Alasense^® (Powder) Instructions for Use

Marketing Authorization Holder

InMed Market LLC (Russia)

Manufactured By

SRIOC SRC, FSUE (Russia)

ATC Code

L01XD04 (Aminolevulinic acid)

Active Substance

Aminolevulinic acid (Grouping name)

Dosage Form

Alasense®

Powder for solution for oral administration and instillations: 1.5 g vial

Dosage Form, Packaging, and Composition

Powder for solution for oral administration and instillations from white or white with a greenish-yellow or creamy tint to light cream color, crystalline.

1.5 g – vials of colorless glass with a capacity of 10 ml (1) – cardboard packs.

Clinical-Pharmacological Group

Photosensitizing drug

Pharmacotherapeutic Group

Photosensitizing agent

Pharmacological Action

Photosensitizing agent, inducer of endogenous photosensitizer synthesis – protoporphyrin IX. 5-aminolevulinic acid is a precursor of protoporphyrin IX in the human body.

The mechanism of action is based on the ability of tumor cells to accumulate increased amounts of photoactive protoporphyrin IX in the presence of exogenous 5-aminolevulinic acid.

Accumulation of protoporphyrin IX in the tumor tissue of the bladder occurs within 1.5-2 hours after intravesical instillation.

A high fluorescent contrast between the tumor and surrounding tissue is recorded during the first hour after the end of instillation and reaches a 3-23-fold magnitude, which allows for clarifying tumor boundaries and detecting visually undetectable tumor formations during fluorescent diagnostics for subsequent organ-preserving treatment without damaging the tissue surrounding the tumor.

Pharmacokinetics

Accumulation of protoporphyrin IX in the tumor occurs within 3-6 hours after oral administration of the aminolevulinic acid solution and 1-3 hours after instillation.

Then the level of protoporphyrin IX in the tumor gradually decreases, reaching initial values 24-48 hours after aminolevulinic acid administration.

3-6 hours after oral administration of aminolevulinic acid, an increased content of protoporphyrin IX in the blood and its metabolites in the urine of patients is recorded, which reaches maximum values 6-9 hours after drug administration.

After 48 hours, the levels of protoporphyrin IX in the blood and its metabolites in the urine return to baseline.

For 48 hours after aminolevulinic acid administration as an instillation, the vast majority of patients do not experience an increase in the concentration of protoporphyrin IX and its metabolites in blood plasma and urine.

In rare cases, their increase is possible within 3-9 hours after aminolevulinic acid instillation.

After oral administration of aminolevulinic acid, an increased content of protoporphyrin IX in healthy skin may be recorded for 24 hours, which may lead to phototoxic reactions (skin redness, swelling, pigmentation) in case of non-compliance with the light regimen (protection of exposed skin areas from direct sunlight).

After drug administration as an instillation, the level of protoporphyrin IX in healthy skin does not increase.

Indications

Fluorescent diagnostics of malignant neoplasms of the bladder, larynx, trachea, bronchi, oral mucosa and digestive tract, early endometrial cancer, precancerous and tumor pathology of the cervix, metastatic peritoneal lesions.

ICD codes

Dosage Regimen

Prepare the solution immediately before use by dissolving the 1.5 g vial contents in 50 ml of drinking water.

For oral administration, use a dose of 20 mg per kg of body weight. Administer the solution 3-4 hours prior to the diagnostic procedure.

For intravesical instillation into the urinary bladder, dissolve the vial contents in 50 ml of 0.9% sodium chloride solution. Instill the prepared solution into the bladder for 1-2 hours before the diagnostic procedure.

For intrauterine instillation, dissolve the vial contents in a suitable volume as determined by the physician. Administer the solution 1-3 hours prior to the diagnostic procedure.

For other sites, such as the oral mucosa or bronchi, use the appropriate concentration and volume as directed for the specific diagnostic procedure.

Following oral administration, strictly adhere to a 24-hour light protection regimen. Avoid direct sunlight and bright indoor light. Protect skin with clothing.

Do not administer to patients with acute or chronic porphyria. This drug is contraindicated during pregnancy, lactation, and in patients under 18 years of age.

Adverse Reactions

Possible: allergic reactions.

In the first hours after oral administration of aminolevulinic acid when exposed to bright sunlight, phototoxic skin reactions (redness, itching, swelling of exposed skin areas) are possible. Very rarely – transient arterial hypotension and tachycardia.

Contraindications

Hypersensitivity to aminolevulinic acid; acute or chronic porphyria; pregnancy, breastfeeding period; children under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

After oral administration of aminolevulinic acid, it is recommended to observe a light regimen for 24 hours: isolation from direct sunlight (the patient is allowed to stay in a room with artificial light sources); if necessary, use appropriate clothing to protect exposed areas of the body (face, hands) from direct sunlight.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.