Alasens® (Alasense®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAminolevulinic acidAminolevulinic acid
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  • Alasens®
    powder inwards 
    NIOPIK SRC, FSUE     Russia
    • Dosage form: & nbspPowder for solution for oral administration and instillation
    Composition:

    1 bottle contains:

    active substance: 5-aminolevulinic acid hydrochloride 1.5 g

    Excipients: no.

    Description:

    From white or white with a greenish-yellow or cream tinge to a light-colored color, a crystalline powder.

    Pharmacotherapeutic group:Photosensitizing agent
    ATX: & nbsp

    V.04   Diagnostic drugs

    L.01   Antineoplastic agents

    Pharmacodynamics:

    5-aminolevulinic acid is a precursor of protoporphyrin IX in the human body. The mechanism of its action is based on the ability of tumor cells to increase accumulation in the presence of exogenous 5-aminolevulinic acid photoactive protoporphyrin IX, the presence of which can be determined by the specific fluorescence caused by special radiation sources. Protoporphyrin IX accumulates and persists in a significant amount in the tumor for several hours, while in normal cells it rapidly converts to a photoneactive heme under the action of ferrochelatase enzyme.The result is a high fluorescent contrast of the tumor with respect to the surrounding tissue, reaching 10-15 times the size for various tumors. This allows us to clarify the boundaries of tumors and to identify visually undetectable tumor formations during fluorescent diagnostics.

    Pharmacokinetics:

    Accumulation of protoporphyrin IX in the tumor occurs within 3-6 hours after administration of Alasens® solution inside and 1-3 hours after instillation. Then, the level of protoporphyrin IX in the tumor gradually decreases, reaching the baseline values ​​in 24-48 hours after taking the drug. After 3-6 hours after taking Alasens® inside, an increased content of protoporphyrin IX in the blood and its metabolites in the urine of patients is recorded, which reaches the maximum values ​​6-9 hours after taking the drug. After 48 hours, the levels of protoporphyrin IX in the blood and its metabolites in urine return to the original levels. During 48 hours after administration of Alasens® solution as instillation, in the vast majority of patients there is no increase in the concentration of protoporphyrin IX and its metabolites in blood plasma and urine.In rare cases, it is possible to increase them within 3-9 hours after instalation of Alasens®. After taking Alasens® solution inside, the increased content of protoporphyrin IX in healthy skin can be registered within 24 hours, which can lead to phototoxic reactions (redness of the skin, swelling of the pigmentation) in case of non-observance of the light regime (protection of exposed skin from direct sunlight). After taking the drug in the form of instillation, the level of protoporphyrin IX in healthy skin does not increase.

    Indications:

    Fluorescent diagnosis of malignant neoplasms of the bladder, larynx, trachea, bronchi, oral mucosa and digestive tract, early endometrial cancer, pre-tumor and tumor pathology of the cervix, metastatic lesions of the peritoneum.

    Contraindications:

    Hypersensitivity to the drug.

    Acute or chronic porphyria.

    Pregnancy or lactation.

    Children's age (up to 18 years).

    Pregnancy and lactation:

    The effect in pregnant and lactating is not studied.

    Dosing and Administration:

    The route of administration is inside. To carry out fluorescent diagnosis of malignant neoplasms of the larynx,trachea, bronchi, oral mucosa and digestive tract, early endometrial cancer, pre-tumor and tumor pathology of the cervix and metastatic lesions of the peritoneum Alasens® are taken orally at doses of 10-30 mg / kg in the form of a solution in 50-200 ml of drinking water for 3 -6 hours before the diagnosis. A solution of the preparation Alasens® is prepared immediately before taking. The method of introduction is instillation. To carry out fluorescent diagnosis of malignant neoplasms of the bladder and endometrium, Alasens® is used as an instillation of 50 ml of a 1.5% or 3% sterile solution that is injected into the bladder or uterine cavity 1-2 hours before the diagnosis. The solution is prepared no earlier than 1 hour before use by dissolving the required amount of Alasens® powder in 50 ml of sterile 5% sodium hydrogen carbonate solution. As a source of radiation that stimulates the fluorescence of protoporphyrin IX in tissues during examination of patients, the sources of optical radiation of the firms "Karl Storz", "Richard Wolf" (Germany) and other certified equipment with a wavelength in the range from 375 to 480 nm are used.The resulting two-dimensional fluorescent image is observed using a video system.

    Use in children

    The possibility of use in children (under the age of 18 years) has not been studied.

    Side effects:

    Allergic reactions are possible.

    In the first hours after ingestion of Alasens® during exposure to bright sunlight, phototoxic skin reactions (redness, itching, swelling of open skin areas) are possible.

    Very rarely possible transient hypotension and tachycardia.

    Overdose:

    A significant excess of the Alasens® dose may lead to a temporary increase in the activity of "liver" transaminases, which does not require special treatment methods.

    Interaction:Not identified.
    Special instructions:

    After taking Alasens ® inside, it is recommended to observe the light regime within 24 hours:

    - isolation from direct sunlight (allowing the patient to be in a room with artificial light sources);

    - if necessary, use appropriate clothing to protect exposed areas of the body (face, hands) from direct sunlight.

    Effect on the ability to drive transp. cf. and fur:

    There is no data on the impact on the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Powder for solution for oral administration and instillation.

    Packaging:For 1.5 g in vials colorless from a glass tube for antibiotics with a capacity of 10 ml or in bottles of colorless import capacity of 10 ml, corked rubber stoppers with aluminum caps. Each bottle together with the instruction for use is placed in a pack of cardboard box.
    Storage conditions:

    In dry, dark place at a temperature of not more than 8 ° C.

    In a place inaccessible to children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001848
    Date of registration:21.09.2012
    Expiration Date:21.09.2017
    The owner of the registration certificate:NIOPIK SRC, FSUE NIOPIK SRC, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.06.2017
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