3. The Radachlorin Photosensitizer – Intravenous Solution
Pharmaceutical Form and Package
Radachlorin is a 0.35 % dark-green solution for intravenous administration. Radachlorin comes in 10-ml glass vials singly in a cardboard box with instruction enclosed. Each vial contains 35 mg (3.5 mg/ml) of active agent (in the form of sodium salt of chlorin e6) diluted in 10 ml of water for injections.
Indications
Radachlorin is used to destroy malignant tumors of various origins. Radachlorin can be used both independently from and in combination with cytotoxic chemotherapy and radiotherapy to increase the therapeutic effect produced by them. Radachlorin also prevents implantation metastases formation arising from an intraoperative action onto tissues.
Mechanism of Action
Radachlorin is a high-selective photosensitizer applied in photodynamic therapy (PDT). Radachlorin is rapidly (within a span of 2.5 – 3.0 hours) accumulated in malignant tumors. Maximum ratio of contrast of the medicine ranges from 3.0 to 40, depending on a nosological type of a tumor. Radachlorin is effective when excited by light exposure at a wavelength of 661 – 662 nm. As a result, it starts to actively generate cytotoxic particles (such as singlet oxygen) in a tumor tissue. Radachlorin is a high-cytophototoxic drug aimed at various types of tumor cells. Thus, it is considered to be able to prevent tumor growth. A practical absence of the dark cytotoxicity and a rapid elimination of this drug from skin and mucosae make Radachlorin especially beneficial in PDT. The use of Radachlorin causes no damage to healthy organs or tissues, nor does it make skin hypersensitive to daylight. Chemotherapy and radiotherapy are able to potentiate the clinical effect produced by PDT.
Contraindications
High sensitivity to the medicine.
Significant renal and hepatic failure.
Cardiovascular diseases at the decompensation stage.
Pregnancy and nursing time.
Pediatric use.
Method of Administration and Dosage
Radachlorin is injected in a single-shot manner by means of intravenous drop infusion within 30 minutes at a dose of 0.5 – 1.0 mg/kg of the patient’s body weight. 2.5 – 3 hours after the medicine injection, a session of local irradiation of a tumor is performed at a dose of 200 – 500 J/cm2 at a radiation power density of 250 – 400 mW/cm2. The light dose and the radiation power are set depending on the localization and size of a tumor, and its nosological nature.
The PDT session is performed with the help of laser devices which generate radiation at a wavelength of 661 – 662 nm.
Solution Preparation for Intravenous Infusion
A calculated dose of Radachlorin is dissolved in 100 ml of normal saline.
Side Effects
The body temperature rise (up to 37 – 38°C) and fever within 30 minutes; a presence of pains in the area of irradiation which can be stopped by intake of analgesics and antihistamines.
The blood pressure boost in patients with the accompanying cardiovascular diseases.
Overdosage
Symptoms: anhelation; tachycardia; blood pressure boost; excitation being changed to depression; hypothermia.
Treatment: symptomatic therapy (there is no a specific antidote).
Compatibility with Other Medicines
It is possible to use Radachlorin together with analgesics.
It is not recommended to use local anesthetic drugs (infiltration anesthesia).
It is not recommended to use drugs having an acid pH factor.
Precautions
Within 24 hours after the medicine injection, a patient should strictly follow light regime (it is prohibited to be exposed to direct sunlight, to watch TV programs, etc.).
Right from the first day of using Radachlorin, sun blocking creams should be used to protect open skin areas.
Storage Conditions
Radachlorin should be stored at a temperature from 0 to +8°C in a dark place, out of the reach of children.
Shelf Life
12 months from manufacture date printed on the package.
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