, the medicines like “Bien”, “Reparef-2” favour early epithelization of wound defect, intensify the growth of connective tissue, decrease in pain syndrome.
The form of release
100 ml bottles contain 100 mg lyophilized powder to prepare solution for injections.