Photon - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

Liofilizate for solution for infusion

Composition:Active substance:

Trisodium salt of chlorin E6 (in terms of chlorin E6) - 25 mg, 50 mg or 100 mg;

Excipients:

povidone low molecular weight - 25 mg, 50 mg or 100 mg, sodium hydroxide - up to pH 7.8-9.0.

Description:The porous mass is greenish-black in color. A purple hue is allowed.

Pharmacotherapeutic group:Photosensitizing agent.

ATX: & nbsp

Drugs used in photodynamic and radiation therapy

Pharmacodynamics:The active substance of Photolon - chlorin E6 - selectively accumulates in pathological tissue (benign and malignant neoplasms of various genesis and localization, mainly characterized by neovascularization) and when exposed to light with a wavelength of 660-670 nm, provides a photosensitizing effect, leading to damage to the tumor tissue. Photon is a highly informative diagnostic tool in the spectrofluorescence study.

Pharmacokinetics:After intravenous administration of Photolon, the maximum amounts of the drug in the tumor are recorded after 3 hours from the time of administration, then the concentration of the active substance slowly decreases.In vascular endothelial cells, the maximum amounts of the drug are detected 10-15 minutes after the start of the infusion. After 24 hours after intravenous injection of Photolon, trace amounts of the drug are found in the blood. Photon penetrates well through tissue and cell barriers, it is found in the thymus, skin, head and bone marrow, spleen, ovaries, adrenal glands, heart, pancreas, stomach, kidneys, liver, lungs.

Indications:

In oncology: photodynamic therapy of malignant neoplasms - skin cancer (squamous and basal cell), melanoma, intradermal and subcutaneous metastases of melanoma, breast cancer and its intradermal metastases, cancer of the mucous membranes, incl. hollow organs (vulva, cervix uteri (in t, ch. cervical intraepithelial neoplasia of MP st.), esophagus, rectum, etc.);

- Diagnosis of malignant neoplasms by the spectro fluorescent method.

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

Contraindications:Hypersensitivity, marked renal or hepatic insufficiency, diseases of the cardiovascular system in the stage of decompensation, pregnancy, lactation period, children's age.

Dosing and Administration:

In oncology: the Photon solution is prepared ex tempore. The drug is used intravenously in a dose of 2.0-2.5 mg / kg of body weight of the patient. The calculated dose of Photolone is dissolved in 200 ml of physiological solution and infused intravenously dropwise for 30 minutes. 3-4 hours after the administration of the drug, a local irradiation of the tumor in a dose of 100-600 J / cm2 is performed per session with laser devices generating radiation with a wavelength of 660-670 nm.

In ophthalmology: Photolone solution is prepared ex tempore. The drug is used in a dose of 6 mg / m2 of the body surface of the patient. The calculated dose is dissolved in an appropriate volume of 0.9% sodium chloride solution to a final concentration

2 mg / ml (12.5 ml of solvent are added to the contents of the bottle with 25 mg of Photolon, 25 ml of solvent are added to the contents of the bottle containing 50 mg of Photolone, 50 ml of solvent are added to the contents of the bottle containing 100 mg of Photolone). The dose of Photolon 10.6 mg corresponds to 5.3 ml of the solution; a dose of 14.4 mg - 7.2 ml of solution. Then, the volume of the solution is adjusted with 0.9% sodium chloride solution to 30 ml.The resulting Photolone solution is administered intravenously at a rate of

3 ml / min using a syringe programmable doser. Simultaneously with the onset of infusion, a timer is included. The duration of administration is 10 minutes. Laser irradiation is carried out 10-15 min after the start of the injection of Photolon (but not later ZO min.). The intensity of the optical radiation. 600 mW / cm². The dose of irradiation is 50 J / cm². Approximately 83 seconds are required to achieve the required dose of irradiation, provided that the above parameters of irradiation are observed.

Side effects:An increase in body temperature and pain in the irradiation zone (stopping analgesic drugs), increasing blood pressure in patients with concomitant diseases of the cardiovascular system. When administered in therapeutic doses, it has a weakly expressed systemic phototoxicity. In the first week after the administration of the drug, if the light regime is disturbed, hyperemia and edema of the open surfaces of the body (without pigmentation) may develop. Potential ophthalmic side effects (very rare) can be reduced visual acuity, visual field defects, lacrimation, subretinal hemorrhage, vitreous hemorrhage.

Overdose:

Symptoms: dyspnea, tachycardia, increased blood pressure, agitation, followed by oppression, hypothermia. When conducting a photodynamic therapy session with Photolone in the treatment of ophthalmic pathology, an overdose of the drug, as well as an excess of the irradiation dose, is possible. In these cases, complications associated with the nonselective effect of the photosensitizer on the retinal vessels, including: lack of perfusion of the normal retinal capillaries, vitreous hemorrhage, subretinal and intra-retinal bleeding, increased fibrosis, a sharp decrease in visual acuity within 7 days after PDT, which can be permanently persistent.

Treatment: symptomatic therapy (there is no specific antidote).

Interaction:

Possible joint application with analgesics. It is not recommended to use local anesthetics (infiltration anesthesia). Appointment of "biene", reparaff, contributes to the early epithelization of the wound defect, strengthening the growth of connective tissue, reducing pain syndrome. Photon should not be administered concomitantly with medication,affecting the photosensitivity (antibiotics of tetracycline and fluoroquinolone series, sulfonamides, phenothiazine derivatives, hypoglycemic drugs - derivatives of sulfonylureas (glibenclamide, thiazide diuretics, griseofulvin) and other drugs with known photosensitizing activity).

Do not use Photon at the same time with medicines that may impair the effectiveness of the treatment (beta-carotene, ethanol, beckons). The simultaneous administration of drugs with known damaging effects against the liver, as well as those that can affect the metabolism of chlorine and prolong systemic phototoxicity (inhibitors and inducers of CYP3A4-dimethidine, ketoconazole, intraconazole, erythromycin, saquinard, ritonavir, rifampicin).

Special instructions:Starting from the first day of Photolon application, open body surfaces should be treated with a photoprotective cream. During the treatment, sun and ultraviolet radiation should be avoided. The patient should be instructed about the need for strict adherence to the light regime (exposure to direct sunlight, watching TV, etc.) is excluded.The preparation should be administered in a darkened room.

Form release / dosage:Lyophilizate for the preparation of a solution for infusions of 25 mg, 50 mg and 100 mg.

Packaging:For 25 mg in vials or 50 mg and 100 mg in bottles of glass. Each bottle or bottle, along with instructions for use, is placed in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015948 / 01

Date of registration:02.12.2009 / 30.11.2012

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Information update date: & nbsp03.03.2016

Illustrated instructions

Instructions

Photon (Photolon)