Universal reference book for medicines
Product name: RADAHLORIN (RADAHLORIN)

Active substance: nonappropriate

Type: Photosensitizing drug

Manufacturer: РАДА-ФАРМА (Russia)
Composition, form of production and packaging
Liquid extract
1 fl.

extract spirulina platensis 100 g

the content of the sum of sodium chlorine E6, sodium chlorine P6 and sodium purpurine 5 not less than 6.5%

bottles of dark glass (1) - wrapping paper.

Liquid extract 1 fl.

extract spirulina platensis 25 g

the content of the sum of sodium chlorine E6, sodium chlorine P6 and sodium purpurine 5 not less than 6.5%

Vials of dark glass (1) - wrapping paper.

Liquid extract 1 fl.

extract spirulina platensis 50 g

the content of the sum of sodium chlorine E6, sodium chlorine P6 and sodium purpurine 5 not less than 6.5%

bottles of dark glass (1) - wrapping paper.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Radachlorin (a modified natural mixture of chlorins from microalgae of the genus Spirulina, about 70-90% of which is chlorin e 6 ) is a second-generation photosensitizer intended for fluorescent diagnosis (FD) and photodynamic therapy (PDT) of malignant tumors.

The PDT method is based on the ability of Radachlorin to selectively accumulate in the skin tumor with its intravenous administration and generate singlet oxygen, which has a toxic effect on tumor cells and modifies the effect on their plasma membranes when exposed to light at a wavelength corresponding to one of the absorption peaks (406 , 506, 536, 608, or 662 nm).

In the development of the effect after PDT with the drug Radachlorin, there are 3 stages:

Stage 1 - a characteristic reaction to light exposure in PDT, manifested in the form of edema and hyperemia of the irradiation zone of different severity;

Stage 2 - necrosis of the tumor, which is formed 2-4 days after the PDT session;

Stage 3 - rejection of necrotic masses and epithelization of the wound defect in 2-8 weeks, depending on the size of the tumor.

Radachlorin in doses of 0.5-2.4 mg / kg with irradiation of the tumor with laser radiation 3 hours after the administration of the drug has no mutagenic effect and does not damage the DNA of normal cells.

PHARMACOKINETICS

After a single intravenous administration of Radachlorin in doses of 0.5-2.4 mg / kg, it is distributed between blood and tissues for 0.5-5 hours.
C max Radachlorin in the blood serum reaches 15-30 minutes and rapidly decreases, making, after administration at a dose of 0.5 mg / kg, after 1 h - 10 μg / l. after 3 hours - 5 μg / l, after 24 hours - 1 μg / l.
C max Radachlorin in the tumor after 1 h (10-20 mcg / ml), but with a faster excretion of it from the surrounding healthy tissue, the maximum therapeutic index (contrast index) is observed 3 hours after the administration of the drug.
The concentration of the drug in the tumor tissue is higher than in the surrounding healthy tissues an average of 3-6 times. depends on the morphological structure of the tumor, and is 2-10 μg / ml.
Rapid removal of radachlorin from blood, skin and mucous membranes and a high contrast index exclude damage to healthy organs and tissues, and increased sensitivity of skin to daylight

The highest levels of Radachlorin 3 hours after the administration are created in the liver, kidneys, tumor tissue.

About 70-80% Radachlorin is metabolized in the liver to biladienes (linear tetrapyrroles, which are also products of heme metabolism).
The drug is excreted unchanged with faeces (15%) and urine (3%). The cumulative excretion of radachlorin with feces and urine in the first 12 hours averages 15-20% of the administered dose of the drug. The main part (98%) of Radachlorin is excreted or metabolized within the first 48 hours. The trace amounts of the drug are determined in the skin for up to 6 days.
INDICATIONS

- fluorescent diagnosis of skin cancer;

- photodynamic therapy of superficial skin tumors (excluding melanoma).

DOSING MODE

The drug is administered once in the form of IV drip infusion for 30 minutes.

Light exposure to radiation with a wavelength of 662 ± 3 nm begins 3 hours after the end of the infusion.

The optimal mode of exposure is the administration of the drug at a dose of 1-1.2 mg / kg and light exposure to radiation with a wavelength of 662 +3 nm at a dose of 300 J / cm 2 .
Subject to the possibility of re-treatment of patients with partial effect or stabilization, it is possible to use 2 other regimens: 0.5-0.6 mg / kg - 300 J / cm2 ; 1-1.2 mg / kg - 200 J / cm 2 .
In this case, the choice of treatment should be carried out individually, taking into account the form and prevalence of the tumor process.

When exposed to a laser, remote surface irradiation is used through a quartz light guide with or without microlenses.

As a source of laser radiation, a diode laser with a wavelength of 662 ± 3 nm is used.

To identify additional foci and clarify the boundaries of the tumor, it is recommended to combine the administration of radachlorin with fluorescent diagnostics, for example, using spectrofluorimeters.
The intensity of fluorescence reaches a maximum 3 hours after the administration of the drug and is substantially higher for a dose of 1.2 mg / kg. The fluorescent contrast at the tumor / normal border varies within the range of (2-4) / 1 (for a dose of 0.6 mg / kg) and (4-6) / 1 (for a dose of 1.2 mg / kg).
Preparation of a solution for intravenous infusion

The contents of one or more vials are diluted in 200 ml of one of the following infusion solutions: 0.9% sodium chloride solution;
5% or 10% dextrose solution; 10% mannitol solution; Ringer's solution; 4% or 8% potassium chloride solution.
To prepare the solution, do not use infusion solutions with an acidic pH.

SIDE EFFECT

With PDT Radachlorin:

- Pain at the site of the irradiated focus during the entire procedure of PDT and up to 1 hour after PDT.
The severity of the pain syndrome varies depending on the prevalence of the pathological process and the individual sensitivity of the patients;
- edema of surrounding tissues and soft tissues of the head, lasting 2-7 days;

- skin itching, reactions of increased sensitivity of normal skin to laser radiation.

CONTRAINDICATIONS

- Pregnancy;

- the period of breastfeeding;

- Children's age (no experience with the drug);

- Hypersensitivity to any of the components of the drug.

With caution , the drug should be used in patients with diabetes mellitus



PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation.

APPLICATION FOR CHILDREN

Contraindicated in children (no experience with the drug).

SPECIAL INSTRUCTIONS

During laser exposure, the doctor and patient should use protective glasses with a light filter that absorbs radiation at 662 ± 3 nm.

To stop painful reactions, use local anesthetics, NSAIDs, opioid analgesics.

Radachlorin should not be administered by the same syringe or through the same system for IV injections, through which other medications were administered.

In patients undergoing PDT with Radachlorin, an increase in the absolute number of leukocytes in the peripheral blood can be observed with an increase in the number of granulocytes, which is most likely due to the general reaction of the body to the development of the inflammatory process in the treatment zone (necrosis).

Necrosis in the treatment zone usually begins to form in 2-4 days, and the rejection of the scab occurs in 2-8 weeks after exposure to the laser.

OVERDOSE

In cases of overdose, appropriate symptomatic and detoxification therapy should be used.

DRUG INTERACTION

The incompatibility of Radachlorin with simultaneous administration with drugs having an acid pH value of the medium, for example, with ascorbic acid, has been revealed.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Store at a temperature of 0 ° to 8 ° C in a place protected from light and inaccessible to children.
The preparation can be stored diluted at a temperature of 2-8 ° C not more than 24 hours before the introduction. The prepared solution is stable under conditions of room illumination or in daylight, however, direct light exposure should be avoided.
Shelf life - 1.5 years.
Do not use after the expiration date printed on the package.
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